Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04364230 | Melanoma Vaccine Against Neoantigen and Shared Antigens by CD40 Activation and TLR Agonists In Patients With Melanoma (Including Ocular Melanoma) | PHASE1 | COMPLETED | 22 | — | — | Sep 28, 2020 | Mar 14, 2024 | Jul 16, 2024 | 2 | United States |
| NCT03617328 | Vaccination With 6MHP, With or Without Systemic CDX-1127, in Patients With Stage II-IV Melanoma | PHASE1 | COMPLETED | 33 | — | — | Nov 13, 2018 | Jan 19, 2024 | Feb 6, 2024 | 2 | United States |
Number of participants with dose-limiting toxicities based on CTCAE v5.0
Number of participants with durable or persistent CD4+ Th1 responses to the melanoma vaccine at either day 85 or day 176, or both
Number of participants with dose-limiting toxicities based on CTCAE v5.0
Number of participants with CD4+ T cell responses to 6 MHP persisting to day 127 or later.
| Arm | Type | Description |
|---|---|---|
| All Participants | EXPERIMENTAL | 6MHP (200mcg of each peptide) and 300mcg of NeoAg-mBRAF will be co-administered locally with 0.9mg of polyICLC and CDX-1140. There will be a dose escalation of CDX-1140 (50mcg, 200mcg, 800mcg, 3.0mg). A vaccine containing all of these components will be given on days 1, 22, 43, and 64. The vaccine will be given subcutaneously/intradermally. |
| Arm A: 6MHP/Montanide ISA-51 + polyICLC + CDX-1127 | EXPERIMENTAL | 200 mcg of 6MHP plus 0.9 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered subcutaneously on days 1, 8, 15, and 36. 200 mcg of 6MHP in Montanide ISA-51 adjuvant (without polyICLC) will be administered subcutaneously/intradermally on day 176. CDX-1127 (3mg/kg) will be administered intravenously on days 1, 36, and 78. |
| Arm B: 6MHP/Montanide ISA-51 + polyICLC | EXPERIMENTAL | 200 mcg of 6MHP plus 0.9 mg of polyICLC emulsified in Montanide ISA-51 adjuvant will be administered subcutaneously on days 1, 8, 15, and 36. 200 mcg of 6MHP in Montanide ISA-51 adjuvant (without polyICLC) will be administered subcutaneously/intradermally on day 176. |
| Name | Type | Description |
|---|---|---|
| 6MHP | DRUG | 6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides |
| NeoAg-mBRAF | DRUG | BRAF 586-614 (V600E) peptide to which a histidine has been added to the N-terminus, resulting in BRAF 585-614 (V600E). |
| PolyICLC | DRUG | polyICLC, local adjuvant |
| CDX-1140 | DRUG | CDX-1140, local adjuvant |
| Montanide ISA-51 | DRUG | Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant |
| CDX-1127 | DRUG | CDX-1127, anti-CD27 monoclonal antibody |
Main Inclusion Criteria: 1. a. For individuals with primary cutaneous, mucosal, or unknown melanoma, an individual must have stage IB ulcerated, II, III, or IV melanoma at original diagnosis or at restaging after recurrence, and be rendered clinically free of disease by surgery, other therapy, or s...