E-Newsletter - December 2022
Recently Activated Trials

 

Recently activated alLIANCE TRIALS
now ENROLLING PARTICIPANTS


Advanced Uterine Leiomyosarcoma

Alliance A092104: A randomized phase 2/3 study of olaparib plus temozolomide versus investigator’s choice for the treatment of patients with advanced uterine leiomyosarcoma after progression on prior chemotherapy
Overview: This phase II/III trial compares the effect of the combination of olaparib and temozolomide to the usual treatment (trabectedin and pazopanib) for uterine leiomyosarcoma that has spread to other places in the body (advanced) after initial chemotherapy has stopped working. Olaparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Temozolomide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of tumor cells in the body. The combination of olaparib and temozolomide may work better than the usual treatment in shrinking or stabilizing advanced uterine leiomyosarcoma after initial chemotherapy has stopped working.

Study Chair: Matthew Ingham, MD, Columbia University
Activated: 12/9/2022  | CT.gov Link: https://bit.ly/Alliance-A092104

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Advanced Rectal Cancer

Alliance A022104: The Janus Rectal Cancer Trial: A randomized phase II trial testing the efficacy of triplet versus doublet chemotherapy to achieve clinical compolete response in patients with locally advanced rectal cancer
Overview: This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) 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. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.

Study Chair: J. Joshua Smith, MD, Memorial Sloan Kettering Cancer Center
Activated: 11/9/2022 | CT.gov Link: https://bit.ly/Alliance-A022104

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Multicancer Early Detection | Reference Set

Alliance A212102: Blinded reference set for multicancer early detection blood tests
Overview: This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.

Study Chair: Marie E. Wood, MD, University of Colorado
Activated: 8/1/2022  | CT.gov Link: https://bit.ly/AllianceA212102

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Metastatic Hormone-sensitive Prostate Cancer (A-DREAM)

Alliance A032101: A phase 2 trial of ADT interruption in patients responding exceptionally to AR-pathway inhibitor in metastatic hormone-sensitive prostate cancer (mHSPC): A-DREAM
Overview: This phase II trial examines antiandrogen therapy interruptions in patients with hormone-sensitive prostate cancer that has spread to other places in the body (metastatic) responding exceptionally well to androgen receptor-pathway inhibitor therapy. The usual treatment for patients with metastatic prostate cancer is to receive hormonal medications including a medication to decrease testosterone levels in the body and a potent oral hormonal medication to block growth signals from male hormones (like testosterone) in the cancer cells. Patients whose cancer is responding exceptionally well to this therapy may take a break from these medications according to their doctor's guidance. This trial may help doctors determine if stopping treatment can allow for testosterone recovery.

Study Chair: Atish Choudhury, MD, PhD, Dana-Farber Cancer Institute
Activated: 7/15/2022  | CT.gov Link: https://bit.ly/Alliance-A032101

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Mepitel Film | Radiation Dermatitis (Breast Cancer)

Alliance A221803: Mepitel film for the reduction of radiation dermatitis in breast cancer patients undergoing post-mastectomy radiation therapy: A randomized phase III clinical trial
Overview: This phase III trial studies how well Mepitel Film works in reducing radiation dermatitis (redness and peeling) in patients with breast cancer during radiation therapy after a mastectomy. Mepitel Film may reduce the severity of skin redness and peeling in the area of radiation.

Study Chair: Kimberly Corbin, MD, Mayo Clinic
Activated: 6/15/2022  | CT.gov Link: https://bit.ly/AllianceA221803

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Resected Mucosal Melanoma

Alliance A091903: A randomized phase II trial of adjuvant nivolumab with or without cabozantinib in patients with resected mucosal melanoma
Overview: This phase II trial tests whether nivolumab in combination with cabozantinib works in patients with mucosal melanoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It works by blocking the action of an abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving nivolumab in combination with cabozantinib could prevent cancer from returning.

Study Chair: Alexander Shoushtari, MD, Memorial Sloan Kettering Cancer Center
Activated: 6/1/2022  | CT.gov Link: https://bit.ly/Alliance-A091903

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Pancreatic Neuroendocrine Tumors

Alliance A022001: Phase II randomized, prospective trial of lutetium lu 177 dotatate PRRT versus capecitabine and temozolomide in well-differentiated pancreatic neuroendocrine tumors
Overview: This phase II compares capecitabine and temozolomide to lutetium Lu 177 dotatate for the treatment of pancreatic neuroendocrine tumors that have spread to other parts of the body (advanced) or are not able to be removed by surgery (unresectable). Chemotherapy drugs, such as capecitabine and temozolomide, 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. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. The purpose of this study is to find out whether capecitabine and temozolomide or lutetium Lu 177 dotatate may kill more tumor cells in patients with advanced pancreatic neuroendocrine tumors.

Study Chair: Timothy J. Hobday, MD, Mayo Clinic
Activated: 3/16/2022  | CT.gov Link: https://bit.ly/Alliance-A022001

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Metastatic Urothelial Cancer (MAIN-CAV)

Alliance A032001: MAIN-CAV: Phase III randomized trial of maintenance cabozantinib and avelumab vs maintenance avelumab after first-line platinum-based chemotherapy in patients with metastatic urothelial cancer
Overview: This phase III trial compares the effect of adding cabozantinib to avelumab versus avelumab alone in treating patients with urothelial cancer that has spread to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and avelumab together may further shrink the cancer or prevent it from returning/progressing.

Study Chair: Shilpa Gupta, MD, Cleveland Clinic
Activated: 3/10/2022 | CT.gov Link: https://bit.ly/Alliance-A032001

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Breast Cancer | BRCA 1 Germline Mutation (BRCA-P)

Alliance A211801: BRCA-P: A randomized, double-blind, placebo-controlled, multi-center, international phase 3 study to determine the preventive effect of denosumab on breast cancer in women carrying a BRCA1 germline mutation
Overview: This phase III trial compares denosumab to placebo for the prevention of breast cancer in women with a BRCA1 germline mutation. A germline mutation is an inherited gene change which, in the BRCA1 gene, is associated with an increased risk of breast and other cancers. Denosumab is a monoclonal antibody that is used to treat bone loss in order to reduce the risk of bone fractures in healthy people, and to reduce new bone growths in cancer patients whose cancer has spread to their bones. Research has shown that denosumab may also reduce the risk of developing breast cancer in women carrying a BRCA1 germline mutation.

Study Chair: Judy E. Garber, MD, MPH, Dana-Farber Cancer Institute
Activated: 2/23/2022 | CT.gov Link: https://bit.ly/Alliance-A211801

 

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