Neoadjuvant Sitravatinib in Combination With Nivolumab in Patients With Clear Cell Renal Cell Carcinoma

Part of paid clinical trials in Houston, Texas.

Sponsor
Mirati Therapeutics Inc.
Study ID
NCT03680521
Phase
PHASE2
Status
Completed

Conditions

  • Clear Cell Renal Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sitravatinib — DRUG
    Sitravatinib oral capsule administered daily for 6-8 weeks in segments 1 and 2.
  • Nivolumab — DRUG
    Nivolumab administered as 240 mg IV every 2 weeks for 4-6 weeks in segment 2.

Study Details

The study will evaluate the clinical activity of sitravatinib in combination with nivolumab in patients with locally-advanced clear cell renal cell carcinoma (ccRCC) in the neoadjuvant setting prior to nephrectomy.

Key Dates

Start date
Oct 10, 2018
Status verified
Sep 2023
Primary completion
Apr 27, 2020
Completion
May 18, 2023

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sitravatinib and nivolumab
    Sitravatinib oral capsule administered daily 2 weeks alone then in combination with nivolumab administered as 240 mg IV every 2 weeks. Total treatment duration: 6-8 weeks prior to planned nephrectomy.

Primary Outcome Measure

Percentage of Participants Who Achieved a Point in Time Objective Response (Either Complete or Partial Response [CR or PR]) Prior to Surgery [ Time Frame: Baseline to date of surgery (maximum time to surgery was approximately 13 weeks) ]

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
MD Anderson Cancer Center· Houston, TX

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