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

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ClinicalTrials.gov Identifier: NCT04887870
Recruitment Status : Not yet recruiting
First Posted : May 14, 2021
Last Update Posted : May 19, 2021
Sponsor:
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

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

Condition or disease Intervention/treatment Phase
Advanced or Metastatic Solid Malignancies Drug: Sitravatinib Drug: Nivolumab Drug: Pembrolizumab Drug: Enfortumab Vedotin-Ejfv Drug: Ipilimumab Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

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 recepor 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




Primary Outcome Measures :
  1. Frequency of subjects experiencing treatment-related AEs. [ Time Frame: 24 Months ]
    Frequency of subjects experiencing treatment-related AEs.


Secondary Outcome Measures :
  1. Time to clinical or radiographic progression on study. [ Time Frame: 24 Months ]
    Time to clinical or radiographic progression on study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04887870


Contacts
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Contact: Mirati Therapeutics Study Locator Services 18448935530 miratistudylocator@emergingmed.com

Sponsors and Collaborators
Mirati Therapeutics Inc.
Investigators
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Study Director: Ronald Shazer, MD Mirati Therapeutics Inc.
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Responsible Party: Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT04887870    
Other Study ID Numbers: 516-014
First Posted: May 14, 2021    Key Record Dates
Last Update Posted: May 19, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Pembrolizumab
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents