Ipilimumab in Treating Patients With Metastatic or Recurrent Human Papilloma Virus-Related Cervical Cancer
|ClinicalTrials.gov Identifier: NCT01693783|
Recruitment Status : Active, not recruiting
First Posted : September 26, 2012
Last Update Posted : May 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cervical Adenocarcinoma Cervical Squamous Cell Carcinoma, Not Otherwise Specified Human Papillomavirus Infection Recurrent Cervical Carcinoma Stage IVA Cervical Cancer AJCC v6 and v7 Stage IVB Cervical Cancer AJCC v6 and v7||Biological: Ipilimumab Other: Laboratory Biomarker Analysis||Phase 2|
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 every 3 months for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||December 3, 2012|
|Estimated Primary Completion Date :||June 1, 2018|
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: Laboratory Biomarker Analysis
- 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 ]Tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest.
- Objective Response Rate Using Response Evaluation Criteria in Solid Tumors [ Time Frame: Up to 1 year ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the diameters of target lesions; Overall Response (OR) = CR + PR.
- Antitumor Activity (Partial Response, Complete Response, and Stable Disease) Using Immune-related Response Criteria (irRC) [ Time Frame: Up to 1 year ]Immune-Related Complete Response (irCR): complete disappearance of all lesions for at least 4 weeks from the date of documentation of complete response. Immune-Related Partial Response (irPR): The sum of the products of the two largest perpendicular diameters of all index lesions is measured and captured as the SPD baseline. At each subsequent tumor assessment, the sum of the products of the two largest perpendicular diameters of all index lesions and of new measurable lesions are added together to provide the Immune Response Sum of Product Diameters (irSPD). A decrease, relative to baseline of the irSPD compared to the previous SPD baseline, of 50% or greater is considered an immune Partial Response (irPR). irStable Disease (irSD): does not meet criteria for irCR or irPR, in the absence of progressive disease.
- 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 ]
- Disease Stabilization [ Time Frame: Up to 1 year ]As per RECIST v1.1, stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
- Markers of Immune Population, Evaluated in Archival Tissue [ Time Frame: Baseline ]
- Predictive Value of Baseline C-reactive Protein [ Time Frame: Up to week 3 of course 4 ]
- Progression Free Survival [ Time Frame: Time from start of treatment to time of progression or death, whichever occurs first, assessed up to 1 year ]Progressive disease (PD), as per RECIST v1.1, is defined as at least a 20% increase in the sum of the diameters of target lesions and an absolute increase of at least 5mm, or the appearance of one or more new lesions. Computed using the Kaplan-Meier method.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693783
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010|
|University of California Davis Comprehensive Cancer Center|
|Sacramento, California, United States, 95817|
|City of Hope South Pasadena|
|South Pasadena, California, United States, 91030|
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|Tom Baker Cancer Centre|
|Calgary, Alberta, Canada, T2N 4N2|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|BC Cancer Research Centre|
|Vancouver, British Columbia, Canada, V5Z 1L3|
|BCCA-Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Juravinski Cancer Centre at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8V 5C2|
|London Regional Cancer Program|
|London, Ontario, Canada, N6A 4L6|
|Ottawa Hospital and Cancer Center-General Campus|
|Ottawa, Ontario, Canada, K1H 8L6|
|University Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Amit Oza||University Health Network Princess Margaret Cancer Center P2C|