Summary

for males ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

The purpose of this study is to evaluate the safety of the combination of JNJ-63723283 with apalutamide and to define a population of participants with metastatic castration-resistant prostate cancer (mCRPC) who respond to treatment with the combination of JNJ-63723283 and apalutamide.

Official 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

Details

This study is of participants with mCRPC who have progressed after therapy with an androgen receptor (AR)-targeted agent and have not received chemotherapy. Participants must have confirmed prostate-specific antigen (PSA) progression per Prostate Cancer Clinical Trials Working Group (PCWG3) criteria. The primary hypothesis is that treatment with JNJ-63723283 and apalutamide is safe and leads to improvement in the 12-week PSA response rate. The study consists of Screening period (28 days prior to Cycle 1 Day 1), Treatment Period, End-of-Treatment Visit (performed after the last dose of study drug is administered), and Follow-up Period (participants will have Follow-up assessment every 12 weeks after the End-of-Treatment Visit). The efficacy, safety, and pharmacokinetics of JNJ-63723283 in combination with apalutamide will be evaluated.

Keywords

Castration-Resistant Prostatic Neoplasms Prostatic Neoplasms Prostatic Neoplasms, Castration-Resistant JNJ-63723283 480 mg Apalutamide 240 mg

Eligibility

You can join if…

Open to males ages 18 years and up

  • Pathologically confirmed adenocarcinoma of the prostate
  • Metastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans(visceral or lymph node disease). CT-portion of positron emission tomography (PET)/CT scan may be used for eligibility. If lymph node metastasis is the only evidence of metastatic disease, it must be greater than (>=) 1.0 centimeter (cm) in the short axis and above the level of the iliac bifurcation
  • Progressed while on therapy with one class of androgen receptor (AR)-targeted agent for metastatic castration-resistant prostate cancer (mCRPC). No washout is required and no additional therapy may have been administered between discontinuation of

AR-targeted agent and study treatment: Cohort 1: Only prior abiraterone acetate plus prednisone/prednisolone (AA-P); Cohort 2: Only prior enzalutamide or apalutamide

  • Surgical or medical castration, with testosterone levels of less than (<)50 nanogram per deciliter (ng/dL). If the participant is being treated with gonadotropin-releasing hormone (GnRH) analogs (participant who has not undergone bilateral orchiectomy), this therapy must have been initiated at least 4 weeks prior to first dose of study drug and must be continued throughout the study
  • Eastern Cooperative Oncology Group Performance Status (ECOG) prostate-specific (PS)grade of 0 or 1

You CAN'T join if...

  • Small cell or neuroendocrine carcinoma of the prostate
  • Brain metastases
  • Prior treatment with an anti-programmed cell death receptor-1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4)antibody
  • Prior chemotherapy, except for docetaxel for hormone-sensitive prostate cancer (HSPC)
  • Prior therapy with poly adenosine diphosphate (ADP)-ribose polymerase (PARP)inhibitors

Locations

  • University of California San Francisco (UCSF) - Prostate Cancer Center not yet accepting patients
    San Francisco California 94158-2350 United States
  • University of California, Los Angeles UCLA not yet accepting patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
Links
To learn how to participate in this trial please click here.
ID
NCT03551782
Phase
Phase 1
Study Type
Interventional
Last Updated
July 3, 2018