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6MHP · 2 trials · 3 indications
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...
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6MHP is an investigational monoclonal antibody being studied for the treatment of melanoma, including ocular and uveal melanoma. It is currently in Phase 1 clinical development and has not been approved by the FDA. Two Phase 1 trials have been completed, enrolling a total of 55 patients.
6MHP is being developed by Celldex Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol CLDX. The company is conducting clinical trials to evaluate the safety and efficacy of 6MHP in patients with melanoma.
6MHP is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total enrollment of 55 patients. The drug is investigational and has not received FDA approval. It is being studied for the treatment of melanoma, including ocular and uveal melanoma.
6MHP has been studied in two completed Phase 1 trials. The first, NCT03617328, enrolled 33 patients with stage II-IV melanoma and evaluated vaccination with 6MHP with or without systemic CDX-1127. The second, NCT04364230, enrolled 22 patients with melanoma, including ocular and uveal melanoma, and tested a vaccine against neoantigen and shared antigens.
6MHP is not the same as CDX-1127. In clinical trial NCT03617328, 6MHP was administered with or without systemic CDX-1127, indicating they are separate agents. CDX-1127 is a systemic treatment, while 6MHP is a monoclonal antibody vaccine being studied for melanoma.