Substudy 02C is part of a larger research study that is testing experimental treatments for melanoma, a type of skin cancer. The larger study is the umbrella study. The goal of substudy 02C is to evaluate the safety and efficacy of investigational treatment arms in participants with Stage III melanoma who are candidates for neoadjuvant therapy to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available. Arm 1: Pembrolizumab + Vibostolimab, Arm 2: Pembrolizumab + Gebasaxturev, and Arm 3: Pembrolizumab were added in the base protocol on 13-Nov-2019, and enrollment into those arms has been completed. Arm 4: Pembrolizumab + MK-4830 was added in Amendment 04 on 20-Dec-2021, and enrollment into that arm has been completed. Arm 5: Favezelimab + Pembrolizumab and Arm 6: Pembrolizumab + all-trans retinoic acid (ATRA) were added in Amendment 06 on 25-Jun-2022, and enrollment is ongoing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
146
Administered via IV infusion at a specified dose on specified days
Administered via IV infusion at a specified dose on specified days
Administered via IT injection at a specified dose on specified days
Administered via IV infusion at a specified dose on specified days
Administered via IV infusion at a specified dose on specified days
Administered via oral capsules at a specified dose on specified days
The Angeles Clinic and Research Institute ( Site 3009)
Los Angeles, California, United States
Providence Saint John's Health Center ( Site 3010)
Santa Monica, California, United States
University of Colorado, Anschutz Cancer Pavilion ( Site 3012)
Aurora, Colorado, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 3022)
Baltimore, Maryland, United States
NYU Clinical Cancer Center ( Site 3002)
New York, New York, United States
Percentage of participants who experience an adverse event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience an AE will be reported.
Time frame: Up to ~16 months
Percentage of participants who discontinue study treatment due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study treatment due to an AE will be reported.
Time frame: Up to ~12 months
Pathological complete response (pCR) rate
pCR rate is defined as the proportion of participants with complete absence of viable tumor in the treated tumor bed. Assessments are according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by central review of the pathology results. RECIST 1.1 has been modified for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Time frame: Up to ~1.5 months
Near pathological complete response (near pCR) rate
Near pCR is defined as the proportion of participants with \>0% but ≤10% of viable tumor cells in the treated tumor bed. Assessments are according to RECIST 1.1 by central review of the pathology results. RECIST 1.1 has been modified for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Time frame: Up to ~1.5 months
Pathological partial response (pPR) rate
pPR rate is defined as the proportion of participants with \>10% but ≤50% of the treated tumor bed occupied by viable tumor cells. Assessments are according to RECIST 1.1 by central review of the pathology results. RECIST 1.1 has been modified for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Time frame: Up to ~1.5 months
Recurrence-free survival (RFS)
RFS is defined as the time from the date of surgery to (1) any recurrence (local, regional, or distant) as assessed by the investigator or (2) death due to any cause (both cancer and noncancer causes of death). Assessments are according to RECIST 1.1 which has been modified for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
Time frame: Up to ~60 months
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Duke Cancer Institute ( Site 3005)
Durham, North Carolina, United States
Martha Morehouse Tower ( Site 3020)
Columbus, Ohio, United States
Oregon Health & Science University ( Site 3013)
Portland, Oregon, United States
University of Pennsylvania Abramson Cancer Center ( Site 3008)
Philadelphia, Pennsylvania, United States
West Cancer Center - East Campus ( Site 3014)
Germantown, Tennessee, United States
...and 19 more locations