Evidence map›Paper›PMID 41672597›Full record

Trial reportJournal for immunotherapy of cancer2026

DART/SWOG/NCI phase II anti-CTLA-4/PD-1 trial: clear cell carcinomas of ovary, endometrium, cervix.

Young Kwang Chae, Megan Othus, Sandip P Patel, Floortje J Backes, David M O'Malley, Mihaela Cristea, Aung Naing, Katherine Kurnit, Ramez N Eskander, Scott T Goodrich and 24 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02834013 (DART), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT02834013 phase2active not recruitingnot on this map

DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2017 to 2027Enrolled798ConditionsAcinar Cell Carcinoma, Adenoid Cystic Carcinoma, Adrenal Cortical Carcinoma, Adrenal Gland PheochromocytomaArmsBiospecimen Collection, Computed Tomography, Echocardiography Test, Ipilimumab, Magnetic Resonance Imaging
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. 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

34 authors.

Young Kwang Chae *Northwestern University, Chicago, Illinois, USA chaelabmeeting@gmail.com patel@ucsd.edu rkurzrock@mcw.edu.ORCID http://orcid.org/0000-0003-1557-7235
Megan OthusSWOG Statistics and Data Management Center, Seattle, Washington, USA.ORCID http://orcid.org/0000-0001-8176-6371
Sandip P Patel *University of California at San Diego Moores Cancer Center, Sacramento, La Jolla, USA chaelabmeeting@gmail.com patel@ucsd.edu rkurzrock@mcw.edu.
Floortje J BackesOhio State University, Columbus, Ohio, USA.
David M O'MalleyOhio State University, Columbus, Ohio, USA.
Mihaela CristeaCity of Hope Comprehensive Cancer Center, Duarte, California, USA.
Aung NaingMD Anderson Cancer Center, Houston, Texas, USA.ORCID http://orcid.org/0000-0002-4803-8513
Katherine KurnitUniversity of Chicago, Chicago, Illinois, USA.
Ramez N EskanderUniversity of California at San Diego Moores Cancer Center, Sacramento, La Jolla, USA.
Scott T GoodrichParkview Regional Medical Center, Fort Wayne, Indiana, USA.
William R RobinsonTulane University School of Medicine, New Orleans, Louisiana, USA.
Jennifer ScaliciUniversity of South Alabama Mitchell Cancer Institute, South Alabama, Alabama, USA.
John ChanCalifornia Pacific Medical Center Pacific Campus, San Francisco, California, USA.
Hussein Ali-AhmadMichigan CRC NCORP, Ann Arbor, Michigan, USA.
John HaysOhio State University, Columbus, Ohio, USA.
Colleen McCormickLegacy Good Samaritan Hospital and Medical Center, Portland, Oregon, USA.
Edward J KimUniversity of California Davis, Davis, California, USA.
Thanasak SueblinvongKaiser Permanente NCORP, Honolulu, Hawaii, USA.
Amina AhmedRush University Medical Center, Chicago, Illinois, USA.
Jean SiedelUniversity of Michigan, Ann Arbor, Michigan, USA.
Jessica Thomes PepinMinnesota Oncology Hematology PA, Woodbury, Minnesota, USA.
Justin Neal Bottsford-MillerMontana NCORP, Bozeman, Montana, USA.
Seth Olusegun FagbemiWisconsin NCORP, Marshfield, Wisconsin, USA.
Anthony John JaslowskiWisconsin NCORP, Marshfield, Wisconsin, USA.
Hye Sung KimNorthwestern University, Chicago, Illinois, USA.
Liam Il-Young ChungNorthwestern University, Chicago, Illinois, USA.
Carolyn Moloney-LineenNorthwestern University, Chicago, Illinois, USA.
Christine M McLeodSWOG Data Operations Center, Seattle, Washington, USA.
Helen X ChenNational Cancer Institute, Investigational Drug Branch, Cancer Therapy Evaluation Program, Bethesda, Maryland, UK.
Elad SharonNational Cancer Institute, Investigational Drug Branch, Cancer Therapy Evaluation Program, Bethesda, Maryland, UK.
Howard StreicherNational Cancer Institute, Investigational Drug Branch, Cancer Therapy Evaluation Program, Bethesda, Maryland, UK.
Christopher W RyanOregon Health and Science University, Portland, Oregon, USA.
Charles D BlankeSWOG Group Chair's Office, Knight Cancer Institute, Portland, Oregon, USA.
Razelle KurzrockMedical College of Wisconsin, Milwaukee, Wisconsin, USA chaelabmeeting@gmail.com patel@ucsd.edu rkurzrock@mcw.edu.

Funding

SWOG Statistics & Data Management Center complex - extension supplement for GY06U10CA180819 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI MEGAN OTHUS · 2014 to 2026
$115.2M
Staff InvestigatorsP30CA093373 · NCI · UNIVERSITY OF CALIFORNIA DAVIS · PI KC KENT LLOYD · 2002 to 2026
$84.9M
UM LAPs -UG1 GrantUG1CA233160 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ANNE F SCHOTT · 2019 to 2026
$5.4M
NCI NIH HHS P30 CA093373NCI NIH HHS U10 CA180819NCI NIH HHS UG1 CA233160
6 · The paper itself

Abstract

backgroundDual anti-CTLA-4/PD-1 inhibitors show efficacy in numerous malignancies. We are the first to report on the efficacy of ipilimumab-nivolumab immunotherapy in a dedicated cohort of patients with gynecologic clear cell carcinomas (CCCs), which are rare, aggressive cancers.

methodsDART is a multicenter, multicohort phase II trial of ipilimumab (1 mg/kg intravenously every 6 weeks) plus nivolumab (240 mg intravenously every 2 weeks), with primary objective as Response Evaluation Criteria in Solid Tumors (RECIST)-based overall response rate (ORR). Secondary objectives were ORR by immune RECIST (iRECIST), progression-free survival (PFS), overall survival (OS), clinical benefit rate (CBR; overall response plus stable disease (SD) ≥6 months), and toxicity.

resultsOverall, in this cohort of 32 patients with gynecologic CCC (N=19 ovarian, N=8 endometrial, N=5 cervical; 1-8 prior therapies; 3 had prior PD-1 inhibitor exposure), an ORR of 9.38% was seen. This included two complete responses (CRs) (both ovarian origin) that are ongoing at >3 years and one partial response (PR). Overall ORR increased to 12.5% when including one PR by iRECIST criteria for a patient with cervical CCC lasting 26 months, with an OS of 32.0 months. The CBR was 21.88% overall for all 32 (7/32) evaluable patients with gynecologic CCC. This included two CR, one PR, and two patients with SD >6 months with ovarian CCC and one PR by iRECIST and one SD >6 months in two patients with cervical CCC. PFS for the seven patients with CBR was 63.6+, 47.8+, 40.5+, 50.8+, 7.4, 26, and 58.1+ months. Median OS was 21.7 months for all 32 evaluable patients. Seven of 32 patients (21.9%) discontinued therapy because of toxicity; there were no treatment-related deaths.

conclusionsIpilimumab plus nivolumab demonstrated durable antitumor activity in certain patients with CCC of gynecological origin, particularly in those with CCC of ovarian origin. Safety is consistent with the known profile of ipilimumab and nivolumab. Correlative studies to better identify which patients will respond to combined ipilimumab and nivolumab are ongoing. TRIAL REGISTRATION NUMBER: NCT02834013.

Indexed as

Adenocarcinoma, Clear CellAntineoplastic Combined Chemotherapy ProtocolsEndometrial NeoplasmsImmune Checkpoint InhibitorsOvarian NeoplasmsUterine Cervical NeoplasmsAdultAgedCTLA-4 AntigenFemaleHumansIpilimumabMiddle AgedNivolumabProgrammed Cell Death 1 ReceptorCTLA-4 AntigenCTLA4 protein, humanImmune Checkpoint InhibitorsIpilimumabNivolumabPDCD1 protein, humanProgrammed Cell Death 1 ReceptorCombination therapyImmune Checkpoint InhibitorOvarian CancerSolid tumor

Identifiers

PMID41672597
PMCPMC12911695

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.