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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04887870
Recruitment Status : Enrolling by invitation
First Posted : May 14, 2021
Last Update Posted : February 6, 2023
Sponsor:
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE April 28, 2021
First Posted Date  ICMJE May 14, 2021
Last Update Posted Date February 6, 2023
Actual Study Start Date  ICMJE June 30, 2021
Estimated Primary Completion Date April 19, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2021)		 Frequency of subjects experiencing treatment-related AEs. [ Time Frame: 24 Months ]
Frequency of subjects experiencing treatment-related AEs.
Original Primary Outcome Measures  ICMJE
 (submitted: May 13, 2021)		 To evaluate the safety and tolerability of sitravatinib alone or in combination with other therapeutic agents in patients with advanced or metastatic solid malignancies. [ Time Frame: 24 Months ]
Frequency of subjects experiencing treatment-related AEs.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2021)		 Time to clinical or radiographic progression on study. [ Time Frame: 24 Months ]
Time to clinical or radiographic progression on study.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2021)		 To evaluate time to clinical or radiographic progression on study in patients with advanced or metastatic solid malignancies receiving sitravatinib alone or in combination with other therapeutic agents. [ Time Frame: 24 Months ]
Time to clinical or radiographic progression on study.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent Study
Official Title  ICMJE A Multicenter, Open-label Rollover Study of Sitravatinib Alone or in Combination With Other Anticancer Therapies in Patients With Advanced or Metastatic Solid Malignancies
Brief Summary A Study of Sitravatinib Alone or in Combination with Other Anticancer Therapies in Advanced or Metastatic Malignancies
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced or Metastatic Solid Malignancies
Intervention  ICMJE
  • Drug: Sitravatinib
    Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
    Other Name: MGCD516
  • Drug: Nivolumab
    Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
    Other Name: OPDIVO
  • Drug: Pembrolizumab
    Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody
    Other Name: KEYTRUDA
  • 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 Name: PADCEV
  • Drug: Ipilimumab
    Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody
    Other Name: YERVOY
Study Arms  ICMJE 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.
Interventions:
  • Drug: Sitravatinib
  • Drug: Nivolumab
  • Drug: Pembrolizumab
  • Drug: Enfortumab Vedotin-Ejfv
  • Drug: Ipilimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: May 13, 2021)		 200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 19, 2024
Estimated Primary Completion Date April 19, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04887870
Other Study ID Numbers  ICMJE 516-014
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Mirati Therapeutics Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mirati Therapeutics Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ronald Shazer, MD Mirati Therapeutics Inc.
PRS Account Mirati Therapeutics Inc.
Verification Date February 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP