Substudy 02A: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Participants With Programmed Cell-death 1 (PD-1) Refractory Melanoma (MK-3475-02A/KEYMAKER-U02)

STATUS

Recruiting
End date

Apr 3, 2030
participants needed

200
sponsor

Merck Sharp & Dohme LLC

Send

Updated on 13 July 2022

See if I qualify

metastatic melanoma

cancer

pembrolizumab

alopecia

mk-3475

immunomodulators

advanced melanoma

immunologic adjuvant

Summary

Substudy 02A 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 02A is to evaluate the safety and efficacy of investigational treatment arms in participants with PD-1 refractory melanoma to identify the investigational agent(s) that, when used in combination, are superior to the current treatment options/historical control available.

Details

Condition	Melanoma
Treatment	Pembrolizumab, ATRA, Lenvatinib, MK-7684, MK-1308, vibostolimab, Guavonlimab, Quavonlimab
Clinical Study Identifier	NCT04305041
Sponsor	Merck Sharp & Dohme LLC
Last Modified on	13 July 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Has histologically or cytologically confirmed melanoma
	Has unresectable Stage III or Stage IV melanoma, not amenable to local therapy
	Has progressed on treatment with an anti-PD-1/L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other therapies
	Has imaging documenting progression per RECIST 1.1 and iRECIST after initiation of an anti-PD-1/L1 agent, or by RECIST 1.1 if progression occurred on adjuvant therapy or in the setting of rapid progression
	Has not received more than 3 lines of therapy for their advanced melanoma
	Has provided a tumor biopsy
	Male participants who receive lenvatinib or ATRA are abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 7 days after the last dose of lenvatinib or ATRA; for male participants who only receive pembrolizumab, quavonlimab, vibostolimab, or a combination, no contraception measures are needed
	Female participant are not pregnant or breastfeeding and are either not a woman of child-bearing potential (WOCBP) OR use a contraceptive method that is highly effective or are abstinent from heterosexual intercourse during the intervention period and for at least 120 days after the last dose of pembrolizumab, quavonlimab, vibostolimab or 30 days after the last dose of lenvatinib or ATRA, whichever occurs last
	Has adequate organ function
	Has resolution of toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia)
Exclusion Criteria
	Has a diagnosis of immunodeficiency or is receiving immunosuppressive therapy within 7 days before the first dose of study intervention
	Has a known additional malignancy that is progressing or requires active treatment within the past 2 years
	Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
	Has ocular or mucosal melanoma
	Has known hypersensitivity including previous clinically significant hypersensitivity reaction to treatment with another mAb
	Has an active autoimmune disease that has required systemic treatment in the past 2 years
	Has an active infection requiring systemic therapy
	Has known history of human immunodeficiency virus (HIV)
	Has known history of hepatitis B
	Has a history of (noninfectious) pneumonitis
	Has a history of active tuberculosis (TB)
	Has received prior systemic anticancer therapy within 4 weeks prior to randomization
	Has received prior radiotherapy within 2 weeks of first dose of study intervention
	Has had major surgery <3 weeks prior to first dose of study intervention
	Has received a live vaccine within 30 days before the first dose of study intervention
	Has participated in a study of an investigational agent within 4 weeks prior to the first dose of study intervention
	Has had an allogeneic tissue/solid organ transplant
	Has a pre-existing Grade ≥3 gastrointestinal fistula or nongastrointestinal fistula
	Has radiographic evidence of encasement of invasion of major blood vessel or of intratumoral cavitation
	Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study intervention
	Has clinically significant cardiovascular disease within 12 months from first dose of study intervention

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Substudy 02A: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents in Participants With Programmed Cell-death 1 (PD-1) Refractory Melanoma (MK-3475-02A/KEYMAKER-U02)