Evidence map›Paper›PMID 36255393›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2023

Phase II Trial of Pembrolizumab and Anti-CD3 x Anti-HER2 Bispecific Antibody-Armed Activated T Cells in Metastatic Castration-Resistant Prostate Cancer.

Ulka N Vaishampayan, Archana Thakur, Wei Chen, Abhinav Deol, Meera Patel, Kimberlee Dobson, Brenda Dickow, Dana Schalk, Amy Schienschang, Sarah Whitaker and 4 more

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

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 7% 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

29 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

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  20. HER2-targeted therapies beyond breast cancer - an update.Nature reviews. Clinical oncology · 2024
    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

14 authors at 2 institutions in 1 country.

Ulka N Vaishampayan *Karmanos Cancer Center, Wayne State University, Detroit, Michigan.ORCID 0000-0001-5800-4571
Archana Thakur *Emily Couric Cancer Center, University of Virginia, Charlottesville, Virginia.ORCID 0000-0003-3876-9555
Wei ChenKarmanos Cancer Center, Wayne State University, Detroit, Michigan.ORCID 0000-0001-6048-1860
Abhinav DeolKarmanos Cancer Center, Wayne State University, Detroit, Michigan.ORCID 0000-0003-0947-8871
Meera PatelKarmanos Cancer Center, Wayne State University, Detroit, Michigan.ORCID 0000-0003-4127-3147
Kimberlee DobsonKarmanos Cancer Center, Wayne State University, Detroit, Michigan.ORCID 0000-0001-9138-2726
Brenda DickowKarmanos Cancer Center, Wayne State University, Detroit, Michigan.ORCID 0000-0001-7010-5359
Dana SchalkEmily Couric Cancer Center, University of Virginia, Charlottesville, Virginia.ORCID 0000-0002-3895-1907
Amy SchienschangEmily Couric Cancer Center, University of Virginia, Charlottesville, Virginia.ORCID 0000-0002-8709-8762
Sarah WhitakerEmily Couric Cancer Center, University of Virginia, Charlottesville, Virginia.ORCID 0000-0003-4058-2845
Amanda PolendEmily Couric Cancer Center, University of Virginia, Charlottesville, Virginia.ORCID 0000-0002-7640-5122
Joseph A FontanaKarmanos Cancer Center, Wayne State University, Detroit, Michigan.
Elisabeth I HeathKarmanos Cancer Center, Wayne State University, Detroit, Michigan.ORCID 0000-0003-1381-2713
Lawrence G LumEmily Couric Cancer Center, University of Virginia, Charlottesville, Virginia.ORCID 0000-0001-7561-6035
The Barbara Ann Karmanos Cancer Institute · USUniversity of Virginia · US

Funding

Women's Oncology Program - WONP30CA044579 · NCI · UNIVERSITY OF VIRGINIA CHARLOTTESVILLE · PI Dina Gould Halme · 1987 to 2026
$72.1M
Tumor Biology and Microenvironment (Program 1)P30CA022453 · NCI · WAYNE STATE UNIVERSITY · PI PAUL M STEMMER · 1985 to 2026
$68.4M
NCI NIH HHS P30 CA022453NCI NIH HHS P30 CA044579
6 · The paper itself

Abstract

purposeA phase II study was conducted to evaluate the safety and efficacy of the combination of HER2 bispecific antibody (HER2Bi)-armed activated T cells (HER2 BAT) and programmed death 1 inhibitor, pembrolizumab. PATIENTS AND

methodsPatients with metastatic castration-resistant prostate cancer (mCRPC) with 0 to 1 performance status and normal liver, kidney, and marrow function, pre- or post-docetaxel chemotherapy were eligible. Primary endpoint was 6-month progression-free survival (PFS). Peripheral blood mononuclear cells were obtained by a single apheresis, shipped to University of Virginia, activated with OKT3 and expanded for 14 days in IL2, harvested, and armed with HER2Bi and cryopreserved. HER2 BATs were infused twice weekly for 4 weeks and pembrolizumab was administered every 21 days for a maximum duration of 6 months starting 1 to 3 weeks prior to HER2 BATs infusion.

resultsFourteen patients were enrolled with a median age of 69 (range 57-82 years) and median PSA of 143.4 (range 8.2-4210 ng/dL). Two patients had peritoneal metastases, 1 had lymph node (LN) only metastases and 11 had bone metastases of which 7 had bone and LN metastases. All were pretreated with androgen receptor axis targeted agents and 7 (50%) had prior docetaxel chemotherapy. The toxicities were grade1-2 infusion reactions with fever, chills, headaches, nausea and/or myalgias. Primary endpoint of 6 month PFS was achieved in 5 of 14 patients (38.5%; 95% confidence interval, 19.5%-76.5%). Median PFS was 5 months and median survival was 31.6 months.

conclusionsThe safety and promising efficacy makes this combination worthy of future investigation in mCRPC.

Indexed as

Prostatic Neoplasms, Castration-ResistantAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsDocetaxelHumansLeukocytes, MononuclearMaleMiddle AgedT-LymphocytesAntibodies, Monoclonal, HumanizedDocetaxelpembrolizumab

Identifiers

PMID36255393
PMCPMC9812860
OpenAlexW4306731864

What OpenQuestion holds

Textmetadata
LicenceTDM
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.