A Trial of Lenvatinib Plus Pembrolizumab in Participants With Hepatocellular Carcinoma
Completed · Phase 1
Conditions studied: Hepatocellular Carcinoma
In brief
This is an open-label Phase 1b study designed to evaluate the tolerability and safety of lenvatinib in combination with pembrolizumab in participants with hepatocellular carcinoma (HCC). The study will evaluate objective response rate and duration of response by modified Response Evaluation Criteria In Solid Tumors (mRECIST) for HCC and Response Evaluation Criteria In Solid Tumors (RECIST 1.1) based on independent imaging review (IIR).
Key facts
- Study ID
- NCT03006926
- Run by
- Eisai Co., Ltd.
- People needed
- 104
- Starts
- 2017-02-13
- Expected to finish
- 2022-11-22
- Last updated by the study team
- 2023-12-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Confirmed diagnosis of hepatocellular carcinoma (HCC)
- HCC for which no other appropriate therapy is available. Note: Expansion Part: No prior systemic therapy for advanced/unresectable HCC
- Stage B (not applicable for transarterial chemoembolization [TACE]), or stage C based on Barcelona Clinic Liver Cancer (BCLC) staging system
- At least 1 measurable target lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)
- Child-Pugh score A
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1
- Total triiodothyronine (T3) or free T3 and free thyroxine (T4) are within normal limits. (control by thyroid replacement therapy is acceptable.) Participants with T3, free T3 or free T4 abnormalities at screening who are asymptomatic can be eligible
- Adequately controlled blood pressure
- Adequate renal function
- Adequate bone marrow function
- Adequate blood coagulation function
- Adequate liver function
- Males or females age ≥ 18 years at the time of informed consent
- Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol
You may not qualify if…
- Prior treatment with lenvatinib or any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
- Active malignancy (except for HCC or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 36 months
- Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial
- Active infection (any infection requiring systemic treatment). Hepatitis B or C [HBV/HCV] is allowed
- Participants with CNS metastases are not eligible, unless they have completed local therapy (eg, whole brain radiation therapy [WBRT], surgery or radiosurgery) and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (eg, radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment
Where it is running
- California Pacific Medical Center (CPMC) — San Francisco, California, United States
- Ronald Reagan UCLA Medical Center — Santa Monica, California, United States
- Mercy Medical Center — Baltimore, Maryland, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Icahn School of Medicine Mount Sinai — New York, New York, United States
- BRCR Global Texas — Edinburg, Texas, United States
- Hôpital Haut-Levêque Centre médico-chirurgical Magellan — Pessac, Bordeaux, France
- Centre Eugène Marquis de Rennes — Rennes, Brittany Region, France
- CHU Toulouse — Toulouse, Occitanie, France
- Hôpital Timone — Marseille, Provence-Alpes-Côte d'Azur Region, France
- IRCCS Istituto Clinico Humanitas — Milan, Lombardy, Italy
- Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi — Bologna, Province Of Bologna, Italy
- Eisai Trial Site 2 — Kashiwa, Chiba, Japan
- Eisai Trial Site 4 — Kawasaki, Kanagawa, Japan
- Eisai Trial Site 3 — Sayama, Osaka, Japan
- Eisai Trial Site 1 — Chuo-ku, Tokyo, Japan
- Republican Clinical Oncology Dispensary — Ufa, Bashkortostan Republic, Russia
- St. Petersburg City Clinical Oncology Dispansery — Saint Petersburg, Leningradskaya Oblast', Russia
- S.I. Russian Oncological Research Center n.a. N. N. Blokhin RAMS — Moscow, Moscow Oblast, Russia
- Altay Regional Oncology Dispensary — Barnaul, Russia
- Hospital Universitario Marqués de Valdecilla — Santander, Cantabria, Spain
- Hospital General Universitario Gregorio Marañón — Madrid, Madrid, Spain
- Hospital Universitario 12 de Octubre — Madrid, Madrid, Spain
- Hospital Infanta Cristina de Badajoz — Badajoz, Province of Badajoz, Spain
- Hospital Universitario de Salamanca — Salamanca, Province of Salamanca, Spain
Full record on ClinicalTrials.gov
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