E-Newsletter - December 2022
Ongoing Alliance Trials


ONGOING ALLIANCE TRIALS ENROLLING PARTICIPANTS NOW

Alliance A011801 (COMPASS HER2 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

Alliance A021502 (ATOMIC/Advanced Colon Cancer/DNA Mismatch Repair)

Frank Sinicrope, MD (Mayo Clinic) leads Alliance A021502 (Randomized trial of FOLFOX alone or combined with atezolizumab as adjuvant therapy for patients with stage III colon cancer and deficient DNA mismatch repair or microsatellite instability (ATOMIC)). This 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. 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 combination chemotherapy with atezolizumab may work better than combination chemotherapy alone in treating patients with colon cancer. this trial opened on September 12, 2017. To learn more about this trial, visit CT.gov. (ClinicalTrials.gov Identifier: NCT02912559) | Alliance Member Site

Alliance A021602 (CABINET/Advanced Neuroendocrine Tumors)

Jennifer Chan, MD, MPH (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 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. To learn more, visit https://bit.ly/AllianceA021602 | Alliance Member Site

Alliance A021703 (SOLARIS/Colorectal Cancer)

Kimmie Ng, MD (Dana-Farber Cancer Institute) leads Alliance A021703 (Randomized double-blind phase III trial of vitamin D3 supplementation in patients with previously untreated metastatic colorectal cancer (SOLARIS)). This phase III trial looks at how well vitamin D3 given with standard chemotherapy and bevacizumab works in treating patients with colorectal cancer that has spread to other parts of the body. Vitamin D3 helps the body use calcium and phosphorus to make strong bones and teeth. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, oxaliplatin, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as bevacizumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving vitamin D3 with chemotherapy and bevacizumab may work better in shrinking or stabilizing colorectal cancer. It is not yet known whether giving high-dose vitamin D3 in addition to chemotherapy and bevacizumab would extend patients' time without disease compared to the usual approach (chemotherapy and bevacizumab). This trial opened on September 30, 2019. To learn more about this trial, visit CT.gov. (ClinicalTrials.gov Identifier: NCT04094688) | Alliance Member Site

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

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

Arpit Rao, MD (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. To learn more, visit http://bit.ly/Alliance-A031902 | Alliance Member Site

Alliance A032002 (Platinum Ineligible/Refractory Metastatic Urothelial Cancer)

Himanshu Nagar, MD (Weill Cornell Medicine) leads Alliance A032002 (Phase II randomized trial of atezolizumab versus atezolizumab and radiation therapy for platinum ineligible/refractory metastatic urothelial cancer (ART)). This phase II trial compares the effect of adding radiation therapy to an immunotherapy drug called atezolizumab vs. atezolizumab alone in treating patients with urothelial cancer that has spread to other places in the body (metastatic). The addition of radiation to immunotherapy may shrink the cancer, but it could also cause side effects. 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. 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 high precision. This method may kill tumor cells with fewer doses over a shorter period and may cause less damage to normal tissue than conventional radiation therapy. The combination of atezolizumab and radiation therapy may be more efficient in killing tumor cells. The trial opened on December 1, 2021. To learn more, visit https://bit.ly/Alliance-A032002 | Alliance Member Site

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

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

Alliance A071702 (Somatically Hypermutated Recurrent Glioblastoma)

Gavin P. Dunn, MD (Massachusetts General Hospital), Eva Galanis, MD (Mayo Clinic), and David Reardon, MD (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 Alliancrial 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. To learn more, visit http://bit.ly/AllianceA071702 | Alliance Member Site

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

Alliance A082002 (Non-small Cell Lung Cancer)

Steven Schild, MD (Mayo Clinic in Arizona) 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

Alliance A171901 (Non-small Cell Lung Cancer)

Aminah Jatoi, MD (Mayo Clinic) and Melisa L. Wong, MD, MAS (Univerisity of California San Francisco) lead Alliance A171901 (Older non-small cell lung cancer patients (>/= 70 years of age) treated with first-line MK-3475 (pembrolizumab) +/- chemotherapy (oncologist's/patient's choice). This trial studies the side effects of pembrolizumab with or without chemotherapy in treating patients with stage IV non-small cell lung cancer that has come back (recurrent) and has spread to other places in the body (advanced). 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. Giving pembrolizumab with or without chemotherapy may shrink the tumor in older patients with non-small cell lung cancer. This trial opened on October 1, 2020. To learn more, visit http://bit.ly/Alliance-A171901


Alliance A211901 (Text-based Cessation Interventions)

Devon Noonan, PhD, MPH, FNP-B, of 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
 

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 | NCI Blog Post

Alliance A221805 (Chemotherapy-induced Peripheral Neuropathy)

Ellen M. Lavoie Smith, PhD, RN, FAAN (University of Alabama School of Nursing) leads Alliance A221805 (Duloxetine to prevent oxaliplatin-Induced chemotherapy-induced peripheral neuropathy: A randomized, double-blind, placebo-controlled phase II to phase III study). This phase II/III trial studies the best dose of duloxetine and how well it works in preventing pain, tingling, and numbness (peripheral neuropathy) caused by treatment with oxaliplatin in patients with stage II-III colorectal cancer. Duloxetine increases the amount of certain chemicals in the brain that help relieve depression and pain. Giving duloxetine in patients undergoing treatment with oxaliplatin for colorectal cancer may help prevent peripheral neuropathy. The trial opened on May 1, 2020. To learn more about this trial, visit CT.gov. (ClinicalTrials.gov Identifier: NCT04137107) | Alliance Member Site


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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