E-Newsletter - December 2020
New Trials Alert


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
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. 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
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. 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
CT.gov Link: http://bit.ly/AllianceA071702



For other articles in this issue of the Alliance E-News newsletter, see below.