Evidence map›Paper›PMID 39627139›Full record

ArticleBMJ open2024

Pembrolizumab (MK-3475) plus platinum and gemcitabine as first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma (PIPER): a phase 2, multicentre, single-arm protocol study in Malaysia.

Sok Ching Cheong, Bawani Selvam, Gwo Fuang Ho, Ibtisam Muhamad Nor, Chih Kiang Tan, Yoke Fui Wong, Soo Hwang Teo, Kue Peng Lim, Annie Wai Yeeng Chai, Abqariyah Yahya and 1 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05286619 (A Study of Pembrolizumab), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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.

NCT05286619 phase2recruitingnot on this map

A Study of Pembrolizumab (MK-3475) Plus Platinum and Gemcitabine as First Line Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (PIPER)

TypeinterventionalSponsorUniversity of MalayaRan2022 to 2028Enrolled63ConditionsRecurrent/Metastatic Head and Neck Squamous Cell CarcinomaArmsPembrolizumab, Cisplatin, Carboplatin, Gemcitabine
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. 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.

Sok Ching CheongCancer Research Malaysia, Subang Jaya, Selangor, Malaysia.
Bawani SelvamCancer Research Malaysia, Subang Jaya, Selangor, Malaysia.
Gwo Fuang HoClinical Oncology Unit, Faculty of Medicine, University of Malaya, Kuala Lumpur, Wilayah Persekutuan, Malaysia.
Ibtisam Muhamad NorDepartment of Radiotherapy & Oncology, General Hospital, Kuala Lumpur, Malaysia.
Chih Kiang TanOncology and Nuclear Medicine Department, Thomson Hospital Kota Damansara, Petaling Jaya, Selangor, Malaysia.
Yoke Fui WongDepartment of Radiotherapy & Oncology, National Cancer Institute, Putrajaya, Malaysia.
Soo Hwang TeoCancer Research Malaysia, Subang Jaya, Selangor, Malaysia.
Kue Peng LimCancer Research Malaysia, Subang Jaya, Selangor, Malaysia.
Annie Wai Yeeng ChaiCancer Research Malaysia, Subang Jaya, Selangor, Malaysia.
Abqariyah YahyaDepartment of Social and Preventive Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Wilayah Persekutuan, Malaysia.
Wan Zamaniah Wan IshakClinical Oncology Unit, Faculty of Medicine, University of Malaya, Kuala Lumpur, Wilayah Persekutuan, Malaysia zamachi@um.edu.my.ORCID 0000-0002-4007-7091

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTreatment combination of pembrolizumab plus platinum and 5-fluorouracil (PF) has increased the survival of recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). The combination of platinum and gemcitabine (PG) has been shown to be superior to PF in the treatment of R/M nasopharyngeal carcinoma patients. Therefore, we hypothesise that the combination of pembrolizumab with PG would be comparable to pembrolizumab with PF as a first-line treatment in R/M HNSCC. METHODS AND ANALYSIS: This is an open-label, multicentre, single-arm, phase 2 study of pembrolizumab plus PG for first-line treatment in subjects with R/M HNSCC in Malaysia. The study is conducted using the Optional Simon optimal 2-stage design. At the initial stage, 26 subjects will be enrolled and if seven or more patients achieve an objective response rate (ORR), then 63 patients will be enrolled. Subjects will be given pembrolizumab 200 mg ETHICS AND DISSEMINATION: The study was approved by the ethics committee of the University Malaya Medical Centre (202213-10884). Findings will be disseminated through conference presentations and peer review publications. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (www. CLINICALTRIAL: gov); NCT05286619.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsDeoxycytidineGemcitabineHead and Neck NeoplasmsNeoplasm Recurrence, LocalSquamous Cell Carcinoma of Head and NeckAdultCisplatinClinical Trials, Phase II as TopicFemaleHumansMalaysiaMaleMiddle AgedMulticenter Studies as TopicAntibodies, Monoclonal, HumanizedCisplatinDeoxycytidineGemcitabinepembrolizumabCHEMOTHERAPYHead & neck tumoursIMMUNOLOGY

Identifiers

PMID39627139
PMCPMC11624792

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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.