EUCTR2020-004490-52-ITActive, not recruitingPhase 1
A Phase 2, Multicenter, Clinical Study to Evaluate the Safety and Efficacy of MK-1308A (Coformulated MK-1308/MK-3475) in Combination withLenvatinib (E7080/MK-7902) in First-line Therapy of Participants with Advanced Hepatocellular Carcinoma -
MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.0 sites110 target enrollmentStarted: June 8, 2021Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 110
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Has an HCC diagnosis confirmed by radiology, histology, or cytology (fibrolamellar and mixed hepatocellular/ cholangiocarcinoma subtypes are not eligible).
- •Radiologic confirmation of diagnosis is provided by the study site and confirmed by BICR. Clinically confirmed diagnosis of HCC as per the AASLD criteria, which requires: Radiographically evident cirrhosis o A liver mass that shows arterial phase hyperenhancement on triphasic CT or MRI, AND EITHER:
- •- > =20 mm with either nonperipheral portal washout or an enhancing capsule
- •- 10-19 mm with nonperipheral portal venous washout AND anenhancing capsule
- •2. Has 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.
- •3. Has a Child-Pugh class A liver score within 7 days prior to first dose of study intervention.
- •4. Has a predicted life expectancy of >3 months.
- •5. Has at least 1 measurable HCC lesion based on RECIST 1.1, confirmed by BICR.
- •6. Has an ECOG PS of 0 to 1 within 7 days prior to first dose of study intervention.
- •7. Is at least 18 years of age at the time of providing documented informed consent.
- •8. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 7 days after receiving the last dose of lenvatinib:
- •- Be abstinent from heterosexual intercourse (abstinent on a long-term and persistent basis) and agree to remain abstinent
- •- Use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause )
- •9. A female participant is eligible to participate if she is not pregnant or breastfeeding, or is not a WOCBP is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, or be abstinent from heterosexual intercourse (abstinent on a long-term and persistent basis) during the intervention period and for at least 120 days after MK-1308A and 30 days after lenvatinib, whichever occurs last after the last dose of study intervention.
- •10. Il partecipante (o un rappresentante legalmente riconosciuto) ha fornito documentato il consenso/assenso informato per lo studio.
- •11. Participants with past or ongoing HCV infection will be eligible. The treated participants must have completed their treatment at least 1 month prior to starting study intervention.
- •12. Participants with controlled hepatitis B will be eligible as long as:
- •- Antiviral therapy for HBV must be given for at least 4 weeks and HBV viral load must be < 500 IU/mL prior to first dose of study drug.
- •Participants on active HBV therapy with viral loads <100 IU/mL should stay on the same therapy throughout study intervention.
- •- Participants positive for antihepatitis B core antibody HBc, negative for HBsAg, and negative or positive for antihepatitis B surface antibody (HBs), with an HBV viral load under 100 IU/mL, do not require HBV antiviral prophylaxis.
- •13. Has adequately controlled BP with or without antihypertensive medications, defined as BP =150/90 mm Hg at Screening and no change in antihypertensive medications within 1 week before Cycle 1 Day 1.
- •14. Has adequate organ function defined in the study protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
Exclusion Criteria
- •1. Has had esophageal or gastric variceal bleeding within the last 6 months. All participants will be screened for esophageal or gastric varices unless such screening has been performed in the past 3 months before first dose of treatment. If varices are present, they should be treated according to institutional standards before starting study intervention; esophageal or gastric varices that require interventional treatment within 28 days prior to first dose of study drug are excluded.
- •2. Has bleeding or thrombotic disorders or use of factor X inhibitors or anticoagulants requiring therapeutic INR monitoring, eg, warfarin or similar agents. Treatment with low molecular weight heparin is permitted.
- •3. Has clinically apparent ascites on physical examination.
- •4. Has inferior vena cava or cardiac involvement of HCC based on imaging, confirmed by BICR.
- •5. Has had clinically diagnosed hepatic encephalopathy in the last 6 months unresponsive to therapy. Participants on rifaximin or lactulose
- •during Screening to control their hepatic encephalopathy are not allowed.
- •6. Has medical contraindications that preclude all forms of contrastenhanced imaging (CT or MRI).
- •7. Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib
- •8. Has a preexisting Grade =3 gastrointestinal or non-gastrointestinal fistula.
- •9. Has clinically significant hemoptysis from any source or tumor bleeding within 2 weeks prior to the first dose of study drug.
- •10. Has clinically significant cardiovascular impairment within 12 months of the first dose of study intervention.
- •11. Has had major surgery to the liver within 4 weeks prior to the first dose of study intervention.
- •12. Has had a minor surgery (ie, simple excision) within 7 days prior to the first dose of study intervention (Cycle 1 Day 1).
- •13. Has serious nonhealing wound, ulcer, or bone fracture.
- •14. Has received any systemic chemotherapy, including anti-VEGF therapy, or any systemic investigational anticancer agents for treatment of HCC.
- •15. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PDL2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX-40, or CD137).
- •16. Has received locoregional therapy to liver (transcatheter chemoembolization, transcatheter embolization, hepatic arterial infusion, radiation, radioembolization, or ablation) within 4 weeks prior to the first dose of study intervention.
- •17. Has received prior radiotherapy to a nonliver region within 2 weeks of start of study intervention.
- •18. Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug.
- •19. Is participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
- •20. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention
- •21. Has a additional malignancy that is progressing or has required active treatment within the past 3 years.
- •22. Has a known history of CNS metastases and/or carcinomatous meningitis as assessed by local site investigator.
- •For more exclusion criteria see the protocol
Investigators
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