Immunotherapy With Nivolumab in Combination With Lenvatinib for Advanced Stage Hepatocellular Carcinoma
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|ClinicalTrials.gov Identifier: NCT03841201|
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced Hepatocellular Carcinoma||Drug: Lenvatinib Drug: Nivolumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open-label, single-arm, multicenter phase II trial|
|Masking:||None (Open Label)|
|Official Title:||IMMUNIB - An Open-label, Single-arm Phase II Study of Immunotherapy With Nivolumab in Combination With Lenvatinib for Advanced Stage Hepatocellular|
|Actual Study Start Date :||June 12, 2019|
|Estimated Primary Completion Date :||February 2022|
|Estimated Study Completion Date :||May 2022|
Other Name: Study treatment
Other Name: Study treatment
- Objective response rate (ORR) according to RECIST 1.1 [ Time Frame: 6 months ]Number and percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) according to RECIST 1.1
- Safety and tolerability (AEs, SAEs according to NCI-CTCAE V 4.03) [ Time Frame: 6 months ]Type, incidence and severity of AEs, SAEs according to NCI-CTCAE V 4.03
- Objective response rate (ORR) according to iRECIST [ Time Frame: 6 months ]Number and percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) according to iRECIST
- Time-to-progression (TTP) [ Time Frame: 6 months ]Time from the date of treatment allocation to the date of first observed disease progression (investigator assessment according to RECIST 1.1).
- Progression free survival (PFS) [ Time Frame: 6 months ]Time from the date of treatment allocation to the date of first observed disease progression (investigator assessment according to RECIST 1.1) or death from any cause.
- Overall survival (OS) [ Time Frame: 6 months ]Time from the date of treatment allocation to the date of death (due to any cause).
- Translational research [ Time Frame: 6 months ]Correlation of biomarkers potentially associated with clinical efficacy (OS, PFS and ORR) from lenvatinib plus nivolumab by molecular quantitation of mRNA expression of parameters like e.g. PD-1, PD-L1 and PD-L2, immune cell infiltrates (IGHM, CD3, CD8, FOXP3, CD68, CD205), chemokines (CXCL9, CXCL10, CXCL13) and invasion markers (MMP7, MMP9).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841201
|Contact: Arndt Vogel, MD||+49 176 1 532 ext firstname.lastname@example.org|
|Contact: Daniel W Mueller, PhD||+49 69 7601 ext email@example.com|
|Hannover Medical School||Recruiting|
|Hannover, Germany, 30625|
|Contact: Arndt Vogel, MD|
|Study Director:||Salah-Eddin Al-Batran, MD||Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest|