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
patients 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 Patients 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 | | Combination treatment arm |
Pembrolizumab | | Combination treatment arm |
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
patients with complete resection of cutaneous melanoma and a high risk of recurrence.
Trial Arms
Name | Type | Description | Interventions |
---|
Combination treatment arm | Experimental | mRNA-4157 and pembrolizumab | |
Control treatment arm | Active Comparator | Pembrolizumab only | |
Eligibility Criteria
Inclusion Criteria:
- Resectable cutaneous melanoma metastatic to a lymph node and at high risk of
recurrence
- Complete resection within 13 weeks before study enrollment
- Disease free at study entry (after surgery) with no loco-regional relapse or distant
metastasis and no clinical evidence of brain metastases
- Has an FFPE tumor sample available suitable for sequencing
- 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
melamonas. 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 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) |
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) |
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: | Incidence and Severity of Adverse Events (AEs) |
Time Frame: | Baseline through 90 days after last pembrolizumab dose |
Safety Issue: | |
Description: | According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) |
Measure: | Discontinuations due to AEs |
Time Frame: | Baseline through 90 days after last pembrolizumab dose |
Safety Issue: | |
Description: | According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) |
Measure: | Overall survival |
Time Frame: | Up to 3 years |
Safety Issue: | |
Description: | OS is defined as the time between the date of first dose of pembrolizumab and the date of death due to any cause |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | ModernaTX, Inc. |
Trial Keywords
- mRNA-4157
- Personalized cancer vaccine
- PCV
- Pembrolizumab
- Moderna
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