Pembrolizumab (MK-3475) in Hepatocellular Carcinoma
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|ClinicalTrials.gov Identifier: NCT02940496|
Recruitment Status : Active, not recruiting
First Posted : October 21, 2016
Last Update Posted : August 13, 2018
The goal of this clinical research study is to learn about the safety and tolerability of pembrolizumab when given to patients with advanced liver cancer.
This is an investigational study. Pembrolizumab is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work.
Up to 15 participants will be enrolled in this study. All will take part at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasms of Digestive Organs Advanced Liver Cancer||Drug: Pembrolizumab||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Pembrolizumab (MK-3475) in Subjects With Advanced Hepatocellular Carcinoma Who Progressed on or Were Intolerant to First-Line Systemic Therapy|
|Actual Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Participants receive Pembrolizumab by vein over about 30 minutes on Day 1 of each 21-day cycle.
Participants may receive Pembrolizumab for up to 35 cycles (about 2 years).
200 mg by vein every 3 weeks.
- Predictive Biomarkers of Pembrolizumab as Second-Line After Sorafenib Systemic Monotherapy in Participants with Advanced Hepatocellular Carcinoma [ Time Frame: 9 weeks ]Analysis method based on binomial distribution (Clopper-Pearson method).
- Objective Response Rate (ORR) of Pembrolizumab as Second-Line After Sorafenib Systemic Monotherapy in Participants with Advanced Hepatocellular Carcinoma [ Time Frame: 2 years ]ORR defined as the proportion of subjects who have a complete response (CR) or partial response (PR) using RECIST 1.1 and with confirmatory assessment as required per irRECIST at any time during the trial.
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): NCT02940496
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ahmed Kaseb, MD||M.D. Anderson Cancer Center|