Evidence map›Paper›PMID 39343510›Full record

Trial reportJournal for immunotherapy of cancer2024

Phase II basket trial of dual anti-CTLA-4 and anti-PD-1 blockade in rare tumors (DART) SWOG S1609: the desmoid tumors.

Young Kwang Chae, Megan Othus, Sandip Patel, Benjamin Powers, Chung-Tsen Hsueh, Rangaswamy Govindarajan, Silvana Bucur, Hye Sung Kim, Liam Il-Young Chung, Christine McLeod and 6 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2024. 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. Trial
  2. Article
  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

16 authors.

Young Kwang Chae *Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA chaelabmeeting@gmail.com.ORCID http://orcid.org/0000-0003-1557-7235
Megan OthusFred Hutchinson Cancer Research Center, Seattle, Washington, USA.
Sandip Patel *University of California San Diego Moores Cancer Center, La Jolla, California, USA.
Benjamin PowersThe University of Kansas Cancer Center, Overland Park, Kansas, USA.
Chung-Tsen HsuehLoma Linda University Cancer Center, Loma Linda, California, USA.
Rangaswamy GovindarajanUniversity of Arkansas for Medical Sciences, Little Rock, Arkansas, USA.
Silvana BucurSt Luke's Cancer Institute, Meridian, Idaho, USA.
Hye Sung KimNorthwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Liam Il-Young ChungNorthwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Christine McLeodSWOG Data Operations Center, Seattle, Washington, USA.
Helen X ChenCancer Therapy Evaluation Program, National Cancer Institute, Bethesda, Maryland, USA.
Elad SharonCancer Therapy Evaluation Program, National Cancer Institute, Bethesda, Maryland, USA.
Howard StreicherCancer Therapy Evaluation Program, National Cancer Institute, Bethesda, Maryland, USA.
Christopher W RyanOregon Health & Science University, Portland, Oregon, USA.
Charles BlankeSWOG Group Chair's Office, Knight Cancer Institute, Portland, OR, USA.
Razelle KurzrockMedical College of Wisconsin, Milwaukee, Wisconsin, USA.

Funding

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
NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180888
6 · The paper itself

Abstract

backgroundDual inhibition using anti-programmed death-1 (PD-1) and anti-cytotoxic T-lymphocyte antigen-4 (CTLA-4) checkpoint inhibitors has proven effective in many cancers. However, its efficacy in rare solid cancers remains unclear. Desmoid tumors are ultrarare soft-tissue tumors, traditionally treated with surgery. This study reviews the first results of using ipilimumab and nivolumab in the desmoid tumor cohort of the SWOG S1609 Dual Anti-CTLA-4 & Anti-PD-1 blockade in Rare Tumors (DART) trial.

methodsDART is a prospective/open-label/multicenter (1,016 US sites)/multicohort phase II trial of ipilimumab (1 mg/kg intravenously every 6 weeks) plus nivolumab (240 mg intravenously every 2 weeks) that opened at 1,016 US sites. The primary endpoint included overall response rate (ORR) defined as confirmed complete (CR) and partial responses (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1. Secondary endpoints include progression-free survival (PFS), overall survival (OS), clinical benefit rate (CBR; stable disease (SD) ≥6 months plus CR and PR) and toxicity.

resultsSixteen evaluable patients (median age: 37) with desmoid tumors and a median of 1.5 prior therapies (with no prior exposure to immunotherapy) were analyzed. The tumors varied in location (eight abdomen, three lower limb, two upper limb, two pelvis, and one neck). ORR was 18.8% (3/16; 3 confirmed PR): 40% regression (PFS 30+ months), 83% regression (PFS 16 months) and 71% regression (PFS 8.4 months). Seven additional patients (43.8%) had prolonged SD over 6 months (PFS: 16.5, 22.4+, 22.6, 30.1, 38.2+, 48.3+ and 60.7+ months). Overall CBR was 62.5% (10/16). Median PFS was 19.4 months, with 6-month PFS of 73% and 1-year PFS of 67%. All patients were alive at 1 year; median OS was not assessable, as 13 patients were alive at analysis. Common adverse events included fatigue, nausea and hypothyroidism, with 50% experiencing grade 3-4 events. There were no grade 5 events.

conclusionTreatment with ipilimumab and nivolumab in desmoid tumors yielded an ORR of 18.8% and a CBR of 62.5% with durable responses seen. This is the first prospective study exploring the efficacy of this combination in this rare disease. Ongoing studies aim to identify markers for response and resistance. Expanded trials are necessary. TRIAL REGISTRATION NUMBER: NCT02834013.

Indexed as

CTLA-4 AntigenDesmoid TumorsAdolescentAdultAgedFemaleHumansImmune Checkpoint InhibitorsIpilimumabMaleMiddle AgedNivolumabProgrammed Cell Death 1 ReceptorProspective StudiesYoung AdultCTLA-4 AntigenCTLA4 protein, humanImmune Checkpoint InhibitorsIpilimumabNivolumabPDCD1 protein, humanProgrammed Cell Death 1 ReceptorCombination therapyImmune Checkpoint InhibitorImmunotherapy

Identifiers

PMID39343510
PMCPMC11440191

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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.