Study of Safety and Tolerability of PDR001 in Combination With Sorafenib and to Identify the Maximum Tolerated Dose and/or Phase 2 Dose for This Combination in Advanced Hepatocellular Patients
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically or cytologically confirmed advanced (unresectable and/or metastatic) HCC
Patients with advanced HCC not amenable for surgical or loco-regional treatment
At least one measureable tumor lesion that that has not been previously locally
Patients with current cirrhotic status of Child-Pugh class A only (5-6 points with total bilirubin \< 2 mg/dL for dose-escalation) with no encephalopathy and no clinical ascites (ascites controlled by diuretics is also excluded in this study).
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Patient must meet required laboratory values at the screening
Normal electrocardiogram at screening
You may not be if
Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
Invasion of the main portal vein and/or tumor involvement in more than 50% of the liver (applicable only for the dose-escalation part)
Patients with Portal-caval shunts
Prior or concomitant systemic anti-cancer treatment for advanced disease
Systemic chronic steroid therapy (≥ 10mg/day prednisone or equivalent) or any immunosuppressive therapy 7 days prior to planned date for first dose of study treatment. Topical, inhaled, nasal and ophthalmic steroids are allowed.
Cardiac or cardiac repolarization abnormality
Patients with active Hepatitis B infection (HBsAg positive) that are not receiving antiviral treatment are excluded
Patients with positive test for hepatitis C ribonucleic acid (HCV RNA)
Loco-regional treatment within 4 weeks prior to initiation of study treatment.
Clareo Health | Study of Safety and Tolerability of PDR001 in Combination With Sorafenib and to Identify the Maximum Tolerated Dose and/or Phase 2 Dose for This Combination in Advanced Hepatocellular Patients
