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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00362713
First received: August 7, 2006
Last updated: January 24, 2011
Last verified: December 2009
  Purpose

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 Intervention Phase
Transitional Cell Carcinoma
Drug: Ipilimumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

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

Secondary Outcome Measures:
  • To evaluate anti-cancer immunological activity in blood and tissue samples compared to pre-treatment or control samples. [ Time Frame: assessed throughout the study ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: March 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00362713

Locations
United States, Texas
The University Of Texas - M.D. Anderson Cancer Center
Houston, Texas, United States, 77230
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00362713     History of Changes
Obsolete Identifiers: NCT00462930
Other Study ID Numbers: CA184-027
Study First Received: August 7, 2006
Last Updated: January 24, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014