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

Phase 2

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Biological: placebo; Biological: aglatimagene besadenovec; Drug: valacyclovir

• Registration Number: NCT02768363
• Lead Sponsor: Candel Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-06
• Study First Submitted QC: 2016-05-09
• Study First Posted: 2016-05-11
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-19
• Last Update Posted: 2024-06-21
• Primary Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 187

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Patients randomized to the placebo arm will receive two corresponding courses of placebo + valacyclovir
CAN-2409	aglatimagene besadenovec	Patients randomized to the active arm will receive two courses of aglatimagene besadenovec (CAN-2409) + valacyclovir
Placebo	valacyclovir	Patients randomized to the placebo arm will receive two corresponding courses of placebo + valacyclovir
CAN-2409	valacyclovir	Patients randomized to the active arm will receive two courses of aglatimagene besadenovec (CAN-2409) + valacyclovir

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Negative biopsy rate at 1-year landmark	1 year
Percentage of patients with adverse events	30 days after last dose of study drug

Trial Locations

Locations (23)

Foothills Urology; 🇺🇸 Golden, Colorado, United States

The University of Chicago; 🇺🇸 Chicago, Illinois, United States

Allegheny Health Network-Triangle Urological Group; 🇺🇸 Pittsburgh, Pennsylvania, United States

VA Portland Health Care System; 🇺🇸 Portland, Oregon, United States

Ralph H. Johnson Veterans Affairs Medical Center; 🇺🇸 Charleston, South Carolina, United States

Jesse Brown VA Medical Center; 🇺🇸 Chicago, Illinois, United States

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States

Kansas City VA Medical Center; 🇺🇸 Kansas City, Missouri, 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

Oklahoma City VA Healthcare System; 🇺🇸 Oklahoma City, Oklahoma, United States

Lancaster Urology; 🇺🇸 Lancaster, Pennsylvania, United States

Woodland Center; 🇺🇸 The Woodlands, Texas, United States

San Antonio VA Healthcare System; 🇺🇸 San Antonio, 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

Southwest Urology, Clinical Research Solutions; 🇺🇸 Middleburg Heights, Ohio, United States

Sierra Nevada Health Care System VA; 🇺🇸 Reno, Nevada, United States

Southeast Louisiana Veterans Health Care System; 🇺🇸 New Orleans, Louisiana, United States

Instituto Nacional de Ciencias Medicas y Nutrición, Salvador Subirán; 🇲🇽 Mexico City, Mexico

Oregon Urology Insitute; 🇺🇸 Springfield, Oregon, United States