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Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma

StatusRecruiting
PhaseEarly Phase 1
Started2021-05-24
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Jul 22, 2026 → Apr 2027
See other at-risk trials from H. Lee Moffitt Cancer Center and Research Institute

Amendment history

2026-09-17
Primary completion pushed: 2026-07-22 → 2027-04
Completion moved earlier: 2027-07 → 2027-04
2026-02-26
Study Status v15
Primary completion date2026-07→2026-07-22
Completion date2026-07→2027-07
2025-12-08
Study Status, Contacts/Locations v14
Study sitescontacts updated at 1 of 1 site
2025-09-09
Study Status v13
Primary completion date2025-07→2026-07
2025-05-21
Study Status v12
Re-verified, no change to tracked fields
Show 11 earlier versions
2025-02-11
Study Status, Contacts/Locations v11
Primary completion date2025-01→2025-07
Completion date2026-01→2026-07
2024-11-26
Study Status, Contacts/Locations v10
Study sitescontacts updated at 1 of 1 site
2024-07-23
Study Status v9
Primary completion date2026-01→2025-01
Completion date2027-01→2026-01
2024-02-13
Study Status v8
Re-verified, no change to tracked fields
2023-09-21
Study Status, Contacts/Locations v7
Study sitescontacts updated at 1 of 1 site
2023-04-17
4 amendments v3-v6
4 re-verifications since 2021-12-29, no change to tracked fields
2021-07-12
Study Status v2
Start date2021-01-29→2021-05-24
2021-06-25
Study Status, Eligibility v1
Eligibility criteria+22 characters
[...] Criteria: Participants may have received prior therapy with an anti-PD-1/PD-L1 or CTLA-4 inhibitor or a BRAF and/or a MEK inhibitor if it was completed at least 6 [...] o had prior disease progression while on BRAF/MEK inhibitor or anti-PD-1/PD-L1 therapy are not eligible. (Progression after stopping treatment is permitted.) Participants may have received prior therapy an anti-PD-1/PD-L1 or CTLA-4 inhibitor. Participants must not have had adverse events related to enc [...]
2021-02-04
Original filing
The purpose of this study is to assess rate of disease relapse and hazard rate of disease relapse after neoadjuvant therapy based on the statuses of pathologic complete response or non-pathologic complete response, and postoperative adjuvant therapy.
Trial Details
NCT Number NCT04741997
Lead Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborators: Pfizer
Conditions Melanoma Stage III, Melanoma Stage IV, BRAF V600 Mutation
Enrollment 50 participants
Start Date 2021-05-24
Primary Completion 2027-04 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-09-16