NCT 04305054
Brief Summary
Substudy 02B is part of a larger research study where researchers are looking for new ways to treat advancedat a late stage, far along melanomaa type of cancer that develops from melanocytes, which are the cells that produce pigment generally in the skin (but can develop in other areas of the body) that has not been treated before. The larger study is the umbrella study. Researchers want to know if adding other treatments to pembrolizumab can treat advanced melanoma. The goals of this study are to learn:
- About the safety and how well people tolerate pembrolizumab given with other treatments
- How many people have melanoma that responds (gets smaller or goes away) to treatment
Arm 1: Pembrolizumab + Vibostolimab was added in the base protocol on 13-Nov-2019, and enrollment into this arm has been completed. Arm 2: Pembrolizumab was added in the base protocol on 13-Nov-2019, and enrollment stopped prematurely on 15-Aug-2022. Arm 3: Coformulation Pembrolizumab/Quavonlimab was added in Amendment 01 on 20-Oct-2020, and enrollment stopped prematurely on 15-Aug-2022. Arm 4: Coformulation Pembrolizumab/Quavonlimab + Lenvatinib was added in Amendment 01 on 20-Oct-2020, and enrollment is ongoing. Arm 5: Coformulation Favezelimab/Pembrolizumab was added in Amendment 03 on 01-DEC-2022 and has paused enrollment, Arm 6: Coformulation Favezelimab/Pembrolizumab + All-trans Retinoic Acid (ATRA) was added in Amendment 03 on 01-DEC-2022 and has paused enrollment, and Arm 7: Coformulation Favezelimab/Pembrolizumab + Vibostolimab was added in Amendment 03 on 01-DEC-2022 and enrollment was stopped prematurely on 22-SEP-2023.
Intervention / Treatment
- Biological: Pembrolizumab
- Biological: Vibostolimab
- Biological: Pembrolizumab/Quavonlimab
- Drug: Lenvatinib
- Biological: Favezelimab/Pembrolizumab
- Drug: ATRA
Inclusion Criteria:
- Has histologically or cytologically confirmed melanoma
- Has unresectable Stage III or Stage IV melanoma, not amenable to local therapy
- Has been untreated for advanced disease.
- Has provided a tumor biopsyremoval of a section of tissue to analyse for cancer cells
- If capable of producing sperm, male participants agree to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dosethe amount of medication taken of study intervention (7 days):
- Abstains from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agrees to remain abstinent OR
- Uses contraception unless confirmed to be azoospermic
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- Is not a WOCBP OR
- Is a WOCBP and Uses a contraceptive method that is highly effective, with low user dependency, or be abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is:
- MK-4280A: 120 days
- MK-1308A: 120 days
- MK-7684: 50 days
- MK-3475: 120 days
- Lenvatinib: 30 days
- ATRA: 30 days
- Has adequate organ function
- Has resolution of toxic effect(s) of the most recent prior therapy to Gradea description of how abnormal cancer cells and tissue look under a microscope when compared to healthy cells 1 or less (except alopeciathe partial or complete absence of hair from areas of the body where it normally grows; baldness and Grade 2 neuropathy)