Trial results for the combination of pembrolizumab (Keytruda) and GX-188E vaccination in patients with HPV 16 and/or 18+ advanced cervical cancer were posted on ClinicalTrials.gov on 2025-07-30. The Phase 1/2 study (NCT03444376) reported an overall response rate (ORR) of 41.4% in one part of the study and observed 0 dose-limiting toxicities.
Background
The trial investigated the combination of GX-188E vaccination and pembrolizumab for the treatment of advanced, non-resectable HPV-positive cervical cancer. Pembrolizumab is an established immunotherapy, and this study explored its potential synergy with the investigational GX-188E vaccine in this specific patient population.
Trial design
The study (NCT03444376) was a Phase 1/2, multi-center, open-label trial. It enrolled 65 participants with advanced, non-resectable HPV-positive cervical cancer. The trial evaluated the combination of GX-188E vaccination and Keytruda®.
Key results
The trial results provided insights into the safety and efficacy of the combination therapy:
- For the "DLT Evaluation for Safety and Tolerability (Part A)", 0 participants experienced dose-limiting toxicities.
- Regarding "ORR for Efficacy (Part B&C)", the overall response rate was reported as 41.4% (95% Confidence Interval) and 35.0% (95% Confidence Interval) in different analyses.
- In "ORR for Efficacy (Part A)", the overall response rate was 50.0% (95% Confidence Interval).
- For "BORR (Part B&C)", the best overall response rate was reported as 50.0% (95% Confidence Interval), 41.4% (95% Confidence Interval), and 35.0% (95% Confidence Interval).
- The median "Time-to-Best Response" was observed at 2.07 Months (90% Confidence Interval), 2.10 Months (90% Confidence Interval), and 2.10 Months (90% Confidence Interval) across different measurements.
- The median "Duration of Response (DOR)" was reported as 5.78 Months (95% Confidence Interval), with one measurement listed as NA Months (95% Confidence Interval).
What this means
The findings from this Phase 1/2 trial suggest that the combination of GX-188E vaccination and pembrolizumab demonstrates an encouraging safety profile, with 0 dose-limiting toxicities observed. The reported overall response rates, including a 50.0% ORR in Part A and 41.4% in Part B&C, indicate potential clinical activity in patients with advanced HPV-positive cervical cancer. These results support further investigation into this combination therapy as a potential treatment option for this challenging patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03444376, titled "The Combination of GX-188E Vaccination and Pembrolizumab in Patients With HPV 16 and/or 18+ Advanced Cervical Cancer," were posted on 2025-07-30 on clinicaltrials.gov.