Evidence map›Paper›PMID 38358334›Full record

ArticleCancer2024

SWOG 1609 cohort 48: anti-CTLA-4 and anti-PD-1 for advanced gallbladder cancer.

Sandip P Patel, Elizabeth Guadarrama, Young Kwang Chae, Michael J Dennis, Benjamin C Powers, Chih-Yi Liao, William A Ferri, Thomas J George, Elad Sharon, Christopher W Ryan and 4 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter Study
In one paragraph

Article in 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 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
7.4field-weighted citation impact, top 2% 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.

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

15 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
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  3. 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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  4. 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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  6. 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 PatelDivision of Medical Oncology, University of California San Diego Moores Cancer Center, La Jolla, California, USA.ORCID https://orcid.org/0000-0002-8387-4840
Elizabeth GuadarramaSt. Martin's University, Lacey, Washington, USA.
Young Kwang ChaeDivision of Medical Oncology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.ORCID https://orcid.org/0000-0003-1557-7235
Michael J DennisDivision of Medical Oncology, University of California San Diego Moores Cancer Center, La Jolla, California, USA.ORCID https://orcid.org/0000-0002-8175-5311
Benjamin C PowersDivision of Hematology/Oncology, University of Kansas Medical Center, Kansas City, Kansas, USA.
Chih-Yi LiaoDivision of Hematology/Oncology, University of Chicago Comprehensive Cancer Center, Chicago, Illinois, USA.
William A FerriDivision of Hematology/Oncology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
Thomas J GeorgeDivision of Hematology/Oncology, University of Florida Health Cancer Center, Gainesville, Florida, USA.ORCID https://orcid.org/0000-0002-6249-9180
Elad SharonDivision of Cancer Treatment and Diagnosis, National Cancer Institute, Cancer Therapy Evaluation Program, Bethesda, Maryland, USA.ORCID https://orcid.org/0000-0002-0044-9719
Christopher W RyanDivision of Hematology and Oncology, Oregon Health and Science University Knight Cancer Institute, Portland, Oregon, USA.
Megan OthusSWOG Statistics and Data Management Center/Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Gabby LopezSWOG Statistics and Data Management Center/Fred Hutchinson Cancer Center, Seattle, Washington, USA.ORCID https://orcid.org/0009-0005-4174-9071
Charles D BlankeSWOG Group Chair's Office, Knight Cancer Institute, Oregon Health and Science University, Portland, Oregon, USA.
Razelle KurzrockDivision of Medical Oncology, Medical College of Wisconsin Froedtert Cancer Center, Milwaukee, Wisconsin, USA.
Fred Hutch Cancer Center · USOregon Health & Science University · USUniversity of California San Diego Medical Center · USFroedtert Hospital · USNational Cancer Institute · MYNorthwestern University · USSaint Martin's University · USUniversity of Chicago · USUniversity of Florida Health · USUniversity of Kansas Medical Center · USUniversity of Pittsburgh · 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
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
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
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-sponsored Clinical Trial Research SpecialistR50CA281930 · NCI · UNIVERSITY OF FLORIDA · PI Thomas J. George · 2023 to 2026
$461k
Bristol-Myers SquibbNCI NIH HHS R50 CA281930NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180868NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA233198NIH HHS U010CA180819NIH HHS U10CA180821NIH HHS U10CA180868NIH HHS U10CA180888
6 · The paper itself

Abstract

introductionMost patients with advanced gallbladder cancer are treated with multiagent chemotherapy. Immune checkpoint inhibitors offer the possibility of a durable response with less toxicity. This prospective, multicenter, open-label study was designed to evaluate the anticancer activity of nivolumab plus ipilimumab in patients with advanced gallbladder cancer.

methodsNineteen patients with advanced gallbladder cancer refractory to ≥1 previous therapy received nivolumab 240 mg intravenously every 2 weeks and ipilimumab 1 mg/kg intravenously every 6 weeks until disease progression or unacceptable toxicity. The primary end point was confirmed radiographic overall response rate (ORR) (complete response [CR] + partial response [PR] confirmed on subsequent scan); secondary end points included unconfirmed overall response, clinical benefit rate (confirmed and unconfirmed responses + stable disease >6 months), progression-free survival, overall survival, and toxicity.

resultsThe confirmed ORR was 16% (CR, n = 1 [5%]; PR, n = 2 [11%]); all were microsatellite stable, and the confirmed CR had undetectable programmed death-ligand 1 by immunohistochemistry. The unconfirmed ORR and clinical benefit rates were both 32%. The median duration of response was 14.8 months (range, 4-35.1+ months). The 6-month progression-free survival was 26% (95% CI, 12-55). The median overall survival was 7.0 months (95% CI, 3.9-19.1). The most common toxicities were fatigue (32%), anemia (26%), and anorexia (26%). Aspartate aminotransferase elevation was the most common grade 3/4 toxicity (11%). There was 1 possibly related death (sepsis with attendant hepatic failure).

conclusionsIpilimumab plus nivolumab was well tolerated and showed modest efficacy with durable responses in previously treated patients with advanced gallbladder cancer. CLINICAL

trial registrationNCT02834013 (ClincialTrials.gov). PLAIN LANGUAGE SUMMARY: This prospective study assessed the efficacy and safety of nivolumab plus ipilimumab in 19 patients with advanced gallbladder cancer refractory to previous therapy. The combination demonstrated modest efficacy with a 16% confirmed overall response rate, durable responses, and manageable toxicities, suggesting potential benefits for this challenging patient population.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCTLA-4 AntigenGallbladder NeoplasmsIpilimumabNivolumabProgrammed Cell Death 1 ReceptorAdultAgedAged, 80 and overFemaleHumansImmune Checkpoint InhibitorsMaleMiddle AgedProgression-Free SurvivalProspective StudiesCTLA-4 AntigenCTLA4 protein, humanImmune Checkpoint InhibitorsIpilimumabNivolumabPDCD1 protein, humanProgrammed Cell Death 1 Receptorbiliary tract cancerimmune checkpoint inhibitoripilimumabnivolumab

Identifiers

PMID38358334
PMCPMC11309904
OpenAlexW4391839912

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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.