Condition: Hepatocellular Carcinoma · Sponsor: Merck Sharp & Dohme LLC
This study will evaluate the safety and efficacy of pembrolizumab (MK-3475) versus placebo as adjuvant therapy in participants with hepatocellular carcinoma (HCC) and complete radiological response after surgical resection or local ablation. The primary hypotheses of this study are that adjuvant pembrolizumab is superior to placebo with respect to: 1) recurrence-free survival (RFS) as assessed by blinded independent central review (BICR); and 2) overall survival (OS).
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Inclusion Criteria: * Has a diagnosis of HCC by radiological criteria and/or pathological confirmation. * Has an eligibility scan (CT of the chest, triphasic CT scan or MRI of the abdomen, and CT or MRI of the pelvis) confirming complete radiological response ≥4 weeks after complete surgical resection or local ablation. Randomization needs to occur within 12 weeks of the date of surgical resection or local ablation. * Has no radiologic evidence of disease prior to enrollment. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to Cycle 1, Day 1. * Has a Child-Pugh class A liver score (5 to 6 points) within 7 days prior to Cycle 1, Day 1. * Has alpha fetoprotein (AFP) concentration lower than 400 ng/mL within 28 days prior to Cycle 1, Day 1. * Has controlled hepatitis B (Hep B). * Has recovered adequately from toxicity and/or complications from the local intervention (surgical resection or local ablation) prior to starting study treatment. * If female, is not pregnant or breastfeeding, and at least one of the following conditions applies: 1) Is not a woman of childbearing potential (WOCBP); or 2) Is a WOCBP and using a contraceptive method that is highly effective or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (a WOCBP must have a negative pregnancy test within 72 hours before the first dose of study treatment). * If undergoing surgical resection, has submitted a tumor tissue sample during Screening. * Has adequate organ function. Exclusion Criteria: * Has a known additional malignancy that is progressing or has required active antineoplastic treatment (including hormonal) or surgery within the past 3 years. * Has had esophageal or gastric variceal bleeding within the last 6 months. * Has clinically apparent ascites on physical examination. * Has had clinically diagnosed hepatic encephalopathy in the last 6 months. * Has received local therapy to liver ablation other than with radiofrequency or microwave ablation. * Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * Has an active infection requiring systemic therapy. * Has dual active Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) infection at study entry. * Has a known history of human immunodeficiency virus (HIV) infection. * Has known active tuberculosis (TB; Bacillus tuberculosis). * Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137). * Has received prior systemic anti-cancer therapy for HCC including investigational agents. * Is receiving any of the following prohibited concomitant therapies:1) Antineoplastic systemic chemotherapy or biological therapy; 2) Immunotherapy not specified in this protocol; 3) Investigational agents other than pembrolizumab; 4) Radiation therapy; 5) Oncological surgical therapy; or systemic glucocorticoids for any purpose other than to modulate symptoms from an AE that is suspected to have an immunologic etiology. * Has received a live vaccine within 30 days prior to the first dose of study treatment. * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to Cycle 1, Day 1. * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to Cycle 1, Day 1. * Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. * Has an active autoimmune disease that has required systemic treatment in past 2 years. * Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study. * Has had an allogenic tissue/solid organ transplant.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Banner MD Anderson Cancer Center ( Site 0026) | Gilbert, Arizona, United States | — |
| The University of Arizona Cancer Center - North Campus ( Site 0039) | Tucson, Arizona, United States | — |
| City of Hope Medical Center ( Site 0027) | Duarte, California, United States | — |
| Smilow Cancer Hospital at Yale New Haven ( Site 0042) | New Haven, Connecticut, United States | — |
| Regional Cancer Center ( Site 0054) | Fort Myers, Florida, United States | — |
| Indiana University Simon Cancer Center ( Site 0075) | Indianapolis, Indiana, United States | — |
| University of Iowa ( Site 0067) | Iowa City, Iowa, United States | — |
| James Graham Brown Cancer Center ( Site 0088) | Louisville, Kentucky, United States | — |
| University of Louisville ( Site 0059) | Louisville, Kentucky, United States | — |
| University Medical Center New Orleans ( Site 0014) | New Orleans, Louisiana, United States | — |
| Massachusetts General Hospital ( Site 0062) | Boston, Massachusetts, United States | — |
| Boston Medical Center ( Site 0025) | Boston, Massachusetts, United States | — |
+ 237 more locations — full list on the registry record.
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice. By subscribing you agree to our Terms of Use and Privacy Policy.