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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

NCT ID: NCT02988440

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-20

Study Completion Date

2020-02-27

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Keywords

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HCC Hepatocellular carcinoma Hepatocellular carcinoma (HCC) PDR001 liver cancer immunotherapy liver malignant hepatoma Hepatocellular cancer advanced hepatocellular carcinoma (HCC) advanced liver cancer liver cancer progression sorafenib anti-PD1 first line

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PDR001 + Sorafenib

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

Group Type OTHER

PDR001

Intervention Type DRUG

PDR001 will be administered intravenously

Sorafenib

Intervention Type DRUG

Sorafenib is formulated as a tablet.

Interventions

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PDR001

PDR001 will be administered intravenously

Intervention Type DRUG

Sorafenib

Sorafenib is formulated as a tablet.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Novartis Investigative Site

Montreal, Quebec, Canada

Site Status

Novartis Investigative Site

Essen, , Germany

Site Status

Novartis Investigative Site

Hong Kong, , Hong Kong

Site Status

Novartis Investigative Site

Rozzano, MI, Italy

Site Status

Novartis Investigative Site

Kashiwa, Chiba, Japan

Site Status

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Site Status

Novartis Investigative Site

Pamplona, Navarre, Spain

Site Status

Novartis Investigative Site

Taipei, , Taiwan

Site Status

Countries

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France Switzerland United States Canada Germany Hong Kong Italy Japan Spain Taiwan

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17724

Results for CPDR001G2101 from Novartis Clinical Trials Website

Other Identifiers

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2016-004131-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CPDR001G2101

Identifier Type: -

Identifier Source: org_study_id