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

Conditions

• Clear-Cell Renal Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sitravatinib — DRUG
  Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases
• Nivolumab — DRUG
  Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
• Ipilimumab — DRUG
  Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody

Study Details

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.

Key Dates

Start date

Aug 11, 2020

Status verified

Jun 2024

Primary completion

Jun 30, 2023

Completion

Jun 30, 2023

Study Design

Enrollment

22 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 1: Dose Escalation
  Patients with poor- or intermediate-risk RCC with clear cell component for first-line treatment.
• Experimental: Phase 1b Dose Escalation Cohort A
  Patients with poor- or intermediate-risk RCC with clear cell component for first-line treatment
• Experimental: Phase 1b Dose Escalation Cohort B
  Patients with favorable-risk RCC with clear cell component for first-line treatment.

Primary Outcome Measure

Frequency of patients experiencing treatment-emergent AEs [ Time Frame: Through study completion, an average of 12 months ]

Locations (1)

Find similar trials in Houston, TX

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