Renown Health Oncology Clinical Trials

775-982-5050

Select a category from the list below.

Bladder

A031702

Type: Interventional
Disease Category: Rare genitourinary tumors
Study Title: Phase II Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Rare Genitourinary Tumors
Description: This phase II trial studies how well the combination of cabozantinib, nivolumab, and ipilimumab work in treating patients with rare genitourinary (GU) tumors that have spread to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving combination of cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone.
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S1806

Type: Interventional
Disease Category: Bladder Carcinoma Infiltrating the Muscle of the Bladder Wall, Bladder Urothelial Carcinoma, Stage II, III, IIIA Bladder Cancer
Study Title: Phase III Randomized Trial of Concurrent Chemoradiotherapy With or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer (Study SWOG/NRG 1806)
Description: This phase III trial studies how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with localized muscle invasive bladder cancer. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as gemcitabine, cisplatin, fluorouracil and mitomycin-C, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with radiation therapy may kill more tumor cells. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab with radiation therapy and chemotherapy may work better in treating patients with localized muscle invasive bladder cancer compared to radiation therapy and chemotherapy without atezolizumab.
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A031501

Type: Interventional
Disease Category: Stage II Bladder Urothelial Carcinoma, Stage III Bladder Urothelial Carcinoma
Study Title: Phase III Randomized Adjuvant Study of MK-3475 (Pembrolizumab) in Muscle Invasive and Locally Advanced Urothelial Carcinoma (AMBASSADOR) Versus Observation
Description: This randomized phase III trial studies how well pembrolizumab works in treating patients with bladder cancer that has spread from where it started to nearby tissue or lymph nodes. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.
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S1602

Type: Interventional
Disease Category: Stage: 0, 0is, I Bladder Urothelial Carcinoma
Study Title: A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming With Intradermal BCG Before Intravesical Therapy for BCG-Naive High-Grade Non-muscle Invasive Bladder Cancer
Description: This randomized phase III trial studies Tokyo-172 strain bacillus Calmette-Guerin (BCG) solution with or without a vaccination using Tokyo-172 strain BCG to see how well it works compared with TICE BCG solution in treating patients with bladder cancer that has not spread to muscle. BCG is a non-infectious bacteria that when instilled into the bladder may stimulate the immune system to fight bladder cancer. Giving different versions of BCG with vaccine therapy may prevent bladder cancer from returning.
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**Physician Training Required**

Bone Metastases

OsteoCool (OPuS One)

Type: Interventional
Disease Category: Metastasis to bone & spine
Study Title: OsteoCool Tumor Ablation Post-Market Study (OPuS One)
Description: The OsteoCool™ RF Ablation system has 510k regulatory clearance in the United States, Conformité Européene (CE) mark in Europe, and Health Canada Licence in Canada. The goal of this study is to collect real-world outcomes among a cohort of patients in the US, EUR and CAN with metastatic malignant lesions in a vertebral body, painful metastatic lesions involving bone (in the US, patients with metastatic lesions involving the bone must have failed or were not candidates for standard therapy), and in EUR and CAN, benign bone tumors such as osteoid osteoma who receive treatment with the OsteoCool™ RF Ablation system. Additionally, the study will collect device, procedure and/or therapy related adverse events and device deficiencies. Lastly, subject outcomes (such as pain relief, quality of life, and function) will be evaluated using validated assessment measures.
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Brain

N0577

Type: Interventional
Disease Category: Brain and Central Nervous System Tumors
Study Title: Phase III Intergroup Study of Radiotherapy With Concomitant and Adjuvant Temozolomide Versus Radiotherapy With Adjuvant PCV Chemotherapy in Patients With 1p/19q Co-deleted Anaplastic Glioma or Low Grade Glioma
Description: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.
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Breast

URCC-18007

Type: Interventional
Disease Category: Stage I, IA, IB, II , IIA, IIB, III, IIIA, IIIB, IIIC Breast Cancer, Cancer Fatigue, Cancer Survivor, Complete Remission
Study Title: Randomized Placebo Controlled Trial of Bupropion For Cancer Related Fatigue
Description: This phase III trial studies how well bupropion works in reducing cancer related fatigue in stage I-III breast cancer survivors. Bupropion is a drug that is used to treat depression, as well as to help people quit smoking. Cancer and its treatment can cause fatigue. Giving bupropion may improve cancer related fatigue in breast cancer survivors.
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A171601

Type: Interventional
Disease Category: Estrogen Receptor-positive Breast Cancer, HER2/Neu Negative, Stage IV Breast Cancer
Study Title: A Phase II Trial Assessing the Tolerability of Palbociclib in Combination With Letrozole or Fulvestrant in Patients Aged 70 and Older With Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer
Description: This phase II trial studies the side effects and how well palbociclib and letrozole or fulvestrant works in treating patients aged 70 years and older with estrogen receptor positive, HER2 negative breast cancer that has spread to other places in the body. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as letrozole or fulvestrant, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving palbociclib and letrozole or fulvestrant may work better in treating patients with breast cancer. The trial will explore factors other than chronologic age that can affect toxicity rates as identified using a cancer-specific geriatric assessment.
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RTOG-1119

Type: Interventional
Disease Category: ERBB2 Gene Amplification, HER2 Positive Breast Carcinoma, Invasive Breast Carcinoma, Metastatic Malignant Neoplasm in the Brain, Recurrent Breast Carcinoma, Stage IV Breast Cancer
Study Title: Phase II Randomized Study of Whole Brain Radiotherapy/Stereotactic Radiosurgery in Combination With Concurrent Lapatinib in Patients With Brain Metastasis From HER2-Positive Breast Cancer: A Collaborative Study of NRG Oncology and KROG
Description: This randomized phase II trial studies how well whole-brain radiation therapy or stereotactic radiosurgery with or without lapatinib ditosylate works in treating patients with breast cancer that has too many of a protein called human epidermal growth factor receptor 2 (HER2) on its cells and has spread to the brain. Radiation therapy uses high energy x rays to kill tumor cells and shrink tumors. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether whole-brain radiation therapy or stereotactic radiosurgery together with lapatinib ditosylate is an effective treatment for brain metastasis from breast cancer.
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NSABP-B-51

Type: Interventional
Disease Category: Stage IB, II Breast Cancer
Study Title: A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients With Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy
Description: This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer
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S1418

Type: Interventional
Disease Category: Estrogen Receptor Negative, HER2/Neu Negative, Invasive Breast Carcinoma, Progesterone Receptor Negative,
Stage: 0,I,IA,IB,II,IIA,IIB,III,IIIA,IIIB,IIIC Breast Cancer,Triple-Negative Breast Carcinoma
Study Title: A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer With ≥ 1 CM Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy
Description: This randomized phase III trial studies how well pembrolizumab works in treating triple-negative breast cancer. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.
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NRG-BR003

Type: Interventional
Disease Category: Breast Adenocarcinoma, Estrogen Receptor Negative, HER2/Neu Negative, Progesterone Receptor Negative, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Stage IIIC Breast Cancer, Triple-Negative Breast Carcinoma
Study Title: A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel With or Without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer
Description: This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.
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EA1131

Type: Interventional
Disease Category: Estrogen Receptor Negative, HER2/Neu Negative, Invasive Breast Carcinoma, Progesterone Receptor Negative, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Triple-Negative Breast Carcinoma
Study Title: A Randomized Phase III Post-operative Trial of Platinum Based Chemotherapy vs. Capecitabine in Patients With Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy
Description: This randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to capecitabine in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant). Drugs used in chemotherapy, such as cisplatin, carboplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cisplatin or carboplatin is more effective than capecitabine in treating patients with residual triple negative basal-like breast cancer.
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A011401

Type: Interventional
Disease Category: Breast Carcinoma
Study Title: Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women With Early Breast Cancer: Breast Cancer WEight Loss Study (BWEL Study)
Description: This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.
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A011502

Type: Interventional
Disease Category: Node Positive HER2 Negative Breast Cancer
Study Title: A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for Node Positive HER2 Negative Breast Cancer: The ABC Trial
Description: This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer.
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E1Q11

Type: Interventional
Disease Category: Malignant Neoplasm
Study Title: EROS: Engendering Reproductive Health Within Oncologic Survivorship
Description: This clinical trial studies reproductive health program in patients with cancer. A reproductive health program may improve patients’ understanding of reproductive risks and receipt of appropriate treatment to achieve their reproductive health goals
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**Physician Requirements**
**Trial open to eligible breast and gynecologic cancer patients**

Colorectal

NRG-GI004

Type: Interventional
Disease Category: Colorectal Adenocarcinoma, Mismatch Repair Deficiency, Stage IV Colorectal Cancer, Stage IVA Colorectal Cancer, Stage IVB Colorectal Cancer
Study Title: Colorectal Cancer Metastatic dMMR Immuno-Therapy (COMMIT) Study: A Randomized Phase III Study of mFOLFOX6/Bevacizumab Combination Chemotherapy With or Without Atezolizumab or Atezolizumab Monotherapy in the First-Line Treatment of Patients With Deficient DNA Mismatch Repair (dMMR) Metastatic Colorectal Cancer
Description: This randomized phase III trial studies how well combination chemotherapy, bevacizumab, and/or atezolizumab work in treating patients with deficient deoxyribonucleic acid (DNA) mismatch repair colorectal cancer that has spread to other places in the body. Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab and atezolizumab, may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy, bevacizumab, and atezolizumab may work better in treating patients with colorectal cancer.
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NRG-GI002

Type: Interventional
Disease Category: Rectal Adenocarcinoma, Stage II Rectal Cancer, Stage III Rectal Cancer
Study Title: A Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer
Description: This randomized phase II trial studies how well veliparib or pembrolizumab work with combination chemotherapy and radiation therapy in treating patients with rectal cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as modified (m)FOLFOX6 regimen, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving veliparib or pembrolizumab with combination chemotherapy and radiation therapy may kill more tumor cells, make the tumor smaller, and reduce the amount of normal tissue that needs to be removed.
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A021502

Type: Interventional
Disease Category: Colon Adenocarcinoma, DNA Repair disorder, Lynch Syndrome, Stage III, IIIA, IIIB, & IIIC Colon Cancer
Study Title: Randomized Trial of Standard Chemotherapy Alone or Combined With Atezolizumab as Adjuvant Therapy for Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Description: This randomized phase III trial studies combination chemotherapy and atezolizumab to see how well it works compared with combination chemotherapy alone in treating patients with stage III colon cancer and deficient deoxyribonucleic acid (DNA) mismatch repair. Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy with atezolizumab may work better than combination chemotherapy alone in treating patients with colon cancer.
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Education

DCP-001

Type: Observational
Disease Category: Malignant neoplasms
Study Title: Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program (NCORP)
Description: Screening tool used to collect expanded demographic and clinical data (e.g., SES, co-morbidities, method of diagnosis) across the NCORP network to help identify and best characterize patients that are screened but not enrolled in cancer control studies.
**Trial open to eligible cancer patients with a diverse range of disease types**

E1Q11

Type: Interventional
Disease Category: Malignant Neoplasm
Study Title: EROS: Engendering Reproductive Health Within Oncologic Survivorship
Description: This clinical trial studies reproductive health program in patients with cancer. A reproductive health program may improve patients’ understanding of reproductive risks and receipt of appropriate treatment to achieve their reproductive health goals
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**Physician Requirements**
**Trial open to eligible breast and gynecologic cancer patients**

Gastrointestinal

S1815

Type: Interventional
Disease Category: Stage III Distal Bile Duct Cancer, Stage III Gallbladder Cancer, Stage III Intrahepatic Cholangiocarcinoma, Stage IIIA Distal Bile Duct Cancer, Stage IIIA Gallbladder Cancer, Stage IIIA Intrahepatic Cholangiocarcinoma, Stage IIIB Distal Bile Duct Cancer, Stage IIIB Gallbladder Cancer, Stage IIIB Intrahepatic Cholangiocarcinoma, Stage IV Distal Bile Duct Cancer, Stage IV Gallbladder Cancer, Stage IV Intrahepatic Cholangiocarcinoma, Stage IVA Gallbladder Cancer, Stage IVB Gallbladder Cancer, Unresectable Extrahepatic Bile Duct Carcinoma, Unresectable Gallbladder Carcinoma, Unresectable Intrahepatic Cholangiocarcinoma
Study Title: A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers
Description: This phase III trial studies how well gemcitabine hydrochloride and cisplatin given with or without nab-paclitaxel work in treating patients with newly diagnosed biliary tract cancers that have spread to other places in the body. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not known if giving gemcitabine hydrochloride and cisplatin with or without nab-paclitaxel may work better at treating biliary tract cancers.
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A021602

Type: Interventional
Disease Category: Digestive System Neuroendocrine Neoplasm, Lung Neuroendocrine Neoplasm, Lung Carcinoid Tumor, Pancreatic Neuroendocrine Tumor
Study Title: Randomized, Double-Blinded Phase III Study of Cabozantinib Versus Placebo in Patients With Advanced Neuroendocrine Tumors After Progression on Everolimus (CABINET)
Description: This randomized phase III trial studies cabozantinib S-malate to see how well it works compared with placebo in treating patients with neuroendocrine tumors previously treated with everolimus that have spread to nearby tissues or lymph nodes, have spread to other places in the body, or cannot be removed by surgery. Cabozantinib S-malate is a chemotherapy drug known as a tyrosine kinase inhibitor, and it targets specific tyrosine kinase receptors, that when blocked, may slow tumor growth.
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EA2142

Type: Interventional
Disease Category: Gastric Neuroendocrine Carcinoma, Intestinal Neuroendocrine Carcinoma, Pancreatic Neuroendocrine Carcinoma
Study Title: Randomized Phase II Study of Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced G3 Non-small Cell Gastroenteropancreatic Neuroendocrine Carcinomas
Description: This randomized phase II trial studies how well temozolomide and capecitabine work compared to standard treatment with cisplatin or carboplatin and etoposide in treating patients with neuroendocrine carcinoma of the gastrointestinal tract or pancreas that has spread to other parts of the body (metastatic) or cannot be removed by surgery. Drugs used in chemotherapy, such as temozolomide, capecitabine, cisplatin, carboplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Certain types of neuroendocrine carcinomas may respond better to treatments other than the current standard treatment of cisplatin and etoposide. It is not yet known whether temozolomide and capecitabine may work better than cisplatin or carboplatin and etoposide in treating patients with this type of neuroendocrine carcinoma, called non-small cell neuroendocrine carcinoma.
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Genetics

SQNM-CA-101

Type: Observational
Disease Category: Non-hematologic Cancer
Study Title: Collection of Whole Blood and Tissue Specimens From Patients Diagnosed With Non-Hematologic Cancer for Use in Development of a Noninvasive Liquid Biopsy Assay to Determine the Tumor Genomic Profile in Circulating Cell-Free Tumor DNA
Description: This specimen collection is designed to obtain whole blood and tumor tissue from subjects diagnosed with cancer for the purpose of the development of a noninvasive liquid biopsy assay using next generation sequencing (NGS).
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**Trial open to eligible cancer patients with a diverse range of non-hematologic disease types**

Gynecologic

GOG-0263

Type: Interventional
Disease Category: Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Stage IA, IB, IIA Cervical Cancer
Study Title: Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy
Description: This randomized phase III trial studies radiation therapy with chemotherapy to see how well it works compared to radiation therapy alone in treating patients with stage I or stage II cervical cancer who previously underwent surgery. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation therapy together with chemotherapy is more effective than radiation therapy alone in treating patients with cervical cancer.
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E1Q11

Type: Interventional
Disease Category: Malignant Neoplasm
Study Title: EROS: Engendering Reproductive Health Within Oncologic Survivorship
Description: This clinical trial studies reproductive health program in patients with cancer. A reproductive health program may improve patients’ understanding of reproductive risks and receipt of appropriate treatment to achieve their reproductive health goals
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**Physician Requirements**
**Trial open to eligible breast and gynecologic cancer patients**

Head and Neck

A221701

Type: Interventional
Disease Category: Malignant Neoplasm
Study Title: Phase III Placebo-Controlled Trial to Evaluate Dexamethasone Use for Everolimus-Induced Oral Stomatitis: Prevention Versus Early Treatment Approaches
Description: This phase III trial studies how well dexamethasone works in reducing everolimus-induced oral stomatitis in patients with cancer. Dexamethasone may help to reduce the everolimus-induced oral stomatitis so as to improve quality of life in cancer patients.
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AG013-ODOM-201

Type: Interventional
Disease Category: Oral Mucositis
Study Title: A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Topically-applied AG013 for the Attenuation of Oral Mucositis in Subjects With Cancers of the Head and Neck Receiving Concomitant Chemoradiation Therapy
Description: The purpose of the study is to evaluate the efficacy, safety and tolerability of topically administered AG013 compared to placebo for reducing Oral Mucositis (OM) in patients undergoing chemoradiation for the treatment of head and neck cancer, as measured by the duration, time to development, and overall incidence of OM during the active treatment phase, beginning from the start of chemoradiation therapy (CRT) until 2 weeks following its completion.
The effect of AG013 on patient-reported symptoms and analgesic use during the active treatment phase, and on the cumulative radiation dose administered before the onset of OM will also be evaluated, as will biomarkers and, in a subset of subjects, the PK (pharmacokinetic) profile of AG013.
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NRG-HN001

Type: Interventional
Disease Category: Epstein-Barr Virus Infection, Stage II, III, IVA, IVB Nasopharyngeal Carcinoma
Study Title: Randomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)
Description: There are two study questions we are asking in this randomized phase II/III trial based on a blood biomarker, Epstein Barr virus (EBV) deoxyribonucleic acid (DNA) for locoregionally advanced non-metastatic nasopharyngeal cancer. All patients will first undergo standard concurrent chemotherapy and radiation therapy. When this standard treatment is completed, if there is no detectable EBV DNA in their plasma, then patients are randomized to either standard adjuvant cisplatin and fluorouracil chemotherapy or observation. If there is still detectable levels of plasma EBV DNA, patients will be randomized to standard cisplatin and fluorouracil chemotherapy versus gemcitabine and paclitaxel. Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, fluorouracil, gemcitabine hydrochloride, and paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cisplatin and fluorouracil is more effective than gemcitabine hydrochloride and paclitaxel after radiation therapy in treating patients with nasopharyngeal cancer.
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Hematologic

EA4151

Type: Interventional
Disease Category: Mantle Cell Lymphoma
Study Title: A Randomized Phase III Trial of Consolidation With Autologous Hematopoietic Cell Transplantation Followed by Maintenance Rituximab vs. Maintenance Rituximab Alone for Patients With Mantle Cell Lymphoma in Minimal Residual Disease-Negative First Complete Remission
Description: This randomized phase III trial studies rituximab after stem cell transplant and to see how well it works compared with rituximab alone in treating patients with in minimal residual disease-negative mantle cell lymphoma in first complete remission. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy before a stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient’s bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient’s blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving rituximab with or without stem cell transplant may work better in treating patients with mantle cell lymphoma.
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S1608

Type: Interventional
Disease Category: Grade I-IIIa Follicular Lymphoma, Recurrent Follicular Lymphoma, Refractory Follicular Lymphoma
Study Title: Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma
Description: This randomized phase II trial studies how well obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy work in treating patients with grade I-IIIa follicular lymphoma that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body’s immune system attack the cancer, and may interfere with the ability of the tumor cells to grow and spread. Umbralisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone, and bendamustine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving obinutuzumab with or without umbralisib, lenalidomide, or combination chemotherapy will work better in treating patients with grade I-IIIa follicular lymphoma.
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EA9161

Type: Interventional
Disease Category: CLL/SLL
Study Title: A Randomized Phase III Study of the Addition of Venetoclax to Ibrutinib and Obinutuzumab Versus Ibrutinib and Obinutuzumab in Untreated Younger Patients With Chronic Lymphocytic Leukemia (CLL)
Description: This phase III trial studies how well ibrutinib and obinutuzumab with or without venetoclax work in treating patients with chronic lymphocytic leukemia. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib, obinutuzumab and venetoclax may work better in treating patients with chronic lymphocytic leukemia.
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E4412

Type: Interventional
Disease Category: Recurrent or refractory Classic Hodgkin Lymphoma
Study Title: A Phase I Study With an Expansion Cohort/Randomized Phase II Study of the Combinations of Ipilimumab, Nivolumab and Brentuximab Vedotin in Patients With Relapsed/Refractory Hodgkin Lymphoma
Description: This phase I/II trial studies the side effects and best dose of ipilimumab and nivolumab when given together with brentuximab vedotin, and how well they work in treating patients with Hodgkin lymphoma that has returned after a period of improvement or has not responded to previous treatment. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body’s immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Brentuximab vedotin is a combining monoclonal antibody with an anticancer drug that binds to a protein on the surface of lymphoma cells called cluster of differentiation (CD)30 and may kill the cells. It is not known whether giving brentuximab vedotin and nivolumab with or without ipilimumab may kill more cancer cells.
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NHLBI-MDS

Type: Observational
Disease Category: Myelodysplastic Syndromes (MDS)
Study Title: The National Myelodysplastic Syndromes Natural History Study
Description: Multi-center study enrolling patients suspected or newly diagnosed with myelodysplastic syndromes (MDS), myelodysplastic syndromes/myeloproliferative neoplasms (MDS/MPN) overlap disorder, or idiopathic cytopenia of undetermined significance (ICUS). Participants will be followed long term. Clinical data, blood, and tissue samples will be collected to establish a biorepository to facilitate the study of the natural history of MDS.
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S1712

Type: Interventional
Disease Category: Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Study Title: A Randomized Phase II Study of Ruxolitinib (NSC-752295) in Combination With BCR-ABL Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia (CML) Patients With Molecular Evidence of Disease
Description: This randomized phase II trial studies how well ruxolitinib phosphate and dasatinib or nilotinib work in treating patients with chronic myeloid leukemia. Ruxolitinib, dasatinib, and nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
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Kidney

A031704

Type: Interventional
Disease Category: Clear Cell Renal Cell Carcinoma, Sarcomatoid Renal Cell Carcinoma, Stage IV Renal Cell Cancer
Study Title: PD-Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab vs. VEGF TKI Cabozantinib With Nivolumab: A Phase III Trial in Metastatic Untreated Renal Cell Cancer [PDIGREE]
Description: This phase III trial studies how well nivolumab and ipilimumab, followed by nivolumab versus cabozantinib and nivolumab, work in treating patients with renal cell cancer that is untreated and has spread to other parts of the body. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cabozantinib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known how well cabozantinib and nivolumab work in treating patients with untreated renal cell cancer that has spread to other parts of the body.
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S1500

Type: Interventional
Disease Category: Stage III or IV Renal Cell Cancer, Type 1 or Type 2 Papillary Renal Cell Carcinoma
Study Title: A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005], Savolitinib [NSC #785348], and Sunitinib [NSC #736511]) in Metastatic Papillary Renal Carcinoma (PAPMET)
Description: This randomized phase II trial studies how well cabozantinib-s-malate, crizotinib, volitinib, or sunitinib malate work in treating patients with kidney cancer that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Cabozantinib-s-malate, crizotinib, volitinib, and sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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EA8143

Type: Interventional
Disease Category: Sarcomatoid, Stage II, III, or Unclassified Renal Cell Carcinoma
Study Title: A Phase 3 Randomized Study Comparing PERioperative [neoajuvant] Nivolumab vs. Observation in Patients With Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)
Description: This randomized phase III trial compares nephrectomy (surgery to remove a kidney or part of a kidney) with or without neoadjuvant nivolumab in treating patients with kidney cancer that is limited to a certain part of the body (localized). Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving nivolumab before nephrectomy may make the tumor smaller and reduce the amount of normal tissue that needs to be removed, and after nephrectomy to increase survival. It is not yet known whether nivolumab and nephrectomy is more effective than nephrectomy alone in treating patients with kidney cancer.
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Liver

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Lung (Non-Small Cell)

S1800A

Type: Interventional
Disease Category:Recurrent Lung Non-Small Cell Carcinoma, Stage IV, IVA, IVB Lung Cancer
Study Title: A Phase II Randomized Study of Ramucirumab Plus MK3475 (Pembrolizumab) Versus Standard of Care for Patients Previously Treated With Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)
Description: This phase II Lung-MAP non-Match treatment trial studies how well ramucirumab and pembrolizumab work versus standard of care in treating patients with non-small cell lung cancer that is stage IV or has come back. Immunotherapy with monoclonal antibodies, such as ramucirumab and pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in standard of care chemotherapy for non-small cell lung cancer, such as docetaxel, gemcitabine hydrochloride, and pemetrexed, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ramucirumab and pembrolizumab together may work better in treating patients with non-small lung cancer compared to standard of care.
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EA5163

Type: Interventional
Disease Category: Lung Non-Squamous Non-Small Cell Carcinoma, Stage IIIB & IVA Lung Cancer
Study Title: INSIGNA : A Randomized, Phase III Study of Firstline Immunotherapy Alone or in Combination With Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) With Immunobiomarker SIGNature-Driven Analysis
Description: This phase III trial studies whether pembrolizumab alone as a first-line treatment, followed by pemetrexed and carboplatin with or without pembrolizumab after disease progression is superior to induction with pembrolizumab, pemetrexed and carboplatin followed by pembrolizumab and pemetrexed maintenance in treating patients with stage IV non-squamous non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as pemetrexed and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving first-line pembrolizumab followed by pemetrexed and carboplatin with or without pembrolizumab works better in treating patients with non-squamous non-small cell cancer.
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S1900A

Type: Interventional
Disease Category: Deleterious BRCA1 or BRCA2 Gene Mutation, Loss of Heterozygosity, Lung Non-Small Cell Squamous Carcinoma, Recurrent Large Cell Lung Carcinoma, Recurrent Lung Adenocarcinoma, Recurrent Lung Non-Small Cell Carcinoma, Recurrent Non-Squamous Non-Small Cell Lung Carcinoma, Stage IV Lung Cancer, Stage IVA Lung Cancer, Stage IVB Lung Cancer
Study Title: A Phase II Study of Rucaparib in Patients With Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or Recurrent Non-Small Cell Lung Cancer (LUNG-MAP Sub-Study)
Description: This phase II Lung-MAP trial studies how well rucaparib works in treating patients with genomic loss of heterozygosity (LOH) high and/or deleterious BRCA1/2 mutation stage IV non-small cell lung cancer or that has come back. Rucaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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LUNGMAP

Type: Interventional
Disease Category: Previously Treated Non-Small Cell Lung Cancer
Study Title: LUNGMAP: A Master Protocol To Evaluate Biomarker-Driven Therapies And Immunotherapies In Previously-Treated Non-Small Cell Lung Cancer (Lung-Map Screening Study)
Description: This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes non-match sub-studies which will include all screened patients not eligible for any of the biomarker-driven sub-studies.
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METIS

Type: Interventional
Disease Category: Brain Metastases From Non-small Cell Lung Cancer (NSCLC)
Study Title: Pivotal, Open-label, Randomized Study of Radiosurgery With or Without Tumor Treating Fields (TTFields) (150kHz) for 1-10 Brain Metastases From Non-small Cell Lung Cancer (NSCLC)
Description: The study is a prospective, randomized controlled phase III trial, to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1-10 brain metastases, treated with NovoTTF-100M compared to supportive treatment alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
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A221504

Type: Interventional
Disease Category: Stage IIIB or IV Non-Small Cell Lung Cancer
Study Title: A Randomized, Double-Blind, Placebo-Controlled Pilot Study of an Oral, Selective Peripheral Opioid Receptor Antagonist in Advanced Non-Small Cell Lung Cancer
Description: This randomized pilot clinical trial studies the side effects and best dose of naloxegol and to see how well it works in treating patients with stage IIIB-IV non-small cell lung cancer. Naloxegol may relieve some of the side effects of opioid pain medication and fight off future growth in the cancer.
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LUNAR

Type: Interventional
Disease Category: Nonsmall Cell Lung Cancer
Study Title: Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Standard of Care Therapies for Treatment of Stage 4 Non-small Cell Lung Cancer (NSCLC) Following Platinum Failure (LUNAR)
Description: The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of TTFields, using the NovoTTF-100L System, concurrent with standard therapies for stage 4 NSCLC patients, following progression while on or after platinum based treatment.The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
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A211401

Type: Interventional
Disease Category: Lung Carcinoma
Study Title: Reducing Surgical Complications in Newly Diagnosed Lung Cancer Patients Who Smoke Cigarettes
Description: This randomized phase III trial studies how well management of a tobacco treatment intervention works in reducing surgical complications in patients with newly diagnosed lung cancer who smoke cigarettes. Management of a tobacco treatment intervention compares varenicline (a drug that reduces the craving and withdrawal symptoms that occur with abstinence from nicotine) and behavioral interventions (consisting of a brief clinician-delivered intervention and tobacco quitline [tobacco cessation service available through a toll-free telephone number] follow-up) with placebo (a pill with no active medication) along with similar behavioral interventions. It is not yet known whether management of a tobacco treatment intervention is more effective in reducing surgical complications than placebo.
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**Physician Training Required**

ALCHEMIST A151216

Type: Observational (screening only)
Disease Category: Large Cell Lung Carcinoma, Lung Adenocarcinoma, Stage IB, II, IIA, IIB, IIIA Non-Small Cell Lung Carcinoma AJCC v7, Stage IB, II, IIA, IIB, IIIA Squamous Cell Lung Carcinoma AJCC v7
Study Title: Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)
Description: This research trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patients tumor cells may help doctors select the best treatment for patients that have certain genetic changes.
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ALCHEMIST E4512

Type: Interventional
Disease Category: Stage IB Non-Small Cell Lung Carcinoma, Stage IIA Non-Small Cell Lung Carcinoma, Stage IIB Non-Small Cell Lung Carcinoma, Stage IIIA Non-Small Cell Lung Cancer
Study Title: A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-small Cell Lung Cancer: Crizotinib Versus Placebo for Patients With Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein
Description: This randomized phase III trial studies how well crizotinib works and compares it to placebo in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called anaplastic lymphoma kinase (ALK). Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. Crizotinib may be an effective treatment for patients with non-small cell lung cancer and an ALK fusion mutation.
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ALCHEMIST A081105

Type: Interventional
Disease Category: Stage IB Non-Small Cell Lung Carcinoma AJCC v7, Stage IIA Non-Small Cell Lung Carcinoma AJCC v7, Stage IIB Non-Small Cell Lung Carcinoma AJCC v7, Stage IIIA Non-Small Cell Lung Cancer AJCC v7
Study Title: Randomized Study of Erlotinib vs Observation in Patients With Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)
Description: This randomized phase III trial studies how well erlotinib hydrochloride compared to placebo works in treating patients with stage IB-IIIA non-small cell lung cancer that has been completely removed by surgery. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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NRG-LU002

Type: Interventional
Disease Category: Recurrent Non-Small Cell Lung Carcinoma, Stage IV Non-Small Cell Lung Cancer
Study Title: Maintenance Systemic Therapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial
Description: This randomized phase II/III trial studies how well giving maintenance chemotherapy with or without stereotactic body radiation therapy works in treating patients with stage IV non-small cell lung cancer. Drugs used in maintenance chemotherapy, such as docetaxel, pemetrexed disodium, erlotinib hydrochloride, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Giving maintenance chemotherapy and stereotactic body radiation therapy together may work better than maintenance chemotherapy alone in treating patients with stage IV non-small cell lung cancer.
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Lung (Small Cell)

NRG-LU005

Type: Interventional
Disease Category: Limited Stage Lung Small Cell Carcinoma, Stage I, II, III Lung Cancer
Study Title: Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab
Description: This phase II/III trial studies how well chemotherapy and radiation therapy (chemoradiation) with or without atezolizumab works in treating patients with limited stage small cell lung cancer. Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving chemoradiation with or without atezolizumab may work better in treating patients with limited stage small cell lung cancer.
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A211401

Type: Interventional
Disease Category: Lung Carcinoma
Study Title: Reducing Surgical Complications in Newly Diagnosed Lung Cancer Patients Who Smoke Cigarettes
Description: This randomized phase III trial studies how well management of a tobacco treatment intervention works in reducing surgical complications in patients with newly diagnosed lung cancer who smoke cigarettes. Management of a tobacco treatment intervention compares varenicline (a drug that reduces the craving and withdrawal symptoms that occur with abstinence from nicotine) and behavioral interventions (consisting of a brief clinician-delivered intervention and tobacco quitline [tobacco cessation service available through a toll-free telephone number] follow-up) with placebo (a pill with no active medication) along with similar behavioral interventions. It is not yet known whether management of a tobacco treatment intervention is more effective in reducing surgical complications than placebo.
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**Physician Training Required**

CALGB 30610

Type: Interventional
Disease Category: Lung cancer
Study Title: Phase III Comparison of Thoracic Radiotherapy Regimens in Patients With Limited Small Cell Lung Cancer Also Receiving Cisplatin and Etoposide
Description: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as etoposide, carboplatin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which radiation therapy regimen is more effective when given together with chemotherapy in treating patients with limited-stage small cell lung cancer. This randomized phase III trial is comparing different chest radiation therapy regimens to see how well they work in treating patients with limited-stage small cell lung cancer.
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NRG-CC003

Type: Interventional
Disease Category: Limited-Stage or Extensive-Stage Small Cell Lung Carcinoma
Study Title: Randomized Phase II/III Trial of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance for Small Cell Lung Cancer
Description: This randomized phase II/III trial studies how well whole-brain radiation therapy works and compares it with or without hippocampal avoidance in treating patients with small cell lung cancer that is found in one lung, the tissues between the lungs, and nearby lymph nodes only (limited stage) or has spread outside of the lung in which it began or to other parts of the body (extensive stage). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The hippocampus is part of the brain that is important for memory. Avoiding the hippocampus during whole-brain radiation could decrease the chance of side effects on memory and thinking. It is not yet known whether giving whole-brain radiation therapy is more effective with or without hippocampal avoidance in treating patients with small cell lung cancer.
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**Trial open to eligible brain and lung cancer patients.**

Melanoma

S1801

Type: Interventional
Disease Category: Acral Lentiginous Melanoma, Clinical Stage III-IV Cutaneous Melanoma, Mucosal Melanoma, Pathologic Stage III-IV Cutaneous Melanoma
Study Title: A Phase II Randomized Study of Adjuvant Versus NeoAdjuvant MK-3475 (Pembrolizumab) for Clinically Detectable Stage III-IV High-Risk Melanoma
Description: This phase II trial studies how pembrolizumab works before and after surgery in treating patients with stage III-IV high-risk melanoma. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab before and after surgery may work better in treating melanoma.
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S1616

Type: Interventional
Disease Category: Stage III, IIIA, IIIB, IIIC, IV Cutaneous Melanoma AJCC v7
Study Title: A Phase II Randomized Study of Nivolumab (NSC-732442) With Ipilimumab (NSC-748726) or Ipilimumab Alone in Advanced Melanoma Patients Refractory to an Anti-PD1 or Anti-PD-L1 Agent
Description: This randomized phase II studies how well ipilimumab with or without nivolumab work in treating patients with melanoma that is stage IV or stage II and cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab and nivolumab, may interfere with the ability of tumor cells to grow and spread.
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EA6134

Type: Interventional
Disease Category: Metastatic Melanoma, Recurrent Melanoma, Stage III, IIIA, IIIB, IIIC, IV Cutaneous Melanoma AJCC v7, BRAF Mutation Present
Study Title: A Randomized Phase III Trial of Dabrafenib + Trametinib Followed by Ipilimumab + Nivolumab at Progression vs. Ipilimumab + Nivolumab Followed by Dabrafenib + Trametinib at Progression in Patients With Advanced BRAFV600 Mutant Melanoma
Description: This randomized phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with stage III-IV melanoma that contains a mutation known as BRAFV600 and cannot be removed by surgery. Ipilimumab and nivolumab may block tumor growth by targeting certain cells. Dabrafenib and trametinib may block tumor growth by targeting the BRAFV600 gene. It is not yet known whether treating patients with ipilimumab and nivolumab followed by dabrafenib and trametinib is more effective than treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab.
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**Physician Training Required**

Pancreatic

A021602

Type: Interventional
Disease Category: Digestive System Neuroendocrine Neoplasm, Lung Neuroendocrine Neoplasm, Lung Carcinoid Tumor, Pancreatic Neuroendocrine Tumor
Study Title: Randomized, Double-Blinded Phase III Study of Cabozantinib Versus Placebo in Patients With Advanced Neuroendocrine Tumors After Progression on Everolimus (CABINET)
Description: This randomized phase III trial studies cabozantinib S-malate to see how well it works compared with placebo in treating patients with neuroendocrine tumors previously treated with everolimus that have spread to nearby tissues or lymph nodes, have spread to other places in the body, or cannot be removed by surgery. Cabozantinib S-malate is a chemotherapy drug known as a tyrosine kinase inhibitor, and it targets specific tyrosine kinase receptors, that when blocked, may slow tumor growth.
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PANOVA-3

Type: Interventional
Disease Category: Pancreas Adenocarcinoma
Study Title: Effect of Tumor Treating Fields (TTFields, 150 kHz) as Front-Line Treatment of Locally-advanced Pancreatic Adenocarcinoma Concomitant With Gemcitabine and Nab-paclitaxel (PANOVA-3)
Description: The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of Tumor Treating Fields (TTFields) in combination with gemcitabine and nab-paclitaxel, for front line treatment of locally-advanced pancreatic adenocarcinoma.The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
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EA2142

Type: Interventional
Disease Category: Gastric Neuroendocrine Carcinoma, Intestinal Neuroendocrine Carcinoma, Pancreatic Neuroendocrine Carcinoma
Study Title: Randomized Phase II Study of Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced G3 Non-small Cell Gastroenteropancreatic Neuroendocrine Carcinomas
Description: This randomized phase II trial studies how well temozolomide and capecitabine work compared to standard treatment with cisplatin or carboplatin and etoposide in treating patients with neuroendocrine carcinoma of the gastrointestinal tract or pancreas that has spread to other parts of the body (metastatic) or cannot be removed by surgery. Drugs used in chemotherapy, such as temozolomide, capecitabine, cisplatin, carboplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Certain types of neuroendocrine carcinomas may respond better to treatments other than the current standard treatment of cisplatin and etoposide. It is not yet known whether temozolomide and capecitabine may work better than cisplatin or carboplatin and etoposide in treating patients with this type of neuroendocrine carcinoma, called non-small cell neuroendocrine carcinoma.
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Prostate

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Rare Tumors

S1619

Type: Interventional
Disease Category: Biphasic Mesothelioma, Epithelioid Mesothelioma, Stage I, IA, IB, II, III Pleural Malignant Mesothelioma
Study Title: A Feasibility Trial of Neoadjuvant Cisplatin-Pemetrexed With Atezolizumab in Combination and in Maintenance for Resectable Malignant Pleural Mesothelioma
Description: This phase I pilot trial studies how well atezolizumab, pemetrexed disodium, cisplatin, and surgery with or without radiation therapy in treating patients with stage I-III pleural malignant mesothelioma. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving atezolizumab, pemetrexed disodium, and cisplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving atezolizumab after surgery may kill any remaining tumor cells.
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EAY131 “MATCH”

Type: Interventional
Disease Category: Genetic and Rare Diseases
Study Title: Molecular Analysis for Therapy Choice (MATCH)
Description: This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients’ tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor’s particular genetic abnormality. Identifying these genetic abnormalities first may help doctors plan better treatment for patients with solid tumors, lymphomas, or multiple myeloma.
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**Restrictions: Contact Cancer Research for Eligibility**
**Trial open to eligible cancer patients with a diverse range of disease types**

S1609

Type: Interventional
Disease Category: Rare Tumors
Study Title: DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors
Description: This clinical trial studies nivolumab and ipilimumab in treating patients with rare tumors. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread.
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**Trial open to eligible cancer patients with a diverse range of disease types**

Sarcoma

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Thyroid

No posts found.