MedTrace Logo

A Phase 2 Trial for Men With Metastatic Prostatic Adenocarcinoma

NCT04090775 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-06-21

No results posted yet for this study

Summary

This study seeks to estimate the occurrence of adverse events related to the study treatment (Cryosurgical freezing and Intratumoral Combination Immunotherapy), as well as determine the potential efficacy.

Conditions

  • Metastatic Prostatic Adenocarcinoma

Interventions

DRUG

Opdivo Injectable Product

Opdivo (nivolumab): PD-1 inhibitor antibody Injectable 10mg/mL, only 1 mL injected.

DRUG

Yervoy Injectable Product

Yervoy (ipilimumab): Anti-CTLA-4 antibody Injectable 5mg/mL, only 1 mL injected.

DRUG

Cytoxan

Cytoxan (cyclophosphamide): Chemotherapy agent Both Injectable and Oral low dose: Injectable 250mg/m2, only 1 mL injected. Oral low dose cyclophosphamide: option of either 50mg once daily pill or 25mg twice daily pill for two weeks on, then two weeks off, then two weeks on again.

PROCEDURE

Cryosurgical freezing (cryosurgery)

Cryosurgery, also known as cryoablation, for prostate cancer works by freezing the cancer cells inside the prostate gland. Cryoablation will release intact antigens to prime the immune system.

Sponsors & Collaborators

  • Rampart Health, L.L.C.

    lead INDUSTRY

Principal Investigators

  • David G Bostwick, M.D.,M.B.A. · Rampart Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-28
Primary Completion
2020-07-30
Completion
2022-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04090775 on ClinicalTrials.gov