Evidence map›Paper›PMID 40629097›Full record

ArticleNPJ precision oncology2025

A phase II single-arm study of combination pembrolizumab and olaparib in the treatment of patients with advanced biliary tract cancer.

Narayanan Sadagopan, Hongkun Wang, Chao Yin, Benjamin Adam Weinberg, Marcus Smith Noel, Reetu Mukherji, Xue Geng, John Lindsay Marshall, Aiwu Ruth He

Registry-linked trialAbstract read
In one paragraph

Article in NPJ precision oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04306367 (A Phase II, Single-arm Study of Combination Pembrolizumab and Olaparib in the Treatment of Patients With Advanced Cholangiocarcinoma), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04306367 phase2completednot on this map

A Phase II, Single-arm Study of Combination Pembrolizumab and Olaparib in the Treatment of Patients With Advanced Cholangiocarcinoma

TypeinterventionalSponsorGeorgetown UniversityRan2020 to 2024Enrolled14ConditionsCholangiocarcinomaArmsPembrolizumab, Olaparib
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Narayanan SadagopanLombardi Comprehensive Cancer Center, MedStar Georgetown University Medical Center, 3800 Reservoir Rd NW, Washington, DC, 20007, USA.
Hongkun WangGeorgetown University, Department of Biostatistics, Bioinformatics and Biomathematics, 3700 O St NW, Washington, DC, 20057, USA.
Chao YinLombardi Comprehensive Cancer Center, MedStar Georgetown University Medical Center, 3800 Reservoir Rd NW, Washington, DC, 20007, USA.
Benjamin Adam WeinbergLombardi Comprehensive Cancer Center, MedStar Georgetown University Medical Center, 3800 Reservoir Rd NW, Washington, DC, 20007, USA.
Marcus Smith NoelLombardi Comprehensive Cancer Center, MedStar Georgetown University Medical Center, 3800 Reservoir Rd NW, Washington, DC, 20007, USA.
Reetu MukherjiLombardi Comprehensive Cancer Center, MedStar Georgetown University Medical Center, 3800 Reservoir Rd NW, Washington, DC, 20007, USA.
Xue GengGeorgetown University, Department of Biostatistics, Bioinformatics and Biomathematics, 3700 O St NW, Washington, DC, 20057, USA.
John Lindsay MarshallLombardi Comprehensive Cancer Center, MedStar Georgetown University Medical Center, 3800 Reservoir Rd NW, Washington, DC, 20007, USA.
Aiwu Ruth HeLombardi Comprehensive Cancer Center, MedStar Georgetown University Medical Center, 3800 Reservoir Rd NW, Washington, DC, 20007, USA. Arh2216@cumc.columbia.edu.

Funding

Tissue Culture Shared ResourceP30CA051008 · NCI · GEORGETOWN UNIVERSITY · PI MARCUS S NOEL · 1990 to 2026
$71.5M
NCI NIH HHS P30 CA051008
6 · The paper itself

Abstract

Effective second-line treatment for advanced biliary tract cancer (BTC) remains an unmet need. BTC often presents with homologous recombination repair (HRR) pathway deficiencies and IDH1/IDH2 mutations which suggest responsiveness to Poly (ADP-ribose) polymerase inhibitors. Thirteen patients were enrolled in our open-label, single-site phase II study of pembrolizumab and olaparib in the second-line setting and beyond for patients with advanced BTC. The objective response rate was 15.4% and the disease control rate was 53.8%. The median progression-free survival (PFS) was 5.45 months (95% CI 1.25-7.82), and the median overall survival was 7.21 months (95% CI 4.5-13.8). Both patients with IDH1 mutations and 2 of the 4 patients with HRR mutations achieved a PFS of at least 7.5 months. All BTC patients do not appear to benefit from pembrolizumab plus olaparib, but those with HRR deficiencies and/or IDH mutations may benefit although it would now represent a rechallenge with immunotherapy. Trial registration: NCT04306367, date of registration 3/10/2020.

Identifiers

PMID40629097
PMCPMC12238646

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.