Evidence map›Paper›PMID 39417692›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2024

SWOG/NCI Phase II Dual Anti-CTLA-4/PD-1 Blockade in Rare Tumors: Nonepithelial Ovarian Cancer.

Young Kwang Chae, Megan Othus, Sandip Pravin Patel, Kelly J Wilkinson, Emily M Whitman-Purves, Jayanthi Lea, John M Schallenkamp, Nabil Adra, Leonard J Appleman, Mitchell Alden and 16 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

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

8 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Review
  5. Epigenetic regulation in gynecological cancers: a paradigm shift in immunotherapy strategies.Journal of experimental & clinical cancer research : CR · 2025
    Review
  6. Review
  7. Review
  8. 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

26 authors.

Young Kwang Chae *Northwestern University, Chicago, Illinois.ORCID 0000-0003-1557-7235
Megan OthusSWOG Statistics and Data Management Center, Seattle, Washington.ORCID 0000-0001-8176-6371
Sandip Pravin Patel *Moores Cancer Center, University of California San Diego, San Diego, California.ORCID 0000-0002-8387-4840
Kelly J WilkinsonUniversity of Mississippi, Jackson, Mississippi.ORCID 0009-0000-8869-2926
Emily M Whitman-PurvesThe Mark H. Zangmeister Center, Columbus NCORP, Columbus, Ohio.ORCID 0009-0007-1868-7532
Jayanthi LeaSimmons Cancer Center-Dallas, UT Southwestern, Dallas, Texas.ORCID 0000-0002-8657-4309
John M SchallenkampBillings Clinic Cancer Center, Montana NCORP, Billings, Montana.ORCID 0000-0003-1492-7168
Nabil AdraIndiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana.ORCID 0000-0001-8905-8329
Leonard J ApplemanUPMC Hillman Cancer Center, Pittsburgh, Pennsylvania.ORCID 0000-0003-4951-7388
Mitchell AldenDoylestown Hospital, Thomas Jefferson University, Doylestown, Pennsylvania.ORCID 0009-0000-4586-9154
Jessica Thomes PepinMinnesota Oncology Hematology PA-Woodbury, Metro Minnesota Community Oncology Research Consortium, Woodbury, Minnesota.ORCID 0009-0000-5116-8151
John A EllertonNevada Cancer Research Foundation, Las Vegas, Nevada.ORCID 0009-0005-8205-2318
Andrew PoklepovicVirginia Commonwealth University, Richmond, Virginia.ORCID 0000-0002-4015-5037
Adam WalterProMedica Flower Hospital, Sylvania, Ohio.ORCID 0000-0001-5819-5160
Murtuza M RampurwalaUniversity of Chicago Medicine, Orland Park, Illinois.ORCID 0000-0002-2825-186X
William R RobinsonTulane University School of Medicine, New Orleans, Louisiana.ORCID 0009-0003-1429-4396
Hye Sung KimNorthwestern University, Chicago, Illinois.ORCID 0000-0002-7256-7597
Liam Il-Young ChungNorthwestern University, Chicago, Illinois.ORCID 0000-0001-6541-793X
Christine M McLeodSWOG Data Operations Center, Seattle, Washington.ORCID 0009-0001-3250-2799
Gabby LopezSWOG Statistics and Data Management Center, Seattle, Washington.ORCID 0009-0005-4174-9071
Helen X ChenInvestigational Drug Branch, Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, Maryland.ORCID 0000-0001-9959-8417
Elad SharonInvestigational Drug Branch, Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, Maryland.ORCID 0000-0002-0044-9719
Howard StreicherInvestigational Drug Branch, Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, Maryland.ORCID 0000-0003-3683-9804
Christopher W RyanOregon Health & Science University, Portland, Oregon.ORCID 0000-0002-4259-1123
Charles D BlankeSWOG Group Chair's Office, Knight Cancer Institute, Portland, Oregon.ORCID 0000-0002-6493-7834
Razelle KurzrockMedical College of Wisconsin, Milwaukee, Wisconsin.ORCID 0000-0003-4110-1214

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
SWOG Statistics & Data Management Center complex - extension supplement for GY06U10CA180819 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Michael L. LeBlanc · 2014 to 2026
$115.2M
Montana Cancer Consortium NCORPUG1CA189872 · NCI · MONTANA CANCER CONSORTIUM · PI Jeffrey Warren Allen, John M. Schallenkamp · 2014 to 2026
$11.0M
Columbus NCORP RFA-CA-18-016UG1CA189954 · NCI · COLUMBUS COMMUNITY CLINICAL ONCOLOGY PRG · PI Aruna Gowda, Malolan S Rajagopalan · 2014 to 2026
$9.8M
Northwestern University Lead Academic Participating Site Supplement Year 2UG1CA233320 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI BENSON, AL B, MATEI, DANIELA E · 2019 to 2025
$5.5M
Medical College of Wisconsin Lead Academic Participating Site RenewalUG1CA233198 · NCI · MEDICAL COLLEGE OF WISCONSIN · PI William H Bradley, Elizabeth M Gore · 2019 to 2026
$5.0M
Hutchinson Center as Lead Academic Participating Site (UG1)UG1CA233328 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Evan Yu · 2019 to 2026
$4.3M
Bristol Myers Squibb Foundation (BMSF)Center for Cancer Research (CCR) U10CA180819Center for Cancer Research (CCR) U10CA180888NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180868NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA189872NCI NIH HHS UG1 CA189954NCI NIH HHS UG1 CA233198NCI NIH HHS UG1 CA233320NCI NIH HHS UG1 CA233328
6 · The paper itself

Abstract

purposeThe role of dual checkpoint inhibition (ipilimumab at 1 mg/kg intravenously every 6 weeks and nivolumab at 240 mg intravenously every 2 weeks) in advanced rare/ultrarare nonepithelial ovarian cancers is yet to be explored. PATIENTS AND

methodsDual anti-CTLA-4 and anti-PD-1 blockade in rare tumor is a prospective, multicenter (1,016 US sites), multicohort, single-arm phase II trial conducted through the Early Therapeutics and Rare Cancer SWOG/NCI Committee, assessing ipilimumab (anti-CTLA-4; 1 mg/kg every 6 weeks) and nivolumab (anti-PD-1; 240 mg every 2 weeks) in adults with advanced nonepithelial ovarian cancers who lack beneficial standard therapy. The primary outcome was overall response rate [ORR; complete response (CR)/partial response (PR)]; secondary outcomes were progression-free survival (PFS), overall survival, clinical benefit rate [stable disease (SD) ≥6 months plus ORR], and toxicity.

resultsSeventeen patients (median age: 64; number of prior therapies ranged from 0 to 8 with no immunotherapy exposure; eight granulosa, six carcinosarcomas, one Sertoli-Leydig, one yolk sac, and one Wolffian) were evaluated. In granulosa cell tumors, ORR was 25% (n = 2/8; one CR and one PR) and clinical benefit rate was 50% (n = 4/8); PFS was 58.3 (CR), 50.7+ (PR), 30.4 (SD), and 8.7 (SD) months. Median PFS was 3.5 months [95% confidence interval, 1.7-11.2 months]; median overall survival was 42.5 months (95% confidence interval, 10.1 months-not reached). One Sertoli-Leydig cell tumor showed a 22% regression (PFS, 11.2 months). Carcinosarcomas had no response. Three participants (18%) discontinued treatment due to grade 3 to grade 4 adverse events.

conclusionsIpilimumab-nivolumab shows activity in treatment-refractory granulosa cell tumors, with 25% (n = 2/8) of patients experiencing either CR or PR lasting more than 4 years.

Indexed as

CTLA-4 AntigenOvarian NeoplasmsProgrammed Cell Death 1 ReceptorAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansImmune Checkpoint InhibitorsIpilimumabMiddle AgedNivolumabProgression-Free SurvivalProspective StudiesCTLA-4 AntigenCTLA4 protein, humanImmune Checkpoint InhibitorsIpilimumabNivolumabPDCD1 protein, humanProgrammed Cell Death 1 Receptor

Identifiers

PMID39417692
PMCPMC11737520

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Registered trials

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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.