At a glance
ClinicalIndex Comparison Record- ✓Histopathologic confirmation of prostate cancer (pathology report acceptable if no specimen available)
- ✓Biochemical recurrence with PSA doubling time of 5-15 months
- ✓Rising PSA ≥0.8 ng/mL post-prostatectomy or ≥2 ng/mL above nadir post-radiation, confirmed by 3 values ≥1 week apart over ≥1 month
- ✓ECOG performance status 0-1 (Karnofsky ≥80%)
- ✕HIV positive or active autoimmune disease (with exceptions for type 1 diabetes, vitiligo, alopecia, and resolved autoimmunity not requiring systemic immunosuppression)
- ✕Other immunodeficiency diseases or history of organ/stem-cell transplantation (except non-immunosuppressive transplants)
- ✕Systemic corticosteroids for >14 days within 28 days of treatment start (inhaled/topical allowed)
- ✕Prior chemotherapy or immunotherapy within 3 years (except for lead-in cohort with castration-resistant disease)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of Combination Immunotherapy in Biochemically Recurrent Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating Antigen direct immunotherapy: PROSTVAC-V, Antigen direct immunotherapy: PROSTVAC-F, and 7 other interventions for Prostate Cancer. Completed, enrolled 40 participants across 1 site.
Detailed Summary
Background: Some people with prostate cancer have a rise in prostate-specific antigen (PSA). This can happen even after treatments like radiation and surgery. Androgen deprivation therapy (ADT) drugs and close monitoring are one standard way to treat this group of people. Another way is to monitor people and their PSA values over time. Researchers want to see if a combination of new drugs can help these people. Objective: To see if the combination treatment of PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec vaccinia), CV301, and MSB0011359C (M7824) can induce an anti-tumor impact in people with biochemically recurrent prostate cancer. Eligibility: People ages 18 and older with certain kinds of prostate cancer Design: Participants will be screened with * Medical history * Physical exam * Blood and urine tests * A scan of the neck, chest, abdomen, and pelvis * A bone scan A sample of tissue that was already taken will be tested. This will confirm the diagnosis, stage, and disease status. Some participants will have close monitoring with four monthly PSA checks. All participants will get two study drugs as shots under the skin. They will get the third drug in a vein. They will get the drugs over at least 7 months. Their vital signs will be checked before they get the drugs and for up to 1 hour after. Participants will have frequent study visits. They will have physical exams, urine and blood tests, and scans. Participants will return to the clinic about 4 weeks after they stop taking the study drugs. They will have a medical history, physical exam, and blood tests. They may also have long-term follow-up visits.
Study Details
Timeline
Interventions
Recombinant vaccinia virus vector antigen direct immunotherapy of the genus Orthopoxvirus. Administered by subcutaneous injection.
Recombinant fowlpox virus vector Antigen direct immunotherapy of the genus Avipoxvirus. Administered by subcutaneous injection.
Fully human bifunctional fusion protein that combines immunoglobulin G1 (IgG1) anti-programmed death-ligand 1 (PD-L1) and Transforming growth factor, beta receptor II (TGFbetaRII) as a monoclonal antibody. Administered via intravenous (IV) infusion over 1 hour.
Recombinant vaccinia virus Antigen direct immunotherapy of the genus Avipoxvirus. Administered subcutaneously.
Screening, prior to Antigen direct immunotherapy, end of study therapy, then every 6 months as long as participants remain in follow-up. And as clinically indicated after one year.
Screening, prior to Antigen direct immunotherapy, end of study therapy, then every 6 months as long as participants remain in follow-up. And as clinically indicated after one year.
Screening, prior to Antigen direct immunotherapy, end of study therapy, then every 6 months as long as participants remain in follow-up. And as clinically indicated after one year.
Biochemical recurrence group only. Screening, prior to Antigen direct immunotherapy therapy, end of study therapy, then every 6 months as long as participants remain in follow-up. And as clinically indicated after one year.
Screening, prior to Antigen direct immunotherapy, end of study therapy, then every 6 months as long as participants remain in follow-up. And as clinically indicated after one year.