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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 an investigational combination studied in adults with HPV16-positive recurrent or metastatic head and neck squamous cell carcinoma, including HPV-positive oropharyngeal cancer. It is being evaluated in the metastatic head and neck cancer setting in an oncology program.
Pembrolizumab targets PDCD1, also known as PD-1, and acts as an inhibitor of that checkpoint receptor. PDS0101 is an immunotherapy designed to generate HPV16-specific T cell responses. Together the combination pairs checkpoint inhibition with an HPV-directed immune approach in HPV16-positive head and neck cancer.
PDS Biotechnology Corporation, which trades under the ticker PDSB, is developing PDS0101 in combination with pembrolizumab. Pembrolizumab itself is marketed as KEYTRUDA. The combination program is being advanced by PDS Biotechnology in the metastatic head and neck cancer setting.
The pembrolizumab and PDS0101 combination is in Phase 2 clinical development. It is investigational and has not been approved for any indication. The Phase 2 study in HPV16-positive recurrent or metastatic head and neck cancer has been completed.
The combination has been studied in NCT04260126, a Phase 2 trial 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 it is completed.