Evidence map›Paper›PMID 31676670›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2020

Safety and Efficacy of Durvalumab and Tremelimumab Alone or in Combination in Patients with Advanced Gastric and Gastroesophageal Junction Adenocarcinoma.

Ronan J Kelly, Jeeyun Lee, Yung-Jue Bang, Khaldoun Almhanna, Mariela Blum-Murphy, Daniel V T Catenacci, Hyun Cheol Chung, Zev A Wainberg, Michael K Gibson, Keun-Wook Lee and 14 more

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 88 papers, 12 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
88citing papers in PubMed, 12 pooled it
–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.

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

88 citing papers in PubMed, 12 syntheses or guidelines pooled it.

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  15. Exposure-Response Analyses of Tremelimumab Monotherapy or in Combination with Durvalumab in Patients with Unresectable Hepatocellular Carcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
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28 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

24 authors.

Ronan J KellyThe Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine, Baltimore, Maryland. Ronan.Kelly@BSWHealth.org.
Jeeyun LeeDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.ORCID 0000-0002-8491-703X
Yung-Jue BangDepartment of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.
Khaldoun AlmhannaDepartment of Medicine, Warren Alpert Medical School of Brown University, Providence, Rhode Island.
Mariela Blum-MurphyDepartment of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Daniel V T CatenacciDepartment of Medicine, Division of Hematology-Oncology, The University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois.
Hyun Cheol ChungDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.
Zev A WainbergDivision of Hematology-Oncology, Department of Medicine, Ronald Reagan UCLA Medical Center, Los Angeles, California.
Michael K GibsonDivision of Hematology and Oncology, Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, Tennessee.
Keun-Wook LeeDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.ORCID 0000-0002-8491-703X
Johanna C BendellSarah Cannon Research Institute/Tennessee Oncology, Nashville, Tennessee.
Crystal S DenlingerDepartment of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.ORCID 0000-0002-5663-7751
Cheng Ean CheeDepartment of Hematology-Oncology, National University Cancer Institute, Singapore.
Takeshi OmoriDepartment of Surgery, Osaka International Cancer Institute, Osaka, Japan.
Rom LeidnerEarle A. Chiles Research Institute, Robert W. Franz Cancer Center, Providence Portland Medical Center, Providence Cancer Institute, Portland, Oregon.
Heinz-Josef LenzDepartment of Preventive Medicine, Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, California.
Yee ChaoDivision of Medical Oncology, Center for Immuno-oncology, Department of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan.
Marlon C RebelattoOncology Translational Medicine, AstraZeneca, Gaithersburg, Maryland.
Philip Z BrohawnOncology Translational Medicine, AstraZeneca, Gaithersburg, Maryland.
Peng HeEarly Oncology Statistics, AstraZeneca, Gaithersburg, Maryland.
Jennifer McDevittEarly Oncology Clinical Development, AstraZeneca, Gaithersburg, Maryland.
Siddharth ShethEarly Oncology Clinical Development, AstraZeneca, Gaithersburg, Maryland.
Judson M EnglertEarly Oncology Clinical Development, AstraZeneca, Gaithersburg, Maryland.
Geoffrey Y KuGastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.ORCID 0000-0002-0448-1038

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
USC/NORRIS COMPREHENSIVE CANCER CENTER (CORE) SUPPORTP30CA014089 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI Fumito Ito · 1985 to 2026
$181.4M
NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA014089
6 · The paper itself

Abstract

purposeThis randomized, multicenter, open-label, phase Ib/II study assessed durvalumab and tremelimumab in combination or as monotherapy for chemotherapy-refractory gastric cancer or gastroesophageal junction (GEJ) cancer. PATIENTS AND

methodsSecond-line patients were randomized 2:2:1 to receive durvalumab plus tremelimumab (arm A), or durvalumab (arm B) or tremelimumab monotherapy (arm C), and third-line patients received durvalumab plus tremelimumab (arm D). A tumor-based IFNγ gene signature was prospectively evaluated as a potential predictive biomarker in second- and third-line patients receiving the combination (arm E). The coprimary endpoints were objective response rate and progression-free survival (PFS) rate at 6 months.

resultsA total of 113 patients were treated: 6 in phase Ib and 107 (arm A, 27; arm B, 24; arm C, 12; arm D, 25; arm E, 19) in phase II. Overall response rates were 7.4%, 0%, 8.3%, 4.0%, and 15.8% in the five arms, respectively. PFS rates at 6 months were 6.1%, 0%, 20%, 15%, and 0%, and 12-month overall survival rates were 37.0%, 4.6%, 22.9%, 38.8%, and NA, respectively. Treatment-related grade 3/4 adverse events were reported in 17%, 4%, 42%, 16%, and 11% of patients, respectively.

conclusionsResponse rates were low regardless of monotherapy or combination strategies. No new safety signals were identified. Including use of a tumor-based IFNγ signature and change in baseline and on-treatment circulating tumor DNA are clinically feasible and may be novel strategies to improve treatment response in this difficult-to-treat population.

Indexed as

AdenocarcinomaAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsB7-H1 AntigenCirculating Tumor DNACTLA-4 AntigenEsophagogastric JunctionFemaleHumansInterferon-gammaMaleMiddle AgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedB7-H1 AntigenCD274 protein, humanCirculating Tumor DNACTLA-4 AntigenCTLA4 protein, humandurvalumabInterferon-gammatremelimumab

Identifiers

PMID31676670
PMCPMC7748730

What OpenQuestion holds

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Read underepoch 390

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.