Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial

Part of paid clinical trials in La Jolla, California.

Sponsor
Michael B. Atkins, MD
Study ID
NCT05928806
Phase
PHASE2
Status
Suspended

Conditions

  • Advanced Renal Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Botensilimab — DRUG
    Botensilimab 75mg IV
  • Balstilimab — DRUG
    Balstilimab 450mg IV
  • Ipilimumab — DRUG
    Ipilimumab 1mg/kg IV
  • Nivolumab — DRUG
    Nivolumab at induction: 3mg/kg IV Nivolumab at maintenance: 480mg IV

Study Details

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).

Key Dates

Start date
Sep 25, 2023
Status verified
Feb 2026
Primary completion
Nov 10, 2026
Completion
Nov 10, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (botensilimab and balstilimab)
    Arm A subjects will receive 2 cycles of induction treatment with each cycle lasting 6 weeks. Cycle 1 will consist of botensilimab 75mg IV in combination with balstilimab 450mg IV on Day 1 and Day 22. Cycle 2 will consist of balstilimab 450mg IV ONLY on Day 1 and Day 22. Botensilimab will NOT be given in Cycle 2. Subjects will receive 7 cycles of maintenance treatment with each cycle lasting 12 weeks. Cycles 3 and 4 will consist of botensilimab 75mg IV on Day 1 in combination with balstilimab 450mg IV on Day 1, 22, 43 and 64. Cycles 5-9 will consist of balstilimab alone 450 mg IV on Day 1, 22, 43 and 64.
  • Active Comparator: Arm B (ipilimumab and nivolumab)
    Arm B subjects will receive 2 cycles of induction treatment with each cycle lasting 6 weeks. Cycle 1 and 2 will consist of ipilimumab 1 mg/kg IV and nivolumab 3 mg/kg on Day 1 and 22. Subjects will receive 7 cycles of maintenance treatment with each cycle lasting 12 weeks. Nivolumab 480mg IV will be given on Day 1, 29 and 57 of each cycle (every 4 weeks).

Primary Outcome Measure

Determine the objective response rate (ORR) of botensilimab + balstilimab in patients with treatment naïve metastatic ccRCC relative to the ORR of patients treated with ipilimumab + nivolumab. [ Time Frame: 5 years ]

Locations (13)

FacilityCityStateZIPSite coordinators
University of California San DiegoLa JollaCalifornia92093-
Yale University, Yale Cancer CenterNew HavenConnecticut06520-
Georgetown UniversityWashington D.C.District of Columbia20057-
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Dana-Farber - Partners Cancer Care, IncBostonMassachusetts02215-
John Theurer Cancer CenterHackensackNew Jersey07601-
Cornell UniversityIthacaNew York14850-
Columbia University Irving Medical CenterNew YorkNew York10032-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
Penn Medicine Abramson Cancer CenterPhiladelphiaPennsylvania19104-
University of Texas Southwestern Medical CenterDallasTexas75390-

Find similar trials in La Jolla, CA

By research site
University of California San Diego· La Jolla, CAYale University, Yale Cancer Center· New Haven, CTGeorgetown University· Washington D.C., DCWinship Cancer Institute of Emory University· Atlanta, GAIndiana University Melvin and Bren Simon Comprehensive Cancer Center· Indianapolis, INBeth Israel Deaconess Medical Center· Boston, MA

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