Back to resultsRandomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES)
Primary Purpose
Prostate Cancer
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
aglatimagene besadenovec
placebo
valacyclovir
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Immunotherapy, Tumor vaccine, Immuno-oncology, Cytotoxicity, Prostate cancer, Active Surveillance
Eligibility Criteria
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
Sites / Locations
- Foothills Urology
- Jesse Brown VA Medical Center
- The University of Chicago
- Southeast Louisiana Veterans Health Care System
- Walter Reed National Military Medical Center
- Kansas City VA Medical Center
- Sierra Nevada Health Care System VA
- Hackensack University Medical Center
- Advanced Radiation Centers of New York (Integrated Medical Professionals)
- Associated Medical Professionals of NY, PLLC
- Southwest Urology, Clinical Research Solutions
- Oklahoma City VA Healthcare System
- VA Portland Health Care System
- Oregon Urology Insitute
- Lancaster Urology
- Allegheny Health Network-Triangle Urological Group
- Ralph H. Johnson Veterans Affairs Medical Center
- San Antonio VA Healthcare System
- Woodland Center
- Texas Urology Specialists
- Hunter Holmes McGuire VA Medical Center
- Salem VA Medical Center
- Instituto Nacional de Ciencias Medicas y Nutrición, Salvador Subirán
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
CAN-2409
Placebo
Arm Description
Patients randomized to the active arm will receive two courses of aglatimagene besadenovec (CAN-2409) + valacyclovir
Patients randomized to the placebo arm will receive two corresponding courses of placebo + valacyclovir
Outcomes
Primary Outcome Measures
Progression-free survival (PFS)
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
Negative biopsy rate at 1-year landmark
Percentage of patients with adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02768363
Brief Title
Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES)
Official Title
A Randomized Controlled Trial Of AdV-tk + Valacyclovir Administered During Active Surveillance For Newly Diagnosed Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Candel Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Immunotherapy, Tumor vaccine, Immuno-oncology, Cytotoxicity, Prostate cancer, Active Surveillance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
187 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAN-2409
Arm Type
Active Comparator
Arm Description
Patients randomized to the active arm will receive two courses of aglatimagene besadenovec (CAN-2409) + valacyclovir
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients randomized to the placebo arm will receive two corresponding courses of placebo + valacyclovir
Intervention Type
Biological
Intervention Name(s)
aglatimagene besadenovec
Other Intervention Name(s)
AdV-tk, CAN-2409
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
valacyclovir
Intervention Description
Oral prodrug to be given for 14 days starting the day after each aglatimagene besadenovec or placebo injection.
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
Progression-free survival is defined as the time from randomization to evidence of histological disease progression or death due to prostate cancer
Time Frame
Baseline to study completion, approximately 5 years
Secondary Outcome Measure Information:
Title
Negative biopsy rate at 1-year landmark
Time Frame
1 year
Title
Percentage of patients with adverse events
Time Frame
30 days after last dose of study drug
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Foothills Urology
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Jesse Brown VA Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Southeast Louisiana Veterans Health Care System
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Facility Name
Kansas City VA Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
Sierra Nevada Health Care System VA
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Advanced Radiation Centers of New York (Integrated Medical Professionals)
City
North Hills
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Associated Medical Professionals of NY, PLLC
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Southwest Urology, Clinical Research Solutions
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Oklahoma City VA Healthcare System
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
VA Portland Health Care System
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Oregon Urology Insitute
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Lancaster Urology
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Allegheny Health Network-Triangle Urological Group
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Ralph H. Johnson Veterans Affairs Medical Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
San Antonio VA Healthcare System
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-4404
Country
United States
Facility Name
Woodland Center
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Texas Urology Specialists
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Hunter Holmes McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Salem VA Medical Center
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Instituto Nacional de Ciencias Medicas y Nutrición, Salvador Subirán
City
Mexico City
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Randomized Controlled Trial of CAN-2409 Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES)
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