Evidence map›Paper›PMID 39921852›Full record

Trial reportCancer2025

Update on safety and feasibility of the combination of pembrolizumab and pelvic chemoradiation in locally advanced cervical cancer.

Linda R Duska, Gina R Petroni, Premal H Thaker, Erin K Crane, Laura L Holman, Debrorah K Armstrong, Kara Romano, Jennifer Scalici

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 3 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

12 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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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

8 authors.

Linda R DuskaDivision of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Virginia School of Medicine, Charlottesville, Virginia, USA.ORCID https://orcid.org/0000-0002-8878-4123
Gina R PetroniDepartment of Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia, USA.
Premal H ThakerDivision of Gynecologic Oncology, Department of Obstetrics and Gynecology, Washington University School of Medicine and Siteman Cancer Center, St Louis, Missouri, USA.
Erin K CraneDepartment of Obstetrics and Gynecology, Atrium Health Wake Forest Baptist Healthcare System, Charlotte, North Carolina, USA.
Laura L HolmanStephenson Cancer Center, College of Medicine, University of Oklahoma Health Sciences, Oklahoma City, Oklahoma, USA.
Debrorah K ArmstrongMedical Oncology, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.
Kara RomanoDepartment of Radiation Oncology, University of Virginia School of Medicine, Charlottesville, Virginia, USA.
Jennifer ScaliciMitchell Cancer Institute, USA Health, Mobile, Alabama, USA.

Funding

Women's Oncology Program - WONP30CA044579 · NCI · UNIVERSITY OF VIRGINIA CHARLOTTESVILLE · PI Dina Gould Halme · 1987 to 2026
$72.1M
Merck Sharp and DohmeNCI NIH HHS P30 CA044579
6 · The paper itself

Abstract

backgroundThe addition of immune checkpoint inhibitors to standard-of-care chemoradiation (CRT) is established as the new standard of care in high-risk, locally advanced cervical cancer. However, the optimal sequencing of therapies is unknown. Defining safety and feasibility of the combination was a primary objective of this study examining concurrent versus sequential schedules.

methodsPembrolizumab was given after or during CRT in a randomized phase 2 design. Patients aged 18 years and older with locally advanced cervical cancer, stages IB-IVA (according to 2009 International Federation of Gynecology and Obstetrics staging) were randomized 1:1 to treatment regimens. CRT was identical for both arms. Pembrolizumab was administered every 3 weeks for three doses; no maintenance was allowed. Safety assessments included the incidence and severity of adverse events (AEs), and feasibility was measured by the completion of treatment in a predefined timeframe. Translational specimens (blood and tissue) were collected.

resultsIn total, 94 evaluable patients completed treatment. Treatment-related grade ≥2 toxicity was experienced by 85 of 94 patients (90%); 40 patients (43%) had at least one grade 3 AE, and 22 (23%) had at least one grade 4 AE. There were no grade 5 AEs. Eighty percent of patients completed radiotherapy within 56 days, and 85% completed five or six doses of cisplatin and three doses of pembrolizumab (74 of 94 patients; 79%).

conclusionsThe final results of this study support the safety and feasibility of adding pembrolizumab to pelvic CRT, concurrently and sequentially. Progression-free and overall survival were not affected or different between treatment arms. An analysis of the translational end points is ongoing and will inform future study designs.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsChemoradiotherapyUterine Cervical NeoplasmsAdultAgedAntineoplastic Agents, ImmunologicalFeasibility StudiesFemaleHumansMiddle AgedNeoplasm StagingAntibodies, Monoclonal, HumanizedAntineoplastic Agents, Immunologicalpembrolizumabcervical cancerchemoradiationfeasibilityimmunotherapysafety

Identifiers

PMID39921852
PMCPMC11806929

What OpenQuestion holds

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Registered trials

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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.