Evidence map›Paper›PMID 33067319›Full record

Trial reportJournal for immunotherapy of cancer2020

Axitinib plus avelumab in the treatment of recurrent glioblastoma: a stratified, open-label, single-center phase 2 clinical trial (GliAvAx).

Gil Awada, Laila Ben Salama, Jennifer De Cremer, Julia Katharina Schwarze, Lydia Fischbuch, Laura Seynaeve, Stephanie Du Four, Anne-Marie Vanbinst, Alex Michotte, Hendrik Everaert and 4 more

Open access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 6 pooled it
4.5field-weighted citation impact, top 4% 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

36 citing papers in PubMed, 6 syntheses or guidelines pooled it, 55 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Circulating Immune Cell and Outcome Analysis from the Phase II Study of PD-L1 Blockade with Durvalumab for Newly Diagnosed and Recurrent Glioblastoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
    Trial
  8. Review
  9. Review
  10. Biomolecules & biomedicine · 2025
    Article
  11. Review
  12. Review
  13. Article
  14. Glioblastoma Therapy: Past, Present and Future.International journal of molecular sciences · 2024
    Review
  15. Review
  16. Review
  17. Review
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  20. Article
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

14 authors at 3 institutions in 1 country.

Gil Awada *Medical Oncology, Universitair Ziekenhuis Brussel, Brussels, Belgium.ORCID 0000-0001-9535-0430
Laila Ben Salama *Medical Oncology, Universitair Ziekenhuis Brussel, Brussels, Belgium.
Jennifer De CremerPsychology, Vrije Universiteit Brussel, Brussels, Brussels, Belgium.
Julia Katharina SchwarzeMedical Oncology, Universitair Ziekenhuis Brussel, Brussels, Belgium.
Lydia FischbuchMedical Oncology, Universitair Ziekenhuis Brussel, Brussels, Belgium.
Laura SeynaeveNeurology, Universitair Ziekenhuis Brussel, Brussels, Belgium.
Stephanie Du FourNeurosurgery, Universitair Ziekenhuis Brussel, Brussels, Belgium.
Anne-Marie VanbinstRadiology, Universitair Ziekenhuis Brussel, Brussels, Belgium.
Alex MichottePathology, Universitair Ziekenhuis Brussel, Brussels, Belgium.
Hendrik EveraertNuclear Medicine, Universitair Ziekenhuis Brussel, Brussels, Belgium.
Anne RogiersPsychiatry, Centre Hospitalier Universitaire Brugmann, Brussels, Belgium.
Peter TheunsPsychology, Vrije Universiteit Brussel, Brussels, Brussels, Belgium.
Johnny DuerinckNeurosurgery, Universitair Ziekenhuis Brussel, Brussels, Belgium.
Bart NeynsMedical Oncology, Universitair Ziekenhuis Brussel, Brussels, Belgium bart.neyns@uzbrussel.be.
Universitair Ziekenhuis Brussel · BEVrije Universiteit Brussel · BECentre Hospitalier Universitaire Brugmann · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNo treatment demonstrated to improve survival in patients with recurrent glioblastoma (rGB) in a randomized trial. Combining axitinib with the programmed cell death ligand 1 blocking monoclonal antibody avelumab may result in synergistic activity against rGB.

methodsAdult patients with rGB following prior surgery, radiation therapy and temozolomide chemotherapy were stratified according to their baseline use of corticosteroids. Patients with a daily dose of ≤8 mg of methylprednisolone (or equivalent) initiated treatment with axitinib (5 mg oral two times per day) plus avelumab (10 mg/kg intravenous every 2 weeks) (Cohort-1). Patients with a higher baseline corticosteroid dose initiated axitinib monotherapy; avelumab was added after 6 weeks of therapy if the corticosteroid dose could be tapered to ≤8 mg of methylprednisolone (Cohort-2). Progression-free survival at 6 months (6-m-PFS%), per immunotherapy response assessment for neuro-oncology criteria, served as the primary endpoint.

resultsBetween June 2017 and August 2018, 54 patients (27 per cohort) were enrolled and initiated study treatment (median age: 55 years; 63% male; 91% Eastern Cooperative Oncology Group Performance Status 0-1). Seventeen (63%) patients treated in Cohort-2 received at least one dose of avelumab. The 6-m-PFS% was 22.2% (95% CI 6.5% to 37.9%) and 18.5% (95% CI 3.8% to 33.2%) in Cohort-1 and Cohort-2, respectively; median overall survival was 26.6 weeks (95% CI 20.8 to 32.4) in Cohort-1 and 18.0 weeks (95% CI 12.5 to 23.5) in Cohort-2. The best objective response rate was 33.3% and 22.2% in Cohort-1 and Cohort-2, respectively, with a median duration of response of 17.9 and 19.0 weeks. The most frequent treatment-related adverse events were dysphonia (67%), lymphopenia (50%), arterial hypertension and diarrhea (both 48%). There were no grade 5 adverse events.

conclusionThe combination of avelumab plus axitinib has an acceptable toxicity profile but did not meet the prespecified threshold for activity justifying further investigation of this treatment in an unselected population of patients with rGB.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsAxitinibFemaleGlioblastomaHumansMiddle AgedAntibodies, Monoclonal, HumanizedavelumabAxitinibbrain neoplasmsclinical trialscombinationdrug therapyimmunotherapyphase II as topicprogrammed cell death 1 receptor

Identifiers

PMID33067319
PMCPMC7570224
OpenAlexW3092784769

What OpenQuestion holds

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LicenceCC BY-NC
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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.