Durvalumab and Tremelimumab in Treating Chemotherapy Naive Patients With Metastatic Castration-Resistant Prostate Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03204812
Phase
PHASE2
Status
Completed

Conditions

  • Castration-Resistant Prostate Carcinoma
  • Metastatic Malignant Neoplasm in the Bone
  • Prostate Adenocarcinoma
  • Stage IV Prostate Cancer AJCC v8
  • Stage IVA Prostate Cancer AJCC v8
  • Stage IVB Prostate Cancer AJCC v8

Eligibility Criteria

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

Interventions

Study Details

This phase II trial studies the safety, tolerability and how well durvalumab and tremelimumab work in treating participants with castration-resistant prostate cancer who have not received chemotherapy (chemotherapy naïve) and has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as durvalumab and tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Key Dates

First listed
Jul 2, 2017
Start date
Jul 14, 2017
Status verified
Oct 2023
Primary completion
Apr 13, 2021
Completion
Apr 13, 2021

Study Design

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

Arms

  • Experimental: Treatment (tremelimumab, durvalumab)
    Patients receive tremelimumab IV over 60 minutes and durvalumab IV over 60 minutes on day 1. Treatment repeats every 28 days for up to 4 cycles for tremelimumab and up to 13 cycles for durvalumab in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Adverse Events [ Time Frame: from date of the first treatment, up to 43.6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
M D Anderson Cancer Center· Houston, TX

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