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

Moderna

Status and phase: Enrolling; Phase 2

Conditions: Melanoma

Treatments: Drug: mRNA-4157; Biological: Pembrolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03897881

mRNA-4157-P201

Details and patient eligibility

About

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.

Enrollment: 267 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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267 participants in 2 patient groups

mRNA-4157 and Pembrolizumab

Experimental group

Description:

Participants will receive up to 9 doses of mRNA-4157 (every 21 days). Participants may continue on pembrolizumab (every 21 days) until disease recurrence, unacceptable toxicity, or they undergo up to 18 total cycles (approximately 1 year of treatment), whichever is sooner.

Treatment:

Biological: Pembrolizumab

Drug: mRNA-4157

Pembrolizumab

Active Comparator group

Description:

Participants will receive pembrolizumab (every 21 days) until disease recurrence, unacceptable toxicity, or they undergo up to 18 total cycles (approximately 1 year of treatment), whichever is sooner.

Treatment:

Biological: Pembrolizumab