Evidence map›Paper›PMID 31348579›Full record

Trial reportCancer science2019

Efficacy and safety of nivolumab in Japanese patients with uterine cervical cancer, uterine corpus cancer, or soft tissue sarcoma: Multicenter, open-label phase 2 trial.

Kenji Tamura, Kosei Hasegawa, Noriyuki Katsumata, Koji Matsumoto, Hirofumi Mukai, Shunji Takahashi, Hiroyuki Nomura, Hironobu Minami

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer science, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05437692 (A Prospective, Single Arm, Phase II Clinical Study on the Treatment of Locally Advanced Cervical Cancer), which is not on this map. Cited by 65 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
65citing papers in PubMed, 9 pooled it
8.8field-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
3 · Its place in the literature

Who cites it

65 citing papers in PubMed, 9 syntheses or guidelines pooled it, 97 citations in OpenAlex.

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5 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

8 authors at 7 institutions in 1 country.

Kenji TamuraDepartment of Breast and Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.ORCID https://orcid.org/0000-0002-3514-9927
Kosei HasegawaDepartment of Gynecologic Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
Noriyuki KatsumataDepartment of Medical Oncology, Nippon Medical School Musashikosugi Hospital, Kanagawa, Japan.
Koji MatsumotoDepartment of Medical Oncology, Hyogo Cancer Center, Hyogo, Japan.
Hirofumi MukaiDepartment of Breast and Medical Oncology, National Cancer Center Hospital East, Chiba, Japan.
Shunji TakahashiDepartment of Medical Oncology, The Cancer Institute Hospital of JFCR, Tokyo, Japan.
Hiroyuki NomuraDepartment of Obstetrics and Gynecology, Keio University School of Medicine, Tokyo, Japan.
Hironobu MinamiMedical Oncology and Hematology, Kobe University Hospital, Kobe, Japan.ORCID https://orcid.org/0000-0001-8630-9145
Hyogo Prefectural Cancer Center · JPKeio University · JPKobe University Hospital · JPNational Cancer Center Hospital East · JPNippon Medical School · JPSaitama Medical University · JPThe Cancer Institute Hospital · JP

Funding

Bristol-Myers SquibbOno Pharmaceutical
6 · The paper itself

Abstract

Nivolumab is a human monoclonal antibody against the immune checkpoint receptor programmed death-1, inhibiting binding to programmed death-ligand 1 or 2 (PD-L1 or PD-L2). This phase 2 study evaluated the efficacy and safety of nivolumab in patients with advanced/recurrent uterine cervical cancer, uterine corpus cancer, or soft tissue sarcoma (STS). Patients received nivolumab 240 mg at 2-week intervals. Primary endpoint was objective response rate; secondary endpoints included overall survival, progression-free survival, and safety. PD-L1 expression and microsatellite-instability (MSI) status were analyzed as potential efficacy biomarkers. Objective response rate was 25%, 23%, and 0% in patients with cervical cancer (n = 20), corpus cancer (n = 22), and STS (n = 21), respectively. The lower 80% confidence intervals of objective response rates in patients with cervical or corpus cancer exceeded the threshold rate (5%); the primary endpoint was met in cervical and corpus cancer, but not in STS. Median progression-free survival was 5.6, 3.4, and 1.4 months, and 6-month overall survival was 84%, 73%, and 86% in cervical cancer, corpus cancer, and STS, respectively. The objective response rate was higher in patients with cervical cancer with PD-L1-positive (n = 5/15; 33%) versus PD-L1-negative (n = 0/5; 0%) tumors. The two patients with corpus cancer classified as MSI-high responded; the six patients classified as microsatellite stable did not respond. Overall, nivolumab showed acceptable toxicity in all cohorts, with evidence of clinical activity in uterine cervical or corpus cancer, but not in STS. PD-L1 expression in cervical cancer and MSI-high in corpus cancer may predict clinical activity of nivolumab in these cancers.

Indexed as

AdultAgedAntineoplastic AgentsB7-H1 AntigenDrug Administration ScheduleFemaleHumansInfusions, IntravenousJapanMicrosatellite InstabilityMiddle AgedNeoplasm Recurrence, LocalNivolumabProgrammed Cell Death 1 ReceptorProgression-Free SurvivalProspective StudiesAntineoplastic AgentsB7-H1 AntigenCD274 protein, humanNivolumabPDCD1 protein, humanProgrammed Cell Death 1 Receptornivolumabprogrammed death-1soft tissue sarcomauterine cervical canceruterine corpus cancer

Identifiers

PMID31348579
PMCPMC6726684
OpenAlexW2964837614

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.