Trial results for the Phase 2 study (NCT02635360) investigating pembrolizumab in combination with chemoradiation for advanced cervical cancer were posted on ClinicalTrials.gov on 2025-07-03. The study evaluated the safety and effectiveness of this immunotherapy regimen, administered either concurrently with or following chemoradiation.
Background
Pembrolizumab, also known as Keytruda, is an immunotherapy drug classified as a checkpoint inhibitor. This study explored its potential role in treating advanced cervical cancer.
Trial design
The Phase 2 study (NCT02635360), titled 'Pembrolizumab and Chemoradiation Treatment for Advanced Cervical Cancer,' enrolled 94 participants. The trial investigated pembrolizumab in combination with cisplatin and radiation for individuals with advanced cervical cancer. Participants received pembrolizumab either concurrently with or following chemoradiation, with the purpose of evaluating the safety and effectiveness of this combined approach.
Key results
The trial reported several key measurements related to immunologic markers, safety, and clinical response:
- Change in Immunologic Markers Following Combination of Study Drug With Chemoradiation (CD8+: FoxP3+ ratio of cells per mm^2):
- Following Chemoradiation: Mean of 31.31 (Standard Deviation: 124.77)
- Concurrent to Chemoradiation: Mean of 140.33 (Standard Deviation: 812.53)
- Number of Participants With Dose Limiting Toxicities:
- Following Chemoradiation: 0 Participants
- Concurrent to Chemoradiation: 4 Participants
- Metabolic Response Rate on PET/CT Imaging:
- Following Chemoradiation: 2 Participants
- Concurrent to Chemoradiation: 7 Participants
- Incidence of Distant Metastases:
- Following Chemoradiation: 6 Participants
- Concurrent to Chemoradiation: 6 Participants
- Progression Free Survival (Number of Participants):
- Following Chemoradiation: 41 Participants
- Concurrent to Chemoradiation: 38 Participants
- Overall Survival (Number of Participants):
- Following Chemoradiation: 42 Participants
- Concurrent to Chemoradiation: 41 Participants
What this means
The posted results provide data on the immunologic changes, safety profile, and clinical outcomes for pembrolizumab when combined with chemoradiation for advanced cervical cancer. The measurements for dose-limiting toxicities, metabolic response, distant metastases, progression-free survival, and overall survival offer insights into the different administration timings (following versus concurrent to chemoradiation). These findings contribute to the understanding of immunotherapy's role in this challenging cancer setting.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02635360, titled 'Pembrolizumab and Chemoradiation Treatment for Advanced Cervical Cancer,' were posted on 2025-07-03 on clinicaltrials.gov.