Evidence map›Paper›PMID 40588371›Full record

Trial reportJournal for immunotherapy of cancer2025

Phase II basket trial of Dual Anti-CTLA-4 and anti-PD-1 blockade in Rare Tumors (DART) SWOG S1609: pancreatic neuroendocrine neoplasm (PNEN) cohort.

Sandip Pravin Patel, Jillian Fisher, Young Kwang Chae, Luisa Solis Soto, Anup Kasi, Bhavana Konda, Mark Walshauser, Edwin Parra, Jiexin Zhang, Caroline Duault and 22 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2025. 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 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. Review
  3. 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

32 authors.

Sandip Pravin Patel *UC San Diego Health Moores Cancer Center, La Jolla, California, USA spatel@ucsd.edu.ORCID http://orcid.org/0000-0002-8387-4840
Jillian FisherUniversity of Washington, Seattle, Washington, USA.
Young Kwang Chae *Hematology and Oncology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.ORCID http://orcid.org/0000-0003-1557-7235
Luisa Solis SotoTranslational Molecular Pathology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Anup KasiKUMC, Kansas City, Kansas, USA.
Bhavana KondaInternal Medicine, Division Of Medical Oncology, The Ohio State University, Columbus, Ohio, USA.
Mark WalshauserCancer Care Center of O'Fallon, O'Fallon, Illinois, USA.
Edwin ParraTranslational Molecular Pathology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Jiexin ZhangDepartment of Bioinformatics and Computational Biology, University of Texas MD Anderson Cancer Center, Hosuton, Texas, USA.
Caroline DuaultInstitute for Immunity, Transplantation, Infections, Stanford University School of Medicine, Stanford, California, USA.ORCID http://orcid.org/0000-0003-2742-1668
Edgar Gonzalez-KozlovaPrecision Immunology Institute and Tisch Cancer Institute, Department of Immunology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Ganiraju ManyamUniversity of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Jianhua ZhangDepartment of Genomic Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Hong ChenUniversity of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Dzifa Yawa DuoseUniversity of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Caddie Laberiano FernandezUniversity of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Raja LuthraUniversity of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Gheath Al-AtrashUniversity of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Seunghee Kim-SchulzeIcahn School of Medicine at Mount Sinai, New York, New York, USA.
Holden T MaeckerStanford University School of Medicine, Stanford, California, USA.
Ignacio I WistubaUniversity of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Sacha GnjaticMedicine - Hem/Onc, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
J Jack LeeDepartment of Bioinformatics and Computational Biology, University of Texas MD Anderson Cancer Center, Hosuton, Texas, USA.ORCID http://orcid.org/0000-0001-5469-9214
Jianjun ZhangThoracic Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, Texas, UK.ORCID http://orcid.org/0000-0001-7872-3477
Christine M MagnerSWOG, San Antonio, Texas, USA.
Helen X ChenCTEP, National Cancer Institute, Bethesda, Maryland, USA.
Elad SharonNational Cancer Institute, Bethesda, Maryland, USA.
Megan OthusFred Hutchinson Cancer Research Center, Seattle, Washington, USA.ORCID http://orcid.org/0000-0001-8176-6371
Christopher W RyanOHSU, Portland, Oregon, USA.
Charles BlankeOHSU, Portland, Oregon, USA.
Cara L Haymaker *Translational Molecular Pathology, University of Texas MD Anderson Cancer Center, Houston, Texas, USA.ORCID http://orcid.org/0000-0002-1317-9287
Razelle Kurzrock *Medical College of Wisconsin, Milwaukee, Wisconsin, USA.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI DIANE BODURKA · 1985 to 2026
$290.8M
Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
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 MEGAN OTHUS · 2014 to 2026
$115.2M
THE TISCH CANCER INSTITUTE - CANCER CENTER SUPPORT GRANTP30CA196521 · NCI · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI Ramon E Parsons · 2015 to 2026
$35.4M
High-Dimensional Immune Monitoring of NCI-Supported Immunotherapy TrialsU24CA224319 · NCI · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI Sacha Gnjatic, Seunghee Kim-Schulze · 2017 to 2026
$21.5M
Stanford Cancer Immune Monitoring and Analysis Center (CIMAC)U24CA224309 · NCI · STANFORD UNIVERSITY · PI Sean Curtis Bendall, Holden T. Maecker · 2017 to 2026
$19.9M
Translational Cancer Immune Monitoring and Analysis Center (TCIMAC)U24CA224285 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Gheath Al-Atrash, Cara L Haymaker · 2017 to 2026
$16.7M
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
Cancer Immunologic Data Commons (CIDC) Supplement RequestU24CA224316 · NCI · DANA-FARBER CANCER INST · PI CERAMI, ETHAN, MICHOR, FRANZISKA · 2017 to 2022
$6.8M
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
NCI NIH HHS P30 CA016672NCI NIH HHS P30 CA196521NCI NIH HHS R33 CA263705NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180828NCI NIH HHS U10 CA180888NCI NIH HHS U24 CA224285NCI NIH HHS U24 CA224309NCI NIH HHS U24 CA224316NCI NIH HHS U24 CA224319NCI NIH HHS UG1 CA233198NCI NIH HHS UG1 CA233320NCI NIH HHS UG1 CA233331NIDDK NIH HHS U01 DK124165
6 · The paper itself

Abstract

purposeSWOG S1609 EXPERIMENTAL

designTreatment consisted of ipilimumab 1 mg/kg intravenously every 6 weeks with nivolumab 240 mg intravenously every 2 weeks. The primary endpoint was overall response rate (ORR) (Response Evaluation Criteria In Solid TumorsRECIST V.1.1). Secondary endpoints include progression-free survival (PFS), overall survival (OS), and toxicity. Clinical benefit rate (includes ORR plus stable disease (SD)>6 months was examined. Correlative studies were performed. The trial was conducted by the National Cancer Institute/Southwest Oncology Group Early Therapeutics and Rare Cancers Committee and opened at >1,000 sites.

results19 patients with PNEN were enrolled. The median number of lines of prior therapy was 2 (range: 0-4). The ORR was 11% (2/19 patients); the clinical benefit rate (CBR; stable disease >6 months+partial response+complete response), 26% (5/19). The median PFS was 3 months; median OS, 24 months. The longest PFSs were 26 (intermediate grade PNEN), 31 (low grade) and 39+months (intermediate grade). The most common toxicities were fatigue (47% of patients) and aspartate aminotransferase (AST) elevation (32%); the most common grade 3/4 immune-related adverse event (AE) was AST (32%) and bilirubin elevation (26%), with no grade 5 events. Programmed death-ligand 1 expression by chromogenic immunohistochemistry (N=12 patients assessed) did not associate with ORR; tumor mutation burden (TMB) was high in three patients; one of the two patients with partial remission (PFS=26 months) had high TMB (150 mutations/mb). Peripheral effector memory T-cell activation (N=11 patients assessed by cytometry by time-of-flight with 5 having longitudinal analysis) was associated with response, though the number of patients evaluated was limited.

conclusionsLow-dose ipilimumab plus nivolumab demonstrated an 11% ORR and 26% CBR (includes SD>6 months) in patients with refractory PNEN, with durable benefit (>2 years) in 3 (16%) patients. TRIAL REGISTRATION NUMBER: NCT02834013.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCTLA-4 AntigenImmune Checkpoint InhibitorsNeuroendocrine TumorsNivolumabPancreatic NeoplasmsProgrammed Cell Death 1 ReceptorAdultAgedFemaleHumansIpilimumabMaleMiddle AgedCTLA-4 AntigenCTLA4 protein, humanImmune Checkpoint InhibitorsIpilimumabNivolumabPDCD1 protein, humanProgrammed Cell Death 1 ReceptorImmune Checkpoint InhibitorIpilimumabNeuroendocrine and Adrenal TumorNivolumabSolid tumor

Identifiers

PMID40588371
PMCPMC12211841

What Socratic 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 Socratic graph.