Evidence map›Paper›PMID 37890345›Full record

Trial reportGynecologic oncology2023

Niraparib and dostarlimab for the treatment of recurrent platinum-resistant ovarian cancer: results of a Phase II study (MOONSTONE/GOG-3032).

Leslie M Randall, David M O'Malley, Bradley J Monk, Robert L Coleman, Stephanie Gaillard, Sarah Adams, Linda R Duska, Heather Dalton, Robert W Holloway, Marilyn Huang and 11 more

Open access · greenAbstract readMulticenter StudyClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gynecologic oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
5.3field-weighted citation impact, top 4% 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

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 23 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
  5. Review
  6. Article
  7. Review
  8. The diversity of CD8Nature reviews. Immunology · 2025
    Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. 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

21 authors at 17 institutions in 2 countries.

Leslie M RandallVirginia Commonwealth University, Massey Cancer Center, Richmond, VA, USA. Electronic address: Leslie.Randall@vcuhealth.org.
David M O'MalleyThe Ohio State University, James Comprehensive Cancer Center, Columbus, OH, USA.
Bradley J MonkHonorHealth Research Institute, University of Arizona College of Medicine, Phoenix, AZ, USA.
Robert L ColemanSarah Cannon Research Institute (SCRI) (GOG), Nashville, TN, USA.
Stephanie GaillardJohns Hopkins School of Medicine, Baltimore, MD, USA.
Sarah AdamsThe University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, USA.
Linda R DuskaUniversity of Virginia, Charlottesville, VA, USA.
Heather DaltonArizona Center for Cancer Care, Phoenix, AZ, USA.
Robert W HollowayAdventHealth Cancer Institute, Orlando, FL, USA.
Marilyn HuangSylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, FL, USA.
Hye Sook ChonH. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Noelle G ClovenTexas Oncology - Fort Worth, Fort Worth, TX, USA.
Adam C ElNaggarWest Cancer Center & Research Institute, Memphis, TN, USA.
Roisin E O'CearbhaillMemorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, NY, USA.
Steven WaggonerCleveland Clinic, OH, USA.
Aarti TarkarGSK, Collegeville, PA, USA.
Alina StrihaPlus-Project Partnership Ltd, Leeds, UK.
Linda M NelsenGSK, Collegeville, PA, USA.
Amanda BainesGSK, Stevenage, UK.
Vivek SamnotraGSK, Waltham, MA, USA.
Panagiotis A KonstantinopoulosDana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.
GlaxoSmithKline (United States) · USAge UK · GBCleveland Clinic · USDana-Farber Cancer Institute · USFlorida Hospital Cancer Institute · USJohns Hopkins Medicine · USMemorial Sloan Kettering Cancer Center · USMoffitt Cancer Center · USSarah Cannon · USSylvester Comprehensive Cancer Center · USTexas Oncology · USThe Ohio State University · USUniversity of Arizona · USUniversity of New Mexico · USUniversity of Virginia · USVirginia Commonwealth University · USWest Cancer Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

objectiveThis study assessed the efficacy, safety, and health-related quality of life (HRQoL) of the treatment regimen of dostarlimab, a programmed death-1 inhibitor, combined with niraparib, a poly (ADP-ribose) polymerase inhibitor, in patients with BRCA wild type (BRCAwt) recurrent platinum-resistant ovarian cancer (PROC) who had previously received bevacizumab treatment.

methodsThis Phase II, open-label, single-arm, multicenter study, conducted in the USA, enrolled patients with recurrent PROC to receive niraparib and dostarlimab until disease progression or unacceptable toxicity (up to 3 years). A preplanned interim futility analysis was performed after the first 41 patients had undergone ≥1 radiographic evaluation (approximately 9 weeks from the first treatment).

resultsThe prespecified interim futility criterion was met and the study was therefore terminated. For the 41 patients assessed, the objective response rate (ORR) was 7.3% (95% confidence interval: 1.5-19.9); no patients achieved a complete response, 3 patients (7.3%) achieved a partial response (duration of response; 3.0, 3.8, and 9.2 months, respectively), and 9 patients (22.0%) had stable disease. In total, 39 patients (95.1%) experienced a treatment-related adverse event, but no new safety issues were observed. HRQoL, assessed using FOSI, or Functional Assessment of Cancer Therapy - Ovarian Symptom Index scores, worsened over time compared with baseline scores.

conclusionsThe study was terminated due to the observed ORR at the interim futility analysis. This highlights a need for effective therapies in treating patients with recurrent BRCAwt PROC.

Indexed as

Antineoplastic AgentsOvarian NeoplasmsAntibodies, Monoclonal, HumanizedCarcinoma, Ovarian EpithelialFemaleHumansIndazolesNeoplasm Recurrence, LocalPiperidinesPoly(ADP-ribose) Polymerase InhibitorsQuality of LifeAntibodies, Monoclonal, HumanizedAntineoplastic AgentsdostarlimabIndazolesniraparibPiperidinesPoly(ADP-ribose) Polymerase InhibitorsDostarlimabImmunotherapyNiraparibPhase IIPlatinum-resistant ovarian cancerPoly(ADP-ribose) polymerase inhibitors

Identifiers

PMID37890345
PMCPMC11185194
OpenAlexW4387936429

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.