Evaluate the Efficacy of MEDI4736 in Immunological Subsets of Advanced Colorectal Cancer
The purpose of this study is to find out what effects, good and/or bad, MEDI4736 has on the patient and cancer.
MEDI4736 is a type of medication called an antibody. Antibodies are normal proteins in the body that help fight infections and possibly cancer. MEDI4736 is a special type of an antibody produced in a laboratory. MEDI4736 works by blocking a specific protein called the Programmed Death Ligand-1 (PDL-1), located on tumor cells.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study to Evaluate the Efficacy of MEDI4736 in Immunological Subsets of Advanced Colorectal Cancer|
- best response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]according to RECIST 1.1.
- Safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Subjects will be evaluated for occurrence of AEs at each visit. Events will be characterized and reported. Safety will also be monitored by performing physical exams and routine laboratory procedures. Terminology Criteria for Adverse Events" V4.0 (CTCAE).
- Progression-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]Progression-free survival will be measured from the start of treatment with MEDI4736 until the documentation of disease progression or death due to any cause, whichever occurs first.
- Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]Overall survival will be determined as the time from the start of treatment with MEDI4736 until death
|Study Start Date:||October 2014|
|Estimated Primary Completion Date:||July 2017 (Final data collection date for primary outcome measure)|
Experimental: Patients with Advanced Colorectal Cancer
This will be a Simon two-stage design, single arm, phase II study. All subjects will receive MEDI4736 via IV infusion. Subjects will continue treatment for 12 months, or until progression of disease, initiation of alternative cancer therapy, unacceptable toxicity, or other reasons to discontinue treatment occur. Following the 12-month treatment period, subjects without evidence for progressive disease or other reason to discontinue treatment will be monitored without further treatment. Upon evidence of PD (with or without confirmation according to RECIST 1.1) during the monitoring period, administration of MEDI4736 may resume at the Q2W schedule, for up to another 12 months. The same treatment guidelines followed during the initial 12-month treatment period will be followed during the retreatment period, including the same dose and frequency of treatments and the same schedule of assessments.
Patients will be seen the day of administration of MEDI4736. A medical history, with particular reference to toxicities, including medication review, and physical examination will be conducted at each treatment visit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02227667
|Contact: Neil Segal, MD PhD||646 888-4187|
|Contact: Leonard Saltz, MD||646-888-4286|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Neil Segal, MD,PhD 646-888-4187|
|Contact: Leonard Saltz, MD 646-888-4286|
|Principal Investigator: Neil Segal, MD, PhD|
|Principal Investigator:||Neil Segal, MD, PhD||Memorial Sloan Kettering Cancer Center|