Phase 1/2 Study of Tivozanib in Combination With Nivolumab in Subjects With RCC

Sponsor
AVEO Pharmaceuticals, Inc.
Study ID
NCT03136627
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Carcinoma, Renal Cell

Eligibility Criteria

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

Interventions

  • Tivozanib — DRUG
    Tivozanib (AV-951): Phase 1b study and Phase 2a study: Subjects will receive 1 dose of tivozanib daily for 21 days followed by a 7 day rest period (1 cycle = 4 weeks).
  • Nivolumab — DRUG
    Nivolumab: Phase 1b study and Phase 2a study: All subjects will receive IV nivolumab 240 mg every 2 weeks administered over 1 hour.

Study Details

This study will evaluate the safety, tolerability, dose-limiting toxicities, MTD, and preliminary anti-tumor activity of tivozanib in combination with nivolumab in subjects with metastatic renal cell cancer. This will use a standard '3+3' dose-escalation trial design. A cohort of 3 subjects will be enrolled at each dose level. If 1 of 3 subjects experiences a DLT during Cycle 1, that dose level will be expanded to 6 subjects. If 0 of 3 or ≤ 1 of 6 subjects experience a DLT during Cycle 1, escalation to the next dose will occur. If ≥ 2 of 6 subjects experience a DLT during Cycle 1, dose escalation will stop and the prior dose will be considered the MTD. This is a validated trial design for Phase 1 trials. Following completion of the dose-escalation cohorts and determination of MTD, an expansion cohort of up to 20 subjects may be enrolled at MTD to further evaluate safety, tolerability, and preliminary anti-tumor activity of tivozanib in combination with nivolumab in the same target population.

Key Dates

Start date
Mar 22, 2017
Status verified
Dec 2021
Primary completion
Dec 21, 2017
Completion
Jun 18, 2021

Study Design

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

Arms

  • Experimental: Tivozanib (AV-951) plus Nivolumab
    Tivozanib plus Nivolumab:Tivozanib will be administered once daily for 3 weeks followed by 1 week off. Nivolumab will be administered every 2 weeks starting on Day 1.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of tivozanib administered orally in combination with Nivolumab in subjects with advanced renal cell carcinoma. [ Time Frame: 28 days (1 Cycle) ]

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