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 NeoplasmsProstatic NeoplasmsProstatic Neoplasms, Castration-ResistantJNJ-63723283 480 mgApalutamide 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 Centernot yet accepting patients
    San FranciscoCalifornia94158-2350United States
  • University of California, Los Angeles UCLAnot yet accepting patients
    Los AngelesCalifornia90095United 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