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Neoantigen DNA Vaccine in Combination With Nivolumab/Ipilimumab and PROSTVAC in Metastatic Hormone-Sensitive Prostate Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Neoantigen DNA Vaccine in Combination With Nivolumab/Ipilimumab and PROSTVAC in Metastatic Hormone-Sensitive Prostate Cancer

A Pilot Trial of Neoantigen DNA Vaccine in Combination With Nivolumab/Ipilimumab and PROSTVAC in Metastatic Hormone-Sensitive Prostate Cancer

NCT03532217•Washington University School of Medicine

View on ClinicalTrials.gov

Summary

This study study aims to elucidate the immune responses to a shared antigen vaccine (PROSTVAC) and tumor specific antigens generated DNA vaccine in combination with checkpoint blockade using nivolumab (anti-PD-1), and ipilimumab (anti-CTLA-4). Additionally, the investigators will study the impact of the combination immunotherapy on peripheral T cell activation, as well as immune response in the tumor microenvironment. Finally, the investigators will evaluate the safety and tolerability to this novel personalized immunotherapy in combination with checkpoint blockade.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed adenocarcinoma of the prostate.
•High risk/volume metastatic disease, as defined by 4 or more sites of disease or the presence of visceral metastases.
•Must have completed an adequate course of chemo-hormonal, first line therapy for metastatic hormone-sensitive prostate cancer, as determined by the investigator. Patients must remain on stable dose of ADT with castrate levels of testosterone (defined as testosterone \< 50 ng/dL)
•At least 18 years of age.
•PSA may be undetectable after initial chemo-ADT.
•ECOG performance status ≤ 2
•Normal bone marrow and organ function as defined below:
•* Leukocytes ≥ 2,000/ul
•* Absolute neutrophil count ≥ 1,500/ul
•* Platelets ≥ 100,000/ul
+8 more criteria

Exclusion Criteria

•Significant small cell or neuroendocrine component or histology, as determined by the institution's reading pathologist.
•Progression of disease as defined by a rising PSA (3 sequential values, at least 1 week apart) or radiographic progression based on RECIST1.1 or PCWG3 criteria.
•Prior treatment with a checkpoint inhibitor, neoantigen vaccine, or PROSTVAC.
•Participants with active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll.
•Diagnosis of atopic dermatitis or other active exfoliative skin condition
•History of concurrent second cancers requiring active, ongoing systemic treatment
•Currently receiving any other investigational agents.
•Known brain metastases. Prostate cancer patients with known brain metastases must be excluded from this clinical trial because of their poor prognosis, and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
•A history of allergic reactions attributed to compounds of similar chemical or biologic composition to anti-PD-1, anti-CTLA-4, Prostvac-VF Tricom, DNA vaccines, or other agents used in the study.
•Prior allergy or significant systemic reaction to vaccinia.
+10 more criteria

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Key Dates

Start Date

September 14, 2018

Primary Completion Date

April 1, 2022

Completion Date

July 25, 2022

Last Updated

August 5, 2022

Enrollment

ACTUAL participants

Conditions

Metastatic Hormone-Sensitive Prostate Cancer

Interventions

PROSTVAC-V

BIOLOGICAL

PROSTVAC-F

BIOLOGICAL

Nivolumab

DRUG

Ipilimumab

DRUG

Neoantigen DNA vaccine

BIOLOGICAL

TriGrid Delivery System

DEVICE

Tumor biopsy

PROCEDURE

Peripheral blood

PROCEDURE

Fecal samples

PROCEDURE

Leukapheresis

PROCEDURE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 5, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Neoantigen DNA Vaccine in Combination With Nivolumab/Ipilimumab and PROSTVAC in Metastatic Hormone-Sensitive Prostate Cancer

Inclusion Criteria

Exclusion Criteria

TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Quality of Life, Functional and Cognitive Outcomes in Patients With Metastatic Hormone-Sensitive Prostate Cancer

A Study to Learn More About How Safe Darolutamide is Under Real-world Conditions in Participants With Metastatic Hormone-Sensitive Prostate Cancer

A Trial of Immunotherapy Strategies in Metastatic Hormone-sensitive Prostate Cancer