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ACTIVE NOT RECRUITING
NCT02768363
PHASE2

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

Sponsor: Candel Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Official title: A Randomized Controlled Trial Of AdV-tk + Valacyclovir Administered During Active Surveillance For Newly Diagnosed Prostate Cancer

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

187

Start Date

2016-05

Completion Date

2026-12

Last Updated

2025-07-30

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

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.

BIOLOGICAL

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.

DRUG

valacyclovir

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

Locations (23)

Foothills Urology

Golden, Colorado, United States

Jesse Brown VA Medical Center

Chicago, Illinois, United States

The University of Chicago

Chicago, Illinois, United States

Southeast Louisiana Veterans Health Care System

New Orleans, Louisiana, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Kansas City VA Medical Center

Kansas City, Missouri, United States

Sierra Nevada Health Care System VA

Reno, Nevada, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Advanced Radiation Centers of New York (Integrated Medical Professionals)

North Hills, New York, United States

Associated Medical Professionals of NY, PLLC

Syracuse, New York, United States

Southwest Urology, Clinical Research Solutions

Middleburg Heights, Ohio, United States

Oklahoma City VA Healthcare System

Oklahoma City, Oklahoma, United States

VA Portland Health Care System

Portland, Oregon, United States

Oregon Urology Insitute

Springfield, Oregon, United States

Lancaster Urology

Lancaster, Pennsylvania, United States

Allegheny Health Network-Triangle Urological Group

Pittsburgh, Pennsylvania, United States

Ralph H. Johnson Veterans Affairs Medical Center

Charleston, South Carolina, United States

San Antonio VA Healthcare System

San Antonio, Texas, United States

Woodland Center

The Woodlands, Texas, United States

Texas Urology Specialists

Tomball, Texas, United States

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States

Salem VA Medical Center

Salem, Virginia, United States

Instituto Nacional de Ciencias Medicas y Nutrición, Salvador Subirán

Mexico City, Mexico