Clinical trial · Interventional
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)
NCT02988440CI-TRIAL-00048962completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PDR001 | Drug | — | UNRESOLVED |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- PDR001 + Sorafenib
- description
- PDR001 at 400 mg given intravenously every 4 weeks and sorafenib 400 mg taken orally once or twice per day (escalating doses)
- interventionNames
- Drug: PDR001
- Drug: Sorafenib
Primary outcomes (5)
- measure
- Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
- timeFrame
- From baseline until 30 days of last dose of study treatment
- description
- Incidence and severity of AEs and SAEs, including changes in laboratory vital signs and ECGs
- measure
- Incidendence of Dose Limiting Toxicities (DLTs)
- timeFrame
- During the first 8 weeks of treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.