Melanoma Clinical Trial

Substudy 02C: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With Stage III Melanoma Who Are Candidates for Neoadjuvant Therapy (MK-3475-02C/KEYMAKER-U02)

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Has histologically or cytologically confirmed melanoma
Has clinically detectable and resectable Stage IIIB or IIIC or IIID melanoma amenable to surgery

Has been untreated for Stage IIIB, IIIC or IIID melanoma

surgical resection of primary melanoma is allowed
prior radiotherapy to the primary melanoma is allowed
Has provided a baseline tumor biopsy
Male participants who receive gebasaxturev are abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 120 days after the last dose of gebasaxturev
Male participants who receive 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 ATRA
Female participants 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, vibostolimab, gebasaxturev, or MK-4830, favezelimab + pembrolizumab, or 30 days after the last dose of 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 monoclonal antibody (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 or live-attenuated 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 only mucosal lesions
Is not naïve to Talimogene laherparepvec (TVEC) and other oncolytic viruses

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

90

Study ID:

NCT04303169

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 28 Locations for this study

See Locations Near You

The Angeles Clinic and Research Institute ( Site 3009)
Los Angeles California, 90025, United States More Info
Study Coordinator
Contact
310-231-2121
Providence Saint John's Health Center ( Site 3010)
Santa Monica California, 90404, United States More Info
Study Coordinator
Contact
310-582-7455
University of Colorado, Anschutz Cancer Pavilion ( Site 3012)
Aurora Colorado, 80045, United States More Info
Study Coordinator
Contact
720-848-0442
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 3022)
Baltimore Maryland, 21287, United States More Info
Study Coordinator
Contact
410-583-2970
NYU Clinical Cancer Center ( Site 3002)
New York New York, 10016, United States More Info
Study Coordinator
Contact
917-991-4174
Duke Cancer Institute ( Site 3005)
Durham North Carolina, 27710, United States More Info
Study Coordinator
Contact
919-660-9671
Martha Morehouse Tower ( Site 3020)
Columbus Ohio, 43221, United States More Info
Study Coordinator
Contact
614-293-4320
Oregon Health & Science University ( Site 3013)
Portland Oregon, 97239, United States
University of Pennsylvania Abramson Cancer Center ( Site 3008)
Philadelphia Pennsylvania, 19104, United States
West Cancer Center - East Campus ( Site 3014)
Germantown Tennessee, 38138, United States More Info
Study Coordinator
Contact
901-683-0055
Inova Schar Cancer Institute ( Site 3011)
Fairfax Virginia, 22031, United States More Info
Study Coordinator
Contact
571-472-0631
Melanoma Institute Australia ( Site 3402)
Wollstonecraft New South Wales, 2065, Australia More Info
Study Coordinator
Contact
+61299117321
Tasman Oncology Research Pty Ltd ( Site 3403)
Southport Queensland, 4215, Australia More Info
Study Coordinator
Contact
+617755314815
Fiona Stanley Hospital ( Site 3401)
Murdoch Western Australia, 6150, Australia More Info
Study Coordinator
Contact
+61861522222
Hopital La Timone ( Site 3103)
Marseille Bouches-du-Rhone, 13005, France More Info
Study Coordinator
Contact
+33491387991
Institut Claudius Regaud ( Site 3105)
Toulouse cedex 9 Haute-Garonne, 31059, France More Info
Study Coordinator
Contact
+33531155101
Gustave Roussy ( Site 3101)
Villejuif Ile-de-France, 94800, France More Info
Study Coordinator
Contact
+33142114210
Centre Hospitalier Lyon Sud ( Site 3102)
Pierre Benite Rhone, 69495, France More Info
Study Coordinator
Contact
+33478861679
A.P.H. Paris, Hopital Saint Louis ( Site 3107)
Paris , 75010, France More Info
Study Coordinator
Contact
+33142499595
HaEmek Medical Center ( Site 3703)
Afula , 18341, Israel More Info
Study Coordinator
Contact
+97246495723
Rambam Health Care Campus-Oncology ( Site 3704)
Haifa , 31096, Israel More Info
Study Coordinator
Contact
97247776700
Hadassah Ein Karem Jerusalem ( Site 3702)
Jerusalem , 91120, Israel More Info
Study Coordinator
Contact
+97226776781
Rabin Medical Center-Oncology ( Site 3705)
Petah-Tikva , 49414, Israel More Info
Study Coordinator
Contact
+972-3-9378077
Chaim Sheba Medical Center ( Site 3701)
Ramat Gan , 52656, Israel More Info
Study Coordinator
Contact
+97235304907
Istituto Europeo di Oncologia ( Site 3301)
Milano , 20141, Italy More Info
Study Coordinator
Contact
+390294372480
Policlinico Le Scotte - A.O. Senese ( Site 3377)
Siena , 53100, Italy More Info
Study Coordinator
Contact
+390577586303
CHUV Centre Hospitalier Universitaire Vaudois ( Site 3602)
Lausanne Vaud, 1011, Switzerland
Universitaetsspital Zuerich ( Site 3601)
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:

90

Study ID:

NCT04303169

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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