Evidence map›Paper›PMID 38954010›Full record

Trial reportCancer immunology, immunotherapy : CII2024

A randomized phase II clinical trial of stereotactic body radiation therapy (SBRT) and systemic pembrolizumab with or without intratumoral avelumab/ipilimumab plus CD1c (BDCA-1)

Manon Vounckx, Jens Tijtgat, Latoya Stevens, Iris Dirven, Bart Ilsen, Frederik Vandenbroucke, Steven Raeymaeckers, Karolien Vekens, Ramses Forsyth, Xenia Geeraerts and 7 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Cancer immunology, immunotherapy : CII, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04571632 (A Randomized Phase II Clinical Trial of SBRT and Systemic Pembrolizumab With or Without Intratumoral Avelumab/Ipilimumab Plus CD1c), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
–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.

NCT04571632 phase2unknown statusnot on this map

A Randomized Phase II Clinical Trial of SBRT and Systemic Pembrolizumab With or Without Intratumoral Avelumab/Ipilimumab Plus CD1c (BDCA-1)+/ CD141 (BDCA-3)+ Myeloid Dendritic Cells in NSCLC Subtitle v3.0: A Randomized Phase II Clinical Trial of SBRT and Systemic Pembrolizumab With or Without Intratumoral Avelumab/Ipilimumab Plus CD1c (BDCA-1)+/CD141 (BDCA-3)+ Myeloid Dendritic Cells in Solid Tumors.

TypeinterventionalSponsorUniversitair Ziekenhuis BrusselRan2020 to 2023Enrolled36ConditionsNon Small Cell Lung Cancer, Solid TumorArmsAvelumab, Ipilimumab 5 MG/ML, Pembrolizumab 100 MG in 4 ML Injection, CD1c (BDCA-1)+ / CD141 (BDCA-3)+ myDC
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Article
  3. Integrated approaches to sensitizing melanoma to radiotherapy.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2026
    Review
  4. Review
  5. Review
  6. Article
  7. Combinatorial approaches for cancer immunotherapy.Cancer immunology, immunotherapy : CII · 2026
    Article
  8. Review
  9. Review
  10. Review
  11. 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

17 authors.

Manon VounckxDepartment of Medical Oncology, Laboratory for Medical and Molecular Oncology (LMMO), Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090, Brussels, Belgium. Manon.vounckx@uzbrussel.be.
Jens TijtgatDepartment of Medical Oncology, Laboratory for Medical and Molecular Oncology (LMMO), Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090, Brussels, Belgium.
Latoya StevensDepartment of Medical Oncology, Laboratory for Medical and Molecular Oncology (LMMO), Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090, Brussels, Belgium.
Iris DirvenDepartment of Medical Oncology, Laboratory for Medical and Molecular Oncology (LMMO), Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090, Brussels, Belgium.
Bart IlsenDepartment of Radiology, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090, Brussels, Belgium.
Frederik VandenbrouckeDepartment of Radiology, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090, Brussels, Belgium.
Steven RaeymaeckersDepartment of Radiology, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090, Brussels, Belgium.
Karolien VekensDepartment of Medical Oncology, Laboratory for Medical and Molecular Oncology (LMMO), Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090, Brussels, Belgium.
Ramses ForsythDepartment of Pathology, Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090, Brussels, Belgium.
Xenia GeeraertsDepartment of Medical Oncology, Laboratory for Medical and Molecular Oncology (LMMO), Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090, Brussels, Belgium.
Ivan Van RietDepartment of Hematology, Stem Cell Laboratory, Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090, Brussels, Belgium.
Julia Katharina SchwarzeDepartment of Medical Oncology, Laboratory for Medical and Molecular Oncology (LMMO), Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090, Brussels, Belgium.
Sandra TuyaertsDepartment of Medical Oncology, Laboratory for Medical and Molecular Oncology (LMMO), Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090, Brussels, Belgium.
Lore DecosterDepartment of Medical Oncology, Laboratory for Medical and Molecular Oncology (LMMO), Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090, Brussels, Belgium.
Mark De RidderDepartment of Radiotherapy, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090, Brussels, Belgium.
Ines Dufait *Department of Radiotherapy, Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090, Brussels, Belgium.
Bart Neyns *Department of Medical Oncology, Laboratory for Medical and Molecular Oncology (LMMO), Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090, Brussels, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRadiotherapy (RT) synergizes with immune checkpoint blockade (ICB). CD1c(BDCA-1)

methodsIn this phase II clinical trial, anti-PD-1 ICB pretreated oligometastatic patients (tumor agnostic) underwent a leukapheresis followed by isolation of CD1c(BDCA-1)

resultsThirteen patients (10 in arm A, eight non-small cell lung cancer, and five melanoma) were enrolled. Two patients crossed over. One-year PFS rate was 10% in arm A and 0% in arm B. Two patients in arm A obtained a partial response, and one patient obtained a stable disease as best response. In arm B, one patient obtained a SD. Median PFS and OS were 21.8 weeks (arm A) versus 24.9 (arm B), and 62.7 versus 57.9 weeks, respectively. An iatrogenic pneumothorax was the only grade 3 treatment-related adverse event.

conclusionSBRT and pembrolizumab with or without IT avelumab/ipilimumab and IT myDC in oligometastatic patients are safe and feasible with a clinically meaningful tumor response rate. However, the study failed to reach its primary endpoint. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov: NCT04571632 (09 AUG 2020). EUDRACT: 2019-003668-32. Date of registration: 17 DEC 2019, amendment 1: 6 MAR 2021, amendment 2: 4 FEB 2022.

Indexed as

Antibodies, Monoclonal, HumanizedDendritic CellsIpilimumabRadiosurgeryAdultAgedAged, 80 and overAntigens, CD1Antineoplastic Combined Chemotherapy ProtocolsCombined Modality TherapyFemaleGlycoproteinsHumansMaleMiddle AgedMyeloid CellsAntibodies, Monoclonal, HumanizedAntigens, CD1avelumabCD1C protein, humanGlycoproteinsIpilimumabpembrolizumabThrombomodulinIntratumoral immunotherapyMelanomaMyeloid dendritic cell therapyNon-small lung cell carcinomaStereotactic body radiation therapy

Identifiers

PMID38954010
PMCPMC11219623

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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.