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

• Status: Completed
• Trial end date: 2020-02-27
• Target enrollment: 0
• Participant gender: All

Summary

A two part study to determine the maximum tolerated dose and/or recommended phase 2 dose of PDR001 in combination with sorafenib in patients with advanced hepatocellular carcinoma in first line. There will be a dose escalation part and a dose expansion part.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Niacinamide; Sorafenib; Spartalizumab

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.