Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Disease Progression

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

All Drugs and Chemicals

Hematinics

Antineoplastic Agents

Immunomodulating Agents

Liver Extracts

Sorafenib

Spartalizumab

Protein Kinase Inhibitors

Enzyme Inhibitors

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

PDR001 at 400 mg given intravenously every 4 weeks and sorafenib 400 mg taken orally once or twice per day (escalating doses)

PDR001 will be administered intravenously

PDR001

Novartis Pharmaceuticals

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.

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

A Phase Ib Study of PDR001 in Combination With Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC)

Incidence and severity of AEs and SAEs, including changes in laboratory vital signs and ECGs

A dose-limiting toxicity (DLT) was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease progression, inter-current illness, or concomitant medications that met certain criteria as defined in the protocol.

Tolerability measured by the number of subjects who have interruptions of study treatment

Tolerability measured by the number of subjects who have reductions of study treatment

Tolerability measured by the dose intensity of study treatment

Overall response rate (ORR) as per the independent central radiology assessment will be summarized descriptively by dose level. The overall response rate (ORR) is defined as the proportion of patients with best overall response of CR or PR. The best overall response is the best response recorded using the independent central radiology review based on RECIST 1.1 from start of treatment until disease progression, death, start of new therapy, withdrawal of consent or cut-off date, whichever occurs first

The maximum (peak) observed plasma, drug concentration after single dose administration.

The time to reach maximum (peak) plasma drug concentration after single dose administration (time)

Area under the plasma concentration-time curve of sorafenib from time zero to time 't' where t is a defined time point after administration. t=8 hours (AUC0-8)

Area under the plasma concentration-time curve from time zero to the end of the dosing interval tau at steady-state

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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	NCT02988440	Hepatocellular ...	PDR001 Sorafenib	18 Years -	Novartis
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	NCT02988440	Hepatocellular ...	PDR001 Sorafenib	18 Years -	Novartis
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	NCT02988440	Hepatocellular ...	PDR001 Sorafenib	18 Years -	Novartis

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