Evidence map›Paper›PMID 37349318›Full record

ArticleNature communications2023

Nivolumab plus chemoradiotherapy in locally-advanced cervical cancer: the NICOL phase 1 trial.

Manuel Rodrigues, Giulia Vanoni, Pierre Loap, Coraline Dubot, Eleonora Timperi, Mathieu Minsat, Louis Bazire, Catherine Durdux, Virginie Fourchotte, Enora Laas and 18 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Nature communications, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03298893 (A Phase-I Study of Nivolumab in Association With Radiotherapy and Cisplatin in Locally Advanced Cervical Cancers Followed by Adjuvant Nivolumab for up to 6 Months. NiCOL), which is not on this map. Cited by 45 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 5 pooled it
14.2field-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.

NCT03298893 phase1 / phase2completednot on this map

A Phase-I Study of Nivolumab in Association With Radiotherapy and Cisplatin in Locally Advanced Cervical Cancers Followed by Adjuvant Nivolumab for up to 6 Months. NiCOL

TypeinterventionalSponsorInstitut CurieRan2017 to 2022Enrolled21ConditionsCervical Cancer, Locally Advanced Cervical CancerArmsNivolumab Injection, Cisplatin, radiotherapy
3 · Its place in the literature

Who cites it

45 citing papers in PubMed, 5 syntheses or guidelines pooled it, 49 citations in OpenAlex.

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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

28 authors at 3 institutions in 1 country.

Manuel Rodrigues *Department of Medical Oncology, Institut Curie, Paris & Saint-Cloud, France.ORCID 0000-0002-5443-0802
Giulia Vanoni *Center for Cancer Immunotherapy, INSERM U932, PSL Research University, Institut Curie, Paris, France.
Pierre LoapDepartment of Radiation Oncology, Institut Curie, Paris & Saint Cloud, France.
Coraline DubotDepartment of Medical Oncology, Institut Curie, Paris & Saint-Cloud, France.
Eleonora TimperiCenter for Cancer Immunotherapy, INSERM U932, PSL Research University, Institut Curie, Paris, France.ORCID 0000-0002-8357-6587
Mathieu MinsatDepartment of Radiation Oncology, Institut Curie, Paris & Saint Cloud, France.
Louis BazireDepartment of Radiation Oncology, Institut Curie, Paris & Saint Cloud, France.
Catherine DurduxHôpital Européen Georges Pompidou, Department of Radiation Oncology, Paris, France.
Virginie FourchotteService of Breast and Gynecologic Surgery, Institut Curie, Paris, France.
Enora LaasService of Breast and Gynecologic Surgery, Institut Curie, Paris, France.
Nicolas PougetService of Breast and Gynecologic Surgery, Institut Curie, Paris, France.
Zahra Castel-AjgalDepartment of Drug Development and Innovation, Institut Curie, Paris, France.
Gregoire MarretDepartment of Drug Development and Innovation, Institut Curie, Paris, France.
Laetitia LesageDepartment of Pathology Institut Curie, Paris, France.ORCID 0000-0001-8592-2482
Didier MeseureDepartment of Pathology Institut Curie, Paris, France.ORCID 0000-0001-6730-6686
Anne Vincent-SalomonDepartment of Pathology Institut Curie, Paris, France.ORCID 0000-0001-5754-5771
Lolita LecompteInstitut Curie Bioinformatics Platform, INSERM U900, Mines ParisTech, Paris, 75005, France.ORCID 0000-0001-8773-6317
Nicolas ServantInstitut Curie Bioinformatics Platform, INSERM U900, Mines ParisTech, Paris, 75005, France.ORCID 0000-0003-1678-7410
Sophie VacherPharmacogenomics Unit, Service of Genetics, Institut Curie, Paris, France.ORCID 0000-0002-0042-6023
Ivan BiechePharmacogenomics Unit, Service of Genetics, Institut Curie, Paris, France.
Caroline MalhaireDepartment of Radiology, Institut Curie, Paris, 75005, France.ORCID 0000-0002-9235-9816
Virginie HuchetDepartment of Nuclear Medicine, Institut Curie, Paris, 75005, France.
Laurence ChampionDepartment of Nuclear Medicine, Institut Curie, Paris, 75005, France.ORCID 0000-0001-7908-5593
Maud KamalDepartment of Drug Development and Innovation, Institut Curie, Paris, France.
Sebastian AmigorenaCenter for Cancer Immunotherapy, INSERM U932, PSL Research University, Institut Curie, Paris, France.ORCID 0000-0001-8583-8416
Olivier LantzCenter for Cancer Immunotherapy, INSERM U932, PSL Research University, Institut Curie, Paris, France.ORCID 0000-0003-3161-7719
Marion ChevrierService of Biostatistics, Institut Curie, Paris, 75005, France.
Emanuela RomanoDepartment of Medical Oncology, Institut Curie, Paris & Saint-Cloud, France. Emanuela.Romano@curie.fr.ORCID 0000-0002-1574-5545
Institut Curie · FRInserm · FRHôpital Européen Georges-Pompidou · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Concurrent chemoradiotherapy (CRT) with blockade of the PD-1 pathway may enhance immune-mediated tumor control through increased phagocytosis, cell death, and antigen presentation. The NiCOL phase 1 trial (NCT03298893) is designed to determine the safety/tolerance profile and the recommended phase-II dose of nivolumab with and following concurrent CRT in 16 women with locally advanced cervical cancer. Secondary endpoints include objective response rate (ORR), progression free survival (PFS), disease free survival, and immune correlates of response. Three patients experience grade 3 dose-limiting toxicities. The pre-specified endpoints are met, and overall response rate is 93.8% [95%CI: 69.8-99.8%] with a 2-year PFS of 75% [95% CI: 56.5-99.5%]. Compared to patients with progressive disease (PD), progression-free (PF) subjects show a brisker stromal immune infiltrate, higher proximity of tumor-infiltrating CD3

Indexed as

Lung NeoplasmsUterine Cervical NeoplasmsB7-H1 AntigenChemoradiotherapyFemaleHumansNivolumabProgrammed Cell Death 1 ReceptorB7-H1 AntigenNivolumabProgrammed Cell Death 1 Receptor

Identifiers

PMID37349318
PMCPMC10287640
OpenAlexW4381682791

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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.