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Also known as Pembrolizumab Monotherapy
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 an investigational combination being studied for the treatment of metastatic head and neck cancer, specifically HPV16-positive recurrent and/or metastatic head and neck squamous cell carcinoma. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
PDS Biotechnology Corporation (NASDAQ: PDSB) is developing Pembrolizumab and PDS0101. The combination is being studied in a Phase 2 clinical trial for patients with HPV16-positive recurrent and/or metastatic head and neck squamous cell carcinoma.
Pembrolizumab and PDS0101 is in Phase 2 clinical development. It is an investigational combination therapy and has not been approved by the FDA or other regulatory agencies. One Phase 2 trial has been completed, with results not yet reported.
Pembrolizumab and PDS0101 has been studied in one completed Phase 2 trial, NCT04260126, which enrolled 95 participants with HPV16-positive recurrent and/or metastatic head and neck squamous cell carcinoma. The trial was conducted in the United States, Ireland, Puerto Rico, and the United Kingdom.
Pembrolizumab and PDS0101 is also known as pembrolizumab monotherapy, though this name may be misleading. The therapy combines pembrolizumab with PDS0101, an investigational agent, and is being studied as a combination regimen in metastatic head and neck cancer.