RECENT ALLIANCE TRIAL ACTIVATIONS

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
E-mail: marie.wood@cuanschutz.edu
Activated: 8/1/2022  Status: Now recruiting participants
CT.gov Link: https://bit.ly/AllianceA212102

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
E-mail: achoudhury@partners.org   
Activated: 7/15/2022  Status: Now recruiting participants
CT.gov Link: https://bit.ly/Alliance-A032101

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
E-mail: Corbin.Kimberly@mayo.edu    
Activated: 6/15/2022  Status: Now recruiting participants
CT.gov Link: https://bit.ly/AllianceA221803

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
E-mail: shoushta@mskcc.org
Activated: 6/1/2022  Status: Now recruiting participants
CT.gov Link: https://bit.ly/Alliance-A091903

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, of Mayo Clinic
E-mail: hobday.timothy@mayo.edu
Activated: 3/16/2022  Status: Now recruiting participants
CT.gov Link: https://bit.ly/Alliance-A022001

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
E-mail: guptas5@ccf.org
Activated: 3/10/2022 | Status: Now recruiting participants
CT.gov Link: https://bit.ly/Alliance-A032001


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
E-mail: judy_garber@dfci.harvard.edu
Activated: 2/23/2022  Status: Now recruiting participants
CT.gov Link: https://bit.ly/Alliance-A211801


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

Overview: 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.

Study Chair: Steven Schild, MD, Mayo Clinic in Arizona
E-mail: sschild@mayo.edu
Activated: 12/21/2021  Status: Now recruiting participants
CT.gov Link: https://bit.ly/Alliance-A082002


Alliance A032002: Phase II randomized trial of atezolizumab versus atezolizumab and radiation therapy for platinum ineligible/refractory metastatic urothelial cancer (ART)

Overview: 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.

Study Chair: Himanshu Nagar, MD, of Weill Cornell Medicine
E-mail: hnagar@med.cornell.edu
Activated: 12/1/2021  Status: Now recruiting participants
CT.gov Link: https://bit.ly/Alliance-A032002


Alliance A211901: Reaching rural cancer survivors who smoke using text-based cessation interventions

Overview: 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.
Study Chair: Devon Noonan, PhD, MPH, FNP-BC Duke School of Nursing
E-mail: devon.noonan@duke.edu
Activated: 12/1/2021  Status: Now recruiting participants
CT.gov Link: https://bit.ly/Alliance-A211901


Alliance A021901: Randomized phase II trial of lutetium Lu 177 dotatate versus everolimus in somatostatin receptor positive bronchial neuroendocrine tumors

Overview: This phase II trial studies the effect of lutetium Lu 177 dotatate compared to the usual treatment (everolimus) in treating patients with somatostatin receptor positive bronchial neuroendocrine tumors that have spread to other places in the body (advanced). Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. Lutetium Lu 177 dotatate may be more effective than everolimus in shrinking or stabilizing advanced bronchial neuroendocrine tumors.

Study Chair: Thomas Hope, MD, University of California San Francisco
E-mail: thomas.hope@ucsf.edu
Activated: 09/10/2021  Status: Now recruiting participants
CT.gov Link: https://bit.ly/Alliance-A021901


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

Overview: 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.

Study Chair: Neha Mehta-Shah, MD, Washington University School of Medicine
E-mail: mehta-n@wustl.edu
Activated: 07/30/2021
CT.gov Link: https://bit.ly/Alliance-A051902


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

Overview: 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.

Study Chair: Bradley Stish, MD, Mayo Clinic
E-mail: Stish.Bradley@mayo.edu
Activated: 07/30/2021 
CT.gov Link: https://bit.ly/Alliance-A222001


Alliance A031902: CASPAR - A phase III trial of enzalutamide and rucaparib as a novel therapy in first-line metastatic castration-resistant prostate cancer

Overview: 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.

Study Chair: Arpit Rao, MD, University of Minnesota
E-mail: raoa@umn.edu
Activated: 02/19/2021 
CT.gov Link: http://bit.ly/Alliance-A031902

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

Overview: 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.
Study Chair: Ciara C. O'Sullivan, MB, BCh, BAO, Mayo Clinic
E-mail: OSullivan.Ciara@mayo.edu
Activated: 1/06/2021
CT.gov Link: https://bit.ly/Alliance-A011801

Alliance A031901: Duration of immune checkpoint therapy in locally advanced or metastatic urothelial carcinoma: A randomized phase 3 non-inferiority trial
Overview: This phase III Alliance trial compares survival in patients with urothelial cancer who stop immune checkpoint inhibitor treatment after being treated for about a year to those patients who continue treatment with immune checkpoint inhibitors. Stopping immune checkpoint inhibitors early may still make the tumor shrink and patients may have similar survival rates as the patients who continue treatment. Stopping treatment early may also lead to fewer treatment-related side effects, an improvement in mental health, and a lower cost burden to patients.
Study Chair: Xiao X. Wei, MD, MAS, Dana-Farber Cancer Institute
E-mail: xiaox_wei@dfci.harvard.edu
Activated: 12/10/2020
CT.gov Link: https://bit.ly/AllianceA031901


Alliance A191901: Optimizing endocrine therapy through motivational interviewing and text interventions

Overview: This phase III Alliance trial compares an additional support program, using text message reminders and/or telephone-based counseling, with usual care in making sure patients with breast cancer take their endocrine therapy medication as prescribed. Poor medication adherence has been shown to be a serious barrier to effective treatment for patients with breast cancer that is hormone receptor positive. Adding text message reminders and/or telephone-based counseling to usual care may increase the number of days that patients take their endocrine therapy medication as prescribed.

Study Chair: Katherine E. Reeder-Hayes, MD, MBA, MSc, University of North Carolina at Chapel Hill
E-mail: kreeder@med.unc.edu
Activated: 12/10/2020  Status: Now recruiting participants
CT.gov Link: https://bit.ly/Alliance-A191901


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

Overview: 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. Drugs used in chemotherapy, such as 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. Giving olaparib with temozolomide may shrink or stabilize the cancer in patients with pheochromocytoma or paraganglioma better than temozolomide alone.

Study Chair: Jaydira Del Rivero, MD, National Cancer Institute | Email: jaydira.delrivero@nih.gov
Study Chair: Kimberly J. Perez, MD, Dana-Farber Cancer Institute | E-mail: kimberly_perez@dfci.harvard.edu
Activated: 11/02/2020 | Status: Now recruiting participants
CT.gov Link: http://bit.ly/AllianceA021804


Alliance A071702: A phase II study of checkpoint blockade immunotherapy in patients with somatically hypermutated recurrent glioblastoma

Overview: 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. 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 tumor cells to grow and spread. 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).

Study Chair: Gavin P Dunn, MD, Washington University School of Medicine in St. Louis | Email: gpdunn@wustl.edu
Study Co-Chairs: Eva Galanis, MD, Mayo Clinic | E-mail: galanis.evanthia@mayo.edu and David Reardon, MD, Dana-Farber Cancer Institute  |  E-mail: david_reardon@dfci.harvard.edu
Activated: 10/30/2020 | Status: Now recruiting participants
CT.gov Link: http://bit.ly/AllianceA071702


Alliance A171901: Older non-small lung cancer patients (>/= 70 years of age) treated with first-line MK-3475 (pembrolizumab) +/- chemotherapy (oncologist's/patient's choice)

Overview: This Alliance 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.

Study Chair | Study Co-Chair: Aminah Jatoi, MD, Mayo Clinic and Melisa L. Wong, MD, MAS, Univerisity of California San Francisco
E-mail: Jatoi.Aminah@mayo.edu and melisa.wong@ucsf.edu
Activated: 10/01/2020  | Status: Now recruiting participants
CT.gov Link: http://bit.ly/Alliance-A171901