An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)
Purpose
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.
Condition
- Melanoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
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 Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
- Masking Description
- Open Label
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental mRNA-4157 and Pembrolizumab |
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. |
|
|
Active Comparator Pembrolizumab |
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. |
|
Recruiting Locations
Lombardi Cancer Center
Washington, District of Columbia 20007
Washington, District of Columbia 20007
More Details
- Status
- Recruiting
- Sponsor
- ModernaTX, Inc.