Evidence map›Paper›PMID 31924334›Full record

Trial reportGynecologic oncology2020

Phase II evaluation of nivolumab in the treatment of persistent or recurrent cervical cancer (NCT02257528/NRG-GY002).

Alessandro D Santin, Wei Deng, Michael Frumovitz, Natalia Buza, Stefania Bellone, Warner Huh, Samir Khleif, Heather A Lankes, Elena S Ratner, Roisin E O'Cearbhaill and 2 more

2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Gynecologic oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 92 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
92citing papers in PubMed, 3 pooled it
8.6field-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.

NCT05437692 phase2unknown statusnot on this mapstarted 2022, after this paper: background citation

A Prospective, Single Arm, Phase II Clinical Study on the Treatment of Locally Advanced Cervical Cancer (Ⅱ B to Ⅳ a) With Zimberelimab Combined With Concurrent Radiotherapy and Chemotherapy

TypeinterventionalSponsorShanghai Zhongshan HospitalRan2022 to 2025Enrolled19ConditionsLocally Advanced Cervical CancerArmszimberelimab combined With concurrent radiotherapy and chemotherapy
NCT05492123 phase2recruitingnot on this mapstarted 2022, after this paper: background citation

Randomized Phase II Study to Evaluate Induction Nivolumab-Ipilimumab, Followed by Nivolumab With Chemoradiotherapy Versus Chemoradiotherapy for Advanced Cervical Cancer

TypeinterventionalSponsorHospital Israelita Albert EinsteinRan2022 to 2028Enrolled112ConditionsUterine Cervical NeoplasmsArmsNivolumab 40 mg in 4 ml Injection, Ipilimumab 200 MG in 40 ML Injection, Chemoradiation
3 · Its place in the literature

Who cites it

92 citing papers in PubMed, 3 syntheses or guidelines pooled it, 150 citations in OpenAlex.

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  10. Efficacy and safety of zimberelimab (GLS-010) monotherapy in patients with recurrent or metastatic cervical cancer: a multicenter, single-arm, phase II study.International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2023
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32 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

12 authors at 7 institutions in 1 country.

Alessandro D SantinYale University School of Medicine, New Haven, CT, United States of America. Electronic address: Alessandro.santin@yale.edu.
Wei DengNRG Oncology SDMC, CTD Division, Roswell Park Comprehensive Cancer Center, Buffalo, NY, United States of America. Electronic address: dengw@nrgoncology.edu.
Michael FrumovitzDept. of Gynecologic Oncology and Reproductive Medicine, Division of Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX, United States of America. Electronic address: mfrumovitz@mdanderson.org.
Natalia BuzaYale University School of Medicine, New Haven, CT, United States of America. Electronic address: Natalia.buza@yale.edu.
Stefania BelloneYale University School of Medicine, New Haven, CT, United States of America. Electronic address: Stefania.bellone@yale.edu.
Warner HuhUniversity of Alabama at Birmingham, Birmingham, AL, United States of America. Electronic address: whuh@uabmc.edu.
Samir KhleifThe Loop Immuno-Oncology Research Laboratory, Lombardi Cancer Center, Georgetown University, Washington, DC, United States of America. Electronic address: skhleif@augusta.edu.
Heather A LankesBiopathology Center, The Research Institute at Nationwide Children's Hospital, Columbus, OH, United States of America; Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, The Ohio State University Wexner Medical Center, Columbus, OH, United States of America. Electronic address: LankesH@NRGOncology.org.
Elena S RatnerDepartment of Gynecologic Oncology, Gynecology, Obstetrics, Yale University, New Haven, CT, United States of America. Electronic address: elena.ratner@yale.edu.
Roisin E O'CearbhaillDepartment of Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, United States of America. Electronic address: ocearbhr@mskcc.org.
Amir A JazaeriDept. of Gynecologic Oncology and Reproductive Medicine, Division of Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX, United States of America. Electronic address: AAJazaeri@mdanderson.org.
Michael BirrerDepartment of Oncology, University of Alabama Comprehensive Cancer Center, Birmingham, AL, United States of America. Electronic address: mbirrer@uab.edu.
Yale University · USThe University of Texas MD Anderson Cancer Center · USUniversity of Alabama at Birmingham · USGeorgetown University · USMemorial Sloan Kettering Cancer Center · USNationwide Children's Hospital · USRoswell Park Comprehensive Cancer Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Mei-Yin C Polley · 2014 to 2026
$146.4M
Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Convalescent Plasma to Limit Coronavirus Associated ComplicationsUL1TR003167 · NCATS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI KARP, DANIEL D, MCPHERSON, DAVID D · 2019 to 2023
$45.3M
Network Lead Academic Participating Site: Memorial Sloan Kettering Cancer CenterUG1CA233290 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI CAROL AGHAJANIAN, Darren Feldman · 2019 to 2026
$10.2M
NCTN Deep South Research ConsortiumUG1CA233330 · NCI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Charles A. Leath, Andrew M McDonald · 2019 to 2026
$3.7M
Network Lead Academic Participating Site Grant from the Roswell Park Cancer InstituteUG1CA233191 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI LELE, SHASHIKANT, LEVINE, ELLIS G · 2019 to 2025
$3.1M
Integrated genomic analysis of racial disparities in endometrial cancerU01CA176067 · NCI · YALE UNIVERSITY · PI SANTIN, ALESSANDRO D · 2014 to 2018
$1.7M
NCATS NIH HHS UL1 TR001863NCATS NIH HHS UL1 TR003167NCI NIH HHS P30 CA008748NCI NIH HHS U01 CA176067NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180868NCI NIH HHS UG1 CA233191NCI NIH HHS UG1 CA233330
6 · The paper itself

Abstract

purposePatients with persistent/recurrent cervical cancer following platinum-based chemotherapy have limited therapeutic options. The Gynecologic-Oncology-Group conducted a phase II trial to assess efficacy and tolerability of nivolumab, an immune checkpoint inhibitor, in persistent/recurrent cervical carcinoma. PATIENTS AND

methodsKey eligibility criteria included persistent/recurrent cervical cancer, failure of prior systemic therapy and ECOG PS 0-1. Nivolumab 3 mg/kg was given IV every 2 wk. until disease progression or intolerable toxicity. Response was assessed every 8 wk. for 6 months and every 12 wk. thereafter. The primary endpoints were objective response as assessed by RECIST 1.1. The study used a 2-stage group sequential design. PD-L1 expression was evaluated in tumor specimens by immunohistochemistry (IHC) using a combined-positive-score (CPS) cutoff of ≥1%.

resultsOf 26 enrolled patients with persistent/recurrent cervical cancer, 25 were evaluable for response/toxicity with a median age of 45. 36% had ECOG PS of 1, and 100% had received one prior systemic chemotherapy regimen. PD-L1 expression (≥1%) was identified in 77.3% of tumor samples. As of 03/05/19, all patients were off study treatment; median follow-up for survival status was 32 months (range, 2-41.5). There were 21 (84%) patients with a treatment-related adverse event (TRAE) and most were grades 1-2. Six (24%) patients had grade 3 TRAEs with 1 discontinuing nivolumab due to hepatic toxicity. No grade 5 TRAEs occurred, and 2 patients had grade 4 TRAEs. One confirmed partial response (4%; 90% CI, 0.4%-22.9%), duration of response 3.8 months. Thirty-six percent of patients had stable disease (SD) (9/25; 90% CI, 20.2%-54.4%); the median duration of SD was 5.7 months (range, 3.5-12.7). Estimated PFS and OS at 6 months were 16% and 78.4%, respectively.

conclusionSingle agent nivolumab exhibited low antitumor activity and an acceptable safety profile in patients with persistent/recurrent cervical cancer previously treated with platinum-based chemotherapy.

Indexed as

AdultAgedAntineoplastic Agents, ImmunologicalB7-H1 AntigenFemaleHumansMiddle AgedNeoplasm Recurrence, LocalNivolumabProgression-Free SurvivalUterine Cervical NeoplasmsYoung AdultAntineoplastic Agents, ImmunologicalB7-H1 AntigenCD274 protein, humanNivolumabCervical neoplasmsImmune-checkpoint inhibitorsImmunotherapyNivolumabPD-1

Identifiers

PMID31924334
PMCPMC7127981
OpenAlexW3000736809

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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.