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Cancer Vaccine
Immunotherapy for Prostate Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Barinthus Biotherapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Summary
This trial tests a new immunotherapy for prostate cancer in men after local therapy.
Who is the study for?
Men over 18 with prostate cancer recurrence after initial treatment, no metastasis confirmed by scans, and a rising PSA level. They must have stable vital signs, normal organ function tests, agree to contraception or abstinence, and not start hormone therapy for 4 months post-trial entry. Excluded if they've had other cancers (except certain skin cancers), severe allergies to eggs or vaccines, recent vaccinations or immunotherapies, unstable health conditions or active infections.
What is being tested?
The trial is testing VTP-850 prime-boost immunotherapy in men who have biochemical recurrence of prostate cancer after primary treatments like surgery or radiation. It's an open-label study across multiple centers designed to evaluate the safety and efficacy of this new potential vaccine-based treatment.
What are the potential side effects?
While specific side effects are not listed here, typical reactions may include those common to vaccines such as soreness at injection site, feverish symptoms; allergic reactions; immune system responses that could affect various organs; fatigue; and potentially others based on individual health factors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The safety of VTP-850 prime-boost regimens, with the booster dose administered either IM or IV, and the recommended phase 2 regimen (RP2R)
Secondary outcome measures
The PSA response rate to VTP-850
The durability of PSA response rate to VTP-850
The duration of PSA response to VTP-850
+2 moreOther outcome measures
T-Lymphocyte
MFS and TTM of all participants
Prostate
+1 moreFind a Location
Who is running the clinical trial?
Barinthus BiotherapeuticsLead Sponsor
11 Previous Clinical Trials
3,878 Total Patients Enrolled
Vaccitech (UK) LimitedLead Sponsor
10 Previous Clinical Trials
3,833 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't been part of any experimental treatments or surgeries in the last 3 months.I haven't had any cancer except for skin cancer that was fully removed over 3 years ago.I haven't received immunoglobulins or blood products in the last 28 days.I have a history of hepatitis B, C, or HIV.I have received hormone therapy for cancer within the last 6 months.I have been treated for an autoimmune disease with medication in the last 2 years.I haven't taken steroids or immunosuppressants in the last 14 days.I won't start hormone therapy for my cancer within the next 4 months.I have had chemotherapy or immunotherapy for prostate cancer.I am fully active or can carry out light work.I had radiation therapy after prostate surgery within the last 6 months.I am a man aged 18 or older.I had initial treatment for prostate cancer and possibly salvage radiation more than 6 months ago.I do not have major heart, lung, kidney, stomach, hormone, blood, or brain disorders that could affect the study.My PSA level is above 0.3 ng/mL after prostate surgery or has risen by 2 ng/mL after radiation.My prostate cancer was confirmed by a lab test.I have liver disease, but not the excluded types.I haven't had a fever or needed IV antibiotics in the last week.I have received all required vaccines on time.I won't have prostate or metastasis therapy within 4 months after starting VTP-850.I have a weakened immune system or have had an organ or stem cell transplant.My scans show no cancer spread beyond the original site.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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