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Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma

StatusRecruiting
PhasePhase 2
Started2024-05-17
View on ClinicalTrials.gov ↗

Amendment history

2026-03-31
Study Status v12
Re-verified, no change to tracked fields
2026-01-06
Study Status v11
Primary completion date2027-07→2028-11
Completion date2027-07→2028-11
2025-09-29
Study Status, Contacts/Locations v10
Study sitescontacts updated at 1 of 1 site
2025-06-10
2 amendments v8-v9
2 re-verifications since 2025-03-11, no change to tracked fields
2024-12-12
Study Status, Contacts/Locations, IPDSharing v7
Primary completion date2027-03→2027-07
Completion date2027-03→2027-07
Study sitescontacts updated at 1 of 1 site
Show 6 earlier versions
2024-11-11
Study Status, Oversight, Study Design, Contacts/Locations, IPDSharing v6
PhaseEarly Phase 1→Phase 2
Study sitescontacts updated at 1 of 1 site
2024-08-09
Study Status v5
Start date2024-02-28→2024-05-17
2024-07-09
Study Status, Sponsor/Collaborators v4
Collaborators+20 characters
Bristol-Myers Squibb
2024-07-02
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v3
Enrollment target30→90
Study arms3→6
Eligibility criteria+2,476 characters
Inclusion Criteria: This study is divided into 2 sub-studies/parts designated Part 1 and Part 2 that will enroll in sequence starting with Part 1 followed by Part 2. In Part 2, Part 2 Cohort A and Part 2 Cohort B will enroll simultaneously. Inclusion criteria apply to Part 1 and Part 2 unless otherwise specified. Voluntarily agree to participate by giving signed, dated, an [...] s. 18 years of age or older Histologic diagnosis of melanoma (cutaneous, acral, mucosal or unknown primary) belonging to the following American Joint Committee on Canc [...] or T1-4) and (N1b, N1c, N2b, N2c, N3b or N3c) and/or (M1a) [...]
Secondary endpointsdetails revised at 1 of 6 entries
Study title-22 characters
BiomarkerNeoadjuvant Drivenand Patient Selection NeoadjuvantAdjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma
2024-03-12
Study Status v2
Start dateestimated 2024-03→confirmed 2024-02-28
2024-03-06
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
2024-03-05
Original filing
The purpose of this study is to determine if neoadjuvant (treatment before surgery) immunotherapy treatment based on tumor biomarkers results in better participant outcomes. Immunotherapy is the treatment of disease by using a person's own immune system. This study is divided into 2 sub-studies/parts designated Part 1 and Part 2 that will enroll in sequence starting with Part 1 followed by Part 2.
Trial Details
NCT Number NCT06295159
Lead Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborators: Bristol-Myers Squibb
Conditions Melanoma Stage III, Melanoma Stage IV, Advanced Melanoma, Melanoma
Enrollment 90 participants
Start Date 2024-05-17
Primary Completion 2028-11 (estimated)
Study Completion 2028-11 (estimated)
Updated on ClinicalTrials.gov 2026-04-01