Pembrolizumab Trial Results Posted for Advanced Cancer with Genomic Instability

Trial results for pembrolizumab (Keytruda) in treating participants with metastatic, recurrent, or locally advanced cancer and genomic instability were posted on ClinicalTrials.gov on 2026-04-03. The study, NCT03428802, included an assessment of Overall Response Rate (ORR) per RECIST v1.1, which involved 20 participants.

Background

Pembrolizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. This trial investigated its use in participants with metastatic, recurrent, or locally advanced cancers characterized by genomic instability, specifically those with BRCA1 Gene Mutation, BRCA2 Gene Mutation, or POLD1 Gene Mutation, alongside Locally Advanced Solid Neoplasm or Metastatic Malignant Solid Neoplasm.

Trial design

The study, NCT03428802, was a Phase 2 trial that enrolled 21 participants. It investigated pembrolizumab in individuals with BRCA1 Gene Mutation, BRCA2 Gene Mutation, POLD1 Gene Mutation, Locally Advanced Solid Neoplasm, or Metastatic Malignant Solid Neoplasm. The trial's overall status is "ACTIVE_NOT_RECRUITING."

Key results

For the outcome titled "Overall Response Rate (ORR) Per RECIST v1.1," under the "Laboratory Biomarker Analysis" group, the results indicated a count of 20 Participants. This measurement represents the number of participants assessed for this outcome.

What this means

The posting of these results provides initial data from a Phase 2 study of pembrolizumab in a specific population of patients with advanced cancers and genomic instability. While the current data provides a count of participants for the Overall Response Rate outcome, further detailed analysis would be necessary to fully understand the implications for clinical practice regarding efficacy and safety in this patient group.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03428802, titled "Pembrolizumab in Treating Participants With Metastatic, Recurrent or Locally Advanced Cancer and Genomic Instability," were posted on 2026-04-03 on clinicaltrials.gov.