A Randomized Phase 2 Trial of Nivolumab, Relatlimab Plus Ipilimumab vs. Nivolumab Plus Ipilimumab in First-line Advanced Renal Cell Carcinoma (RCC)

NCT06708949 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2024-1337NCI-2025-01553
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Renal Cell Carcinoma, Clear Cell

Outcome Measures

Primary Outcomes (1)

• Safety and Averse events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (2)

Treatment with Nivolumab + Ipilimumab

EXPERIMENTAL

Participants will randonmized to study and treatment will be administered on an outpatient basis.

Drug: Drugs Nivolumab; Drug: Ipilimumab

Treatment with Nivolumab + Relatlimab + Ipilimumab

EXPERIMENTAL

Participants will randonmized to study and treatment will be administered on an outpatient basis.

Drug: Ipilimumab; Drug: BMS-986213 (Relatlimab-Nivolumab FDC)

Interventions

Drugs Nivolumab DRUG

Given by IV Infusion

Treatment with Nivolumab + Ipilimumab

Ipilimumab DRUG

Given by IV Infusion

Treatment with Nivolumab + Ipilimumab; Treatment with Nivolumab + Relatlimab + Ipilimumab

BMS-986213 (Relatlimab-Nivolumab FDC) DRUG

Given by IV Infusion

Treatment with Nivolumab + Relatlimab + Ipilimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide a signed and dated written informed consent.
• ≥ 18 years of age
• Confirmed diagnosis of RCC with a clear cell component
• Stage IV metastatic renal cell carcinoma per American Joint Committee on Cancer
• No prior systemic therapy for RCC. Prior neo/adjuvant systemic therapy is not allowed.
• Karnofsky performance status ≥ 70%.
• 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 progression has been documented in the lesion
• Adequate organ function within 28 days prior to first dose of protocol-indicated treatment, including:
• White blood cell (WBC) ≥ 2,000 /µL
• Absolute neutrophil count (ANC) ≥ 1,500/µL
• Platelets ≥ 100,000/µL
• Serum creatinine \< 1.5 x upper limit of normal (ULN) or creatinine clearance \> 30 mL/min (measured or calculated by Cockroft-Gault formula)
• Total bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who must have total bilirubin \< 3.0 mg/dL)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN

You may not qualify if:

• Prior systemic treatment for RCC of any type including neoadjuvant or adjuvant therapy is not allowed.
• ≤ 28 days before first dose of protocol-indicated treatment:
• Major surgery requiring general anesthesia.
• ≤ 14 days before first dose of protocol-indicated treatment:
• Radiosurgery or radiotherapy
• Minor surgery. (Note: Placement of a vascular access device is not considered minor or major surgery)
• Active infection requiring infusion treatment.
• Any history of or current CNS metastases
• Any condition requiring systemic treatment with either corticosteroids (\> 10 mg/day prednisone or equivalent daily) or other immunosuppressive medications within 14 days prior to initiating protocol-indicated treatment.
• In the absence of active autoimmune disease, subjects are permitted the use of corticosteroids with minimal systemic absorption (e.g. topical, ocular, intra-articular, intranasal, and inhalational) ≤ 10 mg/day prednisone or equivalent daily; and physiologic replacement doses of systemic corticosteroids ≤ 10 mg/day prednisone or equivalent daily (e.g. hormone replacement therapy needed in patients with hypophysitis)
• Active, known or suspected autoimmune disease (see Appendix 1 for a comprehensive list of autoimmune diseases and immune deficiencies).
• Subjects with type I diabetes mellitus; endocrine organ dysfunction (e.g., hypothyroidism) that are controlled and only requiring only hormone replacement; skin disorders such as vitiligo, psoriasis or alopecia not requiring systemic treatment; or conditions not expected by the investigator to recur in the absence of an external trigger are permitted to enroll.
• Known psychiatric condition, social circumstance, or other medical condition reasonably judged by the investigator to unacceptably increase the risk of study participation; or to prohibit the understanding or rendering of informed consent or anticipated compliance with and interpretation of scheduled visits, treatment schedule, laboratory tests and other study requirements.
• History of myocarditis, regardless of etiology
• Troponin T (TnT) or I (TnI) \> 2× institutional upper limit of normal (ULN)

Sponsors & Collaborators

• Bristol-Myers Squibb: collaborator
• M.D. Anderson Cancer Center: lead

Study Sites (5)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Eric Jonasch, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Jonasch, MD

CONTACT

(713) 563-7232; ejonasch@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: March 20, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (5)