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

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

Detailed Description
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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.

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

Conditions
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Advanced or Metastatic Solid Malignancies

Intervention / Treatment
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* Drug: Sitravatinib
* Drug: Nivolumab
* Drug: Pembrolizumab
* Drug: Enfortumab Vedotin-Ejfv
* Drug: Ipilimumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase 2/3: Open label extension of parent study<br>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<br>* Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.<br>* Other names: MGCD516;Drug: Nivolumab<br>* Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody<br>* Other names: OPDIVO;Drug: Pembrolizumab<br>* Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody<br>* Other names: KEYTRUDA;Drug: Enfortumab Vedotin-Ejfv<br>* 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)<br>* Other names: PADCEV;Drug: Ipilimumab<br>* Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody<br>* Other names: YERVOY;|

What is the study measuring?
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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 |