E-Newsletter - December 2023
Ongoing Alliance Trials


ONGOING ALLIANCE TRIALS  |  ENROLLING PARTICIPANTS NOW

Alliance A011801 (CompassHER2 RD/Breast Cancer)

Ciara C. O'Sullivan, MB, BCh, BAO (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. To learn more about this trial, visit https://bit.ly/Alliance-A011801 | Alliance Member Site

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Alliance A021804 (Advanced Pheochromocytoma and Paraganglioma)

Jaydira Del Rivero, MD (National Cancer Institute) and Kimberly J. Perez, MD (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 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. To learn more, viist http://bit.ly/AllianceA021804 | Alliance Member Site

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Alliance A031704 (PDIGREE/Metastatic Untreated Renal Cell Cancer)

Tian Zhang, MD (UT Southwestern Medical Center) leads Alliance A031704 (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)). This phase III trial compares the usual treatment (treatment with ipilimumab and nivolumab followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib in patients with untreated renal cell carcinoma that has spread to other parts of the body. The addition of cabozantinib to the usual treatment may make it work better. 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. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known how well the combination of cabozantinib and nivolumab after initial treatment with ipilimumab and nivolumab works in treating patients with renal cell cancer that has spread to other parts of the body. The trial opened on May 9, 2019. To learn more, visit http://bit.ly/AllianceA031704 | Alliance Member Site

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Alliance A031801 (RadiCaL/Advanced Renal Cell Cancer)

Rana McKay, MD (UC San Diego Health) leads Alliance A031801 (A phase II randomized trial of radium-223 dichloride and cabozantinib in patients with advanced renal cell carcinoma with bone metastasis (RadiCaL)). This phase II trial studies whether adding radium-223 dichloride to the usual treatment, cabozantinib, improves outcomes in patients with renal cell cancer that has spread to the bone. Radioactive drugs such as radium-223 dichloride may directly target radiation to cancer cells and minimize harm to normal cells. Cabozantinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving radium-223 dichloride and cabozantinib may help lessen the pain and symptoms from renal cell cancer that has spread to the bone, compared to cabozantinib alone. The trial opened on December 13, 2019. To learn more, visit http://bit.ly/AllianceA031801 | Alliance Member Site

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Alliance A032101 (A-DREAM/Metastatic Hormone-sensitive Prostate Cancer)

Atish Choudhury, MD, PhD (Dana-Farber Cancer Institute) lead 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). 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. This trial opened on July 5, 2022. To learn more, visit, https://bit.ly/Alliance-A032101 | Alliance Member Site

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Alliance A051902 (Peripheral T-cell Lymphomas)

Neha Mehta-Shah, MD (Washington University School of Medicine) leads Alliance A051902 (A randomized phase II study of CHO(E)P vs. oral azacitidine-CHO(E)P vs. duvelisib-CHO(E)P in previously untreated CD30 negative peripheral T-cell lymphomas). This phase II trial studies the effect of duvelisib or CC-486 and usual chemotherapy consisting of cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone in treating patients with peripheral T-cell lymphoma. Duvelisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as CC-486, cyclophosphamide, doxorubicin, vincristine, etoposide and prednisone, 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. This trial may help find out if this approach is better or worse than the usual approach for treating peripheral T-cell lymphoma. The trial opened on July 30, 2021. To learn more, visit https://bit.ly/Alliance-A051902 | Alliance Member Site

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

Jacob M. Sands, MD (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. To learn more, visit http://bit.ly/Alliance-A081801 | Alliance Member Site

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Alliance A082002 (Non-small Cell Lung Cancer)

Christine Bestvina, MD (University of Chicago Medicine) leads Alliance A082002 (A randomized phase II/III trial of modern immunotherapy based systemic therapy with or without SBRT for PD-L1-negative advanced non-small cell lung cancer). This phase II/III trial compares the addition of radiation therapy to the usual treatment (immunotherapy with or without chemotherapy) vs. usual treatment alone in treating patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (advanced) or has spread to other places in the body (metastatic) whose tumor is also negative for a molecular marker called PD-L1. Stereotactic body radiation therapy (SBRT) is a type of radiation therapy that uses high-energy x-rays to kill tumor cells and shrink tumors. This method uses special equipment to position a patient and precisely deliver radiation to tumors with fewer doses over a shorter period and may cause less damage to normal tissue than conventional radiation therapy. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, 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. Chemotherapy drugs, such as carboplatin, pemetrexed, paclitaxel, 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. The addition of radiation therapy to usual treatment may stop the cancer from growing and increase the life of patients with advanced non-small cell lung cancer who are PD-L1 negative. This trial opened on December 21, 2021.To learn more about this trial, visit CT.gov. (ClinicalTrials.gov Identifier: NCT04929041) | Alliance Member Site

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Alliance A211901 (Text-based Cessation Interventions)

Devon Noonan, PhD, MPH, FNP-B (Duke School of Nursing) leads Alliance A211901 (Reaching rural cancer survivors who smoke using text-based cessation interventions). This phase III trial compares the effect of text-based cessation intervention to a manual in helping rural cancer patients who smoke, quit. Text-based scheduled gradual reduction may reduce the frequency of cigarette use to zero and may be effective in quitting smoking. This trial opened on which opened December 1, 2021. To learn more about this trial, visit CT.gov. (ClinicalTrials.gov Identifier: NCT05008848) | Alliance Member Site

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Alliance A212102 (Blinded Reference Set for Multicancer Early Detection Blood Tests)

Marie E. Wood, MD (University of Colorado) leads Alliance A212102 (Blinded Reference Set for Multicancer Early Detection Blood Tests). 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. This trial opened on August 1, 2022. To learn more, visit https://bit.ly/AllianceA212102 | Alliance Member Site

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Alliance A222001 (Hot Flashed in Men/Androgen Deprivation Therapy)

Bradley Stish, MD (Mayo Clinic) leads Alliance A222001 (A randomized, double-blind, placebo-controlled phase II study of oxybutynin versus placebo for the treatment of hot flashes in men receiving androgen deprivation therapy). This phase II trial compares the effect of oxybutynin versus placebo for reducing hot flashes in men receiving androgen deprivation (hormone) therapy for the treatment of prostate cancer. Androgen deprivation therapy decreases testosterone and other androgens through medications or surgical removal of the testicles. Relative to placebo, low- or high-dose oxybutynin may reduce hot flashes in men receiving androgen deprivation therapy. The trial opened on July 30, 2021. To learn more, visit https://bit.ly/Alliance-A222001 | Alliance Member Site

 

 

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