Evidence map›Paper›PMID 37882676›Full record

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

A Phase II Basket Trial of Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART SWOG 1609 Cohort 47) in Patients with Gestational Trophoblastic Neoplasia.

Sandip P Patel, Megan Othus, Young Kwang Chae, Michael J Dennis, Sarah Gordon, David Mutch, Wolfram Samlowski, William R Rusty Robinson, Elad Sharon, Christopher Ryan and 4 more

Open access · greenAbstract readClinical Trial, Phase II
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 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
6.1field-weighted citation impact, top 3% 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

21 citing papers in PubMed, 23 citations in OpenAlex.

  1. Trial
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  4. A Phase II Basket Trial of Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors SWOG S1609: Vulvar Cancers.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Trial
  5. SWOG/NCI Phase II Dual Anti-CTLA-4/PD-1 Blockade in Rare Tumors: Nonepithelial Ovarian Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Trial
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  14. Immune checkpoint inhibitors in gynecologic oncology: Current status and perspectives.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2025
    Review
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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

14 authors at 11 institutions in 2 countries.

Sandip P Patel *Division of Medical Oncology, University of California San Diego Moores Cancer Center, La Jolla, California.ORCID 0000-0002-8387-4840
Megan OthusSWOG Statistical and Data Management Center/Division of Public Health Sciences, Fred Hutchinson Cancer Center, Seattle, Washington.ORCID 0000-0001-8176-6371
Young Kwang Chae *Division of Medical Oncology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.ORCID 0000-0003-1557-7235
Michael J DennisDivision of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.ORCID 0000-0002-8175-5311
Sarah GordonVirginia Commonwealth University/Massey Cancer Center Division of Hematology, Oncology, Palliative Care, Virginia Commonwealth University, Richmond, Virginia.ORCID 0000-0003-0443-5573
David MutchDivision of Gynecologic Oncology, Washington University School of Medicine, St. Louis, Missouri.ORCID 0000-0002-6921-1581
Wolfram SamlowskiDivision of Medical Oncology, Nevada Cancer Institute, Las Vegas, Nevada.ORCID 0000-0002-0713-914X
William R Rusty RobinsonDivision of Gynecologic Oncology, University of Mississippi Medical Center Cancer Center and Research Institute, Jackson, Mississippi.ORCID 0009-0003-1429-4396
Elad SharonDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Cancer Therapy Evaluation Program, Bethesda, Maryland.ORCID 0000-0002-0044-9719
Christopher RyanDivision of Hematology and Oncology, Oregon Health and Science University Knight Cancer Institute, Portland, Oregon.ORCID 0000-0002-4259-1123
Gabby LopezSWOG Statistical and Data Management Center/Division of Public Health Sciences, Fred Hutchinson Cancer Center, Seattle, Washington.ORCID 0009-0005-4174-9071
Melissa PletsSWOG Statistical and Data Management Center/Division of Public Health Sciences, Fred Hutchinson Cancer Center, Seattle, Washington.ORCID 0009-0005-1449-0674
Charles BlankeSWOG Group Chair's Office/Knight Cancer Institute, Oregon Health & Science University, Portland, Oregon.ORCID 0000-0002-6493-7834
Razelle KurzrockDivision of Medical Oncology, Medical College of Wisconsin Froedtert Cancer Center, Milwaukee, Wisconsin.ORCID 0000-0003-4110-1214
Fred Hutch Cancer Center · USOregon Health & Science University · USComprehensive Cancer Centers of Nevada · USDana-Farber Cancer Institute · USFroedtert Hospital · USNational Cancer Institute · MYNorthwestern University · USUniversity of California San Diego Medical Center · USUniversity of Mississippi Medical Center · USVirginia Commonwealth University · USWashington University in St. Louis · US

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
WASHINGTON UNIVERSITY / SITEMAN CANCER CENTER LEAD ACADEMIC SITEUG1CA233339 · NCI · WASHINGTON UNIVERSITY · PI NANCY L BARTLETT, Clifford Grant Robinson · 2019 to 2026
$11.3M
SOUTHERN NEVADA CANCER RESEARCH FOUNDATION-CCOPU10CA035421 · NCI · SOUTHERN NEVADA CANCER RESEARCH FDN · PI ELLERTON, JOHN A · 1985 to 2014
$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
NCI NIH HHS U10 CA035421NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180868NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA233320NCI NIH HHS UG1 CA233339
6 · The paper itself

Abstract

purposeThe efficacy of immune checkpoint blockade in gestational trophoblastic neoplasia (GTN) remains uncertain. We report the results of the GTN cohort of SWOG S1609 dual anti-CTLA-4 and anti-PD-1 blockade in rare tumors (DART). PATIENTS AND

methodsThis prospective, open-label phase II trial evaluated ipilimumab plus nivolumab across multiple rare tumor cohorts, including GTN. Eligible patients received nivolumab 240 mg, i.v. every 2 weeks and ipilimumab 1 mg/kg i.v. every 6 weeks. The primary endpoint was overall response rate [ORR; complete response (CR) + partial response (PR)] by quantitative serum beta human chorionic gonadotropin (β-hCG); secondary endpoints included progression-free survival (PFS), overall survival (OS), and toxicity.

resultsFour patients with refractory GTN enrolled and received therapy. At 11 months of ongoing follow-up, 3 of 4 patients responded [ORR = 75% (CR, 25%, n = 1, tumor mutation burden = 1 mutation/megabase; PD-L1 tumor proportion score = 50%); PR, 50%, n = 2)]. Responders included malignant gestational trophoblastic neoplasm (n = 1, CR, PFS 11+ months) and choriocarcinoma (n = 2, both PRs, PFS 10+ and 6+ months). One patient with epithelioid trophoblastic tumor experienced disease progression. The 6-month PFS was 75% [95% confidence interval (CI), 43%-100%], and the median PFS was not reached (range, 35-339+ days); all 4 patients were alive at last follow-up. Two patients experienced grade 3 immune-related toxicity (arthralgia and colitis); there were no grade ≥4 events.

conclusionsIpilimumab plus nivolumab demonstrated efficacy in chemotherapy-refractory GTN, an ultra-rare cancer affecting young women. Three of 4 patients achieved ongoing objective responses with a reasonable safety profile at 6-11+ months.

Indexed as

Gestational Trophoblastic DiseaseMelanomaAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansIpilimumabNivolumabPregnancyProspective StudiesIpilimumabNivolumab

Identifiers

PMID37882676
PMCPMC10842092
OpenAlexW4387950106

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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.