Personalized cancer vaccine and pembrolizumab for high-risk melanoma
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)
This study is testing if a personalized cancer vaccine combined with pembrolizumab can help people with high-risk melanoma stay cancer-free longer after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 267 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ModernaTX, Inc. Industry-sponsored |
| Drugs / interventions | pembrolizumab |
| Locations | 22 sites (Tucson, Arizona and 21 other locations) |
| Trial ID | NCT03897881 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a personalized cancer vaccine, mRNA-4157, combined with pembrolizumab as postoperative adjuvant therapy for patients with high-risk melanoma. Participants must have undergone complete resection of their melanoma and be disease-free at the time of enrollment. The goal is to determine if this combination improves recurrence-free survival compared to pembrolizumab alone. The study involves monitoring patients for recurrence after treatment.
Who should consider this trial
Good fit: Ideal candidates are individuals with resectable cutaneous melanoma that has metastasized to a lymph node and are at high risk of recurrence.
Not a fit: Patients with prior malignancies or those who have received systemic anti-cancer treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of melanoma recurrence in high-risk patients.
How similar studies have performed: Other studies using personalized cancer vaccines have shown promise, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Tucson, Arizona and 21 other locations
- University of Arizona — Tucson, Arizona, United States (Recruiting)
- California Pacific Medical Center Research Institute -CPMCRI — San Francisco, California, United States (Recruiting)
- Angeles Clinic and Research Institute — Santa Monica, California, United States (Recruiting)
- University of Colorado Cancer Center — Aurora, Colorado, United States (Recruiting)
- Smilow Cancer Center at Yale New Haven Hospital — New Haven, Connecticut, United States (Recruiting)
- Lombardi Cancer Center — Washington, District of Columbia, United States (Recruiting)
- Orlando Health UF Health Cancer Center — Orlando, Florida, United States (Recruiting)
- Northside Hospital — Atlanta, Georgia, United States (Recruiting)
- UPMC Hillman Cancer Center — Chicago, Illinois, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Washington University School of Medicine — Saint Louis, Missouri, United States (Recruiting)
- Hackensack University Medical Center — Hackensack, New Jersey, United States (Recruiting)
- NYU Langone Medical Center — New York, New York, United States (Recruiting)
- Providence Cancer Institute — Portland, Oregon, United States (Recruiting)
- Sarah Cannon Cancer Center — Nashville, Tennessee, United States (Recruiting)
- Texas Oncology PA — Dallas, Texas, United States (Recruiting)
- Melanoma Institute Australia — North Sydney, New South Wales, Australia (Active_not_recruiting)
- Westmead Hospital — Westmead, New South Wales, Australia (Active_not_recruiting)
- Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (Active_not_recruiting)
- Affinity Clinical Research — Murdoch, Western Australia, Australia (Active_not_recruiting)
- St John of God Hospital Subiaco — Subiaco, Western Australia, Australia (Recruiting)
Study contacts
- Study coordinator: Moderna WeCare Team
- Email: WeCareClinicalTrials@modernatx.com
- Phone: 1-866-663-3762
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.