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Säkerhet och effekt av samformulerad Pembrolizumab/Quavonlimab (MK-1308A) i kombination med Lenvatinib (E7080/MK-7902) vid avancerad hepatocellulär karcinom (MK-1308A-004)

28 juni 2026 uppdaterad av: Merck Sharp & Dohme LLC

En fas 2, multicenter, klinisk studie för att utvärdera säkerheten och effektiviteten av MK-1308A (samformulerad MK-1308/MK-3475) i kombination med lenvatinib (E7080/MK-7902) i första linjens terapi av deltagare med avancerad karcinom hepatocellulärt

Syftet med denna studie är att utvärdera säkerheten och effekten av samformulerat pembrolizumab/quavonlimab (MK-1308A) plus lenvatinib i en första linjens (1L) hepatocellulärt karcinom (HCC)-miljö. Ingen hypotesprövning kommer att utföras.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

116

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • California
      • Duarte, California, Förenta staterna, 91010
        • City of Hope Comprehensive Cancer Center ( Site 0002)
    • Maryland
      • Baltimore, Maryland, Förenta staterna, 21287
        • Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - GI and Immunology ( Site 0013)
    • New York
      • New York, New York, Förenta staterna, 10029
        • Icahn School of Medicine at Mount Sinai ( Site 0009)
    • Oregon
      • Portland, Oregon, Förenta staterna, 97239
        • Oregon Health and Science University ( Site 0006)
    • South Carolina
      • Charleston, South Carolina, Förenta staterna, 29414
        • Charleston Oncology ( Site 0003)
    • Virginia
      • Roanoke, Virginia, Förenta staterna, 24014
        • Blue Ridge Cancer Care ( Site 0008)
    • Washington
      • Seattle, Washington, Förenta staterna, 98101
        • Virginia Mason Medical Center ( Site 0004)
  • Italien
      • Milan, Italien, 20132
        • Ospedale San Raffaele-Oncologia Medica ( Site 0227)
      • Naples, Italien, 80131
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale-Department of Abdominal Oncology ( Site 0230)
    • Milano
      • Rozzano, Milano, Italien, 20089
        • Humanitas-U.O di Oncologia medica ed Ematologia ( Site 0231)
  • Japan
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital ( Site 0156)
    • Chiba
      • Kashiwa, Chiba, Japan, 2778577
        • National Cancer Center Hospital East ( Site 0153)
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 213-8587
        • Toranomon Hospital Kajigaya ( Site 0154)
    • Osaka
      • Sayama, Osaka, Japan, 589-8511
        • Kindai University Hospital- Osakasayama Campus-Department of Gastroenterology and Hepatology ( Site
  • Kina
    • Anhui
      • Hefei, Anhui, Kina, 230071
        • Anhui Provincial Hospital ( Site 0113)
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100142
        • Beijing Cancer hospital-Department of Hepato-Pancreato-Biliary Surgery II ( Site 0107)
    • Fujian
      • Fuzhou, Fujian, Kina
        • Fuzhou General hospital of Nanjing Military Command-Oncology Department ( Site 0105)
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510515
        • Southern Medical University Nanfang Hospital-Liver Cancer Department ( Site 0106)
    • Hubei
      • Wuhan, Hubei, Kina, 430022
        • Wuhan Union Hospital Cancer Center ( Site 0108)
    • Hunan
      • Changsha, Hunan, Kina, 410013
        • Hunan Cancer Hospital-intervention department ( Site 0109)
    • Shaanxi
      • Xi'an, Shaanxi, Kina, 710061
        • The First Affiliated Hospital of Xian Jiaotong University ward1 depattment of medical oncology ( Sit
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200032
        • Zhongshan Hospital,Fudan University ( Site 0103)
      • Shanghai, Shanghai Municipality, Kina, 200040
        • Huashan Hospital Affiliated Fudan University-Surgery Department ( Site 0118)
  • Polen
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polen, 02-034
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Onkologii i Radioterapii ( Site
    • Podkarpackie Voivodeship
      • Przemyśl, Podkarpackie Voivodeship, Polen, 37-700
        • Wojewódzki Szpital im. Św. Ojca Pio w Przemyślu ( Site 0249)
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Polen, 80-952
        • Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0247)
    • West Pomeranian Voivodeship
      • Koszalin, West Pomeranian Voivodeship, Polen, 75-581
        • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0246)
  • Schweiz
      • Bern, Schweiz, 3010
        • Inselspital Bern-Universitätsklinik für Viszerale Chirurgie und Medizin ( Site 0331)
    • Canton of Geneva
      • Geneva, Canton of Geneva, Schweiz, 1211
        • Hôpitaux Universitaires de Genève (HUG) ( Site 0335)
    • Canton of St. Gallen
      • Sankt Gallen, Canton of St. Gallen, Schweiz, 9007
        • Cantonal Hospital St.Gallen-Klinik für Gastroenterologie / Hepatologie ( Site 0334)
    • Canton of Vaud
      • Lausanne, Canton of Vaud, Schweiz, 1011
        • CHUV (centre hospitalier universitaire vaudois) ( Site 0333)
    • Canton of Zurich
      • Zurich, Canton of Zurich, Schweiz, 8091
        • UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 0332)
  • Spanien
      • Barcelona, Spanien, 08035
        • Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 0310)
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spanien, 33011
        • Hospital Universitario Central de Asturias-Hepatology ( Site 0309)
  • Sydkorea
      • Seoul, Sydkorea, 05505
        • Asan Medical Center ( Site 0289)
    • Kyonggi-do
      • Seongnam, Kyonggi-do, Sydkorea, 13620
        • Seoul National University Bundang Hospital-Medical Oncology ( Site 0290)
      • Seoul, Kyonggi-do, Sydkorea, 06351
        • Samsung Medical Center ( Site 0288)
  • Taiwan
      • Tainan, Taiwan, 704
        • NATIONAL CHENG-KUNG UNI. HOSP.-Clinical Trial Research Team of Liver Diseases ( Site 0354)
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital-Oncology ( Site 0351)
      • Taipei, Taiwan, 112201
        • Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine (

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

14 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Beskrivning

Inklusionskriterier:

  • Har en HCC-diagnos bekräftad av radiologi, histologi eller cytologi (fibrolamellära och blandade hepatocellulära/cholangiocarcinoma subtyper är inte kvalificerade)
  • Har Barcelona Clinic Levercancer (BCLC) Stage C-sjukdom, eller BCLC Stage B-sjukdom som inte är mottaglig för lokoregional terapi eller motståndskraftig mot lokoregional terapi och inte mottaglig för en botande behandlingsmetod
  • Har en Child-Pugh klass A-leverpoäng inom 7 dagar före första dos av studieintervention.
  • Har en förväntad livslängd på >3 månader
  • Har minst 1 mätbar HCC-skada baserat på RECIST 1.1, bekräftad av BICR
  • Har en Eastern Cooperative Oncology Group Performance Score (ECOG PS) på 0 till 1 inom 7 dagar före första dos av studieintervention.
  • Deltagare med kontrollerad hepatit B kommer att vara berättigade så länge de uppfyller följande kriterier: antiviral terapi för hepatit B-virus (HBV) måste ges i minst 4 veckor och HBV-virusmängden måste vara mindre än 500 IE/ml före första dosen av studieläkemedlet
  • Har tillräckligt kontrollerat blodtryck med eller utan blodtryckssänkande mediciner
  • Har tillräcklig organfunktion.

Exklusions kriterier:

  • Har haft esofagus- eller gastrisk variceal blödning under de senaste 6 månaderna.
  • Har blödningar eller trombotiska störningar eller användning av faktor X-hämmare eller antikoagulantia som kräver terapeutisk övervakning av internationell normaliserad ratio (INR), t.ex. warfarin eller liknande medel
  • Har kliniskt uppenbar ascites vid fysisk undersökning
  • Har inferior vena cava eller hjärtinblandning av HCC baserat på bildbehandling
  • Har haft kliniskt diagnostiserad leverencefalopati under de senaste 6 månaderna utan att ha svarat på terapi
  • Har medicinska kontraindikationer som utesluter alla former av kontrastförstärkt bildbehandling (datortomografi [CT] eller magnetisk resonanstomografi [MRT])
  • Har gastrointestinal malabsorption, gastrointestinal anastomos eller något annat tillstånd som kan påverka absorptionen av lenvatinib
  • Har en redan existerande grad ≥3 gastrointestinal eller icke-gastrointestinal fistel
  • Har kliniskt aktiv hemoptys (ljusrött blod på minst 0,5 tesked) inom 3 veckor före den första dosen av studieläkemedlet
  • Har kliniskt signifikant kardiovaskulär funktionsnedsättning inom 12 månader efter den första dosen av studieinterventionen, inklusive New York Heart Association (NYHA) klass III eller IV hjärtsvikt, instabil angina, hjärtinfarkt, cerebral vaskulär olycka eller hjärtarytmi associerad med hemodynamisk instabilitet
  • Har genomgått en större leveroperation inom 4 veckor före den första dosen av studieintervention
  • Har genomgått en mindre operation (d.v.s. enkel excision) inom 7 dagar före den första dosen av studieintervention (cykel 1 dag 1)
  • Har allvarliga icke-läkande sår, sår eller benfraktur
  • Har fått någon systemisk kemoterapi, inklusive antivaskulär endoteltillväxtfaktor (VEGF)-terapi, eller något systemiskt prövningsläkemedel mot cancer för behandling av HCC
  • Har tidigare fått behandling med ett anti-PD-1-, anti-PD-L1- eller anti-PD-L2-medel eller med ett medel riktat mot en annan stimulerande eller samhiberande T-cellsreceptor
  • Har fått lokoregional behandling av levern inom 4 veckor före den första dosen av studieintervention
  • Har tidigare fått strålbehandling till en icke-leverregion inom 2 veckor efter start av studieintervention
  • Har fått ett levande eller levande försvagat vaccin inom 30 dagar före den första dosen av studieläkemedlet
  • Deltar för närvarande i eller har deltagit i en studie av ett prövningsmedel eller har använt en prövningsapparat inom 4 veckor före den första dosen av studieintervention
  • Har diagnosen immunbrist eller får kronisk systemisk steroidbehandling eller någon annan form av immunsuppressiv terapi inom 7 dagar före den första dosen av studieintervention
  • Har en känd ytterligare malignitet som fortskrider eller har krävt aktiv behandling under de senaste 3 åren
  • Har en känd historia av, eller några tecken på, metastaser i centrala nervsystemet (CNS) och/eller karcinomatös meningit enligt bedömning av lokal utredare
  • Har allvarlig överkänslighet (≥Grad 3) mot studieintervention och/eller något av deras hjälpämnen
  • Har en aktiv autoimmun sjukdom som har krävt systemisk behandling under de senaste 2 åren
  • Har en historia av (icke-infektiös) pneumonit/interstitiell lungsjukdom som krävde steroider eller har aktuell pneumonit/interstitiell lungsjukdom
  • Har en aktiv infektion som kräver systemisk behandling, med undantag för HBV eller Hepatit C-virus (HCV)
  • Har en känd historia av infektion med humant immunbristvirus (HIV).
  • Har dubbel aktiv HBV-infektion (HBsAg (+) och/eller detekterbart HBV-DNA) och HCV-infektion (anti-HCV antikropp [Ab] positiv och detekterbar HCV RNA) vid studiestart
  • har en historia eller aktuella bevis för något tillstånd, terapi eller laboratorieavvikelse som kan förvirra studiens resultat, störa deltagarens deltagande under hela studiens varaktighet eller inte är i deltagarens bästa intresse att delta, enligt den behandlande utredarens uppfattning
  • Har en känd psykiatrisk störning eller missbruksstörning som skulle störa deltagarnas förmåga att samarbeta med kraven i studien
  • Har genomgått en allogen vävnad/fast organtransplantation

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Pembrolizumab/Quavonlimab + Lenvatinib
Deltagarna får pembrolizumab/quavonlimab via intravenös (IV) infusion var 6:e ​​vecka (Q6W) i upp till 2 år, plus lenvatinib oralt (baserat på faktisk kroppsvikt vid screening) fram till progressiv sjukdom eller oacceptabel toxicitet i upp till 5 år. I händelse av utsättning av pembrolizumab/quavonlimab på grund av oacceptabla toxicitet, kan återstart av behandling med pembrolizumab övervägas.
Biologisk: Pembrolizumab/Quavonlimab
Pembrolizumab/Quavonlimab (400 mg/25 mg) administrerat via IV infusion Q6W.
Andra namn:
  • MK-1308A
Läkemedel: Lenvatinib
Lenvatinib 12 mg (kroppsvikt [BW] ≥60 kg) eller 8 mg (BW
Andra namn:
  • MK-7902
Biologisk: Pembrolizumab
Pembrolizumab (400 mg) administrerat via IV-infusion Q6W, i händelse av oacceptabel toxicitet mot pembrolizumab/quavonlimab.
Andra namn:
  • MK-3475
  • KEYTRUDA®

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants With a Dose-Limiting Toxicity (DLT) in the Safety Lead-in Phase
Tidsram: 3 weeks
DLTs were defined as follows unless determined to be unrelated to study intervention: any Grade 4 nonhematologic toxicity (not laboratory); any Grade 4 hematologic toxicity lasting >7 days (Grade 4 lymphopenia lasting ≥21 days); Grade 3 platelet count decreased if associated with clinically significant hemorrhage; any Grade 3 nonhematologic toxicity (not laboratory) lasting >3 days despite optimal supportive care; any clinically significant Grade 3 or Grade 4 nonhematologic laboratory abnormality if: medical intervention is required to treat participant, or abnormality leads to hospitalization, or abnormality persists for >1 week (or bilirubin if persists >4 weeks); aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) >10.0 times upper limit of normal (ULN) or >10.0 times baseline if baseline >ULN; any febrile neutropenia Grade 3 or Grade 4; a treatment-related adverse event (AE) causing discontinuation of study intervention during the DLT window; any Grade 5 toxicity.
3 weeks
Number of Participants With ≥1 Adverse Event (AE)
Tidsram: Up to approximately 44 months
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants with an AE was reported.
Up to approximately 44 months
Number of Participants With ≥1 Serious Adverse Event (SAE)
Tidsram: Up to approximately 44 months
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was another important medical event. The number of participants with an SAE was reported.
Up to approximately 44 months
Number of Participants With ≥1 Immune-related AE (irAE)
Tidsram: Up to approximately 44 months
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. AEs associated with pembrolizumab/quavonlimab exposure may represent an immune-related response. A list of irAEs was pre-specified for the compound of pembrolizumab/quavonlimab. The number of participants with an irAE was reported.
Up to approximately 44 months
Number of Participants With ≥1 Hepatic AE
Tidsram: Up to approximately 44 months
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Hepatic events of clinical interest (ECIs) included any of the following events if the event is considered not due to disease progression as judged by the investigator: among participants with Baseline ALT <2 × ULN: ALT ≥5 × ULN; among participants with Baseline ALT ≥2 × ULN: ALT >3 × the Baseline level; ALT >500 U/L regardless of baseline level; total bilirubin >3.0 mg/dL; hepatic decompensation diagnosed clinically (regardless of laboratory values) including new onset clinically detectable ascites requiring intervention for >3 days, hepatic encephalopathy, or gastrointestinal bleeding suggestive of portal hypertension. The number of participants with a hepatic AE was reported.
Up to approximately 44 months
Number of Participants Discontinuing Study Treatment Due to an AE
Tidsram: Up to approximately 40 months
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants that discontinued study treatment due to an AE was reported.
Up to approximately 40 months
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Tidsram: Up to approximately 51 months
ORR was defined as the percentage of participants who achieve a confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters [SOD] of target lesions) per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ, and assessed by BICR. The percentage of participants who experienced CR or PR per RECIST 1.1 as assessed BICR was presented.
Up to approximately 51 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
Tidsram: Up to approximately 51 months
For participants who demonstrated confirmed CR or PR per RECIST 1.1 assessed by BICR, DOR was defined as the time from the first documented evidence of CR (disappearance of all target lesions) or PR (at least a 30% decrease in the SOD of target lesions) until progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD was defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR was presented.
Up to approximately 51 months
Disease Control Rate (DCR) Per RECIST 1.1 as Assessed by BICR
Tidsram: Up to approximately 51 months
DCR was defined as the percentage of participants who have achieved CR (disappearance of all target lesions), PR (at least a 30% decrease in the SOD of target lesions), or stable disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) after ≥6 weeks (the start of the window for the first scheduled scan) per RECIST 1.1 assessed by BICR. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The percentage of participants who achieved CR, PR, or SD after ≥6 weeks per RECIST 1.1 assessed by BICR was presented.
Up to approximately 51 months
Progression Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR
Tidsram: Up to approximately 51 months
PFS was defined as the time from the first dose of study intervention to the first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD. PFS per RECIST 1.1 as assessed by BICR was reported.
Up to approximately 51 months
Time-To-Progression (TTP) Per RECIST 1.1 as Assessed by BICR
Tidsram: Up to approximately 51 months
TTP was defined as the time from the first dose of study intervention to the first documented PD per RECIST 1.1 assessed by BICR. Per RECIST 1.1 adjusted for this study to allow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as at least a 20% increase in the SOD of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. TTP per RECIST 1.1 as assessed by BICR was presented.
Up to approximately 51 months
Overall Survival (OS)
Tidsram: Up to approximately 51 months
OS was defined as the time from the first dose of study intervention to death due to any cause.
Up to approximately 51 months
ORR Per Modified RECIST (mRECIST) as Assessed by BICR
Tidsram: Up to approximately 51 months
ORR was defined as the percentage of participants who achieve a confirmed CR (disappearance of any intratumoral arterial enhancement in all target lesions) or a PR (at least a 30% decrease in the SOD of viable [contrast enhancement in the arterial phase] target lesions, taking as reference the baseline SOD of target lesions) per mRECIST as assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. The percentage of participants who experienced CR or PR per mRECIST as assessed BICR was presented.
Up to approximately 51 months
DOR Per mRECIST as Assessed by BICR
Tidsram: Up to approximately 51 months
For participants who demonstrate confirmed CR or PR per mRECIST assessed by BICR, DOR is defined as the time from the first documented evidence of CR (disappearance of any intratumoral arterial enhancement in all target lesions) or PR (at least a 30% decrease in the SOD of viable [contrast enhancement in the arterial phase] target lesions, taking as reference the baseline SOD of target lesions) until PD or death due to any cause, whichever occurs first. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. The DOR as assessed using mRECIST for all participants who experienced a confirmed CR or PR was presented.
Up to approximately 51 months
DCR Per mRECIST as Assessed by BICR
Tidsram: Up to approximately 51 months
DCR was defined as the percentage of participants who have achieved CR (disappearance of any intratumoral arterial enhancement in all target lesions), PR (at least a 30% decrease in the SOD of viable [contrast enhancement in the arterial phase] target lesions, taking as reference the baseline SOD of target lesions), or SD (any cases that do not qualify for either PR or PD) after ≥6 weeks (the start of the window for the first scheduled scan) per mRECIST assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. The percentage of participants who achieved CR, PR, or SD after ≥6 weeks per mRECIST assessed by BICR was presented.
Up to approximately 51 months
PFS Per mRECIST as Assessed by BICR
Tidsram: Up to approximately 51 months
PFS was defined as the time from the first dose of study intervention to the first documented PD per mRECIST by BICR or death due to any cause, whichever occurs first. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. PFS per mRECIST as assessed by BICR was reported.
Up to approximately 51 months
TTP Per mRECIST as Assessed by BICR
Tidsram: Up to approximately 51 months
TTP was defined as the time from the first dose of study intervention to the first documented PD per mRECIST assessed by BICR. mRECIST for HCC allows evaluation of treatment effects that are not reflected in simple total size changes of lesions. Per mRECIST, PD was defined as an increase of at least 20% in the SODs of viable (enhancing) target lesions, taking as reference the smallest SODs of viable (enhancing) target lesions recorded since the treatment started. TTP per mRECIST as assessed by BICR was presented.
Up to approximately 51 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Merck Sharp & Dohme LLC

Utredare

  • Studierektor: Medical Director, Merck Sharp & Dohme LLC

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

16 mars 2021

Primärt slutförande (Faktisk)

29 juli 2025

Avslutad studie (Faktisk)

29 juli 2025

Studieregistreringsdatum

Först inskickad

2 februari 2021

Först inskickad som uppfyllde QC-kriterierna

2 februari 2021

Första postat (Faktisk)

5 februari 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 1308A-004
  • MK-1308A-004 (Annan identifierare: MSD)
  • jRCT2061210033 (Annan identifierare: jRCT (Japan Registry of Clinical Trials))
  • 2020-004490-52 (EudraCT-nummer)
  • 2023-505698-34-00 (Registeridentifierare: EU CT)
  • U1111-1292-3158 (Registeridentifierare: UTN)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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