Description:
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.
Title
- Brief Title: An Efficacy Study of Adjuvant Treatment With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab in Participants With High-Risk Melanoma (KEYNOTE-942)
- Official Title: A Phase 2 Randomized Study of Adjuvant Immunotherapy With the Personalized Cancer Vaccine mRNA-4157 and Pembrolizumab Versus Pembrolizumab Alone After Complete Resection of High-Risk Melanoma (KEYNOTE- 942)
Clinical Trial IDs
- ORG STUDY ID:
mRNA-4157-P201
- NCT ID:
NCT03897881
Conditions
Interventions
Drug | Synonyms | Arms |
---|
mRNA-4157 | | mRNA-4157 and Pembrolizumab |
Pembrolizumab | | Pembrolizumab |
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.
Trial Arms
Name | Type | Description | Interventions |
---|
mRNA-4157 and Pembrolizumab | Experimental | 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. | |
Pembrolizumab | Active Comparator | 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. | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Recurrence-Free Survival (RFS), Assessed Using Radiological Imaging |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | RFS is defined as the time between the date of first dose of pembrolizumab and the date of recurrence (local, regional, or distant metastasis), new primary melanoma, or death (whatever the cause), whichever occurs first. |
Secondary Outcome Measures
Measure: | Distant Metastasis-Free Survival (DMFS), Assessed Using Radiological Imaging |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | DMFS is defined as the time between the date of first dose of pembrolizumab and the date of the first distant metastasis or the date of death (whatever the cause), whichever occurs first. |
Measure: | Number of Participants With Adverse Events (AEs) |
Time Frame: | Baseline through 100 days after last mRNA-4157 dose (for mRNA-4157 and Pembrolizumab combination arm) and up to 90 days after last pembrolizumab dose (for Pembrolizumab only arm) (up to a total of 3 years for both arms) |
Safety Issue: | |
Description: | |
Measure: | Number of Participants Who Discontinued Due to AEs |
Time Frame: | Baseline through 100 days after last mRNA-4157 dose (for mRNA-4157 and Pembrolizumab combination arm) and up to 90 days after last pembrolizumab dose (for Pembrolizumab only arm) (up to a total of 3 years for both arms) |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | ModernaTX, Inc. |
Trial Keywords
- mRNA-4157
- Personalized cancer vaccine
- PCV
- Pembrolizumab
- Moderna
Last Updated
August 6, 2021