E-Newsletter - July 2022
Ongoing Alliance Trials


SIX ONGOING ALLIANCE TRIALS ENROLLING PARTICIPANTS NOW

Alliance A011801 (COMPASS HER2 RD/Breast Cancer)

Ciara C. O'Sullivan, MB, BCh, BAO, of the Mayo Clinic, leads Alliance A011801 (The CompassHER2 trials (Comprehensive use of pathologic response assessment to optimize therapy in HER2-positive breast cancer) CompassHER2 residual disease (RD), a double-blinded, phase III randomized trial of T-DM1 compared with T-DM1 and tucatinib). This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone. The trial opened on January 6, 2021. Learn more: https://bit.ly/Alliance-A011801 | Alliance Member Site

Alliance A021602 (CABINET/Advanced Neuroendocrine Tumors)

Jennifer Chan, MD, MPH, of the Dana-Farber Cancer Institute, leads Alliance A021602 (Randomized, double-blinded phase III study of cabozantinib versus placebo in patients with advanced neuroendocrine tumors after progression on prior therapy (CABINET)). This active randomized phase III trial studies cabozantinib to see how well it works compared with placebo in treating patients with neuroendocrine or carcinoid tumors that cannot be removed by surgery or spread to other places in the body (advanced). Cabozantinib is a tyrosine kinase inhibitor, a drug that targets specific tyrosine kinase receptors, that when blocked, may slow tumor growth. The trial opened on July 18, 2018. Learn more: https://bit.ly/AllianceA021602 | Alliance Member Site

Alliance A021804 (Advanced Pheochromocytoma and Paraganglioma)

Alliance A021804: A prospective, multi-institutional phase II trial evaluating temozolomide vs. temozolomide and olaparib for advanced pheochromocytoma and paraganglioma

Jaydira Del Rivero, MD, of the National Cancer Institute, and Kimberly J. Perez, MD, of the Dana-Farber Cancer Institute, lead Alliance A021804 (A prospective, multi-institutional phase II trial evaluating temozolomide vs. temozolomide and olaparib for advanced). This phase II Alliance trial studies how well the addition of olaparib to the usual treatment, temozolomide, works in treating patients with neuroendocrine cancer (pheochromocytoma or paraganglioma) that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells cannot repair themselves, and they may stop growing. Giving olaparib with temozolomide may shrink or stabilize the cancer in patients with pheochromocytoma or paraganglioma better than temozolomide alone. The trial opened on November 2, 2020. Learn more: http://bit.ly/AllianceA021804 | Alliance Member Site

Alliance A031902 (CASPAR/Metastatic Castration-resistant Prostate Cancer)

Arpit Rao, MD, of the University of Minnesota, lead Alliance A031902 (CASPAR - A phase III trial of enzalutamide and rucaparib as a novel therapy in first-line metastatic castration-resistant prostate cancer). This randomized, placebo-controlled phase III trial evaluates the benefit of rucaparib and enzalutamide combination therapy versus enzalutamide alone for the treatment of men with prostate cancer that has spread to other places in the body (metastatic) and has become resistant to testosterone-deprivation therapy (castration-resistant). Enzalutamide helps fight prostate cancer by blocking the use of testosterone by the tumor cells for growth. Poly adenosine diphosphate (ADP)-ribose polymerase (PARP) inhibitors, such as rucaparib, fight prostate cancer by prevent tumor cells from repairing their DNA. Giving enzalutamide and rucaparib may make patients live longer or prevent their cancer from growing or spreading for a longer time, or both. It may also help doctors learn if a mutation in any of the homologous recombination DNA repair genes is helpful to decide which treatment is best for the patient. The trial opened on February 19, 2021. Learn more: http://bit.ly/Alliance-A031902 | Alliance Member Site

Alliance A071702 (Somatically Hypermutated Recurrent Glioblastoma)

Gavin P. Dunn, MD
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of the Massachusetts General Hospital, Eva Galanis, MD, of the Mayo Clinic, and David Reardon, MD, of the Dana-Farber Cancer Institute, lead Alliance A071702 (A phase II study of checkpoint blockade immunotherapy in patients with somatically hypermutated recurrent glioblastoma). This phase II Alliance trial studies the effect of immunotherapy drugs (ipilimumab and nivolumab) in treating patients with glioblastoma that has recurred and carries a high number of mutations. Cancer is caused by changes (mutations) to genes that control the way cells function. Tumors with high number of mutations may respond well to immunotherapy. Giving ipilimumab and nivolumab may lower the chance of recurrent glioblastoma with high number of mutations from growing or spreading compared to usual care (surgery or chemotherapy). The trial opened in October 30, 2020. Learn more: http://bit.ly/AllianceA071702 | Alliance Member Site

Alliance A081801 (ACCIO/Resected Non-small Cell Lung Cancer)

Jacob M. Sands, MD, of the Dana-Farber Cancer Institute, leads Alliance A080801 (Integration of immunotherapy into adjuvant therapy for resected NSCLC: ALCHEMIST chemo-IO ). This phase III ALCHEMIST trial tests the addition of pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB IIIA or IIIB non-small cell lung cancer that has been removed by surgery. 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. Chemotherapy drugs, such as cisplatin, pemetrexed, carboplatin, 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. Giving pembrolizumab with usual chemotherapy may help increase survival times in patients with stage IIA, IIB IIIA or IIIB non-small cell lung cancer. The trial opened on June 3, 2020. Learn more: http://bit.ly/Alliance-A081801 | Alliance Member Site

 

 

 

For other articles in this issue of the Alliance E-news Newsletter, see below: