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

NCT06343077 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STUDY-22-00106
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer Patients on Active Surveillance

Keywords

Prostate Cancer; Active Surveillance; Vaccination; Immunotherapy; drug POLY-ICLC; Gleason Grade 2 (Gleason 3+4); Gleason Grade 1 (Gleason 3+3)

Outcome Measures

Primary Outcomes (4)

• Proportion of subjects without Gleason group upgrade after treatment

  Proportion of subjects without Gleason group upgrade after treatment with Poly-ICLC or control, as determined by histological examination of prostate biopsy at the one year time point.

  at 12 months

• Proportion of subjects without Gleason group upgrade after treatment

  Proportion of subjects without Gleason group upgrade after treatment with Poly-ICLC or control, as determined by histological examination of prostate biopsy at the three years time point.

  at 36 months

• Proportion of subjects without Gleason group downgrade after treatment

  Proportion of subjects with Gleason group downgrade after treatment with Poly-ICLC or control, as determined by histological examination of prostate biopsy at the one year time point.

  at 12 months

• Proportion of subjects without Gleason group downgrade after treatment

  Proportion of subjects with Gleason group downgrade after treatment with Poly-ICLC or control, as determined by histological examination of prostate biopsy at the 3 years time point.

  at 36 months

Secondary Outcomes (4)

• Number of subjects who experience adverse events per NCI-CTCAE 5.0

  At 12 months

• Number of subjects who experience adverse events per NCI-CTCAE 5.0

  At 36 months

• Number of subjects who receive prostate cancer treatment

  At 12 months

• Number of subjects who receive prostate cancer treatment

  At 36 months

Study Arms (2)

Hiltonol (Poly-ICLC)

ACTIVE COMPARATOR

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.

Drug: Poly-ICLC intramuscular (IM) injection; Drug: Poly-ICLC, Intertumoral (IT) injection

Control (Standard of Care)

NO INTERVENTION

Interventions

Poly-ICLC intramuscular (IM) injection 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.

Also known as: Hiltonol®, Polyinosinic-Polycytidylic acid stabilized with polylysine and carboxymethylcellulose

Hiltonol (Poly-ICLC)

Poly-ICLC, Intertumoral (IT) injection DRUG

1 mg IT once (week 2)

Also known as: Hiltonol®, Polyinosinic-Polycytidylic acid stabilized with polylysine and carboxymethylcellulose

Hiltonol (Poly-ICLC)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ashutosh Kumar Tewari: lead
• Oncovir, Inc.: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai (ISMMS)

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Injections; poly ICLC

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Sujit S Nair, PhD

  Assistant Professor and Director of GU Immunotherapy Research

  STUDY DIRECTOR

• Dimple Chakravarty, PhD

  Assistant Professor

  STUDY DIRECTOR

Central Study Contacts

Monali Fatterpekar, PhD

CONTACT

212-241-0751; monali.fatterpekar@mountsinai.org

Cristina Pasat-karasik, RN

CONTACT

Cristina.Pasat-karasik@mountsinai.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and System Chair, Milton and Carroll Petrie Department of Urology

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 2, 2024
• Study Start: January 16, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 2, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. For individual participant data meta-analysis. Proposals should be directed to monali.fatterpekar@mountsinai.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link tbd).

Locations

US (1)