Apalutamide Plus Cetrelimab in Patients With Treatment-Emergent Small Cell Neuroendocrine Prostate Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
Rahul Aggarwal
Study ID
NCT04926181
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apalutamide — DRUG
    240 mg once daily, for a 28 day cycle
  • Cetrelimab — BIOLOGICAL
    480 mg given through intravenous infusion (IV) on day 1 of every 28-day treatment cycle and administered over a 60-minute infusion

Study Details

Despite the low androgen receptor (AR) transcriptional activity of treatment-emergent small cell neuroendocrine prostate cancer, there is persistent AR expression observed in the majority of treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC) biopsies. This indicates that epigenetic dysregulation leads to reprogramming away from an AR-driven transcriptional program. Therefore, continuation of AR blockade in the form of apalutamide may provide additive benefit compared to immune checkpoint blockade alone. The investigators hypothesize that the combination of apalutamide plus cetrelimab will achieve a clinically significant composite response rate with sufficient durability of response in mCRPC patients with evidence of treatment-emergent small cell neuroendocrine prostate cancer

Key Dates

Start date
Mar 16, 2022
Status verified
Apr 2025
Primary completion
Mar 31, 2024
Completion
Mar 31, 2024

Study Design

Enrollment
2 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm: Apalutamide + Cetrelimab
    Participants will be given Apalutamide tablets combined with infusions of Cetrelimab in 28-day cycles, for up maximum of two years.

Primary Outcome Measure

Composite Response Rate [ Time Frame: Up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143-

Find similar trials in San Francisco, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of California, San Francisco· San Francisco, CA

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