Study of Cabozantinib as 2nd Line Treatment in Subjects With Locally Advanced or Metastatic Renal Cell Carcinoma (RCC) With a Clear-Cell Component Who Progressed After 1st Line Treatment With Checkpoint Inhibitors
- Sponsor
- Ipsen
- Study ID
- NCT03945773
- Phase
- PHASE2
- Status
- Completed
Conditions
- Locally Advanced or Metastatic Renal Cell Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Cabozantinib — DRUGOral tablets of 60mg, 40mg and 20 mg.
Study Details
The overall objective of this study is to evaluate the efficacy and safety of cabozantinib as 2nd line treatment in subjects with unresectable, locally advanced or metastatic RCC with a clear-cell component, who progressed after prior Checkpoint Inhibitors (CPI) therapy with ipilimumab and nivolumab in combination or CPI combined with Vascular Endothelial Growth Factor (VEGF)-targeted therapy.
Key Dates
- Start date
- Jan 8, 2020
- Status verified
- Feb 2026
- Primary completion
- May 11, 2023
- Completion
- Feb 12, 2026
Study Design
- Enrollment
- 127 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort ASubjects who radiographically progressed after one prior line by CPI therapy with ipilimumab and nivolumab.
- Experimental: Cohort BSubjects who radiographically progressed after one prior line by CPI therapy combined with VEGF-targeted therapy.
Primary Outcome Measure
Cohort A: Objective Response Rate (ORR) Assessed by Independent Central Review [ Time Frame: Tumour assessments performed at Screening/Baseline (within 28 days prior start of study treatment) and every 12 weeks, up to approximately 40 months ]