BridgeMD
Adjuvant Therapy with Pembrolizumab Versus Placebo in Participants with Hepatocellular Carcinoma and Complete Radiological Response after Surgical Resection or Local Ablation
EU CTIS ID: 2022-501971-24-00
What this study is testing
1. To compare Recurrence-Free Survival (RFS) 2. To compare Overall Survival (OS)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Has a diagnosis of HCC by radiological criteria and/or pathological confirmation.
- If undergoing surgical resection, has submitted a tumor tissue sample during Screening.
- Has adequate organ function.
- 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.
You likely can't join if
- Has a known additional malignancy that is progressing or has required active antineoplastic treatment (including hormonal) or surgery within the past 3 years.
- 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.
See the full eligibility criteria
Who can join
- Has a diagnosis of HCC by radiological criteria and/or pathological confirmation.
- If undergoing surgical resection, has submitted a tumor tissue sample during Screening.
- Has adequate organ function.
- 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).
What rules you out
- Has a known additional malignancy that is progressing or has required active antineoplastic treatment (including hormonal) or surgery within the past 3 years.
- 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 esophageal or gastric variceal bleeding within the last 6 months.
- Has had an allogenic tissue/solid organ transplant.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong
- Turkey
- Ukraine
- Canada
- Israel
- Korea, Republic of
- Switzerland
- Brazil
- New Zealand
- China
- Argentina
- Malaysia
- Taiwan
- United Kingdom
- Japan
- United States
- Australia
- Russian Federation
- Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong; Turkey; Ukraine; Canada; Israel; Korea, Republic of and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.