Evidence map›Paper›PMID 39964352›Full record

ArticleClinical cancer research : an official journal of the American Association for Cancer Research2025

Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer.

Matthew D Galsky, Karen A Autio, Christopher R Cabanski, Kristopher Wentzel, Julie N Graff, Terence W Friedlander, Timothy R Howes, Kristin M Shotts, Julie Densmore, Marko Spasic and 14 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03835533 (A Multicenter, Open-Label, Exploratory Platform Study to Evaluate Biomarkers and Immunotherapy Combinations for the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing 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.

NCT03835533 phase1completednot on this map

A Multicenter, Open-Label, Exploratory Platform Study to Evaluate Biomarkers and Immunotherapy Combinations for the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer

TypeinterventionalSponsorParker Institute for Cancer ImmunotherapyRan2019 to 2022Enrolled43ConditionsMetastatic Castration-resistant Prostate CancerArmsNKTR-214 (Cohort A), Nivolumab (Cohort A, B and C), Stereotactic body radiation therapy (SBRT) (Cohort B), CDX-301 (Cohort B and C), Poly-ICLC (Cohort B)
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Review
  3. Article
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  5. Review
  6. Article
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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

24 authors.

Matthew D Galsky *Division of Hematology and Medical Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York.ORCID 0000-0001-7655-9378
Karen A Autio *Genitourinary Oncology Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York.ORCID 0000-0003-0720-0390
Christopher R CabanskiParker Institute for Cancer Immunotherapy, San Francisco, California.ORCID 0009-0007-9938-1331
Kristopher WentzelThe Angeles Clinic and Research Institute, Los Angeles, California.ORCID 0009-0002-3954-0322
Julie N GraffKnight Cancer Institute, Oregon Health & Science University, Portland, Oregon.ORCID 0000-0002-5708-2794
Terence W FriedlanderDivision of Hematology/Oncology, Department of Medicine, University of California, San Francisco, San Francisco, California.ORCID 0000-0002-3630-4941
Timothy R HowesParker Institute for Cancer Immunotherapy, San Francisco, California.ORCID 0000-0002-0370-0200
Kristin M ShottsParker Institute for Cancer Immunotherapy, San Francisco, California.ORCID 0009-0003-2498-709X
Julie DensmoreParker Institute for Cancer Immunotherapy, San Francisco, California.ORCID 0009-0006-0191-1780
Marko SpasicParker Institute for Cancer Immunotherapy, San Francisco, California.ORCID 0009-0005-5693-312X
Diane M Da SilvaParker Institute for Cancer Immunotherapy, San Francisco, California.ORCID 0000-0001-7317-4886
Richard O ChenPersonalis, Inc., Menlo Park, California.ORCID 0000-0002-2842-4476
Jennifer LataInovio Pharmaceuticals, Plymouth Meeting, Pennsylvania.ORCID 0009-0000-2137-6865
Jeffrey SkolnikInovio Pharmaceuticals, Plymouth Meeting, Pennsylvania.ORCID 0000-0002-0476-9453
Tibor KelerCelldex Therapeutics, Inc., Hampton, New Jersey.ORCID 0000-0003-1757-4230
Michael J YellinCelldex Therapeutics, Inc., Hampton, New Jersey.ORCID 0000-0002-1164-7614
Theresa M LaValleeParker Institute for Cancer Immunotherapy, San Francisco, California.ORCID 0000-0002-1769-3195
Justin FairchildParker Institute for Cancer Immunotherapy, San Francisco, California.ORCID 0000-0002-4478-7146
Silvia BoffoBristol Myers Squibb, New York, New York.ORCID 0000-0002-6352-160X
Jill O'Donnell-TormeyCancer Research Institute, New York, New York.ORCID 0009-0007-1843-3671
Ute DuganParker Institute for Cancer Immunotherapy, San Francisco, California.ORCID 0009-0008-9408-2671
Nina BhardwajDivision of Hematology and Medical Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York.ORCID 0000-0003-1865-4187
Sumit K SubudhiDivision of Cancer Medicine, Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0001-5208-7732
Lawrence FongDivision of Hematology/Oncology, Department of Medicine, University of California, San Francisco, San Francisco, California.ORCID 0000-0002-6428-428X

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
Determinants of response to cancer immunotherapyR35CA253175 · NCI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Lawrence Fong · 2021 to 2026
$5.8M
Cancer Research Institute (CRI)National Institutes of Health (NIH) R35CA253175NCI NIH HHS P30 CA008748NCI NIH HHS R35 CA253175Parker Institute for Cancer Immunotherapy (PICI)Prostate Cancer Foundation (PCF)
6 · The paper itself

Abstract

purposeCurrent immune checkpoint therapies offer limited benefits for metastatic castration-resistant prostate cancer. Novel combinations may enhance immunotherapy efficacy. PATIENTS AND

methodsWe conducted an open-label, noncomparative platform trial (NCT03835533) in metastatic castration-resistant prostate cancer to assess nivolumab-based combinations. The cohorts were as follows: (A) bempegaldesleukin 0.006 mg/kg and nivolumab 360 mg i.v. every 3 weeks; (B) stereotactic body radiotherapy 30 to 50 Gy, CDX-301 75 μg/kg s.c. for 5 days, poly-ICLC 1 mg intramuscularly weekly twice for 3 weeks, and nivolumab 480 mg every 4 weeks; and (C) CDX-301 75 μg/kg for 10 days, INO-5151 3 mg intramuscularly on lead-in day 8, day 1 of cycles 1 to 3, and then every 12 weeks, and nivolumab 480 mg every 4 weeks. The primary endpoint was safety; secondary endpoints included composite response rate (radiographic, PSA, or circulating tumor cell responses), 6-month disease control rate, progression-free survival, and overall survival. Serial blood and tissue samples were analyzed for pharmacodynamics and association with disease control.

resultsA total of 43 patients were enrolled (n = 14, 15, and 14 in cohorts A, B, and C, respectively). Grade 3 to 4 treatment-related adverse events occurred in 10 (71%), 2 (13%), and 2 (14%) patients, respectively, with one grade 5 treatment-related adverse event in cohort A. Composite response rates were 7% (1/14), 33% (5/15), and 7% (1/14). Across cohorts, 6-month disease control was associated with preexisting memory/regulatory T cells, TNFα, and other inflammatory pathways.

conclusionsCohort B, which combined radiotherapy with CDX-301, poly-ICLC, and nivolumab, demonstrated encouraging clinical activity. Preexisting rather than treatment-induced immune activation was associated with clinical benefit across cohorts, highlighting the importance of baseline immune fitness.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsImmunotherapyProstatic Neoplasms, Castration-ResistantAgedAged, 80 and overCombined Modality TherapyHumansMaleMiddle AgedNeoplasm MetastasisNivolumabTranslational Research, BiomedicalTreatment OutcomeNivolumab

Identifiers

PMID39964352
PMCPMC11995007

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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.