A phase 1b study of JNJ-637233283 an Apalutamide in Subjects with mCRP
Research type
Research Study
Full title
An Open-label, Multicenter, Phase 1b Study of JNJ-63723283, a PD-1 Inhibitor, Administered in Combination with Apalutamide in Subjects with Metastatic Castration- Resistant Prostate Cancer
IRAS ID
269641
Contact name
Alison Birtle
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2018-000182-37
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Metastatic castration-resistant prostate cancer (mCRPC) is prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels. Many early-stage prostate cancers need normal levels of testosterone to grow, but castrate-resistant prostate cancers do not.
This is a Phase 1b study aiming to identify a subset of patients who currently have mCRPC, who have progressed on therapy with abiraterone acetate plus prednisone/prednisolone (AA-P), apalutamide, or enzalutamide (all routine treatments for prostate cancer), and who respond to a combination of cetrelimab and apalutamide (the study drugs). Apalutamide is an anti-androgen (a class of drugs that prevent androgens like testosterone from mediating their biological effects in the body) which is currently being developed for the treatment of prostate cancer. Cetrelimab is an antibody (protein produced by the immune system that targets certain proteins) that targets and blocks a specific protein to improve anti-cancer activity. Apalutamide is taken orally as a pill. Cetrelimab is delivered via an intravenous infusion.
The study has 5 cohorts (groups) of patients. All study participants will receive the same treatment on the study, regardless of which cohort they are assigned to. The study consists of a Screening phase, a Treatment phase and a Follow-up phase. Participants will remain in the Treatment period for up to 2 years, unless they withdraw or meet any of the discontinuation criteria (e.g. disease progression).
REC name
London - Fulham Research Ethics Committee
REC reference
19/LO/1489
Date of REC Opinion
7 Oct 2019
REC opinion
Favourable Opinion