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Pembrolizumab and PDS0101 · 1 trial · 4 indications
RECIST 1.1
| Arm | Type | Description |
|---|---|---|
| Pembrolizumab and PDS0101 | EXPERIMENTAL | Pembrolizumab will be administered via IV Infusion followed by subcutaneous injections of PDS0101 five times throughout the course of the study. Pembrolizumab monotherapy will be administered every cycle there is not a combination treatment until disease progression or up to Cycle 35. |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab (KEYTRUDA®) and PDS0101 | COMBINATION_PRODUCT | IV infusion of pembrolizumab 200 mg + two 0.5mL sub-cutaneous injections of PDS0101 administered on Cycle 1, 2, 3, 4 and 12. IV infusion of Pembrolizumab 200 mg monotherapy will be administered Cycles 5 - 11 and 13 - 35. |
Inclusion Criteria: * The participant (or legally acceptable representative if applicable) provides written informed consent for the study. * Be ≥18 years of age on the day of signing the informed consent. * Checkpoint-naïve subjects: Have a history of histologically- confirmed diagnosis of squamou...
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Pembrolizumab and PDS0101 is a combination regimen being studied in metastatic head and neck cancer, including recurrent head and neck cancer and HPV16 positive oropharyngeal squamous cell carcinoma. It pairs the anti-PD-1 antibody pembrolizumab with the investigational immunotherapy PDS0101. The combination is in Phase 2 clinical development and is not approved for any indication.
Pembrolizumab targets PDCD1, also known as PD-1, and acts as an inhibitor of that checkpoint receptor. PDS0101 is an investigational immunotherapy designed to stimulate an immune response against HPV16 positive tumors. Together the regimen aims to combine checkpoint inhibition with immune activation in HPV16 positive head and neck cancer.
PDS Biotechnology Corporation, which trades on the Nasdaq under the ticker PDSB, is developing PDS0101. The company is evaluating PDS0101 in combination with pembrolizumab, which is marketed as KEYTRUDA. The combination program is focused on HPV16 positive head and neck cancer and is in Phase 2 development.
The pembrolizumab and PDS0101 combination is in Phase 2 clinical development. It is investigational and has not been approved by the FDA for any indication. The Phase 2 study evaluating the combination in HPV16 positive recurrent or metastatic head and neck squamous cell carcinoma has been completed.
The combination has been evaluated in one Phase 2 trial, NCT04260126, titled Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC. The trial enrolled 95 participants across the United States, Ireland, Puerto Rico, and the United Kingdom, and its status is completed.