Study of Pembrolizumab and Radiotherapy in Liver Cancer
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|ClinicalTrials.gov Identifier: NCT03316872|
Recruitment Status : Recruiting
First Posted : October 20, 2017
Last Update Posted : December 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Pembrolizumab Radiation: Stereotactic Body Radiotherapy (SBRT)||Phase 2|
Pembrolizumab will be administered intravenously as a 30-minute infusion at a dose of 200 mg every 21 days, until disease progression or intolerable toxicity.
Stereotactic radiotherapy will commence on day 2 of the first cycle of pembrolizumab, and will be delivered in 5 fractions over 8-15 days in accordance with institutional protocol.
Subjects will be re-evaluated for response every 12 weeks. In addition to a baseline scan, confirmatory scans should also be obtained 4-8 weeks following initial documentation of objective response.
Response and progression will be evaluated in this study using both RECIST 1.1and (iRECIST) guideline (Seymor 2017).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pembrolizumab and Stereotactic Radiotherapy Combined in Subjects With Advanced Hepatocellular Carcinoma - A Phase II Study|
|Actual Study Start Date :||February 15, 2018|
|Estimated Primary Completion Date :||April 2, 2021|
|Estimated Study Completion Date :||April 2, 2022|
Experimental: Pembrolizumab and Stereotactic Body Radiotherapy (SBRT)
Pembrolizumab, intravenously, at a dose of 200 mg, once every 3 weeks
SBRT starting Day 2 of Cycle 1 of pembrolizumab treatment, given in 5 fractions over 10-15 days.
Pembrolizumab is a humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
Other Name: KEYTRUDA
Radiation: Stereotactic Body Radiotherapy (SBRT)
SBRT involves delivery of high doses of radiation therapy in smaller fractions
- Overall response rate [ Time Frame: 3 years ]To assess the systemic efficacy of combined SBRT and pembrolizumab in subjects with advanced HCC who have experienced disease progression after previous therapy, as measured by overall response rate (ORR).
- Response rate in non-irradiated tumor lesions [ Time Frame: 3 years ]To measure the abscopal effect that is shrinkage of untreated tumors occurs concurrently with shrinkage of tumors within the scope of the localized treatment.
- Progression-free survival rate [ Time Frame: 3 years ]To determine the progression-free survival (PFS), in subjects receiving combination treatment with pembrolizumab and SBRT for advanced HCC who have experienced disease progression after sorafenib therapy.
- Overall survival rate [ Time Frame: 3 years ]To determine the overall survival (OS) in subjects receiving combination treatment with pembrolizumab and SBRT for advanced HCC who have experienced disease progression after sorafenib therapy.
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): NCT03316872
|Contact: Jennifer J. Knox, M.D.||firstname.lastname@example.org|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Jennifer J. Knox, M.D. 416-946-2399|
|Principal Investigator: Jennifer J. Knox, M.D.|
|Principal Investigator:||Jennifer J. Knox, M.D.||Princess Margaret Cancer Centre|