A Randomized Controlled Trial Of AdV-tk + Valacyclovir Administered During Active Surveillance For Newly Diagnosed Prostate Cancer
Overview
- Phase
- Phase 2
- Intervention
- aglatimagene besadenovec
- Conditions
- Prostate Cancer
- Sponsor
- Candel Therapeutics, Inc.
- Enrollment
- 187
- Locations
- 23
- Primary Endpoint
- Progression-free survival (PFS)
- Status
- Active, not recruiting
- Last Updated
- 9 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
CAN-2409
Patients randomized to the active arm will receive two courses of aglatimagene besadenovec (CAN-2409) + valacyclovir
Intervention: aglatimagene besadenovec
CAN-2409
Patients randomized to the active arm will receive two courses of aglatimagene besadenovec (CAN-2409) + valacyclovir
Intervention: valacyclovir
Placebo
Patients randomized to the placebo arm will receive two corresponding courses of placebo + valacyclovir
Intervention: placebo
Placebo
Patients randomized to the placebo arm will receive two corresponding courses of placebo + valacyclovir
Intervention: valacyclovir
Outcomes
Primary Outcomes
Progression-free survival (PFS)
Time Frame: 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 Outcomes
- Negative biopsy rate at 1-year landmark(1 year)
- Percentage of patients with adverse events(30 days after last dose of study drug)