NL-OMON49591
Completed
Phase 2
Phase 2 INSPIRE trial: Ipilimumab with Nivolumab in molecular-Selected patients with castration-resistant PRostate cancer - INSPIRE
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- advanced prostate cancer
- Sponsor
- Radboud Universitair Medisch Centrum
- Enrollment
- 69
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Written informed consent.
- •2\. Histological diagnosis of adenocarcinoma of the prostate. Patients who have
- •no histological diagnosis must be willing to undergo a biopsy to prove prostate
- •adenocarcinoma.
- •3\. Metastatic Castration\-Resistant Prostate Cancer (mCRPC), metastatic disease
- •defined either by measurable disease by RECIST1\.1 criteria and/or presence of
- •bone\-metastatic disease evaluable per PCWG3 criteria. For cohort 1, measurable
- •disease is compulsory.
- •4\. An immunogenic phenotype, consisting of one of the next criteria:
- •1, mismatch repair deficiency and/or a high mutational burden of \>7 mutations
Exclusion Criteria
- •1\. Prior treatment with checkpoint immunotherapy (CTLA\-4, or PD\-1 and PD\-L1
- •antagonists) for cohort 1\. For cohort 2 patients may have prior treatment with
- •monotherapy CTLA\-4 or PD\-1 or PD\-L1\.
- •2\. Surgery, chemotherapy within 4 weeks prior to trial entry / randomisation
- •into the study. Any other therapies for prostate cancer, other than GnRH
- •analogue therapy and osteoporosis preventing agents, are not allowed.
- •3\. Radiotherapy within 2 weeks prior to trial entry. Radiation\-related side
- •effects higher than grade 1, or above baseline.
- •4\. Participation in another interventional clinical trial and any concurrent
- •treatment with any investigational drug within 4 weeks prior to trial entry /
Outcomes
Primary Outcomes
Not specified
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