KURZPROTOKOLL MK-3475-224

KURZPROTOKOLL
MK-3475-224
Öffentlicher Titel
Phase II Studie zu Pembrolizumab als Zweitlinienbehandlung bei Patienten mit
Leberzellkarzinom
Wissenschaftl. Titel
A Phase II Study of Pembrolizumab (MK-3475) as Monotherapy in Subjects With
Previously Systemically Treated Advanced Hepatocellular Carcinoma
Kurztitel
MK-3475-224
Studienart
multizentrisch, prospektiv, Therapiestudie, einarmig
Studienphase
Phase II
Erkrankung
GASTRO: Leberzellkarzinom: Zweitlinie oder höher
Einschlusskriterien
-
Has histologically or cytologically confirmed diagnosis of HCC (fibrolamellar and
mixed hepatocellular/cholangiocarcinoma subtypes are not eligible) based on
pathology report.
-
Has Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B
disease not amenable to locoregional therapy or refractory to locoregional therapy,
and not amenable to a curative treatment approach.
-
Has a Child-Pugh Class A liver score within 7 days of first dose of study drug.
-
Has a predicted life expectancy >3 months.
-
Has measurable disease based on Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1 as confirmed by the blinded central imaging vendor.
-
Has a performance status of 0 or 1 using the Eastern Cooperative Oncology Group
(ECOG) Performance Scale within 7 days of first dose of study drug.
-
Has documented objective radiographic progression after stopping treatment with
sorafenib or else intolerance to sorafenib.
-
Participants with chronic infection by Hepatitis C Virus (HCV) who are untreated are
allowed on study. In addition, participants with successful HCV treatment (defined as
sustained virologic response [SVR] 12 or SVR 24) are allowed as long as 4 weeks
have passed between completion of HCV therapy and start of study drug.
-
Is willing to use an adequate method of contraception for the course of the study
through 120 days after the last dose of study drug (male and female participants of
childbearing potential).
-
Demonstrates adequate organ function.
-
s currently participating and receiving study therapy or has participated in a study of
an investigational agent and received study therapy, herbal/complementary oral or IV
medicine, or used an investigational device within 4 weeks of the first dose of study
drug. Participant must also have recovered from associated therapy (i.e., to Grade 1
or baseline) and from adverse events due to any prior therapy.
-
Has received sorafenib within 14 days of first dose of study drug.
-
Has had esophageal or gastric variceal bleeding within the last 6 months.
-
Has clinically apparent ascites on physical examination.
-
Has portal vein invasion at the main portal branch (Vp4), inferior vena cava, or
cardiac involvement of HCC based on imaging.
-
Has had encephalopathy in the last 6 months. Participants on rifaximin or lactulose to
control their encephalopathy are not allowed.
-
Had a solid organ or hematologic transplant.
-
Had prior systemic therapy for HCC other than sorafenib, or intercurrent local therapy
to the liver tumor between sorafenib and study drug.
-
Has active autoimmune disease that has required systemic treatment in past 2 years
(i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive
drugs).
Ausschlusskriterien
© Universitäres Centrum für Tumorerkrankungen (UCT) am Universitätsklinikum Frankfurt
Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.uct-frankfurt.de
Stand: 16.01.2017; Seite 1 von 2
KURZPROTOKOLL
MK-3475-224
-
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any
other form of immunosuppressive therapy within 7 days prior to the first dose of study
drug.
-
Has received locoregional therapy to liver (transcatheter chemoembolization [TACE],
transcatheter embolization [TAE], radiation, radioembolization, or ablation) or major
surgery to liver or other site within 6 weeks prior to the first dose of study drug. Minor
surgery (e.g., simple excision, tooth extraction) must have occurred at least 7 days
prior to the first dose of study drug (Cycle 1, Day 1). Participants must have
recovered adequately (i.e., Grade 1 or baseline) from the toxicity and/or
complications from any intervention prior to starting study drug.
-
Has a diagnosed additional malignancy within 5 years prior to first dose of study
treatment with the exception of curatively treated basal cell carcinoma of the skin,
squamous cell carcinoma of the skin and/or curatively resected in situ cervical and/or
breast cancers.
-
Has radiographically detectable central nervous system (CNS) metastases and/or
carcinomatous meningitis.
-
Has evidence or history of interstitial lung disease or active noninfectious
pneumonitis.
-
Has an active infection requiring systemic therapy.
-
Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the study.
-
Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the trial, starting with the screening visit through 120 days after
the last dose of trial treatment.
-
Has received prior immunotherapy including anti-programmed death-1 (anti-PD-1),
anti-PD-ligand-1 (anti-PD-L1), or anti-PD-L2 agents, or if the participant has
previously participated in Merck pembrolizumab (MK-3475) clinical stduies.
-
Has a known history of human immunodeficiency virus (HIV)
-
Has untreated active Hepatitis B (HBV).
-
Has dual infection with HBV/HCV or other hepatitis combinations at study entry.
-
Has received a live vaccine within 30 days of planned start of study drug (Cycle 1,
Day 1).
Alter
18 Jahre und älter
Status
Aktiv
Beginn der Rekrutierung
01.08.2016
Fallzahl
100
Prüfzentren
Universitätsklinikum Frankfurt
Medizinische Klinik I, Gastroenterologie/Hepatologie
Theodor-Stern-Kai 7
60590 Frankfurt am Main
Dr. Silke Flebbe
Tel: 069 87699
[email protected]
Sponsoren
MSD SHARP & DOHME GMBH (Hauptsponsor)
Registrierung in anderen
Studienregistern
ClinicalTrials 02702414
EUDRACT 2015-004566-28
© Universitäres Centrum für Tumorerkrankungen (UCT) am Universitätsklinikum Frankfurt
Ohne Gewähr für Richtigkeit oder Vollständigkeit, www.uct-frankfurt.de
Stand: 16.01.2017; Seite 2 von 2