Vidutolimod (CMP-001) in Combination With Nivolumab for the Treatment of Metastatic Castration Resistant Prostate Cancer

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT05445609
Phase
PHASE2
Status
Suspended

Conditions

  • Metastatic Prostate Adenocarcinoma
  • Stage IV Prostate Cancer AJCC v8

Eligibility Criteria

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

Interventions

  • VLP-encapsulated TLR9 Agonist CMP-001, — DRUG
    Given SC or IT
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

This phase II trial tests whether vidutolimod with nivolumab works to destroy tumor cells in patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Nivolumab is an antibody working by attaching to and blocking a molecule called PD 1. PD 1 is a protein that is present on different types of cells in the immune system and controls parts of the immune system by shutting it down. Antibodies (proteins in the immune system which act to stop infection harming the body) that block PD 1 can potentially prevent PD 1 from shutting down the immune system, thus allowing immune cells to recognize and destroy cancer cells. Vidutolimod (CMP-001) is a Toll-like receptor 9 (TLR9) agonist, with the ability to generate tumor-targeted T cells capable of killing a tumor both locally and systemically in combination with checkpoint inhibitors (nivolumab, in this case), thus potentially improving outcomes for people whose tumors are progressing. Giving nivolumab and vidutolimod may kill more cancer cells in patients with metastatic prostate cancer.

Key Dates

Start date
Jun 7, 2023
Status verified
Sep 2025
Primary completion
Jun 23, 2027
Completion
Jun 23, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment ((vidutolimod, nivolumab)
    Patients receive vidutolimod SC on days 1 and 7 of cycle 1, IT on day 14 of cycle 1 and days 1 and 14 of cycle 2, and then SC on day 1 of subsequent cycles. Patients also receive nivolumab IV over 30 minutes on days 1 and 14 of cycle 2 and on day 1 of subsequent cycles. Cycles of nivolumab repeat every 4 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. Cycles of vidutolimod repeat every 4 weeks for up to 6 months in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Safety of Treatment [ Time Frame: Up to 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-

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By research site
Emory University Hospital/Winship Cancer Institute· Atlanta, GA

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