E-Newsletter - February 2022
Spotlight on Alliance Trials
MARCH IS ... National KIDNEY Cancer Awareness month
Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults. Other less common types of kidney cancer can occur. Currently, Alliance has two RCC trials now enrolling participants. Take a look.
Tian Zhang, MD, of 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)).
Alliance A031704 (PDIGREE) is a phase III trial that looks at how well nivolumab and ipilimumab, followed by nivolumab versus cabozantinib and nivolumab, work in treating patients with renal cell cancer that is untreated and has spread to other parts of the body. 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. Drugs used in chemotherapy, such as cabozantinib, 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. It is not yet known how well cabozantinib and nivolumab work in treating patients with untreated renal cell cancer that has spread to other parts of the body. This trial opened to enrollment on May 9, 2019. To learn more about this trial, visit. CT.gov. ClinicalTrials.gov Identifier: NCT03793166 | Alliance Website
Rana R. McKay, MD, of the University of California San Diego, 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).
Alliance A031801 (RadiCaL) is a phase II trial that studies whether adding radium-223 dichloride to the usual treatment, cabozantinib, improves outcome 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. This trial opened to enrollment on December 13, 2019. To learn more about this trial, visit. CT.gov. ClinicalTrials.gov Identifier: NCT04071223 | Alliance Website
Special note: Drs. Zhang and McKay will host a Joint GU Webinar (PDIGREE and RadiCaL) on Wednesday, March 9, 2022, from 12 pm-1 pm EST (9 am-10 am PST). Alliance welcomes representatives from participating and pending sites to attend the virtual meeting. Visit CTSU.org for a webinar invitation. (See Protocol Update, 02-Feb-2022, A031704 and A031801).
For other articles in this issue of the Alliance E-News newsletter, see below.
- Message From the Group Statistician - Sumithra J. Mandrekar, PhD
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Navigating Ethical Dilemmas, Guiding Investigators During the Conduct of Oncology Clinical Trials
Fay J. Hlubocky, PhD, MA, and Jeffrey M. Peppercorn, MD, MPH - Co-Chairs, Alliance Ethics Committee -
Increased Skill Level, Training of Clinical Research Professionals Now Required to Meet Complexities of New Clinical Trials
Jennifer Dill, CCRP - Chair, Alliance Clinical Research Professionals Committee
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Spotlight on Alliance Trials
A211801 (BRCA-P Breast Cancer Prevention Study)
March is . . . -
National Colorectal Cancer Awareness Month
A021502: ATOMIC (DNA Mismatch Repair)
A021703: SOLARIS (Vitamin D Supplementation)
A221805 (Peripheral Neuropathy) -
National Kidney Cancer Awareness Month
A301704: PDIGREE (Metastatic Untreated RCC)
A031801: RadiCaL (Advanced RCC/Bone Metastasis)
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Alliance Foundation Funding Opportunity
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Alliance in the News
Alliance A011502 | Aspirin Doesn’t Improve iDFS in Breast Cancer
Alliance A021804 | NCI Clinical Trial Spotlight: Testing the Addition of an Anticancer Drug, Olaparib, to the Usual Chemotherapy (Temozolomide) for Advanced Neuroendocrine Cancer
AFT-05 (PALLAS) | Safety of Adjuvant CDK4/6 Inhibitors During the COVID-19 Pandemic
CALGB 90601 | Results of Bevacizumab-Chemotherapy Combinations for Patients with Advanced Urothelial Cancer - Expert Commentary
Alliance A041202 | Anti-CD20 Monoclonal Antibodies for Chronic Lymphocytic Leukemia
New Cancer Research | NCI Seeks to Develop Clinical Trial of MCED Tests
Cancer Research Opinion | Congressional Inaction Harms Federally Funded Oncology Research and Our Patients: The Time for the Cancer Community to Act is Now
Alliance Group Chair | Monica Bertagnolli, M.D., FACS joins Prevent Cancer Board of Directors
Alliance Ethics Committee Co-Chair | Jeffrey Peppercorn, MD, MPH, Named Editor-in-Chief of JCO Oncology Practice
Alliance Committee Co-Chair | Ian E. Krop, MD, PhD, Named Chief Clinical Research Officer, Associate Cancer Center Director for Clinical Research at Yale Cancer Center