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Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial

NCT05928806 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-02-11

No results posted yet for this study

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).

Conditions

  • Advanced Renal Cell Carcinoma

Interventions

DRUG

Botensilimab

Botensilimab 75mg IV

DRUG

Balstilimab

Balstilimab 450mg IV

DRUG

Ipilimumab

Ipilimumab 1mg/kg IV

DRUG

Nivolumab

Nivolumab at induction: 3mg/kg IV Nivolumab at maintenance: 480mg IV

Sponsors & Collaborators

  • Agenus Inc.

    collaborator INDUSTRY

  • Georgetown University

    collaborator OTHER

  • Michael B. Atkins, MD

    lead OTHER

Principal Investigators

  • Michael B Atkins, MD · Georgetown University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-25
Primary Completion
2026-11-10
Completion
2027-11-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05928806 on ClinicalTrials.gov