Melanoma Clinical Trial

An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)

Summary

The purpose of this study is to assess whether postoperative adjuvant therapy with mRNA-4157 and pembrolizumab improves recurrence free survival (RFS) compared to pembrolizumab alone in participants with complete resection of cutaneous melanoma and a high risk of recurrence.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Resectable cutaneous melanoma metastatic to a lymph node and at high risk of recurrence
Complete resection within 13 weeks prior to the first dose of pembrolizumab
Disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases
Has an formalin fixed paraffin embedded (FFPE) tumor sample available suitable for sequencing
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Normal organ and marrow function reported at screening

Key Exclusion Criteria:

Prior malignancy, unless no evidence of that disease for at least 5 years prior to study entry
Prior systemic anti-cancer treatment (except surgery and interferon for thick primary melanomas. Radiotherapy after lymph node dissection is permitted)
Live vaccine within 30 days prior to the first dose of pembrolizumab
Transfusion of blood or administration of colony stimulating factors within 2 weeks of the screening blood sample
Active autoimmune disease
Immunodeficiency, systemic steroid therapy, or any other immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab
Solid organ or allogeneic bone marrow transplant
Pneumonitis or a history of (noninfectious) pneumonitis that required steroids
Prior interstitial lung disease
Clinically significant heart failure
Known history of human immunodeficiency virus (HIV)
Known active hepatitis B or C
Active infection requiring treatment

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

267

Study ID:

NCT03897881

Recruitment Status:

Recruiting

Sponsor:

ModernaTX, Inc.

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There are 21 Locations for this study

See Locations Near You

University of Arizona
Tucson Arizona, 85719, United States More Info
Montaser Shaheen
Contact
812-230-1521
[email protected]
California Pacific Medical Center Research Institute -CPMCRI
San Francisco California, 94115, United States More Info
Kevin Kim, MD
Contact
415-885-8600
[email protected]
Angeles Clinic and Research Institute
Santa Monica California, 90404, United States More Info
Mark Faries, MD
Contact
310-582-7020
[email protected]
University of Colorado Cancer Center
Aurora Colorado, 80045, United States More Info
Karl Lewis, MD
Contact
720-848-0637
[email protected]
Smilow Cancer Center at Yale New Haven Hospital
New Haven Connecticut, 06520, United States More Info
Sarah Weiss, MD
Contact
203-785-6378
[email protected]
Lombardi Cancer Center
Washington District of Columbia, 20007, United States More Info
Geoffrey Gibney, MD
Contact
813-745-3437
[email protected]
Orlando Health UF Health Cancer Center
Orlando Florida, 32806, United States More Info
Sajeve Thomas
Contact
954-663-7551
[email protected]
UPMC Hillman Cancer Center
Chicago Illinois, 60637, United States More Info
Jason Luke
Contact
773-702-0963
[email protected]
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Ryan Sullivan, MD
Contact
617-632-5470
[email protected]
Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States More Info
Elizabeth Buckbinder
Contact
617-632-9271
[email protected]
Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Leonel Hernandez Aya, MD
Contact
314-747-7510
[email protected]
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States More Info
Andrew Pecora, MD
Contact
551-996-5814
[email protected]
NYU Langone Medical Center
New York New York, 10016, United States More Info
Jeffrey Weber, MD
Contact
212-731-6262
[email protected]
Providence Cancer Institute
Portland Oregon, 97213, United States More Info
Mathew Taylor
Contact
503-494-8534
[email protected]
Sarah Cannon Cancer Center
Nashville Tennessee, 37203, United States More Info
Meredith McKean, MD
Contact
615-329-7274
[email protected]
Texas Oncology PA
Dallas Texas, 75246, United States More Info
Charles Cowey, MD
Contact
214-370-1000
[email protected]
Melanoma Institute Australia
North Sydney New South Wales, 2060, Australia
Westmead Hospital
Westmead New South Wales, 2145, Australia
Princess Alexandra Hospital
Woolloongabba Queensland, 4102, Australia
Affinity Clinical Research
Murdoch Western Australia, 6150, Australia
St John of God Hospital Subiaco
Subiaco Western Australia, 6008, Australia More Info
Tarek Meniawy
Contact
+61861023640
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

267

Study ID:

NCT03897881

Recruitment Status:

Recruiting

Sponsor:


ModernaTX, Inc.

How clear is this clinincal trial information?

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