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Completed

NCT Number: NCT04887870

Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent Study

A Study of Sitravatinib Alone or in Combination with Other Anticancer Therapies in Advanced or Metastatic Malignancies

Completed

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Key information

Conditions

Advanced or Metastatic Solid Malignancies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Rocky Mountain Cancer Centers - Littleton, Littleton, Colorado, United States

Loading trial locations.

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.

The current study is designed to allow continued access to sitravatinib and to evaluate the safety and tolerability of sitravatinib alone or in combination with other anticancer therapies in patients who are deriving clinical benefit in a previous parent clinical trial.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Currently receiving sitravatinib single- agent or in combination with other therapeutic agent(s) in another Mirati- sponsored protocol
  • Currently tolerating the treatment regimen in the parent protocol
  • Experiencing clinical benefit with or without prior radiographic progression from the treatment regimen in the parent protocol in the opinion of the investigator and the investigator determines that continuing treatment is in the patient's best interest

Exclusion criteria

  • Known or suspected presence of other cancer
  • Other life- threatening illness or organ system dysfunction compromising safety evaluation

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

Pembrolizumab

Drug

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

Other names: KEYTRUDA

Enfortumab Vedotin-Ejfv

Drug

Enfortumab is a Nectin-4 directed antibody-drug conjugate (ADC) comprised of a monoclonal antibody conjugated to the small molecule microtubule disrupting agent, monomethyl auristatin E (MMAE)

Other names: PADCEV

Ipilimumab

Drug

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

Other names: YERVOY

Primary outcomes

  1. Frequency of subjects experiencing treatment-related AEs.

    Time frame: 24 Months

    Frequency of subjects experiencing treatment-related AEs.

Secondary outcomes

  1. Time to clinical or radiographic progression on study.

    Time frame: 24 Months

    Time to clinical or radiographic progression on study.

Sponsors and collaborators

Lead sponsor

Mirati Therapeutics Inc.

Industry

Registry information

Official study title

A Multicenter, Open-label Rollover Study of Sitravatinib Alone or in Combination With Other Anticancer Therapies in Patients With Advanced or Metastatic Solid Malignancies

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 14, 2021
Registry last updated
Oct 10, 2025

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.