Study of Sitravatinib, Nivolumab and Ipilimumab in Advanced or Metastatic Clear-Cell Renal Cell Carcinoma or Other Solid Malignancies

NCT04518046 | Completed Phase 1 FDA Drug

• 1 other identifier: 516-008
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Study 516-008 is an open-label Phase 1 dose escalation/Phase 1b dose expansion study evaluating the safety and tolerability, clinical activity, and PK of sitravatinib in combination with nivolumab and ipilimumab for the treatment of ccRCC and potentially other solid tumor types.

Conditions

Clear-Cell Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Frequency of patients experiencing treatment-emergent AEs

  Characterization of AEs by incidence, severity, timing, seriousness \& relationship to study treatment

  Through study completion, an average of 12 months

Secondary Outcomes (3)

• Objective Response Rate (ORR) in accordance with RECIST v1.1

  Through duration of study, average of 10 months

• Duration of Response (DOR)

  Through duration of study, average of 10 months

• Progression-free Survival (PFS)

  Through duration of study, average of 10 months

Study Arms (3)

Phase 1: Dose Escalation

EXPERIMENTAL

Patients with poor- or intermediate-risk RCC with clear cell component for first-line treatment.

Drug: Sitravatinib; Drug: Nivolumab; Drug: Ipilimumab

Phase 1b Dose Escalation Cohort A

EXPERIMENTAL

Patients with poor- or intermediate-risk RCC with clear cell component for first-line treatment

Drug: Sitravatinib; Drug: Nivolumab; Drug: Ipilimumab

Phase 1b Dose Escalation Cohort B

EXPERIMENTAL

Patients with favorable-risk RCC with clear cell component for first-line treatment.

Drug: Sitravatinib; Drug: Nivolumab; Drug: Ipilimumab

Interventions

Sitravatinib DRUG

Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases

Also known as: MGCD516

Phase 1: Dose Escalation; Phase 1b Dose Escalation Cohort A; Phase 1b Dose Escalation Cohort B

Nivolumab DRUG

Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody

Also known as: OPDIVO

Phase 1: Dose Escalation; Phase 1b Dose Escalation Cohort A; Phase 1b Dose Escalation Cohort B

Ipilimumab DRUG

Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody

Also known as: YERVOY

Phase 1: Dose Escalation; Phase 1b Dose Escalation Cohort A; Phase 1b Dose Escalation Cohort B

Eligibility Criteria

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

You may qualify if:

• Confirmed diagnosis of Clear-Cell Renal Cell Carcinoma (for initial cohorts under consideration)
• No prior treatment with systemic therapy (for initial cohorts under consideration)
• Adequate bone marrow and organ function

You may not qualify if:

• Known or suspected presence of other cancer
• Brain metastases (for initial cohorts under consideration)
• Carcinomatous meningitis
• Immunocompromising conditions
• Impaired heart function
• Active or prior documented autoimmune disease

Sponsors & Collaborators

• Mirati Therapeutics Inc.: lead

Study Sites (1)

MD Anderson

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Msaouel P, Yu K, Yuan Y, Chen J, Yan X, Karki M, Duan F, Sheth RA, Rao P, Sircar K, Shah AY, Zurita AJ, Genovese G, Li M, Yeh CC, Dang M, Han G, Chu Y, Hallin M, Olson P, Yang R, Slavin D, Der-Torossian H, Chin CD, Tannir NM, Wang L, Gao J. Sitravatinib in combination with nivolumab plus ipilimumab in patients with advanced clear cell renal cell carcinoma: a phase 1 trial. Nat Commun. 2025 Jan 10;16(1):578. doi: 10.1038/s41467-024-55642-8.

  PMID: 39794332 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

sitravatinib; Nivolumab; 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

• Curtis Chin, MD

  Mirati Therapeutics Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Following the identification of the recommended dose of sitravatinib in combination with NIVO/IPI Phase 1 dose escalation, two Phase 1b dose expansion cohorts will enroll patients with ccRCC based on IMDC risk. All patients receive the same treatment.

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 19, 2020
• Study Start: August 11, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)