A Randomized Phase 2 Trial of Nivolumab, Relatlimab Plus Ipilimumab vs. Nivolumab Plus Ipilimumab in First-line Advanced Renal Cell Carcinoma (RCC)
M.D. Anderson Cancer Center
Summary
This is a phase 2 stratified, randomized, multicenter, study investigating the efficacy of a triplet arm treating with nivolumab 480 mg every 4 weeks (Q4W), relatlimab 160 mg Q4W and ipilimumab 1 mg/kg every 8 weeks (Q8W) intravenous (IV) versus a doublet arm treating with nivolumab 480 mg Q3W and ipilimumab 1mg/kg Q3W IV in first-line advanced RCC.
Description
Primary Objectives: To determine the safety and tolerability of nivolumab, relatlimab and ipilimumab in patients with untreated advanced RCC • To assess the ORR of nivolumab, relatlimab and ipilimumab in patients with untreated advanced RCC
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Willing and able to provide a signed and dated written informed consent. 2. ≥ 18 years of age 3. Confirmed diagnosis of RCC with a clear cell component 4. Stage IV metastatic renal cell carcinoma per American Joint Committee on Cancer 5. No prior systemic therapy for RCC. Prior neo/adjuvant systemic therapy is not allowed. 6. Karnofsky performance status ≥ 70%. 7. At least one measurable lesion as defined by RECIST 1.1 (Appendix 3) • A tumor lesion situated in a previously irradiated area is considered a measurable/target lesion only if subsequent disease progressio…
Interventions
- DrugDrugs Nivolumab
Given by IV Infusion
- DrugIpilimumab
Given by IV Infusion
- DrugBMS-986213 (Relatlimab-Nivolumab FDC)
Given by IV Infusion
Locations (5)
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Duke University Medical CenterDurham, North Carolina
- Vanderbilt University Medical CenterNashville, Tennessee
- University of Texas Southwestern Medical CenterDallas, Texas
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas