Trial reportScience advances2026
Immune biomarkers of response and resistance to ipilimumab and nivolumab in metastatic castration-resistant prostate cancer.
Trial report in Science advances, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03651271 (An Exploratory Study of Nivolumab With or Without Ipilimumab According to the Percentage of Tumoral CD8 Cells in Participants With Advanced Metastatic Cancer), which is not on this map. Not yet cited in PubMed.
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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.
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.
An Exploratory Study of Nivolumab With or Without Ipilimumab According to the Percentage of Tumoral CD8 Cells in Participants With Advanced Metastatic Cancer
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
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Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Immune checkpoint therapies have shown limited efficacy in metastatic castration-resistant prostate cancer (mCRPC). The AMADEUS prostate expansion cohort (NCT03651271) evaluated the efficacy, safety, and biomarkers of escalating ipilimumab doses combined with nivolumab. Patients received ipilimumab 1 milligram per kilogram (mg/kg) + nivolumab 360 mg (I1+N360), ipilimumab 3 mg/kg + nivolumab 1 mg/kg (I3+N1), or ipilimumab 5 mg/kg + nivolumab 1 mg/kg (I5+N1). Coprimary endpoints were 6-month disease control rate (DCR) and changes in tumoral CD8 percentage. Thirty-two patients were enrolled. DCRs were 33% (4 of 12) for I1+N360, 20% (1 of 5) for I3+N1, and 20% (3 of 15) for I5+N1. Across cohorts, tumoral CD8 percentage increased by a median of 5.0%. Although higher ipilimumab doses were tolerable, I1+N360 achieved similar disease control and immune activation with a more favorable safety profile. Early disease progression was associated with increased expression of a TREM2-associated myeloid gene signature, which was also significantly enriched in two independent prostate cancer datasets.
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