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Clinical Trials in the USA / NCT02768363
Active, not recruiting Phase 2

Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES)

NCT02768363 · tracked via the Priya Life Science USA tracker
Sponsor
Candel Therapeutics, Inc
Phase
Phase 2
Started
2016-05
Last updated
2026-10-02

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

aglatimagene besadenovec →placebovalacyclovir →

aglatimagene besadenovec: Aglatimagene besadenovec will be delivered to the prostate via trans-rectal ultrasound guided injection followed by 14 days of oral prodrug, valacyclovir. The second aglatimagene besadenovec injection will be 2-3 weeks after the first followed by 14 days of valacyclovir.

placebo: Placebo will be delivered to the prostate via trans-rectal ultrasound guided injection followed by 14 days of oral prodrug, valacyclovir. The second placebo injection will be 2-3 weeks after the first followed by 14 days of valacyclovir.

valacyclovir: Oral prodrug to be given for 14 days starting the day after each aglatimagene besadenovec or placebo injection.

Study summary

The purpose of this study is to evaluate the effectiveness of CAN-2409 immunotherapy in patients undergoing active surveillance for localized prostate cancer. CAN-2409 involves the use of aglatimagene besadenovec to kill tumor cells and stimulate a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. CAN-2409 has been well tolerated in previous trials in patients with prostate cancer and other tumor types. Biochemical, pathologic and immune responses have been demonstrated in newly diagnosed and recurrent prostate cancer. The hypothesis is that CAN-2409 can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the CAN-2409 or control arm at a 2:1 ratio. Both arms receive standard of care active surveillance evaluations.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria include: * Histologically confirmed adenocarcinoma of the prostate * Patients choosing active surveillance * Patients meeting definition of NCCN low risk, intermediate risk OR patients having only one NCCN high-risk feature * NCCN Low Risk is defined as having all of the following: PSA \< 10 ng/ml, Gleason ≤ 6, T1-T2a * NCCN Intermediate Risk is defined as having at least one of the following and no high risk features: PSA 10-20 ng/ml, Gleason score =7, T2b-T2c * High Risk with a single high risk feature is defined as having only one of the following: PSA\>20 ng/ml, Gleason score 8-10, or T3a * Excluded are those in the following risk groups: High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1 * Patients must be planning and medically able to tolerate multiple transrectal ultrasound guided injections. * ECOG Performance status 0-2 Exclusion Criteria include: * Active liver disease, including known cirrhosis or active hepatitis * Patients on systemic corticosteroids (\>10 mg prednisone per day) or other immunosuppressive drugs * Known HIV+ patients * Regional lymph node involvement or distant metastases * Other current malignancy (except squamous or basal cell skin cancers) * Other serious co-morbid illness or compromised organ function that, in the opinion of the investigator, would interfere with treatment or follow up * Prior treatment for prostate cancer except TURP. If prior TURP, patients must be deemed able to receive prostate biopsy and multiple intra-prostatic injections by the investigator * Patients taking 5-alpha-reductase inhibitors (e.g. finasteride, dutasteride) * Patients who had or plan to use ADT or have history of an orchiectomy. * Patients who are planning to undergo radical treatment for prostate cancer within 12 months. * Known sensitivity or allergic reactions to acyclovir or valacyclovir

Primary outcome measure(s)

  • Progression-free survival (PFS) — Baseline to study completion, approximately 5 years
    Progression-free survival is defined as the time from randomization to evidence of histological disease progression or death due to prostate cancer

Trial sites (23)

FacilityCityRegionStatus
Foothills Urology Golden Colorado
Jesse Brown VA Medical Center Chicago Illinois
The University of Chicago Chicago Illinois
Southeast Louisiana Veterans Health Care System New Orleans Louisiana
Walter Reed National Military Medical Center Bethesda Maryland
Kansas City VA Medical Center Kansas City Missouri
Sierra Nevada Health Care System VA Reno Nevada
Hackensack University Medical Center Hackensack New Jersey
Advanced Radiation Centers of New York (Integrated Medical Professionals) North Hills New York
Associated Medical Professionals of NY, PLLC Syracuse New York
Southwest Urology, Clinical Research Solutions Middleburg Heights Ohio
Oklahoma City VA Healthcare System Oklahoma City Oklahoma
VA Portland Health Care System Portland Oregon
Oregon Urology Insitute Springfield Oregon
Lancaster Urology Lancaster Pennsylvania
Allegheny Health Network-Triangle Urological Group Pittsburgh Pennsylvania
Ralph H. Johnson Veterans Affairs Medical Center Charleston South Carolina
San Antonio VA Healthcare System San Antonio Texas
Woodland Center The Woodlands Texas
Texas Urology Specialists Tomball Texas
Hunter Holmes McGuire VA Medical Center Richmond Virginia
Salem VA Medical Center Salem Virginia
Instituto Nacional de Ciencias Medicas y Nutrición, Salvador Subirán Mexico City Mexico

On this site

📄 Valtrex (valacyclovir) drug profile →

More Candel Therapeutics, Inc. trials in the USA

A Biomarker Study in Men With Localized Prostate Cancer Treated With Aglatimagene Besadenovec Recruiting
Phase 3 Study of ProstAtak® Immunotherapy With Standard Radiation Therapy for Localized Prostate Cancer Active, not recruiting
Aglatimagene Besadenovec + Prodrug and Pembrolizumab vs Docetaxel for Stage IV Non-Squamous NSCLC Progressing on Pembrolizumab (AURORA) Recruiting
CAN-2409 Plus Prodrug With Standard of Care Immune Checkpoint Inhibitor for Stage III/IV NSCLC Active, not recruiting

Other trials for the same condition

A Single-Arm, Blinded, Fluorescent PSMA Histopathology Trial of AS1986NS Active, not recruiting
Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) Active, not recruiting
Study of STM-416p Administered to Patients Undergoing Radical Prostatectomy Recruiting
dMD-002 Pilot Study in Patients With Cavernous Nerve Injury Following Radical Prostatectomy Starting soon
Phase I/II Study of [225Ac]Ac-PSMA-R2 in PSMA-positive Prostate Cancer, With/Without Prior 177Lu-PSMA RLT Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02768363 on ClinicalTrials.gov ↗ ← All trials in the USA