Ignite Creation Date:
2024-05-06 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04714697
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-01-19
First Post:
2021-01-07
Brief Title:
Cabozantinib as Subsequent Therapy to an Immune Checkpoint Based Therapy in Renal Cell Carcinoma
Sponsor:
Asan Medical Center
Organization:
Asan Medical Center
Study Overview
Official Title:
Cabozantinib as Subsequent Therapy to an Immune Checkpoint Based Therapy in Renal Cell Carcinoma Phase 2 Interventional Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 12 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-1PD-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 investigators opinion or until there is unacceptable toxicity or the need for subsequent systemic anticancer therapy Treatment may continue after radiographic progression per RECIST 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None