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JOURNAL ONKOLOGIE – STUDIE

A Study of Combination Therapies With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer (MK-3475-06A)

Rekrutierend

NCT-Nummer:
NCT05342636

Studienbeginn:
Juli 2022

Letztes Update:
22.04.2024

Wirkstoff:
Pembrolizumab, coformulation favezelimab/pembrolizumab, MK-4830, Lenvatinib, Irinotecan, Paclitaxel

Indikation (Clinical Trials):
Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Merck Sharp & Dohme LLC

Collaborator:
-

Studienleiter

Medical Director
Study Director
Merck Sharp & Dohme LLC

Kontakt

Studienlocations
(3 von 45)

Institut für Klinisch Onkologische Forschung-Klink für Onkologie und Hämatologie ( Site 2801)
60488 Frankfurt
(Hessen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 496976014187» Ansprechpartner anzeigen
Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 2806)
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +493514584794» Ansprechpartner anzeigen
Charité Campus Virchow-Klinikum-Klinik Hämatologie Onkologie Tumorimmunologie ( Site 2804)
13353 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +4930450657306» Ansprechpartner anzeigen
Clínica las Condes ( Site 2403)
7591047 Santiago
ChileAbgeschlossen» Google-Maps
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1200)
20133 Milan
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 390223903835» Ansprechpartner anzeigen
Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (
20141 Milano
ItalyAbgeschlossen» Google-Maps
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1403)
34722 Istanbul
TurkeyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +905063509061» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

The master protocol is MK-3475-U06.

Ein-/Ausschlusskriterien

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of metastatic or locally advanced

unresectable ESCC

- Has experienced investigator documented radiographic or clinical disease progression

on one prior line of standard therapy.

- Has an evaluable baseline tumor sample (newly obtained or archival) for analysis

- Has adequately controlled blood pressure (BP) with or without antihypertensive

medications

- Participants who have adverse events (AEs) due to previous anticancer therapies must

have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who

are adequately treated with hormone replacement or participants who have ≤Grade 2

neuropathy are eligible

Exclusion Criteria:

- Direct invasion into adjacent organs such as the aorta or trachea

- Has experienced weight loss >10% over approximately 2 months prior to first dose of

study therapy

- Has received an investigational agent or has used an investigational device within 4

weeks prior to study intervention administration

- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any

other form of immunosuppressive therapy within 7 days prior to the first dose of study

medication

- Known additional malignancy that is progressing or has required active treatment

within the past 3 years, except basal cell carcinoma of the skin, squamous cell

carcinoma of the skin, or carcinoma in situ that has undergone potentially curative

therapy

- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis

- Active autoimmune disease that has required systemic treatment in past 2 years

- History of human immunodeficiency virus (HIV) infection

- History of Hepatitis B or known active Hepatitis C virus infection

- History of allogenic tissue/solid organ transplant

- Clinically significant cardiovascular disease within 12 months from first dose of

study intervention

- Participants with known gastrointestinal (GI) malabsorption or any other condition

that may affect the absorption of lenvatinib

- Has risk for significant GI bleeding, such as:

- Has had a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days

prior to allocation/randomization

- Has significant bleeding disorders, vasculitis, or has had a significant bleeding

episode from the GI tract within 12 weeks prior to allocation/randomization

Studien-Rationale

Primary outcome:

1. Number of Participants Experiencing a Dose-limiting Toxicity (DLT) During Safety Lead-in Phase (Time Frame - Up to approximately 3 weeks):
A DLT is defined as any drug-related adverse event (AE) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0, observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle.

2. Number of Participants Experiencing an Adverse Event (AE) During Safety Lead-in Phase (Time Frame - Up to approximately 3 Weeks):
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

3. Number of Participants Who Discontinue Study Treatment Due to an AE During Safety Lead-in Phase (Time Frame - Up to approximately 3 weeks):
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

4. Objective Response Rate (ORR) (Time Frame - Up to approximately 119 weeks):
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.

Secondary outcome:

1. Progression-Free Survival (PFS) (Time Frame - Up to approximately 216 weeks):
PFS is defined as the time from allocation to the first documented progressive disease (PD) as assessed by RECIST 1.1 or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.

2. Duration of Response (DOR) (Time Frame - Up to approximately 216 weeks):
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters 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. DOR as assessed by BICR will be presented.

3. Overall Survival (OS) (Time Frame - Up to approximately 216 weeks):
OS is defined as the time from the date of allocation to death from any cause.

4. Number of Participants Experiencing at Least One Adverse Event (AE) During the Efficacy Phase (Time Frame - Up to approximately 216 weeks):
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

5. Number of Participants Who Discontinue Study Treatment Due to An AE During the Efficacy Phase (Time Frame - Up to approximately 104 weeks):
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

Studien-Arme

  • Experimental: Pembrolizumab plus chemotherapy
    Participants will receive pembrolizumab intravenously plus chemotherapy (investigator's choice of irinotecan or paclitaxel) at specified doses on specified days for a total treatment duration of up to approximately 2 years.
  • Experimental: Coformulation Favezelimab/Pembrolizumab plus Chemotherapy
    Participants will receive coformulation of favezelimab/pembrolizumab administered intravenously plus chemotherapy (investigator's choice of irinotecan or paclitaxel) at specified doses on specified days for a total treatment duration of up to approximately 2 years.
  • Experimental: Pembrolizumab plus MK-4830 plus Chemotherapy
    Participants will receive pembrolizumab intravenously plus MK-4830 plus chemotherapy (investigator's choice of irinotecan or paclitaxel) at specified doses on specified days for a total treatment duration of up to approximately 2 years.
  • Experimental: Pembrolizumab plus MK-4830 plus lenvatinib
    Participants will receive pembrolizumab intravenously plus MK-4830 plus lenvatinib orally at specified doses on specified days for a total treatment duration of up to approximately 2 years.

Geprüfte Regime

  • Pembrolizumab (MK-3475 / KEYTRUDA® / ):
    200 mg administered via intravenous (IV) infusion every 3 weeks (Q3W)
  • Coformulation favezelimab/pembrolizumab (MK-4280A):
    800 mg favezelimab + 200 mg pembrolizumab administered via IV infusion on day 1 and then Q3W
  • MK-4830 (anti-immunoglobulin-like transcript 4 (ILT4)):
    800 mg administered via IV infusion Q3W
  • Lenvatinib (MK-7902 / LENVIMA® / ):
    20 mg administered via oral capsules each day
  • Irinotecan:
    180 mg/m^2 administered via IV infusion on day 1 of every 14-day cycle.
  • Paclitaxel:
    80-100 mg/m^2 administered via IV infusion on Days 1, 8 and 15 of every 28 day cycle

Quelle: ClinicalTrials.gov


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