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ePoster Display

642TiP - Phase II CA184-585 (INSPIRE) trial of ipilimumab with nivolumab for molecular-selected patients with castration-resistant prostate cancer

Date

16 Sep 2021

Session

ePoster Display

Topics

Tumour Immunology;  Clinical Research;  Targeted Therapy;  Immunotherapy;  Translational Research

Tumour Site

Prostate Cancer

Presenters

Niven Mehra

Citation

Annals of Oncology (2021) 32 (suppl_5): S626-S677. 10.1016/annonc/annonc702

Authors

N. Mehra1, I. Kloots2, P. Slootbeek1, M. den Brok2, G. Adema3, L. Kerkmeijer3, R.J. Smeenk3, H. Westdorp4, H. Bloemendal1, J. Schalken5, N.P. van Erp6, M. Binder7, J. De Vries8, W. Gerritsen1

Author affiliations

  • 1 Medical Oncology Department, Radboud University Medical Centre Nijmegen, 6500 HB - Nijmegen/NL
  • 2 Medical Oncology, Radboud University Medical Center, 6525 GA - Nijmegen/NL
  • 3 Department Of Radiation Oncology, Radboud University Medical Center, 6525 GA - Nijmegen/NL
  • 4 Medical Oncology And Tumor Immunology, Radboud University Medical Center, 6525 GA - Nijmegen/NL
  • 5 Urology Department, Radboud University Medical Center, Nijmegen, 6525 GA - Nijmegen/NL
  • 6 Pharmacy, Radboud University Medical Center, 6525GA - Nijmegen/NL
  • 7 Department Of Internal Medicine Iv, Oncology/hematology, Martin-Luther-University Halle-Wittenberg, 06120 - Halle/DE
  • 8 Tumour Immunology Department, Radboud University Medical Center, 6525 GA - Nijmegen/NL

Resources

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Abstract 642TiP

Background

Immune checkpoint blockade (ICB) benefits a limited number of unselected patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). Only 3-5% of pts with high tumour mutational burden (hTMB)/ or microsatellite instable (MSI) currently have approval for treatment with anti-PD1 ICB. More pts may benefit, particular those with DNA damage repair alterations. Also, higher responses are witnessed with combinatory nivolumab 1mg/kg (NIVO-1) with ipilimumab 3mg/kg (IPI-3). NIVO-1/IPI-3 showed substantial grade 3-4 toxicity, limiting applicability of this regimen in mCRPC. The aim of this study is to investigate the efficacy and safety of a new treatment regimen of NIVO and IPI, in a molecular-selected population.

Trial design

A total of 75 biomarker-selected mCRPC pts are to be included in this open-label non-randomized phase II trial. Inclusion started on 19 January 2021. Selection criteria are a homologous recombination deficiency or BRCA2 inactivation, MSI or mismatch repair deficiency, a hTMB and a tandem duplication signature or CDK12 inactivation. Other key inclusion criteria are ECOG 0-1 and measurable disease per RECIST1.1. The study has two cohorts, of which main cohort 1 (n=50) will assess efficacy in pts naïve for ICB, and an exploratory cohort 2 (n=25). Pts will be treated with NIVO-3 and IPI-1 for 4 Q3W cycles, followed by NIVO 480mg Q4W up to one year. Efficacy will be assessed by a disease control rate (DCR) lasting at least 6 months. Safety data will comprise all-grade treatment-emergent adverse events (TEAEs) in 75 pts. Key secondary endpoints are best ORR per RECIST 1.1. criteria, biochemical response rate per PCWG3 criteria, and radiographic progression-free survival per irRECIST. Translational objectives are aimed to optimize and validate predictive signatures from tissue and liquid biopsies. The trial will require a baseline and an on-trial tissue biopsy. Exploratory objectives will include in-depth genomic and transcriptomic assessment, multispectral immunohistochemical analyses of immune infiltrate, circulating tumour DNA and T-cell receptor repertoire analyses.

Clinical trial identification

NCT04717154.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

BMS.

Disclosure

All authors have declared no conflicts of interest.

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