Evidence map›Paper›PMID 23535954›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2013

Ipilimumab alone or in combination with radiotherapy in metastatic castration-resistant prostate cancer: results from an open-label, multicenter phase I/II study.

S F Slovin, C S Higano, O Hamid, S Tejwani, A Harzstark, J J Alumkal, H I Scher, K Chin, P Gagnier, M B McHenry and 1 more

3 registry-linked trialsAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 282 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
282citing papers in PubMed, 8 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.

NCT00323882 phase1 / phase2completednot on this map

A Phase I/II, Open-label, Dose-escalation Study of MDX-010 Administered Every 3 Weeks for 4 Doses in Patients With Metastatic Hormone-Refractory Prostate Cancer

TypeinterventionalSponsorBristol-Myers SquibbRan2006 to 2013Enrolled75ConditionsProstate Cancer, Neoplasm MetastasisArmsMDX-010
NCT02623595 phase2withdrawnnot on this mapstarted 2016, after this paper: background citation

A Prospective Single-arm Multi-center Phase II Study: Assessment of the Safety and Abscopal Effects of SBRT in Combination With rhGM-CSF for Stage IV NSCLC Patients Who Failed in Second-line Chemotherapy

TypeinterventionalSponsorWuhan UniversityRan2016 to 2019Enrolled0ConditionsCarcinoma, Non-Small-Cell LungArmsStereotactic body radiotherapy, rhGM-CSF
NCT04770272 phase2terminatednot on this mapstarted 2021, after this paper: background citation

An Adaptive Randomized Neoadjuvant Two Arm Trial in Triple-negative Breast Cancer Comparing a Mono Atezolizumab Window Followed by a Atezolizumab - CTX Therapy With Atezolizumab - CTX Therapy (neoMono)

TypeinterventionalSponsorPalleos Healthcare GmbHRan2021 to 2024Enrolled442ConditionsTriple-negative Breast CancerArmsAtezolizumab 840 MG in 14 ML Injection, Atezolizumab 1200 MG in 20 ML Injection, Carboplatin, Paclitaxel, Epirubicin
3 · Its place in the literature

Who cites it

282 citing papers in PubMed, 8 syntheses or guidelines pooled it.

  1. Pooled it
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  9. Trial
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  12. A Phase Ib Study of Atezolizumab with Radium-223 Dichloride in Men with Metastatic Castration-Resistant Prostate Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021
    Trial
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  16. Ipilimumab with Stereotactic Ablative Radiation Therapy: Phase I Results and Immunologic Correlates from Peripheral T Cells.Clinical cancer research : an official journal of the American Association for Cancer Research · 2017
    Trial
  17. Radium-223 decreases PD-L1 expression in bone metastases: A study with [European journal of nuclear medicine and molecular imaging · 2026
    Article
  18. Article
  19. CTLA-4: a promising immunosuppressive immune checkpoint in prostate cancer therapy.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  20. Review

222 more citing papers are in PubMed but not listed here.

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

11 authors.

S F SlovinDepartment of Medicine, Memorial Sloan-Kettering Cancer Center, New York. Electronic address: slovins@mskcc.org.
C S HiganoDepartment of Medicine, Seattle Cancer Care Alliance, University of Washington, Seattle.
O HamidDepartment of Translational Research/Immunotherapy, The Angeles Clinic and Research Institute, Santa Monica.
S TejwaniDepartment of Hematology-Oncology, Henry Ford Health System, Detroit.
A HarzstarkDepartment of Medicine, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco.
J J AlumkalDivision of Hematology and Medical Oncology, Knight Cancer Institute, Oregon Health and Science University, Portland.
H I ScherDepartment of Medicine, Memorial Sloan-Kettering Cancer Center, New York.
K ChinDepartment of Oncology Global Clinical Research, Bristol-Myers Squibb, Wallingford, USA.
P GagnierDepartment of Oncology Global Clinical Research, Bristol-Myers Squibb, Wallingford, USA.
M B McHenryDepartment of Oncology Global Clinical Research, Bristol-Myers Squibb, Wallingford, USA.
T M BeerDivision of Hematology and Medical Oncology, Knight Cancer Institute, Oregon Health and Science University, Portland.

Funding

SPORE In Prostate CancerP50CA092629 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Yu Chen, MICHAEL J MORRIS · 2001 to 2026
$63.0M
NCI NIH HHS P50 CA092629
6 · The paper itself

Abstract

backgroundThis phase I/II study in patients with metastatic castration-resistant prostate cancer (mCRPC) explored ipilimumab as monotherapy and in combination with radiotherapy, based on the preclinical evidence of synergistic antitumor activity between anti-CTLA-4 antibody and radiotherapy. PATIENTS AND

methodsIn dose escalation, 33 patients (≥6/cohort) received ipilimumab every 3 weeks × 4 doses at 3, 5, or 10 mg/kg or at 3 or 10 mg/kg + radiotherapy (8 Gy/lesion). The 10-mg/kg cohorts were expanded to 50 patients (ipilimumab monotherapy, 16; ipilimumab + radiotherapy, 34). Evaluations included adverse events (AEs), prostate-specific antigen (PSA) decline, and tumor response.

resultsCommon immune-related AEs (irAEs) among the 50 patients receiving 10 mg/kg ± radiotherapy were diarrhea (54%), colitis (22%), rash (32%), and pruritus (20%); grade 3/4 irAEs included colitis (16%) and hepatitis (10%). One treatment-related death (5 mg/kg group) occurred. Among patients receiving 10 mg/kg ± radiotherapy, eight had PSA declines of ≥50% (duration: 3-13+ months), one had complete response (duration: 11.3+ months), and six had stable disease (duration: 2.8-6.1 months).

conclusionsIn mCRPC patients, ipilimumab 10 mg/kg ± radiotherapy suggested clinical antitumor activity with disease control and manageable AEs. Two phase III trials in mCRPC patients evaluating ipilimumab 10 mg/kg ± radiotherapy are ongoing. ClinicalTrials.gov identifier: NCT00323882.

Indexed as

AdenocarcinomaAgedAged, 80 and overAntibodies, MonoclonalAntineoplastic AgentsChemoradiotherapyHumansImmunotherapyIpilimumabKaplan-Meier EstimateMaleMaximum Tolerated DoseMiddle AgedProstate-Specific AntigenProstatic NeoplasmsTreatment OutcomeAntibodies, MonoclonalAntineoplastic AgentsIpilimumabProstate-Specific Antigenimmunotherapyipilimumabmetastatic castration-resistant prostate cancerphase I/II trialprostate-specific antigen and radiotherapy

Identifiers

PMID23535954
PMCPMC3707423

What OpenQuestion holds

Textmetadata
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.