Spots Global Cancer Trial Database for Ipilimumab in Treating Patients With Metastatic or Recurrent Human Papilloma Virus-Related Cervical Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Ipilimumab in Treating Patients With Metastatic or Recurrent Human Papilloma Virus-Related Cervical Cancer
Official Title: A Phase 2 Study of Ipilimumab in Women With Metastatic or Recurrent HPV-Related Cervical Carcinoma of Either Squamous Cell or Adenocarcinoma Histologies
Study ID: NCT01693783
Study Description
Brief Summary: This phase II trial studies how well ipilimumab works in treating patients with human papilloma virus (HPV)-related cervical cancer that has come back or that has spread to other areas of the body. Monoclonal antibodies, such as ipilimumab, can find tumor cells and help kill them or carry tumor-killing substances to them.
Detailed Description: PRIMARY OBJECTIVES: I. To assess the safety of ipilimumab in eligible patients with recurrent or metastatic cervical cancer. II. To assess the antitumor activity of ipilimumab in eligible patients with recurrent or metastatic cervical cancer via assessment of objective response rates (ORR). SECONDARY OBJECTIVES: I. To assess the antitumor activity of ipilimumab through secondary endpoints including of disease stabilization and progression free survival (PFS). II. Assessment of antitumor activity of ipilimumab using immune-related response criteria (irRC) III. Assessment of the predictive value of baseline C-reactive protein. IV. Assess the biologic responses of exposure to ipilimumab via correlative studies involving analysis of lymphocyte subsets and assessment of cervical cancer-antigen specific T cells anti-tumor response. V. Evaluation of archival tissue with regard to markers of immune population in correlation with clinical stage and response to treatment. OUTLINE: Patients receive ipilimumab intravenously (IV) over 90 minutes. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving objective response or stable disease continue to receive maintenance therapy comprising ipilimumab IV over 90 minutes once every 12 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
City of Hope Comprehensive Cancer Center, Duarte, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
City of Hope South Pasadena, South Pasadena, California, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
BC Cancer Research Centre, Vancouver, British Columbia, Canada
BCCA-Vancouver Cancer Centre, Vancouver, British Columbia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
London Regional Cancer Program, London, Ontario, Canada
Ottawa Hospital and Cancer Center-General Campus, Ottawa, Ontario, Canada
University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
Contact Details
Name: Amit M Oza
Affiliation: University Health Network Princess Margaret Cancer Center P2C
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
