Spots Global Cancer Trial Database for Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial
Official Title: Phase 2 Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial
Study ID: NCT05928806
Conditions
Study Description
Brief Summary: This study is a randomized, open label, multicenter Phase II trial to evaluate the efficacy and safety of botensilimab (a novel Fc enhanced Tree depleting anti-CTLA4) and balstilimab (a novel anti-PD1) relative to ipilimumab and nivolumab in treatment naïve patients with metastatic ccRCC. The study will plan to enroll 120 eligible patients randomized in a 2:1 fashion to Arm A and Arm B. Patients in all IMDC Risk Groups are included. This study utilizes a Simon's two stage design which is described in the protocol. Patients randomized to Arm A will receive botensilimab in combination with balstilimab. Patients randomized to Arm B will receive ipilimumab in combination with nivolumab. Study treatment on both arms will continue until toxicity, disease progression or a maximum of 96 total weeks (12 weeks induction, 84 weeks maintenance).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California San Diego, La Jolla, California, United States
Yale University, Yale Cancer Center, New Haven, Connecticut, United States
Georgetown University, Washington, District of Columbia, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana-Farber - Partners Cancer Care, Inc, Boston, Massachusetts, United States
Penn Medicine Abramson Cancer Center, Philadelphia, Pennsylvania, United States
Contact Details
Name: Michael B Atkins, MD
Affiliation: Georgetown University
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
