PRO-MERIT (Prostate Cancer Messenger RNA Immunotherapy)

Part of paid clinical trials in Tucson, Arizona.

Sponsor
BioNTech SE
Study ID
NCT04382898
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • BNT112 — BIOLOGICAL
    Intravenous bolus injection
  • Cemiplimab — DRUG
    Intravenous infusion

Study Details

Open-label, multicenter, dose titration and four-arm expansion trial to evaluate the safety, tolerability, immunogenicity, and preliminary efficacy of BNT112 cancer vaccine (BNT112) monotherapy or in combination with cemiplimab in patients with metastatic castration resistant prostate cancer (mCRPC: Part 1 and Part 2 Arms 1A and 1B) and in patients with high-risk, localized prostate cancer (LPC). As of February 2023, the trial only recruited LPC patients and no longer mCRPC patients.

Key Dates

Start date
Dec 19, 2019
Status verified
Mar 2025
Primary completion
Jan 23, 2024
Completion
Jan 23, 2024

Study Design

Enrollment
75 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 (mCRPC) - dose titration
    BNT112 monotherapy Enrollment into this arm is completed.
  • Experimental: Part 2 Arm 1A (mCRPC) - expansion cohort
    BNT112 in combination with cemiplimab Enrollment into this arm is completed.
  • Experimental: Part 2 Arm 1B [1] (mCRPC) - expansion cohort
    BNT112 monotherapy Enrollment into this arm is completed.
  • Experimental: Part 2 Arm 2 (LPC) - expansion cohort
    BNT112 in combination with cemiplimab
  • Experimental: Part 2 Arm 3 (LPC) - expansion cohort
    BNT112 monotherapy
  • Experimental: Part 2 Arm 1B [2] (mCRPC) - expansion cohort
    Following progression after BNT112 monotherapy, patients in Arm 1b have the option to be treated with cemiplimab monotherapy Enrollment into this arm is completed.

Primary Outcome Measure

Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (21 days) ]

Locations (5)

FacilityCityStateZIPSite coordinators
The University of Arizona Cancer CenterTucsonArizona85724-
University of Miami Hospital & Clinics /Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
University of Pittsburgh Cancer Inst.PittsburghPennsylvania15215-
Urology San Antonio P.A.San AntonioTexas78229-
University of Virginia Cancer CenterCharlottesvilleVirginia22908-

Find similar trials in Tucson, AZ

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
The University of Arizona Cancer Center· Tucson, AZUniversity of Miami Hospital & Clinics /Sylvester Comprehensive Cancer Center· Miami, FLUniversity of Pittsburgh Cancer Inst.· Pittsburgh, PAUrology San Antonio P.A.· San Antonio, TXUniversity of Virginia Cancer Center· Charlottesville, VA

Related Studies