Melanoma Clinical Trial

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)

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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

200

Study ID:

NCT04305041

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 35 Locations for this study

See Locations Near You

The Angeles Clinic and Research Institute ( Site 1009)
Los Angeles California, 90025, United States More Info
Study Coordinator
Contact
310-231-2121
UCLA Hematology & Oncology ( Site 1004)
Los Angeles California, 90095, United States More Info
Study Coordinator
Contact
310-794-6892
Providence Saint John's Health Center ( Site 1010)
Santa Monica California, 90404, United States More Info
Study Coordinator
Contact
310-582-7455
University of Colorado, Anschutz Cancer Pavilion ( Site 1012)
Aurora Colorado, 80045, United States More Info
Study Coordinator
Contact
720-848-0442
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 1022)
Baltimore Maryland, 21287, United States More Info
Study Coordinator
Contact
410-583-2970
NYU Clinical Cancer Center ( Site 1002)
New York New York, 10016, United States More Info
Study Coordinator
Contact
917-991-4174
Duke Cancer Institute ( Site 1005)
Durham North Carolina, 27710, United States More Info
Study Coordinator
Contact
919-660-9671
Martha Morehouse Tower ( Site 1020)
Columbus Ohio, 43221, United States More Info
Study Coordinator
Contact
614-293-4320
Oregon Health & Science University ( Site 1013)
Portland Oregon, 97239, United States
University of Pennsylvania Abramson Cancer Center ( Site 1008)
Philadelphia Pennsylvania, 19104, United States More Info
Study Coordinator
Contact
215-316-5151
West Cancer Center - East Campus ( Site 1014)
Germantown Tennessee, 38138, United States More Info
Study Coordinator
Contact
901-683-0055
University of Texas MD Anderson Cancer Center ( Site 1006)
Houston Texas, 77030, United States More Info
Study Coordinator
Contact
713-792-2921
Inova Schar Cancer Institute ( Site 1011)
Fairfax Virginia, 22031, United States More Info
Study Coordinator
Contact
571-472-0631
Calvary Mater Newcastle-Medical Oncology ( Site 1404)
Waratah New South Wales, 2298, Australia More Info
Study Coordinator
Contact
+61249211561
Melanoma Institute Australia ( Site 1402)
Wollstonecraft New South Wales, 2065, Australia More Info
Study Coordinator
Contact
+61299117321
Tasman Oncology Research Pty Ltd ( Site 1403)
Southport Queensland, 4215, Australia More Info
Study Coordinator
Contact
+61 7 5613 2480
Fiona Stanley Hospital ( Site 1401)
Murdoch Western Australia, 6150, Australia More Info
Study Coordinator
Contact
+61861522222
Hopital La Timone ( Site 1103)
Marseille Bouches-du-Rhone, 13005, France More Info
Study Coordinator
Contact
+33491388591
Hopital Saint Andre ( Site 1108)
Bordeaux Gironde, 33075, France More Info
Study Coordinator
Contact
+33556794705
Institut Claudius Regaud ( Site 1105)
Toulouse cedex 9 Haute-Garonne, 31059, France More Info
Study Coordinator
Contact
+33531155101
Gustave Roussy ( Site 1101)
Villejuif Ile-de-France, 94800, France More Info
Study Coordinator
Contact
+33142114210
Centre Hospitalier Lyon Sud ( Site 1102)
Pierre Benite Rhone, 69495, France More Info
Study Coordinator
Contact
+33478861628
A.P.H. Paris, Hopital Saint Louis ( Site 1107)
Paris , 75010, France More Info
Study Coordinator
Contact
+33142499595
HaEmek Medical Center ( Site 1703)
Afula , 18341, Israel More Info
Study Coordinator
Contact
+97246495723
Rambam Health Care Campus-Oncology ( Site 1704)
Haifa , 31096, Israel More Info
Study Coordinator
Contact
+97247776700
Hadassah Ein Karem Jerusalem ( Site 1702)
Jerusalem , 91120, Israel More Info
Study Coordinator
Contact
+97226776781
Chaim Sheba Medical Center ( Site 1701)
Ramat Gan , 52656, Israel More Info
Study Coordinator
Contact
+97235304907
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1399)
Milano , 20133, Italy More Info
Study Coordinator
Contact
00390223902557
Istituto Europeo di Oncologia ( Site 1301)
Milano , 20141, Italy More Info
Study Coordinator
Contact
+390294379224
Istituto Nazionale Tumori Fondazione Pascale ( Site 1302)
Napoli , 80131, Italy More Info
Study Coordinator
Contact
+390815903431
Istituto Oncologico Veneto IRCCS ( Site 1355)
Padova , 35128, Italy More Info
Study Coordinator
Contact
00390498215938
Policlinico Le Scotte - A.O. Senese ( Site 1377)
Siena , 53100, Italy More Info
Study Coordinator
Contact
00390577586335
Hôpitaux Universitaires de Genève (HUG)-Oncology ( Site 1603)
Genève Geneve, 1205, Switzerland More Info
Study Coordinator
Contact
+41223729862
CHUV Centre Hospitalier Universitaire Vaudois ( Site 1602)
Lausanne Vaud, 1011, Switzerland
Universitaetsspital Zuerich ( Site 1601)
Zuerich Flughafen Zurich, 8058, Switzerland More Info
Study Coordinator
Contact
+41442552588

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

200

Study ID:

NCT04305041

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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