Phase 1/2 Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors
ModernaTX, Inc.
Summary
The primary goal of this study is to assess the safety and tolerability of mRNA-4359 administered alone and in combination with pembrolizumab or ipilimumab and nivolumab.
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Males or females ≥18 years of age who have provided written informed consent prior to completing any study-specific procedure. For Arm 2d, participants ≥12 years are eligible with informed consent/assent. * Dose Escalation (Arm 1a): Participant has histologically confirmed locally advanced or metastatic cancer (cutaneous melanoma, NSCLC, non-muscle invasive bladder cancer, head and neck squamous cell carcinoma, microsatellite stable colorectal cancer \[MSS CRC\], basal cell carcinoma, or triple negative breast cancer) with measurable disease as determined by RECIST v…
Interventions
- BiologicalmRNA-4359
Intramuscular Injection
- BiologicalPembrolizumab
Intravenous infusion
- BiologicalIpilimumab
Intravenous infusion
- BiologicalNivolumab
Intravenous infusion
Locations (28)
- The Angeles Clinic and Research InstituteLos Angeles, California
- UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California
- University of Colorado Cancer CenterAurora, Colorado
- George Washington UniversityWashington D.C., District of Columbia
- Orlando Health UF Health Cancer CenterOrlando, Florida
- The University of Chicago MedicineChicago, Illinois