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.
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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 approximately 17 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 experienced an AE was reported.
Time frame: Up to approximately 13 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 discontinued study intervention due to an AE was reported.
Time frame: Up to approximately 6 weeks
pCR rate was defined as the percentage of participants with complete absence of viable tumor in the treated tumor bed as assessed by central review of the pathology results. Per protocol, pCR rate with 90% CI was reported.
Time frame: Up to approximately 6 weeks
pCR rate was defined as the percentage of participants with complete absence of viable tumor in the treated tumor bed as assessed by central review of the pathology results. Per protocol, pCR rate with 95% CI was reported.
Time frame: Up to approximately 6 weeks
Near pCR was defined as the percentage of participants with >0% but ≤10% of viable tumor cells in the treated tumor bed as assessed by central review of the pathology results. Per protocol, near pCR rate with 90% CI was reported.
Time frame: Up to approximately 6 weeks
Near pCR was defined as the percentage of participants with >0% but ≤10% of viable tumor cells in the treated tumor bed as assessed by central review of the pathology results. Per protocol, near pCR rate with 95% CI was reported.
Time frame: Up to approximately 6 weeks
pPR rate was defined as the percentage of participants with >10% but ≤50% of the treated tumor bed occupied by viable tumor cells as assessed by central review of the pathology results. Per protocol, pPR rate with 90% CI was reported.
Time frame: Up to approximately 6 weeks
pPR rate was defined as the percentage of participants with >10% but ≤50% of the treated tumor bed occupied by viable tumor cells as assessed by central review of the pathology results. Per protocol, pPR rate with 95% CI was reported.
Time frame: Up to approximately 62 months
RFS was defined as the time from the date of surgery to (1) any recurrence (local, regional, or distant) per RECIST 1.1 as assessed by the investigator or (2) death due to any cause (both cancer and noncancer causes of death). Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). Per protocol, RFS per RECIST 1.1 as assessed by the investigator was presented.
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
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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.
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