18 and older, any sex, with Cholangiocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate (ORR)Primary· up to 2 years
The objective response rate (ORR) is the number of subjects with confirmed Partial Response or Complete Response according to RECIST 1.1, for target lesions assessed by Computed tomography (CT) Scan.
Group
Value
95% CI
Experimental
2
Duration of ResponseSecondary· 3 years
Duration of response (DOR), number of months from first response to progression.
Group
Value
95% CI
Experimental
19.75
6.1 – 33.4
Progression Free Survival (PFS)Secondary· 3 years
Progression free survival (PFS) is the time from enrollment to progression or death from any cause.
Group
Value
95% CI
Experimental
5.45
1.25 – 7.82
Overall Survival (OS)Secondary· 3 years
overall survival (OS) of subjects from the time of enrollment to death from any cause.
Group
Value
95% CI
Experimental
7.21
4.5 – 13.77
Safety and TolerabilitySecondary· 1 year
Number of participants with a treatment-related adverse events as assessed by an Investigator according to CTCAE v4.0
Group
Value
95% CI
Experimental
11
Adverse events — posted to ClinicalTrials.gov
Time frame: All AEs from the time of treatment through 30 days following cessation of study treatment and all AEs meeting serious criteria, from the time of treatment through 90 days following cessation of study treatment, or 30 days following cessation of study treatment if the participant initiates new anticancer therapy, whichever is earlier. Up to 2.5 years. All-Cause Mortality monitored up to 3 years..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The investigators propose an open label, one-arm study to assess the safety and efficacy of olaparib and pembrolizumab in patients with cholangiocarcinoma who have progressed on or cannot tolerate gemcitabine-based therapy.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
· Phase 2, PHASE3
· not yet recruiting
NCT07275216 — Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Stand
· Phase 2
· not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan
· Phase 1, PHASE2
· recruiting
NCT06724042 — Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors
· Phase 1
· not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
Other recruiting trials for Cholangiocarcinoma
Currently open trials in the same condition.
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· recruiting
NCT07291947 — PULSAR Combined With Immunotherapy and Chemotherapy
· Phase 1, PHASE2
· recruiting
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· recruiting
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· NA
· recruiting
NCT07228000 — Bundled Cancer Screening and Genetic Services Navigation
· NA
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NCT07128927 — Assessing the Feasibility of Web-based Insomnia Treatment Among Prostate Cancer Survivors
· NA
· recruiting
NCT06046287 — Daratumumab for Polyneuropathy Associated With MGUS
· Phase 2
· withdrawn
NCT06980103 — Use of a Decision Aid to Resolve Uncertainty About Radioactive Iodine Treatment in Patients With Intermediate Risk Thyro
· NA
· recruiting
NCT07105358 — Visual Plasticity Following Brain Lesions
· NA
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Georgetown University
Last refreshed: 17 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04306367.