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Intratumoral and Systemic Hiltonol® (Poly-ICLC) in Prostate Cancer Patients on Active Surveillance

NCT06343077 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2024-04-02

No results posted yet for this study

Summary

This is a partially blinded randomized controlled phase II pilot study comparing Poly-ICLC (Hiltonol®) treatment vs no treatment, for prostate cancer participants on active surveillance.

Conditions

  • Prostate Cancer Patients on Active Surveillance

Interventions

DRUG

Poly-ICLC intramuscular (IM) injection

1.5 mg IM (week 1), followed by paired 1.5 mg IM weekly from weeks 3-through10, and at weeks 14, 18, 22, 26, 30, 34, 38, 42 and 46 with a 4-week rest period between IM injections.

DRUG

Poly-ICLC, Intertumoral (IT) injection

1 mg IT once (week 2)

Sponsors & Collaborators

  • Oncovir, Inc.

    collaborator INDUSTRY

  • Ashutosh Kumar Tewari

    lead OTHER

Principal Investigators

  • Sujit S Nair, PhD · Assistant Professor and Director of GU Immunotherapy Research

  • Dimple Chakravarty, PhD · Assistant Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-16
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06343077 on ClinicalTrials.gov