Trial results for the Phase 1 study (NCT03144466) investigating pembrolizumab with platinum and radiotherapy in cervix cancer were posted on ClinicalTrials.gov on 2026-05-05. The study was terminated after enrolling only one participant, which limited the scope of the reported outcome data.
Background
Pembrolizumab (Keytruda) is an immunotherapy drug. The study aimed to explore its use in locally advanced cervix cancer, a condition typically managed with radiotherapy, concomitant cisplatin chemotherapy, and brachytherapy. The rationale for investigating immunomodulatory strategies like pembrolizumab in this setting stems from the strong association of 99% of all cervix cancers with human papillomavirus (HPV) infection, alongside challenges in achieving locoregional control and preventing distant metastatic relapse.
Trial design
The study (NCT03144466) was a Phase 1 trial designed to investigate pembrolizumab in combination with platinum and radiotherapy for cervix cancer. The trial was planned to evaluate the safety and response rates of this combination. It had an enrollment of one participant and was ultimately terminated.
Key results
Due to the termination of the study after enrolling only one participant, the reported key measurements reflect data from this single individual in the 'Part A - Starting Dose' group. The results indicated 0 participants with dose-limiting toxicities and 0 participants with late radiotherapy toxicity. For 'Evaluate Toxicities of Treatment' and 'Response Rates', the data showed 1 participant for each outcome, indicating the single enrolled individual was assessed.
What this means
The termination of this Phase 1 trial after enrolling only one participant significantly limits the interpretability and generalizability of the results. While the reported data for the single participant showed no dose-limiting or late radiotherapy toxicities, and assessments were made for overall toxicities and response rates, these findings cannot be extrapolated to a broader patient population. The study's early termination suggests that it did not proceed as initially planned to gather comprehensive safety and efficacy data for pembrolizumab in combination with platinum and radiotherapy for cervix cancer.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03144466, titled 'A Study of Pembrolizumab And Platinum With Radiotherapy in Cervix Cancer,' were posted on 2026-05-05 on clinicaltrials.gov.