Trials / Recruiting
RecruitingNCT05916248
Combination Therapy of Personalized mRNA-0217 Vaccines and Pembrolizumab in Patients With Advanced Solid Tumors
Clinical Study of Personalized Tumor Vaccines mRNA-0217/S001 and Pembrolizumab in Patients With Advanced Solid Tumors
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- Sponsor
- Ruijin Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main objective of this study was to observe and evaluate the safety and tolerability of mRNA-0217/S001 vaccine encoding personalized tumor neoantigens alone/in combination with Pembrolizumab injection for the treatment of advanced solid tumors. The secondary objective was to observe the preliminary efficacy of mRNA-0217/S001 personalized tumor vaccine in the treatment of advanced solid tumors with neoantigen-specific CD4+ and CD8+ T lymphocyte responses, objective tumor response rate (ORR) and disease control rate (DCR), progression-free survival (PFS) and overall survival (OS) caused by mRNA-0217/S001 personalized tumor vaccine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Personalized neoantigen tumor vaccine | Neoantigen tumor vaccine |
| BIOLOGICAL | PD-1 inhibitor | pembrolizumab |
Timeline
- Start date
- 2023-12-20
- Primary completion
- 2026-06-30
- Completion
- 2026-12-30
- First posted
- 2023-06-23
- Last updated
- 2025-04-01
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05916248. Inclusion in this directory is not an endorsement.