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

Urothelial Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00362713
• Other study ID #: CA184-027
• Status: Completed
• Phase: Phase 1
• First received: August 7, 2006
• Last updated: September 29, 2016
• Start date: March 2007
• Est. completion date: October 2009

Study information

• Verified date: December 2009
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00462930

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Urothelial Carcinoma

Intervention

Drug:
• Ipilimumab
Intravenous Solution, Intravenous, One dose every 3 weeks for four weeks, followed through Week 24

Locations

Country	Name	City	State
United States	The University Of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of two dose levels of ipilimumab, given prior to surgery, in this patient population.		assessed throughout the study	Yes
Secondary	To evaluate anti-cancer immunological activity in blood and tissue samples compared to pre-treatment or control samples.		assessed throughout the study	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form