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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00362713
Recruitment Status : Completed
First Posted : August 10, 2006
Last Update Posted : September 30, 2016
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Urothelial Carcinoma Drug: Ipilimumab Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Safety and Dose-Assessment Study of Neoadjuvant Ipilimumab Monotherapy in Patients With Urothelial Carcinoma Undergoing Surgical Resection
Study Start Date : March 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Ipilimumab

Arm Intervention/treatment
Experimental: A
3 mg/kg or 10 mg/kg
Drug: Ipilimumab
Intravenous Solution, Intravenous, One dose every 3 weeks for four weeks, followed through Week 24
Other Names:
  • BMS-734016
  • MDX-010

Primary Outcome Measures :
  1. Safety of two dose levels of ipilimumab, given prior to surgery, in this patient population. [ Time Frame: assessed throughout the study ]

Secondary Outcome Measures :
  1. To evaluate anti-cancer immunological activity in blood and tissue samples compared to pre-treatment or control samples. [ Time Frame: assessed throughout the study ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00362713

United States, Texas
The University Of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb Identifier: NCT00362713     History of Changes
Obsolete Identifiers: NCT00462930
Other Study ID Numbers: CA184-027
First Posted: August 10, 2006    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: December 2009

Additional relevant MeSH terms:
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs