search
Back to results

Study of Sitravatinib, Nivolumab and Ipilimumab in Advanced or Metastatic Clear-Cell Renal Cell Carcinoma or Other Solid Malignancies

Primary Purpose

Clear-Cell Renal Cell Carcinoma

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sitravatinib
Nivolumab
Ipilimumab
Sponsored by
Mirati Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clear-Cell Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed diagnosis of Clear-Cell Renal Cell Carcinoma (for initial cohorts under consideration)
  • No prior treatment with systemic therapy (for initial cohorts under consideration)
  • Adequate bone marrow and organ function

Exclusion Criteria:

  • Known or suspected presence of other cancer
  • Brain metastases (for initial cohorts under consideration)
  • Carcinomatous meningitis
  • Immunocompromising conditions
  • Impaired heart function
  • Active or prior documented autoimmune disease

Sites / Locations

  • MD Anderson

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Phase 1: Dose Escalation

Phase 1b Dose Escalation Cohort A

Phase 1b Dose Escalation Cohort B

Arm Description

Patients with poor- or intermediate-risk RCC with clear cell component for first-line treatment.

Patients with poor- or intermediate-risk RCC with clear cell component for first-line treatment

Patients with favorable-risk RCC with clear cell component for first-line treatment.

Outcomes

Primary Outcome Measures

Frequency of patients experiencing treatment-emergent AEs
Characterization of AEs by incidence, severity, timing, seriousness & relationship to study treatment

Secondary Outcome Measures

Objective Response Rate (ORR) in accordance with RECIST v1.1
Frequency of patients experiencing an objective response
Duration of Response (DOR)
Time in months from date of the first documentation of objective tumor response (CR or PR) to the first documentation of objective PD or to death due to any cause in the absence of documented PD
Progression-free Survival (PFS)
Time from date of first study treatment to first PD or death due to any cause in the absence of documented PD

Full Information

First Posted
August 3, 2020
Last Updated
October 19, 2023
Sponsor
Mirati Therapeutics Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04518046
Brief Title
Study of Sitravatinib, Nivolumab and Ipilimumab in Advanced or Metastatic Clear-Cell Renal Cell Carcinoma or Other Solid Malignancies
Official Title
A Phase 1/1b Study of Sitravatinib in Combination With Nivolumab and Ipilimumab in Patients With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma or Other Solid Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 11, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mirati Therapeutics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Study 516-008 is an open-label Phase 1 dose escalation/Phase 1b dose expansion study evaluating the safety and tolerability, clinical activity, and PK of sitravatinib in combination with nivolumab and ipilimumab for the treatment of ccRCC and potentially other solid tumor types.
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. NIVO/IPI are monoclonal antibodies (mAbs) that inhibit the immune checkpoint proteins programmed death receptor-1 (PD-1) and cytotoxic T- lymphocyte antigen-4 (CTLA-4), respectively. The current study is designed to evaluate the triple combination of sitravatinib plus NIVO/IPI in patients with solid tumor malignancies that have shown favorable responses to NIVO/IPI combinations in previous clinical trials. Combining sitravatinib and NIVO/IPI is predicted to have complementary effects in triggering a tumor-directed immune response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clear-Cell Renal Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Following the identification of the recommended dose of sitravatinib in combination with NIVO/IPI Phase 1 dose escalation, two Phase 1b dose expansion cohorts will enroll patients with ccRCC based on IMDC risk. All patients receive the same treatment.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 1: Dose Escalation
Arm Type
Experimental
Arm Description
Patients with poor- or intermediate-risk RCC with clear cell component for first-line treatment.
Arm Title
Phase 1b Dose Escalation Cohort A
Arm Type
Experimental
Arm Description
Patients with poor- or intermediate-risk RCC with clear cell component for first-line treatment
Arm Title
Phase 1b Dose Escalation Cohort B
Arm Type
Experimental
Arm Description
Patients with favorable-risk RCC with clear cell component for first-line treatment.
Intervention Type
Drug
Intervention Name(s)
Sitravatinib
Other Intervention Name(s)
MGCD516
Intervention Description
Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
OPDIVO
Intervention Description
Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
YERVOY
Intervention Description
Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody
Primary Outcome Measure Information:
Title
Frequency of patients experiencing treatment-emergent AEs
Description
Characterization of AEs by incidence, severity, timing, seriousness & relationship to study treatment
Time Frame
Through study completion, an average of 12 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR) in accordance with RECIST v1.1
Description
Frequency of patients experiencing an objective response
Time Frame
Through duration of study, average of 10 months
Title
Duration of Response (DOR)
Description
Time in months from date of the first documentation of objective tumor response (CR or PR) to the first documentation of objective PD or to death due to any cause in the absence of documented PD
Time Frame
Through duration of study, average of 10 months
Title
Progression-free Survival (PFS)
Description
Time from date of first study treatment to first PD or death due to any cause in the absence of documented PD
Time Frame
Through duration of study, average of 10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of Clear-Cell Renal Cell Carcinoma (for initial cohorts under consideration) No prior treatment with systemic therapy (for initial cohorts under consideration) Adequate bone marrow and organ function Exclusion Criteria: Known or suspected presence of other cancer Brain metastases (for initial cohorts under consideration) Carcinomatous meningitis Immunocompromising conditions Impaired heart function Active or prior documented autoimmune disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Curtis Chin, MD
Organizational Affiliation
Mirati Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
MD Anderson
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of Sitravatinib, Nivolumab and Ipilimumab in Advanced or Metastatic Clear-Cell Renal Cell Carcinoma or Other Solid Malignancies

We'll reach out to this number within 24 hrs