Evidence map›Paper›PMID 33882143›Full record

Trial reportCancer2021

A phase II basket trial of Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART) SWOG S1609: High-grade neuroendocrine neoplasm cohort.

Sandip Pravin Patel, Edward Mayerson, Young Kwang Chae, Jonathan Strosberg, Jue Wang, Bhavana Konda, Jourdain Hayward, Christine M McLeod, Helen X Chen, Elad Sharon and 5 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 74 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 1 pooled it
11.4field-weighted citation impact, top 1% 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

74 citing papers in PubMed, 1 synthesis or guideline pooled it, 108 citations in OpenAlex.

  1. Pooled it
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  6. 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
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  7. 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
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  18. Efficacy and CNS Toxicity of Nivolumab and Ipilimumab in Rare Cancer Brain Metastases: A Multicenter Basket Trial Analysis (NCI/SWOG S1609).Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Article
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  20. Review

14 more citing papers are in PubMed but not listed here.

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

15 authors at 9 institutions in 1 country.

Sandip Pravin PatelMoores Cancer Center, University of California at San Diego, La Jolla, California.ORCID 0000-0002-8387-4840
Edward MayersonSWOG Statistical Center, Seattle, Washington.
Young Kwang ChaeNorthwestern University, Chicago, Illinois.
Jonathan StrosbergMoffitt Cancer Center, Tampa, Florida.
Jue WangUniversity of Arizona, Phoenix, Arizona.
Bhavana KondaOhio State University Comprehensive Cancer Center, Columbus, Ohio.
Jourdain HaywardSWOG Data Operations Center/Cancer Research and Biostatistics, Seattle, Washington.
Christine M McLeodSWOG Data Operations Center/Cancer Research and Biostatistics, Seattle, Washington.
Helen X ChenInvestigational Drug Branch, Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, Maryland.
Elad SharonInvestigational Drug Branch, Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, Maryland.
Megan OthusSWOG Statistical Center, Seattle, Washington.
Christopher W RyanOregon Health and Science University, Portland, Oregon.
Melissa PletsSWOG Statistical Center, Seattle, Washington.
Charles D BlankeSWOG Group Chair's Office, Knight Cancer Institute, Oregon Health and Science University, Portland, Oregon.
Razelle KurzrockMoores Cancer Center, University of California at San Diego, La Jolla, California.ORCID 0000-0003-4110-1214
Fred Hutch Cancer Center · USCancer Research And Biostatistics · USNational Institutes of Health · USOregon Health & Science University · USUniversity of California San Diego · USMoffitt Cancer Center · USNorthwestern University · USThe Ohio State University · USUniversity of Arizona · US

Funding

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
VIRAL MALIGNANCYP30CA023100 · NCI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Jesse Nodora · 1985 to 2026
$124.9M
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
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
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
Hutchinson Center as Lead Academic Participating Site (U10)U10CA180828 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI APPELBAUM, FREDERICK · 2014 to 2018
$3.0M
NCI NIH HHS P30 CA023100NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180828NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA233320NCI NIH HHS UG1 CA233331
6 · The paper itself

Abstract

backgroundThe authors previously reported the results of the nonpancreatic neuroendocrine neoplasm cohort of the SWOG S1609 DART (Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors) trial, which permitted all histologic grades and had a 44% overall response rate (ORR) among patients with high-grade disease. Here they sought to validate their findings in a dedicated prospective cohort of high-grade neuroendocrine neoplasms within S1609.

methodsA prospective, open-label, multicenter, phase 2 clinical trial of ipilimumab plus nivolumab was conducted across multiple rare tumor cohorts. The dedicated, high-grade neuroendocrine neoplasm cohort was examined here. The primary end point was the ORR according to version 1.1 of the Response Evaluation Criteria in Solid Tumors. Secondary end points included progression-free survival (PFS), overall survival (OS), and toxicity.

resultsNineteen patients with high-grade neuroendocrine neoplasms (defined by local pathology review) were enrolled in this cohort of S1609. The most common primary sites were unknown primaries (21%), which were followed by the rectum, gastroesophageal junction, cervix, and pancreas (11%). The median number of lines of prior therapy was 1 (range, 0-3). All patients were microsatellite-stable. The median Ki-67 value was 80%. The ORR was 26% (95% confidence interval [CI], 11%-45%), and the clinical benefit rate (stable disease for ≥6 months plus partial responses plus complete responses) was 32% (95% CI, 13%-57%). The 6-month PFS rate was 32% (95% CI, 16%-61%) with a median PFS of 2.0 months (95% CI, 1.8 months to ∞) and a median OS of 8.7 months (95% CI, 6.1 months to ∞). The most common toxicities were fatigue (32%) and rash (26%), and the most common grade 3/4 immune-related adverse event was rash (15%); there were no events that required treatment discontinuation and no grade 5 events.

conclusionsIpilimumab plus nivolumab demonstrated a 26% ORR in patients with high-grade neuroendocrine neoplasms, with durable responses seen in patients with refractory disease.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsNeuroendocrine TumorsFemaleHumansIpilimumabNivolumabProspective StudiesIpilimumabNivolumabDual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART)high-grade neuroendocrine neoplasmsipilimumabnivolumabS1609

Identifiers

PMID33882143
PMCPMC8606104
OpenAlexW3155998054

What OpenQuestion holds

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Registered trials

None linked

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.