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Completed

NCT Number: NCT04518046

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

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.

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Key information

Conditions

Clear-Cell Renal Cell Carcinoma Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MD Anderson

Houston, Texas, 77030, United States

About this study

Sitravatinib is a spectrum-selective receptor tyrosine kinase (RTK) inhibitor that inhibits several closely related RTKs including the TAM family (Tyro3/Axl/MERTK), VEGFR2, KIT, and MET.

NIVO/IPI are monoclonal antibodies (mAbs) that inhibit the immune checkpoint proteins programmed death receptor-1 (PD-1) and cytotoxic T- lymphocyte antigen-4 (CTLA-4), respectively.

The current study is designed to evaluate the triple combination of sitravatinib plus NIVO/IPI in patients with solid tumor malignancies that have shown favorable responses to NIVO/IPI combinations in previous clinical trials. Combining sitravatinib and NIVO/IPI is predicted to have complementary effects in triggering a tumor-directed immune response.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Sitravatinib

Drug

Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases

Other names: MGCD516

Nivolumab

Drug

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

Other names: OPDIVO

Ipilimumab

Drug

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

Other names: YERVOY

Primary outcomes

  1. Frequency of patients experiencing treatment-emergent AEs

    Time frame: Through study completion, an average of 12 months

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

Secondary outcomes

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

    Time frame: Through duration of study, average of 10 months

    Frequency of patients experiencing an objective response

  2. Duration of Response (DOR)

    Time frame: Through duration of study, average of 10 months

    Time in months from date of the first documentation of objective tumor response (CR or PR) to the first documentation of objective PD or to death due to any cause in the absence of documented PD

  3. Progression-free Survival (PFS)

    Time frame: Through duration of study, average of 10 months

    Time from date of first study treatment to first PD or death due to any cause in the absence of documented PD

Sponsors and collaborators

Lead sponsor

Mirati Therapeutics Inc.

Industry

Registry information

Official study title

A Phase 1/1b Study of Sitravatinib in Combination With Nivolumab and Ipilimumab in Patients With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma or Other Solid Malignancies

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 19, 2020
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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