Evidence map›Paper›PMID 38165683›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2024

Phase I Trial of First-line Bintrafusp Alfa in Patients with Locally Advanced or Persistent/Recurrent/Metastatic Cervical Cancer.

Ana Oaknin, Sharad A Ghamande, Yuka Kasamatsu, Marta Gil-Martin, Juan Francisco Grau-Bejar, Carmen Garcia-Duran, Masashi Sato, Abdul Siddiqui, Surendra Pal Chaudhary, Yulia Vugmeyster and 1 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyClinical Trial, Phase I
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04551950 (Safety Study of Bintrafusp Alfa in Combination With Other Anti-cancer Therapies in Participants With Locally Advanced or Advanced Cervical Cancer), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
4.2field-weighted citation impact, top 6% 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.

NCT04551950 phase1completednot on this map

Safety Study of Bintrafusp Alfa in Combination With Other Anti-cancer Therapies in Participants With Locally Advanced or Advanced Cervical Cancer (INTR@PID 046)

TypeinterventionalSponsorEMD Serono Research & Development Institute, Inc.Ran2020 to 2022Enrolled25ConditionsCervical CancerArmsM7824, Carboplatin, Paclitaxel, Bevacizumab, Cisplatin
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. [Novel therapeutic strategies for liver metastases driven by the common microenvironment].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2026
    Review
  3. Article
  4. Review
  5. Review
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  7. Strategies to target PD-1/PD-L1 in the tumor microenvironment.Cellular oncology (Dordrecht, Netherlands) · 2026
    Review
  8. Article
  9. A Bioimaging Study ofMolecular imaging and biology · 2026
    Article
  10. Review
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

11 authors at 7 institutions in 5 countries.

Ana OakninGynaecologic Cancer Programme, Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.ORCID 0000-0002-3592-7194
Sharad A GhamandeAugusta University, Augusta, Georgia.ORCID 0000-0003-2242-2215
Yuka KasamatsuShizuoka Cancer Center, Suntogun, Japan.ORCID 0000-0003-4161-4941
Marta Gil-MartinInstitut Català d'Oncologia-IDIBELL, L'Hospitalet de Llobregat, Barcelona, Spain.ORCID 0000-0002-8548-5355
Juan Francisco Grau-BejarGynaecologic Cancer Programme, Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.ORCID 0009-0002-3937-4969
Carmen Garcia-DuranGynaecologic Cancer Programme, Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.ORCID 0000-0003-3836-6959
Masashi Satothe healthcare business of Merck KGaA, Darmstadt, Germany.ORCID 0009-0009-3852-4591
Abdul Siddiquithe healthcare business of Merck KGaA, Darmstadt, Germany.ORCID 0009-0007-2409-8320
Surendra Pal ChaudharyEMD Serono, Billerica, Massachusetts.ORCID 0000-0003-1541-8314
Yulia VugmeysterEMD Serono, Billerica, Massachusetts.ORCID 0000-0002-6289-2521
Kosei HasegawaSaitama Medical University International Medical Center, Saitama, Japan.ORCID 0000-0002-1903-7001
Merck (Germany) · DEVall d'Hebron Hospital Universitari · ESAugusta University Health · USInstitut Català d'Oncologia · ESOno Pharmaceutical (United States) · USSaitama International Medical Center · JPSWOG Cancer Research Network · US

Funding

the healthcare business of Merck KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009945) N/A
6 · The paper itself

Abstract

purposeBintrafusp alfa, a first-in-class bifunctional fusion protein composed of the extracellular domain of TGFβ receptor II (a TGFβ "trap") fused to a human IgG1 mAb blocking programmed death-ligand 1 (PD-L1), was evaluated as treatment in patients with locally advanced or persistent, recurrent, or metastatic (P/R/M) cervical cancer. PATIENTS AND

methodsIn this multicenter, open-label, phase Ib trial (NCT04551950), patients with P/R/M cervical cancer received bintrafusp alfa 2,400 mg once every 3 weeks plus cisplatin or carboplatin plus paclitaxel with (Cohort 1A; n = 8) or without (Cohort 1B; n = 9) bevacizumab; patients with locally advanced cervical cancer received bintrafusp alfa 2,400 mg every 3 weeks plus cisplatin plus radiation, followed by bintrafusp alfa monotherapy maintenance (Cohort 2; n = 8). The primary endpoint was safety; secondary endpoints included efficacy (including objective response rate) and pharmacokinetics.

resultsAt the data cutoff of April 27, 2022, patients in Cohorts 1A, 1B, and 2 had received bintrafusp alfa for a median duration of 37.9, 31.1, and 16.7 weeks, respectively. Two dose-limiting toxicities (grade 4 amylase elevation and grade 3 menorrhagia) unrelated to bintrafusp alfa were observed in Cohort 1B and none in other cohorts. Most treatment-emergent adverse events of special interest were grades 1-2 in severity, most commonly anemia (62.5%-77.8%) and bleeding events (62.5%-77.8%). Objective response rate was 75.0% [95% confidence interval (CI), 34.9-96.8], 44.4% (95% CI, 13.7-78.8), and 62.5% (95% CI, 24.5-91.5) in Cohorts 1A, 1B, and 2, respectively.

conclusionsBintrafusp alfa had manageable safety and demonstrated clinical activity, further supporting the investigation of TGFβ/PD-L1 inhibition in human papillomavirus-associated cancers, including cervical cancer.

Indexed as

Uterine Cervical NeoplasmsB7-H1 AntigenCisplatinFemaleHumansImmunologic FactorsNeoplasm Recurrence, LocalPaclitaxelTransforming Growth Factor betaB7-H1 AntigenCisplatinImmunologic FactorsPaclitaxelTransforming Growth Factor beta

Identifiers

PMID38165683
PMCPMC10905521
OpenAlexW4390511577

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.