Pembrolizumab
BiologicalAdministered via IV infusion at a specified dose on specified days
Other names: MK-3475, KEYTRUDA®
NCT Number: NCT04303169
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.
Looking for future studies?
Notify Me18 year–120 year
All sexes
Interventional
Phase 1 / Phase 2
Melanoma Institute Australia ( Site 3402), Wollstonecraft, New South Wales, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered via IV infusion at a specified dose on specified days
Other names: MK-3475, KEYTRUDA®
Administered via IV infusion at a specified dose on specified days
Other names: MK-7684
Administered via IT injection at a specified dose on specified days
Other names: Coxsackievirus A21 (CVA21), Formerly known as CAVATAK®, CAV21, V937
Administered via IV infusion at a specified dose on specified days
Administered via IV infusion at a specified dose on specified days
Other names: MK-4280A
Administered via oral capsules at a specified dose on specified days
Other names: Tretinoin, Vesanoid®
Time frame: Up to ~16 months
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 ~12 months
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 ~1.5 months
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 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
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 ~60 months
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.
Merck Sharp & Dohme LLC
Industry
A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Design of Investigational Agents With or Without Pembrolizumab or Pembrolizumab Alone in Participants With Melanoma (KEYMAKER-U02): Substudy 02C
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04305054
Diabetes Mellitus, Insulin-Dependent, 12, Melanoma
Los Angeles, California, United States
View Trial DetailsNCT04700072
Melanoma, Neoplasms
Los Angeles, California, United States
View Trial DetailsNCT05665595
Melanoma, Neoplasms
La Jolla, California, United States
View Trial DetailsNCT04305041
Melanoma, Neoplasms
Los Angeles, California, United States
View Trial Details