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Ipilimumab + Androgen Depravation Therapy in Prostate Cancer

NCT01377389 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-09-29

Study results available
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Summary

The goal of this clinical research study is to learn if ipilimumab in combination with either Lupron® (leuprolide), Zoladex® (goserelin), or Firmagon® (degarelix) can affect prostate-specific antigen (PSA) levels in patients with prostate cancer. Researchers also want to learn if these drug combinations affect the body's immune system. The safety of these drug combinations will also be studied.

Conditions

Interventions

DRUG

Ipilimumab

10 mg/kg by vein over 90 minutes once every 4 weeks, for 4 weeks.

DRUG

Leuprolide

7.5 mg intramuscular once a month for 8 months

DRUG

Goserelin

3.6 mg subcutaneous once a month for 8 months

DRUG

Degarelix

80 mg subcutaneous once a month for 8 months

Sponsors & Collaborators

Principal Investigators

  • Ana M. Aparicio, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-17
Primary Completion
2017-04-07
Completion
2017-04-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT01377389 on ClinicalTrials.gov