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

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ClinicalTrials.gov Identifier: NCT04518046
Recruitment Status : Recruiting
First Posted : August 19, 2020
Last Update Posted : December 22, 2020
Sponsor:
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

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.

Condition or disease Intervention/treatment Phase
Clear-Cell Renal Cell Carcinoma Drug: Sitravatinib Drug: Nivolumab Drug: Ipilimumab Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention 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)
Primary Purpose: Treatment
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
Actual Study Start Date : August 11, 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : June 2024


Arm Intervention/treatment
Experimental: Phase 1: Dose Escalation
Patients with poor- or intermediate-risk RCC with clear cell component for first-line treatment.
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: Ipilimumab
Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody
Other Name: YERVOY

Experimental: Phase 1b Dose Escalation Cohort A
Patients with poor- or intermediate-risk RCC with clear cell component for first-line treatment
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: Ipilimumab
Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody
Other Name: YERVOY

Experimental: Phase 1b Dose Escalation Cohort B
Patients with favorable-risk RCC with clear cell component for first-line treatment.
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: Ipilimumab
Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody
Other Name: YERVOY




Primary Outcome Measures :
  1. Frequency of patients experiencing treatment-emergent AEs [ Time Frame: Through study completion, an average of 12 months ]
    Characterization of AEs by incidence, severity, timing, seriousness & relationship to study treatment


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) in accordance with RECIST v1.1 [ Time Frame: Through duration of study, average of 10 months ]
    Frequency of patients experiencing an objective response

  2. Duration of Response (DOR) [ Time Frame: Through duration of study, average of 10 months ]
    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

  3. Progression-free Survival (PFS) [ Time Frame: Through duration of study, average of 10 months ]
    Time from date of first study treatment to first PD or death due to any cause in the absence of documented PD



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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:

  • 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

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): NCT04518046


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

Locations
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United States, Texas
MD Anderson Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Mirati Therapeutics Inc.
Investigators
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Study Director: Hirak Der-Torossian, MD Mirati Therapeutics Inc.
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Responsible Party: Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT04518046    
Other Study ID Numbers: 516-008
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents