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

Mirati Therapeutics

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Advanced or Metastatic Solid Malignancies

Treatments: Drug: Enfortumab Vedotin-Ejfv; Drug: Pembrolizumab; Drug: Nivolumab; Drug: Ipilimumab; Drug: Sitravatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT04887870

CA248-0003

516-014

Details and patient eligibility

About

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

Full 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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Phase 2/3: Open label extension of parent study

Experimental group

Description:

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.

Treatment:

Drug: Sitravatinib

Drug: Ipilimumab

Drug: Nivolumab

Drug: Pembrolizumab

Drug: Enfortumab Vedotin-Ejfv