Evidence map›Paper›PMID 35960332›Full record

Trial reportCancer immunology, immunotherapy : CII2023

Pembrolizumab, radiotherapy, and an immunomodulatory five-drug cocktail in pretreated patients with persistent, recurrent, or metastatic cervical or endometrial carcinoma: Results of the phase II PRIMMO study.

Emiel A De Jaeghere, Sandra Tuyaerts, An M T Van Nuffel, Ann Belmans, Kris Bogaerts, Regina Baiden-Amissah, Lien Lippens, Peter Vuylsteke, Stéphanie Henry, Xuan Bich Trinh and 11 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer immunology, immunotherapy : CII, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03192059 (A Phase II Investigation of Pembrolizumab), which is not on this map. Cited by 34 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 2 pooled it
7.6field-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.

NCT03192059 phase2completednot on this map

A Phase II Investigation of Pembrolizumab (Keytruda) in Combination With Radiation and an Immune Modulatory Cocktail in Patients With Cervical and Uterine Cancer (PRIMMO Trial)

TypeinterventionalSponsorUniversity Hospital, GhentRan2017 to 2021Enrolled43ConditionsCervical Cancer, Endometrial Cancer, Uterine CancerArmsPembrolizumab, Radiation, Vitamin D, Aspirin, Lansoprazole
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 2 syntheses or guidelines pooled it, 43 citations in OpenAlex.

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  17. Reirradiation Practice in Gynecological Cancer: Insights from a National Survey in Spain.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors at 10 institutions in 2 countries.

Emiel A De JaeghereDepartment of Medical Oncology (Route 535), Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.
Sandra TuyaertsGynaecologic Oncology, Department of Oncology, KU Leuven, Leuven, Belgium.
An M T Van NuffelAnticancer Fund (ACF), Strombeek-Bever, Belgium.
Ann BelmansBiostatistics and Statistical Bioinformatics Centre (L-BioStat), KU Leuven, Leuven, Belgium.
Kris BogaertsBiostatistics and Statistical Bioinformatics Centre (L-BioStat), KU Leuven, Leuven, Belgium.
Regina Baiden-AmissahGynaecologic Oncology, Department of Oncology, KU Leuven, Leuven, Belgium.
Lien LippensCancer Research Institute Ghent (CRIG), Ghent, Belgium.
Peter VuylstekeDepartment of Hemato-Oncology, Centre Hospitalier Universitaire Université Catholique de Louvain Namur (Sainte-Elisabeth), Namur, Belgium.
Stéphanie HenryDepartment of Hemato-Oncology, Centre Hospitalier Universitaire Université Catholique de Louvain Namur (Sainte-Elisabeth), Namur, Belgium.
Xuan Bich TrinhDepartment of Gynecologic Oncology and Senology, University Hospital Antwerp, Edegem, Belgium.
Peter A van DamDepartment of Gynecologic Oncology and Senology, University Hospital Antwerp, Edegem, Belgium.
Sandrine AspeslaghDepartment of Medical Oncology, University Hospital Brussels, Brussels, Belgium.
Alex De CaluwéDepartment of Radiation Oncology, Jules Bordet Institute, Brussels, Belgium.
Eline NaertDepartment of Medical Oncology (Route 535), Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium.
Diether LambrechtsVIB-KU Leuven Center for Cancer Biology, Leuven, Belgium.
An HendrixCancer Research Institute Ghent (CRIG), Ghent, Belgium.
Olivier De WeverCancer Research Institute Ghent (CRIG), Ghent, Belgium.
Koen K Van de VijverCancer Research Institute Ghent (CRIG), Ghent, Belgium.
Frédéric AmantGynaecologic Oncology, Department of Oncology, KU Leuven, Leuven, Belgium.
Katrien Vandecasteele *Cancer Research Institute Ghent (CRIG), Ghent, Belgium.
Hannelore G Denys *Department of Medical Oncology (Route 535), Ghent University Hospital, C. Heymanslaan 10, 9000, Ghent, Belgium. hannelore.denys@ugent.be.
Ghent University Hospital · BEGhent University · BEAntwerp University Hospital · BEKU Leuven · BEStatistics Belgium · BEUCLouvain · BEAnticancer Fund · BEInstitut Jules Bordet · BEThe Netherlands Cancer Institute · NLVIB-KU Leuven Center for Cancer Biology · BE

Funding

ERA-NET-Transcan-2 G0H7516NFonds Wetenschappelijk Onderzoek 1195919NFonds Wetenschappelijk Onderzoek T002218NKom op tegen Kanker ZKD5584Nationale Loterij SW/OPS/SUB 11719-0001
6 · The paper itself

Abstract

A phase II study (PRIMMO) of patients with pretreated persistent/recurrent/metastatic cervical or endometrial cancer is presented. Patients received an immunomodulatory five-drug cocktail (IDC) consisting of low-dose cyclophosphamide, aspirin, lansoprazole, vitamin D, and curcumin starting 2 weeks before radioimmunotherapy. Pembrolizumab was administered three-weekly from day 15 onwards; one of the tumor lesions was irradiated (8Gyx3) on days 15, 17, and 19. The primary endpoint was the objective response rate per immune-related response criteria (irORR) at week 26 (a lower bound of the 90% confidence interval [CI] of > 10% was considered efficacious). The prespecified 43 patients (cervical, n = 18; endometrial, n = 25) were enrolled. The irORR was 11.1% (90% CI 2.0-31.0) in cervical cancer and 12.0% (90% CI 3.4-28.2) in endometrial cancer. Median duration of response was not reached in both cohorts. Median interval-censored progression-free survival was 4.1 weeks (95% CI 4.1-25.7) in cervical cancer and 3.6 weeks (95% CI 3.6-15.4) in endometrial cancer; median overall survival was 39.6 weeks (95% CI 15.0-67.0) and 37.4 weeks (95% CI 19.0-50.3), respectively. Grade ≥ 3 treatment-related adverse events were reported in 10 (55.6%) cervical cancer patients and 9 (36.0%) endometrial cancer patients. Health-related quality of life was generally stable over time. Responders had a significantly higher proportion of peripheral T cells when compared to nonresponders (p = 0.013). In conclusion, PRIMMO did not meet its primary objective in both cohorts; pembrolizumab, radiotherapy, and an IDC had modest but durable antitumor activity with acceptable but not negligible toxicity.Trial registration ClinicalTrials.gov (identifier NCT03192059) and EudraCT Registry (number 2016-001569-97).

Indexed as

Endometrial NeoplasmsUterine Cervical NeoplasmsAntibodies, Monoclonal, HumanizedFemaleHumansQuality of LifeAntibodies, Monoclonal, HumanizedpembrolizumabDrug therapy, combinationGynecologic neoplasmsImmunomodulationRadioimmunotherapyTumor microenvironment

Identifiers

PMID35960332
PMCPMC9870976
OpenAlexW4291146674

What OpenQuestion holds

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LicenceCC BY
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.