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Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for Treatment of Advanced Solid Tumors (PNeoVCA)
This phase I/II trial tests the safety and tolerability of an experimental personalized vaccine when given by itself and with pembrolizumab in treating patients with solid tumor cancers that have spread to other places in the body (advanced). The experimental vaccine is designed target certain proteins (neoantigens) on individuals' tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving the personalized neoantigen peptide-based vaccine with pembrolizumab may be safe and effective in treating patients with advanced solid tumors.
Details
| Lead sponsor | Mayo Clinic |
|---|---|
| Phase | PHASE1, PHASE2 |
| Status | RECRUITING |
| Enrolment | 132 |
| Start date | Thu Mar 31 2022 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Fri Mar 31 2028 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Anatomic Stage III Breast Cancer AJCC v8
- Anatomic Stage IIIA Breast Cancer AJCC v8
- Anatomic Stage IIIB Breast Cancer AJCC v8
- Anatomic Stage IIIC Breast Cancer AJCC v8
- Anatomic Stage IV Breast Cancer AJCC v8
- Clinical Stage III Cutaneous Melanoma AJCC v8
- Clinical Stage III Gastric Cancer AJCC v8
- Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
- Clinical Stage III Merkel Cell Carcinoma AJCC v8
- Clinical Stage IV Cutaneous Melanoma AJCC v8
Interventions
- Cyclophosphamide
- Neoantigen Peptide Vaccine
- Pembrolizumab
- Sargramostim
- Biospecimen Collection
- Biopsy
- Computed Tomography
- Magnetic Resonance Imaging
Countries
United States