Evidence map›Paper›PMID 31152292›Full record

Trial reportInvestigational new drugs2019

Phase II study of avelumab in multiple relapsed/refractory germ cell cancer.

M Mego, D Svetlovska, M Chovanec, M Rečkova, K Rejlekova, J Obertova, P Palacka, Z Sycova-Mila, U De Giorgi, J Mardiak

Abstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 1 pooled it
9.3field-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.

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

47 citing papers in PubMed, 1 synthesis or guideline pooled it, 83 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Phase II trial of nivolumab monotherapy and biomarker screening in patients with chemo-refractory germ cell tumors.International journal of urology : official journal of the Japanese Urological Association · 2022
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  6. Review
  7. Article
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  11. Malignant germ cells tumor of the ovary.Journal of gynecologic oncology · 2025
    Review
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  13. Review
  14. Article
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  16. Review
  17. Article
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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

10 authors at 4 institutions in 4 countries.

M MegoTranslational Research Unit, Faculty of Medicine, National Cancer Institute, Comenius University, Bratislava, Slovakia. misomego@gmail.com.
D SvetlovskaTranslational Research Unit, Faculty of Medicine, National Cancer Institute, Comenius University, Bratislava, Slovakia.
M Chovanec2nd Department of Oncology, Faculty of Medicine, Comenius University and National Cancer Institute, Klenova 1, 833 10, Bratislava, Slovak Republic.
M RečkovaNational Cancer Institute, Bratislava, Slovak Republic.
K Rejlekova2nd Department of Oncology, Faculty of Medicine, Comenius University and National Cancer Institute, Klenova 1, 833 10, Bratislava, Slovak Republic.
J Obertova2nd Department of Oncology, Faculty of Medicine, Comenius University and National Cancer Institute, Klenova 1, 833 10, Bratislava, Slovak Republic.
P Palacka2nd Department of Oncology, Faculty of Medicine, Comenius University and National Cancer Institute, Klenova 1, 833 10, Bratislava, Slovak Republic.
Z Sycova-MilaNational Cancer Institute, Bratislava, Slovak Republic.
U De GiorgiInstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS - Medical Oncology Department Meldola, Meldola, Italy.
J Mardiak2nd Department of Oncology, Faculty of Medicine, Comenius University and National Cancer Institute, Klenova 1, 833 10, Bratislava, Slovak Republic.
Cancer Institute (WIA) · INNational Cancer Institute · MYComenius University Bratislava · SKIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background Germ cell tumors (GCTs) are highly curable diseases; however, not all patients can be cured. Patients in their second relapse have especially poor prognoses. PD-L1 expression is significantly higher in GCTs than in normal testicular tissue, and high PD-L1 expression is associated with a poor prognosis. This study aimed to determine the efficacy and safety of avelumab, a PD-L1 inhibitor, in patients with GCTs. Methods In this phase 2 study, patients with multiple relapsed and/or refractory GCTs were treated with avelumab at a dose of 10 mg/kg administered biweekly until progression or unacceptable toxicity. The primary endpoint was 12-week progression-free survival (PFS). Fifteen evaluable patients had to be enrolled in the first cohort, and if <8 of 15 patients had 12-week PFS, the study was to be terminated. Here, we report the results of the first stage of the trial. Results From November 2017 to January 2018, 8 patients with a median age of 29 years (range, 22 to 52 months) were enrolled. Patients were pretreated with a median of 5 (range, 1 to 6) previous lines of platinum-based therapies; 5 tumors (62.5%) were absolutely refractory to cisplatin, and 5 patients (62.5%) had visceral nonpulmonary metastases. At a median follow-up period of 2.6 months (range, 0.3 to 14.4), all the patients experienced disease progression, and 7 patients (87.5%) died. The twelve-week PFS was 0%, median PFS was 0.9 months (95% CI 0.5-1.9), and median OS was 2.7 months (95% CI 1.0-3.3). Avelumab was well tolerated, and no severe adverse events were observed. Conclusions This study failed to achieve its primary endpoint. Our data suggest a lack of avelumab efficacy in unselected multiple relapsed/refractory GCTs.

Indexed as

AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsB7-H1 AntigenDrug Resistance, NeoplasmHumansMiddle AgedNeoplasm Recurrence, LocalNeoplasms, Germ Cell and EmbryonalProgression-Free SurvivalYoung AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsavelumabB7-H1 AntigenCD274 protein, humanAvelumabGerm cell tumorsImmune checkpoint inhibitorsPD-L1 expressionRefractory germ cell tumors

Identifiers

PMID31152292
OpenAlexW2947584913

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.