Ipilimumab in Treating Patients With Metastatic or Recurrent Human Papilloma Virus-Related Cervical Cancer
This phase II trial studies how well giving 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.
Cervical Squamous Cell Carcinoma
Human Papilloma Virus Infection
Recurrent Cervical Cancer
Stage IVA Cervical Cancer
Stage IVB Cervical Cancer
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Incidence of adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0 [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]Tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest.
- Progression free survival (PFS) [ Time Frame: Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 1 year ] [ Designated as safety issue: No ]Computed using the Kaplan-Meier method.
- Antitumor activity (partial response [PR], complete response [CR], and stable disease [SD]) using immune-related response criteria (irRC) and Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]Summary statistics, such as mean, median, counts and proportion, will be used.
- Predictive value of baseline C-reactive protein [ Time Frame: Up to week 3 of course 4 ] [ Designated as safety issue: No ]
- Biologic responses of exposure to ipilimumab by analysis of lymphocyte subsets and assessment of cervical cancer-antigen specific T cells anti-tumor response [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
- Markers of immune population, evaluated in archival tissue [ Time Frame: Baseline ] [ Designated as safety issue: No ]
|Study Start Date:||December 2012|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (ipilimumab)
Patients receive ipilimumab 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.
Other Names:Other: laboratory biomarker analysis
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).
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.
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 for 1 year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693783
|United States, California|
|City of Hope||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Mihaela C. Cristea 626-256-4673 email@example.com|
|Principal Investigator: Mihaela C. Cristea|
|University of Southern California/Norris Cancer Center||Recruiting|
|Los Angeles, California, United States, 90033|
|Contact: Lynda D. Roman 323-865-0451 firstname.lastname@example.org|
|Principal Investigator: Lynda D. Roman|
|University of California at Davis Cancer Center||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Edwin A. Alvarez 916-734-6900 email@example.com|
|Principal Investigator: Edwin A. Alvarez|
|City of Hope South Pasadena||Recruiting|
|South Pasadena, California, United States, 91030|
|Contact: Stephen C. Koehler 626-396-2900 Skoehler@cohmg.com|
|Principal Investigator: Stephen C. Koehler|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Gini F. Fleming 773-702-6712 firstname.lastname@example.org|
|Principal Investigator: Gini F. Fleming|
|United States, Pennsylvania|
|Fox Chase Cancer Center||Recruiting|
|Philadelphia, Pennsylvania, United States, 19111|
|Contact: Lainie P. Martin 215-728-3889 lainie.Martin@fccc.edu|
|Principal Investigator: Lainie P. Martin|
|Tom Baker Cancer Centre||Recruiting|
|Calgary, Alberta, Canada, T2N 4N2|
|Contact: Prafull Ghatage 403-521-3721 Prafull.Ghatage@albertahealthservices.ca|
|Principal Investigator: Prafull Ghatage|
|Cross Cancer Institute||Recruiting|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Contact: Katia S. Tonkin 780-432-8514 email@example.com|
|Principal Investigator: Katia S. Tonkin|
|Canada, British Columbia|
|BC Cancer Research Centre||Recruiting|
|Vancouver, British Columbia, Canada, V5Z 1L3|
|Contact: Anna Tinker 604-877-6000 firstname.lastname@example.org|
|Principal Investigator: Anna Tinker|
|Juravinski Cancer Centre at Hamilton Health Sciences||Recruiting|
|Hamilton, Ontario, Canada, L8V 5C2|
|Contact: Holger W. Hirte 905-387-9495 email@example.com|
|Principal Investigator: Holger W. Hirte|
|Cancer Centre of Southeastern Ontario at Kingston General Hospital||Recruiting|
|Kingston, Ontario, Canada, K7L 5P9|
|Contact: James J. Biagi 613-544-2630 firstname.lastname@example.org|
|Principal Investigator: James J. Biagi|
|London Regional Cancer Program||Recruiting|
|London, Ontario, Canada, N6A 4L6|
|Contact: Stephen A. Welch 519-685-8640 email@example.com|
|Principal Investigator: Stephen A. Welch|
|Ottawa General Hospital||Recruiting|
|Ottawa, Ontario, Canada, K1H 8L6|
|Contact: Johanne I. Weberpals 613-737-8899ext76462 firstname.lastname@example.org|
|Principal Investigator: Johanne I. Weberpals|
|University Health Network-Princess Margaret Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Amit M. Oza 416-946-2818 email@example.com|
|Principal Investigator: Amit M. Oza|
|Principal Investigator:||Amit Oza||Princess Margaret Hospital Phase 2 Consortium|