IMMULAB - Immunotherapy With Pembrolizumab in Combination With Local Ablation in Hepatocellular C… (NCT03753659) | Clinical Trial Compass
CompletedPhase 2
IMMULAB - Immunotherapy With Pembrolizumab in Combination With Local Ablation in Hepatocellular Carcinoma (HCC)
Germany30 participantsStarted 2019-05-09
Plain-language summary
This is a multicenter, single arm, prospective, open-label phase II trial investigating the clinical activity of peri-interventional treatment with the anti-PD1 antibody pembrolizumab in HCC patients who are candidates for local ablation via either radiofrequency ablation (RFA) or microwave ablation (MWA) or brachytherapy or combination of TACE with RFA, MWA or brachytherapy.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Histologically confirmed diagnosis of HCC
✓. Has a Child-Pugh Classification score ≤ 6 for assessed liver function within 7 days before allocation (Appendix 4: Child-Pugh Score)
✓. Candidate for local ablation (via either RFA or MWA or brachytherapy or combination of TACE with RFA, MWA or brachytherapy \[ablation technique according to Investigator's choice\]), i.e.:
✓. Patients (including high risk patients) with: :
✓. Has received no prior systemic therapy for HCC NOTE: Patients who have received prior local therapy by transarterial chemoembolization (TACE) are not excluded if TACE has been performed \>8 weeks before study allocation.
✓. Have measurable disease based on RECIST 1.1. Lesions situated in a previously treated (e.g. irradiated or subject to TACE) area are considered measurable if vital tumor has been demonstrated by contrast enhanced imaging in such lesions\*.
✓. Male/female participants who are at least 18 years of age on the day of signing informed consent will be enrolled in this study.
✓. A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:
Exclusion criteria
✕. Extrahepatic disease
✕. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
What they're measuring
1
Objective Response Rate (ORR) According to RECIST 1.1
Timeframe: After 6 weeks (2 cycles) of treatment
Trial details
NCT IDNCT03753659
SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
. Presence of tumor thrombus involving main trunk of portal vein
✕. Has at Screening and/or has had any prior history of Grade ≥ 2 hepatic encephalopathy
✕. Has at Screening pericardial effusion, uncontrollable pleural effusion, or clinically significant ascites defined as meeting either of (a) detectable ascites on Screening physical examination OR (b) has at Screening ascites requiring paracentesis
✕. A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
✕. Has received prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-Programmed death-ligand 1 (anti-PD-L1), or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, Cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), OX 40, CD137).
✕. Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks or at least 5 half-lives of the respective drug/IMP (whichever is longer) prior to allocation.