Nivolumab in Treating Patients With Refractory Metastatic Anal Canal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02314169|
Recruitment Status : Active, not recruiting
First Posted : December 11, 2014
Last Update Posted : May 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Anal Canal Squamous Cell Carcinoma Metastatic Anal Canal Carcinoma Recurrent Anal Canal Carcinoma Stage IV Anal Canal Cancer||Other: Laboratory Biomarker Analysis Biological: Nivolumab||Phase 2|
I. To evaluate overall response rate (ORR) with nivolumab in patients with previously treated metastatic squamous cell carcinoma (SCCA) of the anal canal.
I. To evaluate progression-free survival (PFS) of nivolumab in patients with previously treated metastatic SCCA of the anal canal.
II. To evaluate overall survival (OS) in patients with previously treated metastatic SCCA of the anal canal treated with nivolumab.
III. To evaluate the grade 3 and 4 toxicity rate in patients with previously treated metastatic SCCA of the anal canal when treated with nivolumab.
I. To evaluate ORR, PFS, and OS based on expression of programmed cell death 1 ligand 1 (PD-L1), programmed cell death 1 (PD-1), peritumoral cluster of differentiation (CD)8+ tumor infiltrating lymphocytes (TILs), peritumoral CD4+ TILs, and regulatory T cells as analyzed from tumor biopsies in previously treated patients with metastatic SCCA of the anal canal when treated with nivolumab.
II. To evaluate radiographic responses according to relative changes in proportions of anti-human papillomavirus (HPV) specific CD8+ and CD4+ TILs and regulatory T cells in patients with previously treated metastatic SCCA of the anal canal following treatment with nivolumab, analyzed from serial peripheral blood samples.
Patients receive nivolumab intravenously (IV) over approximately 60 minutes once every two weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 100 days and then every 3 months for 2 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Institutional Phase 2 Study of Nivolumab in Refractory Metastatic Squamous Cell Carcinoma of the Anal Canal|
|Actual Study Start Date :||May 1, 2015|
|Actual Primary Completion Date :||September 1, 2016|
Experimental: Treatment (nivolumab)
Patients receive nivolumab IV over approximately 60 minutes once every two weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
- Overall response rate [ Time Frame: Up to 2 years ]Responses will be assessed using CT scans or magnetic resonance imaging according to standard RECIST 1.1 criteria in order to assess disease progression.
- Incidence of toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 100 days post-treatment ]The frequency of each serious adverse event will be measured relative to the total number of patients treated. Toxicities will be tabulated by type and grade.
- Overall survival [ Time Frame: From initiation of treatment with nivolumab until death, assessed up to 2 years ]Kaplan-Meier analysis will be performed to estimate the median overall survival with a 90% confidence interval.
- Progression-free survival [ Time Frame: From initiation of treatment with nivolumab until the time of disease progression, assessed up to 2 years ]Kaplan-Meier analysis will be performed to estimate the median progression-free survival with a 90% confidence interval.
- Expression of biomarkers using immunohistochemistry and blood samples [ Time Frame: Up to time of treatment discontinuation ]Descriptive statistics including plots, mean, median and standard deviations will be used to summarize data. For continuous outcomes, t-test and analysis of variance will be used to compare outcome measures across patient characteristics. Pair-wise comparisons will be performed using pre- and post-therapy samples from each patient. The chi-square test or Fisher's exact test will be used to test the association between two categorical variables. Both univariate and multivariate logistic regressions will be performed to model prognostic factors.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314169
|United States, California|
|Los Angeles County-USC Medical Center|
|Los Angeles, California, United States, 90033|
|USC / Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|University of California Davis Comprehensive Cancer Center|
|Sacramento, California, United States, 95817|
|United States, District of Columbia|
|MedStar Georgetown University Hospital|
|Washington, D.C., District of Columbia, United States, 20007|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637|
|Decatur Memorial Hospital|
|Decatur, Illinois, United States, 62526|
|UC Comprehensive Cancer Center at Silver Cross|
|New Lenox, Illinois, United States, 60451|
|Southern Illinois University School of Medicine|
|Springfield, Illinois, United States, 62702|
|United States, Missouri|
|Barnes-Jewish West County Hospital|
|Creve Coeur, Missouri, United States, 63141|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210|
|United States, Pennsylvania|
|Penn State Milton S Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033-0850|
|United States, Tennessee|
|Vanderbilt University/Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232|
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|United States, Wisconsin|
|University of Wisconsin Hospital and Clinics|
|Madison, Wisconsin, United States, 53792|
|University Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Cathy Eng||University of Texas MD Anderson Cancer Center LAO|