NCT04714697

Cabozantinib as Subsequent Therapy to an Immune Checkpoint Based Therapy in Renal Cell Carcinoma

Cabozantinib as Subsequent Therapy to an Immune Checkpoint Based Therapy in Renal Cell Carcinoma, Phase 2, Interventional Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 201 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase 2, multicenter, interventional for cohort 1 \& 2, non-interventional for cohort 3, open-label trial of cabozantinib, with ORR as the primary efficacy endpoint. In total, 201 eligible subjects will enroll from 5 sites in Korea. The intervention for this cohort 1\&2 is only IMP, Cabometyx provided by Ipsen (off-label). Also, cohort 3 is just RWD without IMP (on-label)

Detailed description

Cohort 1 (post nivolumab and ipilimumab combination): the subject who failed one prior line by nivolumab and ipilimumab Cohort 2 (post pembrolizumab plus axitinib, pembrolizumab plus lenvatinib, or avelumab and axitinib): the subject who failed one prior line by PD-1/PD-L1 inhibitors in combination with VEGF TKI Cohort 3 (post sequential immunotherapy after VEGFR TKI): the subject who failed the second line by immunotherapy (PD-1 antibody or PD-L1 antibody) following the first line VEGFR TKI Subjects will receive study treatment as long as they continue to experience a clinical benefit in the investigator's opinion or until there is unacceptable toxicity or the need for subsequent systemic anticancer therapy. Treatment may continue after radiographic progression per RECIST 1.1 as long as the investigator believes that the subject is still receiving clinical benefit from study treatment and that the potential benefit of continuing study treatment outweighs potential risks.

Conditions

• Renal Cell Cancer

Interventions

Type	Name	Description
DRUG	Cabometyx	Cabometyx 60mg once daily, oral , up to Progression disease

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-02-28
• Completion: 2025-02-28
• First posted: 2021-01-19
• Last updated: 2021-01-19

Locations

1 site across 1 country: South Korea