Nivolumab for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Emory University Hospital/Winship Cancer Institute, Atlanta, GA
Prostate Cancer+2 More
Nivolumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase II trial tests whether vidutolimod with nivolumab works to destroy tumor cells in patients with castration resistant prostate cancer that has spread to other places in the body (metastatic). Nivolumab is an antibody working by attaching to and blocking a molecule called PD 1. PD 1 is a protein that is present on different types of cells in the immune system and controls parts of the immune system by shutting it down. Antibodies (proteins in the immune system which act to stop infection harming the body) that block PD 1 can potentially prevent PD 1 from shutting down the immune system, thus allowing immune cells to recognize and destroy cancer cells. Vidutolimod (CMP-001) is a Toll-like receptor 9 (TLR9) agonist, with the ability to generate tumor-targeted T cells capable of killing a tumor both locally and systemically in combination with checkpoint inhibitors (nivolumab, in this case), thus potentially improving outcomes for people whose tumors are progressing. Giving nivolumab and vidutolimod may kill more cancer cells in patients with metastatic prostate cancer.

Eligible Conditions

  • Prostate Cancer
  • Adenocarcinoma
  • Malignant neoplasm of prostate

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Prostate Cancer

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: At 1 year

At 1 year
Overall survival (OS)
Radiographic progression free survival (rPFS)
Up to 24 months
ORR
Objective response rate (ORR)
Safety of Treatment
Week 24
Serum prostate-specific antigen (PSA) response

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Prostate Cancer

Trial Design

1 Treatment Group

Treatment ((vidutolimod, nivolumab)
1 of 1
Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Nivolumab · No Placebo Group · Phase 2

Treatment ((vidutolimod, nivolumab)Experimental Group · 2 Interventions: Nivolumab, VLP-encapsulated TLR9 Agonist CMP-001, · Intervention Types: Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~5540

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 1 year
Closest Location: Emory University Hospital/Winship Cancer Institute · Atlanta, GA
Photo of Atlanta 1Photo of Atlanta 2Photo of Atlanta 3
2013First Recorded Clinical Trial
2 TrialsResearching Prostate Cancer
49 CompletedClinical Trials

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,494 Previous Clinical Trials
2,665,953 Total Patients Enrolled
17 Trials studying Prostate Cancer
7,174 Patients Enrolled for Prostate Cancer
Prostate Cancer FoundationOTHER
38 Previous Clinical Trials
2,083 Total Patients Enrolled
23 Trials studying Prostate Cancer
1,604 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
12,930 Previous Clinical Trials
41,294,450 Total Patients Enrolled
531 Trials studying Prostate Cancer
502,319 Patients Enrolled for Prostate Cancer
Mehmet A Bilen, M.D.Principal InvestigatorEmory University Hospital/Winship Cancer Institute

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Histologically confirmed adenocarcinoma of the prostate with metastatic disease.
Hemoglobin concentration > 9 g/dL (within 4 weeks prior to the first dose of CMP-001).
If you are male, you must be at least 18 years of age.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.