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A Phase 1b Safety and Dose-Assessment Study of Neoadjuvant Ipilimumab Monotherapy in Patients With Urothelial Carcinoma Undergoing Surgical Resection

Phase 1
18 Years
Not Enrolling
Transitional Cell Carcinoma

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Trial Information

A Phase 1b Safety and Dose-Assessment Study of Neoadjuvant Ipilimumab Monotherapy in Patients With Urothelial Carcinoma Undergoing Surgical Resection

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

assessed throughout the study

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

March 2007

Completion Date:

October 2009

Related Keywords:

  • Transitional Cell Carcinoma
  • Carcinoma
  • Carcinoma, Transitional Cell



The University Of Texas - M.D. Anderson Cancer Center Houston, Texas  77030