Evidence map›Paper›PMID 38603953›Full record

Trial reportGynecologic oncology2024

Phase II trial of pembrolizumab and epacadostat in recurrent clear cell carcinoma of the ovary: An NRG oncology study GY016.

Lilian T Gien, Danielle M Enserro, Matthew S Block, Steven Waggoner, Linda R Duska, Andrea E Wahner-Hendrickson, Premal H Thaker, Floor Backes, Michael Kidd, Carolyn Y Muller and 6 more

Open access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Gynecologic oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
8.6field-weighted citation impact, top 2% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
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  9. Infiltration of CD8Scientific reports · 2025
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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

16 authors at 13 institutions in 1 country.

Lilian T GienSunnybrook Odette Cancer Centre, Toronto, ONT M4N 3M5, USA. Electronic address: lilian.gien@sunnybrook.ca.
Danielle M EnserroNRG Statistical Center, Roswell Park Comprehensive Cancer Center, Buffalo, NY 14263, USA. Electronic address: EnserroD@nrgoncology.org.
Matthew S BlockMayo Clinic, Rochester, MN 55905, USA. Electronic address: Block.Matthew@mayo.edu.
Steven WaggonerCase Western Reserve University, Cleveland, OH 44195, USA. Electronic address: waggons@ccf.org.
Linda R DuskaUniversity of Virginia Cancer Center, University of Virginia School of Medicine, Charlottesville, VA 22903, USA. Electronic address: lrd5d@virginia.edu.
Andrea E Wahner-HendricksonMayo Clinic, Rochester, MN 55905, USA. Electronic address: Wahner-Hendrickson.Andrea@mayo.edu.
Premal H ThakerWashington University and Siteman Cancer Center, St. Louis, MO 63110, USA. Electronic address: thakerp@wustl.edu.
Floor BackesOhio State University Comprehensive Cancer Center, Hilliard, OH 43026, USA. Electronic address: Floor.Backes@osumc.edu.
Michael KiddMontana Cancer Society NCORP, Billings Clinic Cancer Center, Billings, MT 59101, USA. Electronic address: mkidd@billingsclinic.org.
Carolyn Y MullerNew Mexico Minority Underserved NCORP, UNM Comprehensive Cancer Center, Albuquerque, NM 87131, USA. Electronic address: cmuller@salud.unm.edu.
Paul A DiSilvestroWomen & Infants Hospital, Providence, RI 02905, USA. Electronic address: pdisilvestro@wihri.org.
Allan CovensSunnybrook Odette Cancer Centre, Toronto, ONT M4N 3M5, USA. Electronic address: Al.Covens@sunnybrook.ca.
David M GershensonUniversity of Texas MD Anderson Cancer Center, Houston, TX 77030, USA. Electronic address: DGershen@mdanderson.org.
Kathleen N MooreOklahoma University Health Stephenson Cancer Center, Oklahoma City, OK 73104, USA. Electronic address: Kathleen-Moore@ouhsc.edu.
Carol AghajanianMemorial Sloan Kettering Cancer Center, New York, NY 10065, USA. Electronic address: aghajanc@mskcc.org.
Robert L ColemanUS Oncology Network, 9180 Pinecroft Ave., Shenandoah, TX 77030, USA. Electronic address: Robert.Coleman@usoncology.com.
Mayo Clinic in Arizona · USRegional Cancer Center · USBillings Clinic · USCase Western Reserve University · USMemorial Sloan Kettering Cancer Center · USOU HealthRoswell Park Comprehensive Cancer Center · USThe University of Texas MD Anderson Cancer Center · USThe US Oncology Network · USUniversity of Virginia Cancer CenterUNM Comprehensive Cancer CenterWashington University in St. Louis · USWomen & Infants Hospital of Rhode Island · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI James J. Dignam, GREG YOTHERS · 2014 to 2026
$146.4M
WASHINGTON UNIVERSITY / SITEMAN CANCER CENTER LEAD ACADEMIC SITEUG1CA233339 · NCI · WASHINGTON UNIVERSITY · PI NANCY L BARTLETT, Clifford Grant Robinson · 2019 to 2026
$11.3M
Network Lead Academic Participating Site: Memorial Sloan Kettering Cancer CenterUG1CA233290 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI CAROL AGHAJANIAN, Darren Feldman · 2019 to 2026
$10.2M
OSU as a Network Lead Academic Participating Site for the NCI NCTNUG1CA233331 · NCI · OHIO STATE UNIVERSITY · PI John L. Hays, Dwight H. Owen · 2019 to 2026
$8.9M
NCI NIH HHS P30 CA008748NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS UG1 CA233290NCI NIH HHS UG1 CA233331NCI NIH HHS UG1 CA233339
6 · The paper itself

Abstract

introductionEarly reports of PD-1 inhibition in ovarian clear cell carcinomas (OCCC) demonstrate promising response. We evaluated the combination of pembrolizumab and IDO-1 inhibitor epacadostat in patients with recurrent OCCC.

methodsThis single arm, two-stage, phase 2 trial included those with measurable disease and 1-3 prior regimens. Patients received intravenous pembrolizumab 200 mg every 3 weeks and oral epacadostat 100 mg twice a day. Primary endpoint was overall response rate (ORR), secondary endpoints were toxicity, progression-free survival (PFS) and overall survival (OS). The study was powered to detect an absolute 25% increase in response (15% to 40%).

resultsBetween September 28, 2018 and April 10, 2019, 14 patients enrolled at first stage. Rate of accrual was 2.3 patients per month. Median age was 65 years (44-89), 10 (71.4%) had ≥2 prior regimens. ORR was 21% (95% CI 5-51%) within 7 months of study entry with 3 partial responses, and 4 had stable disease (disease control rate 50%). Median PFS was 4.8 months (95% CI: 1.9-9.6), OS 18.9 months (95% CI: 1.9-NR). Most common grade ≥ 3 adverse events were electrolyte abnormalities and gastrointestinal pain, nausea, vomiting, bowel obstruction. In July 2019, the study reached the pre-specified criteria to re-open to second stage; however, the study closed prematurely in February 2021 due to insufficient drug supply.

conclusionsPembrolizumab and epacadostat demonstrated an ORR of 21% in this small cohort of recurrent OCCC. The rapid rate of accrual highlights the enthusiasm and need for therapeutic studies in patients with OCCC.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsNeoplasm Recurrence, LocalOvarian NeoplasmsSulfonamidesAdenocarcinoma, Clear CellAdultAgedAged, 80 and overFemaleHumansMiddle AgedOximesProgression-Free SurvivalAntibodies, Monoclonal, HumanizedepacadostatOximespembrolizumabSulfonamidesClear cellIDO1OvarianPD-1Pembrolizumab

Identifiers

PMID38603953
PMCPMC11265792
OpenAlexW4394680650

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.