Study of Neoadjuvant Ipilimumab in Patients With Urothelial Carcinoma Undergoing Surgical Resection

NCT ID: NCT00362713

Last Updated: 2016-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2009-10-31

Brief Summary

The purpose of this study is to learn if ipilimumab can be given safely at two different doses given to patients with urothelial cancer who are going to have surgery as part of their treatment. The immunological effectiveness of ipilimumab will also be studied.

Conditions

Urothelial Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

3 mg/kg or 10 mg/kg

Group Type: EXPERIMENTAL

Ipilimumab

Intervention Type: DRUG

Intravenous Solution, Intravenous, One dose every 3 weeks for four weeks, followed through Week 24

Interventions

Ipilimumab

Intravenous Solution, Intravenous, One dose every 3 weeks for four weeks, followed through Week 24

Intervention Type: DRUG

Other Intervention Names

BMS-734016; MDX-010

Eligibility Criteria

Inclusion Criteria

• Previously untreated urothelial cancer requiring surgery for treatment
• Ineligible for chemotherapy
• Adequate hematologic, kidney and liver function

Exclusion Criteria

• Sexually active and fertile individuals or partners of these individuals who are unwilling or unable to use an acceptable method of birth control for the entire trial and up to 4 weeks after the study
• Women who are pregnant or breastfeeding
• Women with a positive pregnancy test on enrollment prior to study drug administration
• Prior treatment with ipilimumab or other anti-CTLA4 antibody, or a CD137 agonist
• Concurrent malignancy, with the exception of adequately treated and cured basal or squamous cell skin cancer, or carcinoma in situ of the cervix (previous malignancy without evidence of disease for 5 years will also be allowed to enter trial)
• Autoimmune disease: subjects with a documented history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) are excluded from this study as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]). Subjects with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome) are excluded from this study
• Patients deemed ineligible for surgery
• Any non-oncology vaccine therapy used for prevention of infectious diseased in the past month
• Concomitant therapy with any of the following: IL-2, interferon or other non-study immunotherapy regimens, chemotherapy; immunosuppressive agents; other investigation therapies; or chronic use of systemic corticosteroids (used in the management of cancer or non-cancer related illnesses)
• Prior radiation therapy for urothelial cancer
• Positive screening tests for or any prior history of HIV, Hepatitis B or Hepatitis C

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

The University Of Texas MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

CA184-027

Identifier Type: -

Identifier Source: org_study_id

NCT00462930

Identifier Type: -

Identifier Source: nct_alias