ESK981 and Nivolumab for the Treatment of Metastatic Castration Resistant Prostate Cancer

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Barbara Ann Karmanos Cancer Institute
Study ID
NCT04159896
Phase
PHASE2
Status
Terminated

Conditions

  • Castration Levels of Testosterone
  • Castration-Resistant Prostate Carcinoma
  • Metastatic Prostate Carcinoma
  • Prostate Carcinoma Metastatic in the Bone
  • Stage IVB Prostate Cancer AJCC v8

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pan-VEGFR/TIE2 Tyrosine Kinase Inhibitor CEP-11981 — DRUG
    Given PO
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

This phase II trial studies the side effects of ESK981 and nivolumab and to see how well they work for the treatment of castration resistant prostate cancer that has spread to other places in the body (metastatic). ESK981 is an investigational drug that targets several important pathways that are believed to play a role in the spread of cancer. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study is being done to see if giving ESK981 and nivolumab together works better in treating metastatic castration resistant prostate cancer compared to usual treatments.

Key Dates

Start date
Nov 13, 2019
Status verified
Jul 2024
Primary completion
Mar 1, 2022
Completion
Mar 1, 2022

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ESK981, nivolumab)
    Patients receive ESK981 PO QD for 5 consecutive days per week, followed by a 2-day break. Patients also receive nivolumab IV on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Prostate Specific Antigen (PSA) >= 50% Response Rate (PSA50) [ Time Frame: From treatment administration up to a maximum duration of 27 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Wayne State University/Karmanos Cancer InstituteDetroitMichigan48201-

Find similar trials in Ann Arbor, MI

By research site
University of Michigan Comprehensive Cancer Center· Ann Arbor, MIWayne State University/Karmanos Cancer Institute· Detroit, MI

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