Immunotherapy With Nivolumab in Combination With Lenvatinib for Advanced Stage Hepatocellular Carcinoma

Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study ID
NCT03841201
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Hepatocellular Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lenvatinib — DRUG
    oral
  • Nivolumab — DRUG
    iv infusion

Study Details

This is an exploratory, open-label, single arm, multicenter phase II trial for the evaluation of efficacy and feasibility (as determined by safety and tolerability) of immunotherapy with nivolumab in combination with lenvatinib for patients with multinodular, advanced stage hepatocellular carcinoma in first line therapy

Key Dates

Start date
Jun 12, 2019
Status verified
May 2023
Primary completion
Oct 27, 2022
Completion
May 2, 2023

Study Design

Enrollment
50 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    * Lenvatinib peroral qd (8 mg for patients with body weight \<60kg and 12 mg for patients with body weight ≥ 60kg) * Nivolumab i.v. q2w (240mg fixed dose IV) max. 36 cycles

Primary Outcome Measure

Objective response rate (ORR) according to RECIST 1.1 [ Time Frame: 6 months ]

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