Trial results for the Phase 2 study (NCT04483544) investigating the combination of pembrolizumab and olaparib in patients with cervical cancer were posted on ClinicalTrials.gov on 2025-04-29. The study, which was terminated, reported an Immune Overall Response Rate of 16.7 percent of participants among the enrolled patients.
Background
The study (NCT04483544) was designed as a non-randomized, open-label Phase 2 clinical trial. Its objective was to evaluate the investigational combination of pembrolizumab with olaparib in patients diagnosed with advanced or recurrent cervical carcinoma following standard chemotherapy.
Trial design
The Phase 2 trial (NCT04483544) enrolled 8 participants diagnosed with Cervical Cancer or Cervical Carcinoma. The study investigated the combination of pembrolizumab and olaparib. It was designed as a non-randomized, open-label study and was ultimately TERMINATED.
Key results
The trial reported several key outcome measurements for the treatment group:
- The Immune Overall Response Rate was 16.7 percent of participants.
- The median Progression Free Survival was 4.5 months.
- The Number of Patient Reporting Treatment-emergent Adverse Events (TEAEs) was 8 Participants, indicating all enrolled participants reported TEAEs.
- The mean Duration of Response was 62 days (Standard Deviation: 0).
What this means
The results from this Phase 2 trial provide initial data on the combination of pembrolizumab and olaparib in advanced or recurrent cervical carcinoma. While an Immune Overall Response Rate of 16.7 percent and a median Progression Free Survival of 4.5 months were observed, the study's termination and small enrollment of 8 participants limit the generalizability and definitive conclusions that can be drawn from these findings. The report that all 8 participants experienced treatment-emergent adverse events highlights safety considerations for this combination in this patient population.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04483544, titled "Pembrolizumab and Olaparib in Cervical Cancer Patients," were posted on 2025-04-29 on clinicaltrials.gov.