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

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Advanced or Metastatic Solid Malignancies
• Intervention / Treatment: Drug: Sitravatinib; Drug: Nivolumab; Drug: Pembrolizumab; Drug: Ipilimumab; Drug: Enfortumab Vedotin-Ejfv

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Beverly Hills Cancer Center
  • Colorado
    • Aurora, Colorado, United States, 90012
      • Rocky Mountain Cancer Centers
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Health Clinics and Surgery Center
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • GU Research Network/Urology Cancer Center
  • New York
    • Clifton Park, New York, United States, 12065
      • New York Oncology Hematology, P.C.
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center - Thoracic Oncology Clinic
  • Texas
    • Denison, Texas, United States, 75020
      • Texas Oncology - Denison Cancer Center
    • Houston, Texas, United States, 77030
      • UT MD Anderson Cancer Center
    • San Antonio, Texas, United States, 78229
      • NEXT Oncology
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • NEXT Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Phase 2/3: Open label extension of parent study; 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.

Drug: Sitravatinib; Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.; Other Names: MGCD516; Drug: Nivolumab; Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody; Other Names: OPDIVO; Drug: Pembrolizumab; Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody; Other Names: KEYTRUDA; Drug: Ipilimumab; Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody; Other Names: YERVOY; Drug: Enfortumab Vedotin-Ejfv; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of subjects experiencing treatment-related AEs.	Frequency of subjects experiencing treatment-related AEs.	24 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to clinical or radiographic progression on study.	Time to clinical or radiographic progression on study.	24 Months

Collaborators and Investigators

• Sponsor: Mirati Therapeutics Inc.
• Investigators: Study Director: Ronald Shazer, MD, Mirati Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 30, 2021
• Primary Completion (ANTICIPATED): April 19, 2024
• Study Completion (ANTICIPATED): April 19, 2024

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: May 13, 2021
• First Posted (ACTUAL): May 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab; Pembrolizumab; Ipilimumab
• Other Study ID Numbers: 516-014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No