Phase 2
N=20
Neoadjuvant Sitravatinib in Combination With Nivolumab in Patients With Clear Cell Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT03680521 ↗Enrolled (actual)
20
Serious AEs
10.0%
Results posted
May 2021
Primary outcome: Primary: Percentage of Participants Who Achieved a Point in Time Objective Response (Either Complete or Partial Response [CR or PR]) Prior to Surgery — 2; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sitravatinib (Drug); Nivolumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mirati Therapeutics Inc.
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved a Point in Time Objective Response (Either Complete or Partial Response [CR or PR]) Prior to Surgery |
2; 0 | — |
| PRIMARY Point in Time Objective Response Prior to Surgery |
0; 0; 2; 0; 4; 11 | — |
| SECONDARY Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) |
7; 13 | — |
| SECONDARY Blood Plasma Concentrations of Sitravatinib |
0.0; 0.6; 2.9; 1.0; 17.0; 13.7 | — |
| SECONDARY Time to Surgery |
56.5; 50.0; 1.0; 1.0 | — |
| SECONDARY Disease Free Survival (DFS) |
NA; NA | — |
| SECONDARY Percentage Change From Baseline in Programmed Death Ligand 1 (PD-L1) Expression in the Tumor |
1.6; 2.5 | — |
| SECONDARY Change From Baseline in Myeloid-derived Suppressor Cells (MDSCs) in the Tumor |
34.5; -55.1 | — |
| SECONDARY Change From Baseline in Regulatory T-cells (Tregs) in the Tumor |
-24.1; 49.6 | — |
| SECONDARY Change From Baseline in CD4+ T-cells in the Tumor |
-114.1; 111.2 | — |
| SECONDARY Change From Baseline in CD8+ T-cells in the Tumor |
-88.3; 30.9 | — |
| SECONDARY Change From Baseline in Ratio of Type 1 to Type 2 Tumor Associated Macrophages in the Tumor |
-1.9; -1.1 | — |
| SECONDARY Change From Baseline of Selected Cytokines in Peripheral Blood |
-78.6; -30.3; 3.1; 3.4; 10.6; 1.9 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Imaging results consistent with locally-advanced RCC
- Candidate for partial or complete nephrectomy as part of treatment plan.
- Measurable disease per RECIST version 1.1.
- ECOG performance status 0 or 1.
- Adequate bone marrow and organ function.
Exclusion Criteria
- Prior systemic anti-tumor treatment for RCC.
- Patients who are receiving any other investigational agents.
- Clinical status indicating that immediate surgery (within 6 weeks) is warranted regardless of whether neoadjuvant therapy is to be administered, as assessed by the treating surgeon.
- Inability to undergo baseline tumor biopsy.
- Active or prior documented autoimmune or immunocompromising conditions.
- Uncontrolled hypertension.
Data sourced from ClinicalTrials.gov (NCT03680521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.