Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial
Public ClinicalTrials.gov record NCT05928806. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 2 Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT05928806
- Recruitment status
- Suspended
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 120 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 25, 2023 (Actual)
- Primary completion
- Nov 10, 2026 (Estimated)
- Completion
- Nov 10, 2027 (Estimated)
- Last update posted
- Feb 11, 2026
2023 – 2027
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Diego | La Jolla | California | 92093 | — |
| Yale University, Yale Cancer Center | New Haven | Connecticut | 06520 | — |
| Georgetown University | Washington D.C. | District of Columbia | 20057 | — |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | — |
| Indiana University Melvin and Bren Simon Comprehensive Cancer Center | Indianapolis | Indiana | 46202 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Dana-Farber - Partners Cancer Care, Inc | Boston | Massachusetts | 02215 | — |
| John Theurer Cancer Center | Hackensack | New Jersey | 07601 | — |
| Cornell University | Ithaca | New York | 14850 | — |
| Columbia University Irving Medical Center | New York | New York | 10032 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| Penn Medicine Abramson Cancer Center | Philadelphia | Pennsylvania | 19104 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05928806, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 11, 2026 · Synced Oct 4, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05928806 live on ClinicalTrials.gov.