Trial results for a Phase 2 study (NCT05634577) investigating pembrolizumab in combination with mitotane for advanced adrenocortical carcinoma were posted on ClinicalTrials.gov on 2025-06-19. The study was terminated early after enrolling only 3 participants, with no efficacy or safety data reported.
Background
The study aimed to evaluate the efficacy and safety of combining pembrolizumab with mitotane in patients diagnosed with advanced adrenocortical carcinoma. The trial's objective was to determine if this drug combination could help control the disease and to assess its safety profile.
Trial design
The study (NCT05634577) was a Phase 2 trial designed to investigate the combination of pembrolizumab and mitotane. It focused on patients with advanced adrenocortical carcinoma. The trial enrolled a total of 3 participants. The study's brief summary indicated an aim to learn if adding pembrolizumab to mitotane could help control adrenocortical carcinoma, as well as to study the safety of this drug combination.
What this means
Due to the early termination of the study after enrolling only 3 participants and the absence of reported outcome measurements or analyses, no conclusions can be drawn regarding the efficacy or safety of pembrolizumab in combination with mitotane for advanced adrenocortical carcinoma from this particular trial. The termination indicates that the study did not proceed to generate meaningful clinical data.
Source
The information regarding this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05634577, titled "A Phase II Study to Evaluate the Efficacy and Safety of Pembrolizumab in Combination With Mitotane in Patients With Advanced Adrenocortical Carcinoma," were posted on 2025-06-19 on clinicaltrials.gov.