Evidence map›Paper›PMID 34687398›Full record

Trial reportTargeted oncology2021

Avelumab in Combination Regimens for Relapsed/Refractory DLBCL: Results from the Phase Ib JAVELIN DLBCL Study.

Eliza A Hawkes, Tycel Phillips, Lihua Elizabeth Budde, Armando Santoro, Nakhle S Saba, Fernando Roncolato, Gareth P Gregory, Gregor Verhoef, Fritz Offner, Cristina Quero and 8 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Targeted oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02951156 (PHASE 1B/PHASE 3 MULTICENTER STUDY OF AVELUMAB), 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
1.4field-weighted citation impact, top 19% 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.

NCT02951156 phase3terminatednot on this map

Phase 1b/phase 3 multicenter study of avelumab (msb0010718c) in combination regimens that include an immune agonist, epigenetic modulator, cd20 antagonist and/or conventional chemotherapy in patients with relapsed or refractory diffuse large b-cell lymphoma (dlbcl) javelin dlbcl

TypeinterventionalSponsorPfizerRan2016 to 2019Enrolled29ConditionsDiffuse Large B-Cell LymphomaArmsAvelumab, Utomilumab, Rituximab, Azacitidine, Bendamustine
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Getting the right combination to break the epigenetic code.Nature reviews. Clinical oncology · 2025
    Review
  5. Review
  6. Review
  7. Review
  8. Review
  9. Review
  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

18 authors at 15 institutions in 7 countries.

Eliza A HawkesOlivia Newton-John Cancer Research Institute, Austin Health, 145 Studley Road, Heidelberg, VIC, Australia. eliza.hawkes@onjcri.org.au.
Tycel PhillipsUniversity of Michigan Health System, Ann Arbor, MI, USA.
Lihua Elizabeth BuddeCity of Hope, Duarte, CA, USA.
Armando SantoroDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy.
Nakhle S SabaSection of Hematology and Medical Oncology, Deming Department of Medicine, Tulane University, New Orleans, LA, USA.
Fernando RoncolatoSt. George Hospital, Kogarah, NSW, Australia.
Gareth P GregorySchool of Clinical Sciences at Monash Health, Monash University, Melbourne, VIC, Australia.
Gregor VerhoefUZ Leuven, Leuven, Belgium.
Fritz OffnerUZ Gent, Gent, Belgium.
Cristina QueroHospital Universitario Virgen de la Victoria, Málaga, Spain.
John RadfordNIHR Manchester Clinical Research Facility, The Christie NHS Foundation Trust and University of Manchester, Manchester, UK.
Krzysztof GiannopoulosExperimental Hematooncology Department, St. John's Cancer Center, Medical University of Lublin, Lublin, Poland.
Don StevensNorton Cancer Institute, Louisville, KY, USA.
Aron ThallPfizer Inc, La Jolla, CA, USA.
Bo HuangPfizer Inc, Groton, CT, USA.
A Douglas LairdPfizer Inc, La Jolla, CA, USA.
Robin SandnerPfizer Inc, Collegeville, PA, USA.
Stephen M AnsellMayo Clinic, Rochester, MN, USA.
Pfizer (United States) · USAustin Health · AUCity of Hope · USGhent University Hospital · BEHospital Clínico Universitario Virgen de la Victoria · ESHumanitas University · ITMayo Clinic in Arizona · USMedical University of Lublin · PLMichigan Medicine · USMonash Health · AUNorton Healthcare · USSt George Hospital · AUTulane University · USUniversitair Ziekenhuis Leuven · BEUniversity of Manchester · GB

Funding

Tracking & Evaluation CoreU54GM104940 · NIGMS · LSU PENNINGTON BIOMEDICAL RESEARCH CTR · PI JUDD E SHELLITO · 2012 to 2026
$69.1M
NIGMS NIH HHS U54 GM104940
6 · The paper itself

Abstract

backgroundRelapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) is associated with a poor prognosis despite the availability of multiple treatment options. Preliminary evidence suggests that DLBCL may be responsive to programmed death ligand 1 (PD-L1)/programmed death 1 inhibitors.

objectiveThe JAVELIN DLBCL study was conducted to assess whether a combination of agents could augment and sustain the antitumor immunity of avelumab, an anti-PD-L1 antibody, in R/R DLBCL.

methodsThis was a multicenter, randomized, open-label, parallel-arm study with a phase Ib and a phase III component. Reported here are the results from the phase Ib study, wherein 29 adult patients with DLBCL were randomized 1:1:1 to receive avelumab in combination with utomilumab (an immunoglobulin G2 4-1BB agonist) and rituximab (arm A), avelumab in combination with utomilumab and azacitidine (arm B), or avelumab in combination with bendamustine and rituximab (arm C). The primary endpoints were dose-limiting toxicities and objective response as assessed by the investigator per Lugano Response Classification criteria.

resultsOf the seven patients in arm A, one (14.3%) experienced two grade 3 dose-limiting toxicities (herpes zoster and ophthalmic herpes zoster); no dose-limiting toxicities were reported in arms B or C. No new safety concerns emerged for avelumab. One partial response was reported in arm A, three complete responses in arm C, and no responses in arm B. Given the insufficient antitumor activity in arms A and B and the infeasibility of expanding arm C, the study was discontinued before initiation of the phase III component.

conclusionsThe low level of clinical activity suggests that PD-L1 inhibitor activity may be limited in R/R DLBCL. CLINICALTRIALS. GOV IDENTIFIER: NCT02951156.

Indexed as

Herpes ZosterLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinAdultAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsHumansRituximabAntibodies, Monoclonal, HumanizedavelumabRituximab

Identifiers

PMID34687398
PMCPMC8613117
OpenAlexW3207566340

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.