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Klinische Studien

MK-3475-937

PrüfplancodeISRCTNEudraCTClinicaltrials.govDRKS
2018-004800-20NCT03867084

Doppelblinde, zweiarmige Phase-III-Studie zum Vergleich der Sicherheit und Wirksamkeit von Pembrolizumab (MK-3475) und von Placebo als adjuvanter Therapie bei Patienten mit Leberzellkarzinom und radiologischer Komplettremission nach chirurgischer Resektion oder lokaler Ablation (KEYNOTE-937)

Status: Aktiv

Studienziel / Fragestellung

Primäres Prüfziel

RFS: Zeit von der Randomisierung bis zur ersten Dokumentation eines Rezidivs (lokal, regionär, Fernmetastase) gemäß BICR oder bis zum Tod beliebiger Ursache (sowohl kanzeröse als auch nichtkanzeröse Todesursachen), je nachdem, welches zuerst eintritt

Gesamtüberleben: Zeit von der Randomisierung bis zum Tod beliebiger Ursache

Sekundäre Prüfziele

Unerwünschte Ereignisse (AEs)
- UE-bedingtes Absetzen der Studienintervention

 

Diagnose

Patienten mit radiologischer Komplettremission nach chirurgischer Resektion des Leberzellkarzinoms in Stadium IB, II oder III gemäß American Joint Committee on Cancer (AJCC), 8. Auflage, mit Adaptionen auf der Grundlage der im Pathologiebefund angegebenen Tumormerkmale, und Patienten mit radiologischer Komplettremission nach lokaler Ablation

Patientenmerkmale

Alter

18-120

Einschlusskriterien

A participant will be eligible for inclusion in the study if all of the criteria are satisfied:
1. Has a diagnosis of HCC documented radiologically by AASLD criteria (participants
undergoing ablation without a prior biopsy; see Appendix 12) and/or pathologically
(participants undergoing ablation and not meeting AASLD criteria, and participants
undergoing surgical resection); fibrolamellar, sarcomatoid and mixed
hepatocellular/cholangiocarcinoma subtypes are not eligible and:
A. Has a complete radiological response after surgical resection (R0 resection) and an
intermediate risk (Stage IB), high risk (Stage II, IIIA) or very high risk of recurrence
(subtypes of Stage IIIB as described below) as per American Joint Committee on
Cancer (AJCC) 8th edition with adaptations based on tumor characteristics as
established by the pathology report.
 Intermediate risk of recurrence: solitary tumor ≥2 cm without microvascular
invasion and not histologic grade 3 or 4.
 High risk of recurrence: solitary tumor ≥2 and <10 cm with microvascular
invasion or same size and histologic grade 3 or 4, or multiple tumors, none
>10 cm, regardless of microvascular invasion or histologic grade.
 Very high risk of recurrence: single tumor or multiple tumors of any size with
macrovascular invasion. Stage IIIB tumor(s) with direct invasion of adjacent
organs or with perforation of visceral peritoneum will not be eligible.

will be centrally confirmed prior to enrollment. If there is a discrepancy between local
and central pathology results, results from the central review will be used to
determine eligibility.
OR
B. Has a complete radiological response after local ablation (only radiofrequency or
microwave ablation are allowed) and intermediate, high risk of recurrence or very
high-risk group.
 Intermediate risk of recurrence: Solitary tumor ≥2 cm and ≤3 cm.
 High risk of recurrence: 2-4 tumors, with all ≤3 cm or one solitary tumor >3 cm
and ≤5 cm.
 Very high-risk group: 2-4 tumors with at least one >3 cm and all ≤5 cm.
Note: If AFP determined at Screening is ≥100 ng/mL, the participant in intermediate
risk group will be upstaged to the high risk of recurrence group, regardless of tumor
size or number of tumors present.
Note: Local ablation can be done in 1-2 procedures to treat the initial diagnosis of
HCC. If 2 procedures are performed, randomization needs to occur within 12 weeks
of the date of the first local ablation.
Note: For all participants, measurement of the tumor(s) will be based on the longest
diameter of the lesion(s). Include participants with first recurrence of HCC and prior
resection/ablation at least 2 years from the current diagnosis, after discussion with the
Sponsor.
Note: For all participants, the number of lesions counted towards risk categorization should
meet diagnostic criteria for HCC either by imaging (AASLD) and/or pathology
confirmation.
2. No more than 12 weeks must have elapsed between the date of the staging and the date of
surgical resection or local ablation.
Note: Initial staging CT scan or MRI should be submitted to the iCRO but is not required
prior to enrollment.
Note: For participants referred for treatment, the staging must be completed prior to
resection or local ablation. This staging must be based on radiologic and pathologic
information available. A second scan may be done for staging. If more than one scans
are done the most recent scan meeting protocol requirements should be used.

Studiendesign

  • Phase III
  • Multizentrisch
  • Prospektiv
  • Zweiarmig
  • Doppelblind

Dokumente (passwortgeschützt)

Zuständigkeiten Gesamtstudie

MSD Sharp & Dohme GMBH

Leiter der klinischen Prüfung

Prof. Dr. med Verena Keitel-Anselmino

Prüfzentren

Klinik für Gastroenterologie, Hepatologie und Infektiologie

Durchführendes Studienzentrum

Status

Aktiv

Prüfer (Hauptprüfer im Zentrum)

Prof. Dr. med Verena Keitel-Anselmino

Studienkontakt im Prüfzentrum

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