Evidence map›Paper›PMID 38167882›Full record

Trial reportNature communications2024

Bipolar androgen therapy plus nivolumab for patients with metastatic castration-resistant prostate cancer: the COMBAT phase II trial.

Mark C Markowski, Mary-Ellen Taplin, Rahul Aggarwal, Laura A Sena, Hao Wang, Hanfei Qi, Aliya Lalji, Victoria Sinibaldi, Michael A Carducci, Channing J Paller and 10 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature communications, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03554317 (COMbination of Bipolar Androgen Therapy and Nivolumab in Patients With Metastatic Castration-Resistant Prostate Cancer), which is not on this map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
18.4field-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.

NCT03554317 phase2completednot on this map

COMbination of Bipolar Androgen Therapy and Nivolumab in Patients With Metastatic Castration-Resistant Prostate Cancer

TypeinterventionalSponsorSidney Kimmel Comprehensive Cancer Center at Johns HopkinsRan2018 to 2023Enrolled45ConditionsCastration-resistant Prostate Cancer, Metastatic Prostate Cancer, Prostate CancerArmsTestosterone cypionate, Nivolumab
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 1 synthesis or guideline pooled it, 44 citations in OpenAlex.

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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

20 authors at 3 institutions in 1 country.

Mark C MarkowskiDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA. mmarko12@jhmi.edu.ORCID 0000-0003-2780-5100
Mary-Ellen TaplinDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Rahul AggarwalHelen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA.ORCID 0000-0001-7003-7982
Laura A SenaDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
Hao WangDivision of Quantitative Sciences, Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.ORCID 0000-0001-6489-6940
Hanfei QiDivision of Quantitative Sciences, Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.ORCID 0000-0002-0072-5752
Aliya LaljiDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
Victoria SinibaldiDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
Michael A CarducciDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
Channing J PallerDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
Catherine H MarshallDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
Mario A EisenbergerDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
David E SaninDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.ORCID 0000-0003-0188-7267
Srinivasan YegnasubramanianDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.ORCID 0000-0003-0744-6606
Carolina Gomes-AlexandreDepartment of Pathology, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Busra OzbekDepartment of Pathology, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Tracy JonesDepartment of Pathology, Johns Hopkins School of Medicine, Baltimore, MD, USA.
Angelo M De MarzoDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.ORCID 0000-0003-4847-5307
Samuel R DenmeadeDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
Emmanuel S AntonarakisDepartment of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
Johns Hopkins University · USDana-Farber Cancer Institute · USUniversity of California, San Francisco · US

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI ALAN KEITH MEEKER · 1985 to 2026
$208.6M
Androgen Activation of Innate Immune Signaling to Enhance Prostate Cancer Immune ResponseR01CA243184 · NCI · JOHNS HOPKINS UNIVERSITY · PI Samuel R Denmeade, Sushant Krishna Kachhap · 2022 to 2026
$2.0M
Bipolar Androgen Therapy for Progressive Castrate Resistant Prostate CancerR01CA184012 · NCI · JOHNS HOPKINS UNIVERSITY · PI DENMEADE, SAMUEL R · 2014 to 2018
$1.3M
NCI NIH HHS P30 CA006973NCI NIH HHS R01 CA184012NCI NIH HHS R01 CA243184
6 · The paper itself

Abstract

Cyclic high-dose testosterone administration, known as bipolar androgen therapy (BAT), is a treatment strategy for patients with metastatic castration-resistant prostate cancer (mCRPC). Here, we report the results of a multicenter, single arm Phase 2 study (NCT03554317) enrolling 45 patients with heavily pretreated mCRPC who received BAT (testosterone cypionate, 400 mg intramuscularly every 28 days) with the addition of nivolumab (480 mg intravenously every 28 days) following three cycles of BAT monotherapy. The primary endpoint of a confirmed PSA

Indexed as

NivolumabProstatic Neoplasms, Castration-ResistantAndrogensAntineoplastic Combined Chemotherapy ProtocolsHumansMaleProgression-Free SurvivalProstate-Specific AntigenAndrogensNivolumabProstate-Specific Antigen

Identifiers

PMID38167882
PMCPMC10762051
OpenAlexW4390507387

What OpenQuestion holds

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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.