Description:
The study will evaluate the clinical activity of nivolumab in combination with the investigational agent sitravatinib in patients with locally-advanced clear cell renal cell carcinoma (ccRCC) in the pre-surgical setting.
Clinical Trials /
Neoadjuvant Sitravatinib in Combination With Nivolumab in Patients With Clear Cell Renal Cell Carcinoma
NCT03680521
Related Conditions:
- Clear Cell Renal Cell Carcinoma
Recruiting Status:
Recruiting
Phase:
Phase 2
Trial Eligibility
Document
Title
- Brief Title: Neoadjuvant Sitravatinib in Combination With Nivolumab in Patients With Clear Cell Renal Cell Carcinoma
- Official Title: A Phase 2 Study of Sitravatinib in Combination With Nivolumab in Patients Undergoing Nephrectomy for Locally-Advanced Clear Cell Renal Cell Carcinoma
Clinical Trial IDs
- ORG STUDY ID: 516-002
- NCT ID: NCT03680521
Conditions
- Clear Cell Renal Cell Carcinoma
Interventions
| Drug | Synonyms | Arms |
|---|---|---|
| Sitravatinib | Sitravatinib and nivolumab | |
| Nivolumab | Sitravatinib and nivolumab |
Purpose
The study will evaluate the clinical activity of nivolumab in combination with the
investigational agent sitravatinib in patients with locally-advanced clear cell renal cell
carcinoma (ccRCC) in the pre-surgical setting.
Detailed Description
Sitravatinib is a receptor tyrosine kinase inhibitor (TKI) that targets multiple closely related receptor tyrosine kinase pathways including VEGFR, PDGF receptor (PDGFR), c-KIT, MET, and the TAM family of receptors (TYRO3, AXL, and MER). Nivolumab is a monoclonal antibody directed against PD-1 and blocks the interaction between PD-1 and its ligands, thereby releasing PD-1-mediated inhibition of T-cell proliferation (including cytotoxic CD8+ T-cells) and cytokine production. Together, sitravatinib and nivolumab may cooperate to elicit greater anti-tumor activity than either agent alone, as sitravatinib is predicted to enhance several steps in the cancer immunity cycle that may augment the efficacy of nivolumab.
Trial Arms
| Name | Type | Description | Interventions |
|---|---|---|---|
| Sitravatinib and nivolumab | Experimental | 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. |
|
Eligibility Criteria
Inclusion Criteria:
1. Imaging results consistent with locally-advanced RCC
2. Candidate for partial or complete nephrectomy as part of treatment plan.
3. Measurable disease as per RECIST version 1.1.
4. ECOG performance status 0 or 1.
5. Adequate bone marrow and organ function.
Exclusion Criteria:
1. Prior systemic anti-tumor treatment for RCC.
2. Patients who are receiving any other investigational agents.
3. 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.
4. Inability to undergo baseline tumor biopsy.
5. Active or prior documented autoimmune or immunocompromising conditions.
6. Uncontrolled hypertension.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Percentage of patients achieving a point in time objective response (either complete or partial response [CR or PR]) prior to surgery. |
| Time Frame: | 6-8 weeks |
| Safety Issue: | |
| Description: |
Secondary Outcome Measures
| Measure: | Number of patients experiencing adverse events (number and percent of patients reporting AEs) |
| Time Frame: | 12 weeks |
| Safety Issue: | |
| Description: |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Mirati Therapeutics Inc. |
Trial Keywords
- ccRCC
- MGCD516
- Antineoplastic Agents
- Immunologic factors
- nivolumab
- Tyrosine Kinase Inhibitor
- VEGFR
- TAM RTKs
- PD-1
- PD-L1
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