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

NCT00362713 | Completed Phase 1

• 1 other identifier: CA184-027
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Safety of two dose levels of ipilimumab, given prior to surgery, in this patient population.

  assessed throughout the study

Secondary Outcomes (1)

• To evaluate anti-cancer immunological activity in blood and tissue samples compared to pre-treatment or control samples.

  assessed throughout the study

Study Arms (1)

A

EXPERIMENTAL

3 mg/kg or 10 mg/kg

Drug: Ipilimumab

Interventions

Ipilimumab DRUG

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

Also known as: BMS-734016, MDX-010

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

The University Of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

Ipilimumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2006
• First Posted: August 10, 2006
• Study Start: March 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: September 30, 2016

Record last verified: 2009-12

Locations

US (1)