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

NCT ID: NCT06343077

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-16
• Study Completion Date: 2026-12-31

Brief 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.

Detailed Description

114 prostate cancer participants on active surveillance will be randomized 2:1 into treatment group, A or control group B respectively. Enrolled group A study participants will receive standard of care (SOC) plus intratumoral (IT) and intramuscular (IM) injections of study drug Poly-ICLC (Hiltonol®) as follows:

Preconditioning: week 1: Paired IM Poly-ICLC, 1.5 mg to reduce tumor induced suppression

Immune Priming: week 2, intratumor poly-ICLC 1.0 mg once,

Boosting: Wk. 3 - 10: Paired 1.5 mg IM poly-ICLC weekly

Maintenance: Month 3-12, Paired IM Poly-ICLC once a month

Control patients in group B will receive standard care (SOC) for patients on Active Surveillance per AUS guidelines.

Comparisons of safety and efficacy will be based on data from concurrently randomized participants. An independent data and safety monitoring board (DSMB) will actively monitor interim data for safety, efficacy or futility.

Seventy-six (76) participants will receive treatment IT/IM Poly-ICLC (Hiltonol®) and 38 participants will serve as controls for a total of 114 study participants. Participants randomized to the treatment arm will receive standard of care (SOC) plus IT/IM Poly-ICLC (Hiltonol®). Participants in the control arm will receive SOC. This is a partially blind randomized controlled phase 2 trial conducted at the Mount Sinai Health System with 114 participants planned for enrollment. Eligible participants will be randomly assigned to one of the two groups.

There will be an interim analysis conducted after half of the participants, 38 receiving Poly-ICLC and 19 controls receiving standard care have completed 1 year of treatment.

Conditions

Prostate Cancer Patients on Active Surveillance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hiltonol (Poly-ICLC)

Enrolled study subjects will receive paired intramuscular (IM) and intertumoral. (IT) injections of the drug Poly-ICLC (Hiltonol®) as follows: Paired 1.5 mg IM (week 1), 1 mg IT once (week 2), 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.

Group Type: ACTIVE_COMPARATOR

Poly-ICLC intramuscular (IM) injection

Intervention Type: DRUG

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.

Poly-ICLC, Intertumoral (IT) injection

Intervention Type: DRUG

1 mg IT once (week 2)

Control (Standard of Care)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Poly-ICLC, Intertumoral (IT) injection

1 mg IT once (week 2)

Intervention Type: DRUG

Other Intervention Names

Hiltonol®; Polyinosinic-Polycytidylic acid stabilized with polylysine and carboxymethylcellulose; Hiltonol®; Polyinosinic-Polycytidylic acid stabilized with polylysine and carboxymethylcellulose

Eligibility Criteria

Inclusion Criteria

• Written informed consent and HIPAA authorization for release of personal health information.

NOTE: HIPAA authorization may be included in the informed consent or obtained separately.

• Age > 18 years at the time of consent.
• ECOG Performance Status of 0-1 within 14 days prior to being registered for protocol therapy (Study Procedure Manual).
• Histologically confirmed adenocarcinoma of the prostate (with previous diagnostic tissue available for tumor marker analysis).
• • ISUP Grade 1(Gleason 3+3) and Grade 2 (Gleason 3+4) and Grade 1 (Gleason 3+3, with PSA≥10, or stage ≥ T2b)
• Estimated life expectancy is ≥ 10 years
• Candidate for primary curative therapy (Radical prostatectomy or radiation) if cancer progresses.
• Tolerated previous transrectal ultrasound guided biopsy procedure under local anesthetic

• Uncomplicated previous TRUS biopsy procedure (i.e., no prior hospitalization due to sepsis, prostatic abscess or severe hemorrhage following TRUS prostate biopsy)
• Willing to undergo the intratumoral (IT) injection of the Poly-ICLC into the prostatic tumor as per the protocol
• No prior hormonal therapy with exception of with the exception of oral 5-alpha-reductase inhibitors (finasteride, dutasteride, etc.). Subjects should be off the medication ≥ 6 months from screening
• No prior radiation therapy (external beam or brachytherapy) to the pelvis or prostate.
• No clinically significant infections as judged by the treating investigator.
• No characteristics suggesting a potential higher risk of infection with intraprostatic injections:

• Recurrent urinary tract infections or history of prostatitis within 3 months prior to enrollment into the study.
• Urine analysis positive for nitrites and leucocyte esterase. Such subjects could be considered for the study after treatment and resolution of the infection.
• Active proctitis
• History of prostatic abscess
• Taking immunosuppressive medication including systemic corticosteroids
• Active hematologic malignancy
• No uncontrolled angina, congestive heart failure or MI within 6 months.
• Subjects with history of HIV (if CD4+ T cell counts are ≥350 cells/μL on established ART therapy), Hepatitis B (with viral load below limits of quantification) or Hepatitis C (who have completed a curative therapy and have a viral load below the limit of quantification) are eligible for this study.
• No treatment with any investigational agent for any medical condition within 28 days prior to being registered for protocol therapy.
• Patients with the potential for impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Contraception must be continued for at least 2 months following the last dose of poly-ICLC. While animal reproductive studies have been negative, the simulated viral infection and anti-proliferative activity of this experimental drug may theoretically affect the developing fetus or nursing infant.
• Adequate end organ function as determined by the following laboratory values:

• White blood cell count (WBC) ≥ 2.5 k/mm^3
• Absolute neutrophil count (ANC) ≥ 1.5 k/mm^3
• Hemoglobin (Hgb) ≥ 8.0 g/dL
• Platelets ≥ 100 k/mm^3
• Calculated creatinine clearance of > 60 cc/min using the Cockcroft-Gault formula:
• Males: [(140 - Age in years) × Actual Body Weight in kg]/[72 × Serum Creatinine (mg/dL)]
• Bilirubin ≤ 2.0 x ULN
• Aspartate aminotransferase (AST) ≤ 2.5 x ULN
• Alanine aminotransferase (ALT) ≤ 2.5 x ULN

Exclusion Criteria

• Received local or systemic curative therapy for prostate cancer
• Subjects with neuroendocrine tumors
• ISUP Gleason Grade Group (>3), or Gleason 3+3 plus PSA ≤ 10 or Stage ≤T2a
• Evidence of locally advanced disease
• Subject has evidence of any other malignancy
• Allergy to any antibiotics, as IT administration requires prophylactic antibiotics.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Oncovir, Inc.

INDUSTRY

Sponsor Role: collaborator

Ashutosh Kumar Tewari

OTHER

Sponsor Role: lead

Responsible Party

Ashutosh Kumar Tewari

Professor and System Chair, Milton and Carroll Petrie Department of Urology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sujit S Nair, PhD

Role: STUDY_DIRECTOR

Assistant Professor and Director of GU Immunotherapy Research

Dimple Chakravarty, PhD

Role: STUDY_DIRECTOR

Assistant Professor

Locations

Icahn School of Medicine at Mount Sinai (ISMMS)

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Monali Fatterpekar, PhD

Role: CONTACT

monali.fatterpekar@mountsinai.org

212-241-0751

Cristina Pasat-karasik, RN

Role: CONTACT

Cristina.Pasat-karasik@mountsinai.org

Facility Contacts

Monali Fatterpekar, PhD

Role: primary

monali.fatterpekar@mountsinai.org

Sujit S Nair, PhD

Role: backup

sujit.nair@mountsinai.org

212-241-7005

Other Identifiers

STUDY-22-00106

Identifier Type: -

Identifier Source: org_study_id