NCT07883759
Neoadjuvant Pembrolizumab in Patients With High Risk, Stage IIB/IIC Cutaneous Melanoma: a Single Arm Proof of Concept Phase IIA Study.
Not Yet Recruiting · Phase 2 · Centre Hospitalier Universitaire de Besancon · registry updated 2026-10-20
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This phase II trial examine whether neoadjuvant PD-1 blockade will achieve a pathological response with manageable toxicity in stage IIB/IIC melanoma. Patients with histologically confirmed AJCC (8th edition) clinical stage IIB (T3b, T4a), or IIC (T4b) primary cutaneous melanoma from a partial biopsy, with residual macroscopic disease without metastases will be included. They will be treated with 2 infusions of Pembrolizumab followed by surgery and adjuvant treatment. The primary objective is to assess the pathological response of the primary tumor. Secondaries objectives include the evaluation of efficacy and safety as well as exploratory biomarkers analysis.
Inclusion
- Age ≥ 18 years
- Primary cutaneous melanoma. Primary acral melanoma are allowed up to 10% of the population (thus, a maximum of 2 patients will be included)
- AJCC 8 melanoma stage IIB or IIC
- a. either T3b (Breslow \>2mm and ulcerated) b. or T4a (\>4mm non-ulcerated) or T4b (Breslow \>4mm and ulcerated)
- Diagnosis confirmed histologically on partial biopsy of lesion (thickest part of the primary tumor)
- Operable primary tumor
Exclusion
- Non-cutaneous melanoma
- Completely operated primary melanoma with no macroscopic residual tumor
- Primary tumor which may become unresectable by the time of the surgery according to physician's opinion
- Clinical or radiographic evidence of nodal, in-transit, satellite or microsatellite metastases or distant melanoma metastases.
- Uncontrolled infection with HIV, HBC, or HCV infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection.
- Patients with known HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection, monitoring will be performed per local standard.