Trial results for the Phase 2 study investigating pembrolizumab (Keytruda) in combination with tadalafil for recurrent or metastatic head and neck cancer were posted on ClinicalTrials.gov on 2026-02-12. The study reported a mean progression-free survival of 21.56 months for participants receiving the combination therapy.
Background
The study investigated the combination of pembrolizumab and tadalafil for advanced head and neck cancer, specifically including Head and Neck Squamous Cell Carcinoma and various stages of Head and Neck Carcinoma.
Trial design
The study (NCT03993353) was a Phase 2 trial that enrolled 7 participants. It investigated the combination of pembrolizumab and tadalafil in individuals with recurrent or metastatic head and neck cancer, including Head and Neck Squamous Cell Carcinoma and Head and Neck Carcinoma Stage III and Stage IV. The trial aimed to examine the safety and efficacy of this combination.
Key results
The trial results for the Tadalafil and Pembrolizumab group included several key measurements:
- The rate of Dose Limiting Toxicity (DLT) was observed in 1 participant.
- Overall Survival (OS) was reported for 3 participants.
- Response Measured by RECIST 1.1 was observed in 1 participant.
- Progression Free Survival had a mean of 21.56 months with a Standard Deviation of 22.98.
- Adverse Event Rates were reported for 6 participants.
What this means
The results from this Phase 2 trial provide preliminary data on the safety and efficacy profile of pembrolizumab and tadalafil in recurrent or metastatic head and neck cancer. The observed mean progression-free survival of 21.56 months and the reported rates of dose-limiting toxicities and adverse events offer initial insights into the combination's potential. Given the small enrollment of 7 participants, these findings are exploratory and would require further investigation in larger studies to confirm clinical benefit and establish a definitive safety profile.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03993353, titled "Tadalafil and Pembrolizumab in Recurrent or Metastatic Head and Neck Cancer," were posted on 2026-02-12 on clinicaltrials.gov.