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JOURNAL ONKOLOGIE – STUDIE

MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)

Rekrutierend

NCT-Nummer:
NCT05007106

Studienbeginn:
September 2021

Letztes Update:
24.04.2024

Wirkstoff:
Pembrolizumab/Vibostolimab Co-Formulation, Pembrolizumab, Lenvatinib, 5-Fluorouracil, Cisplatin, Paclitaxel, Gemcitabine, Carboplatin, Docetaxel, Bevacizumab, Capecitabine, Oxaliplatin

Indikation (Clinical Trials):
Carcinoma, Neoplasms, Cholangiocarcinoma, Breast Neoplasms, Esophageal Neoplasms, Uterine Cervical Neoplasms, Squamous Cell Carcinoma of Head and Neck, Endometrial Neoplasms, Triple Negative Breast Neoplasms, Gallbladder Neoplasms, Ovarian Neoplasms, Stomach Neoplasms, Urinary Bladder Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Merck Sharp & Dohme LLC

Collaborator:
-

Studienleiter

Medical Director
Study Director
Merck Sharp & Dohme LLC

Kontakt

Studienlocations
(3 von 72)

Universitaetsklinikum Heidelberg-Nationales Centrum für Tumorerkrankungen ( Site 1180)
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +4962215636051» Ansprechpartner anzeigen
Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, Pne
72076 Tübingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +4970712982795» Ansprechpartner anzeigen
Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 1172)
40225 Düsseldorf
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +492118117820» Ansprechpartner anzeigen
City of Hope Comprehensive Cancer Center ( Site 1001)
91010 Duarte
United StatesAbgeschlossen» Google-Maps
University of California, Irvine (UCI) Health - UC Irvine Me-Chao Family Comprehensive Cancer Cente
92868-3201 Orange
United StatesAbgeschlossen» Google-Maps
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1051)
K7L 2V7 Kingston
CanadaAktiv, nicht rekrutierend» Google-Maps
Princess Margaret Cancer Centre ( Site 1056)
M5G 2M9 Toronto
CanadaAktiv, nicht rekrutierend» Google-Maps
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 1136)
oo168 Roma
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 390630158545» Ansprechpartner anzeigen
Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (
20141 Milano
ItalyAbgeschlossen» Google-Maps
Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Sperimentazioni Cliniche ( Site 1134)
80131 Napoli
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 00393331891929» Ansprechpartner anzeigen
Seoul National University Hospital-Internal Medicine ( Site 1312)
03080 Seoul
Korea, Republic ofAktiv, nicht rekrutierend» Google-Maps
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1311)
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +82-2-2228-8132» Ansprechpartner anzeigen
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1101
02-781 Warszawa
PolandRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +48 22 546 33 81» Ansprechpartner anzeigen
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1104)
75-581 Koszalin
PolandRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 48502204953» Ansprechpartner anzeigen
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1204)
34722 Istanbul
TurkeyRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 90 216 606 52 00» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy

of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer

therapies in participants with selected advanced solid tumors. The primary hypothesis is that

pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of

objective response rate or progression-free survival in participants with cervical cancer.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- One of the following histologically or cytologically confirmed, advanced (unresectable

or metastatic) solid tumors:

- Squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix

- Endometrial cancer

- Head and neck squamous cell carcinoma (HNSCC)

- Unresectable biliary adenocarcinoma (gallbladder or biliary tree [intrahepatic or

extrahepatic] cholangiocarcinoma)

- Adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic

Siewert type 1 adenocarcinoma of the gastroesophageal junction (GEJ).

- Triple-negative breast cancer (TNBC)

- Hepatocellular carcinoma (HCC)

- Urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra

- Ovarian cancer

- Gastric cancer

- Measurable disease per RECIST v1.1 as assessed by BICR or local site investigator.

- Adequately controlled blood pressure (BP) with or without antihypertensive

medications.

- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV

on anti-retroviral therapy (ART).

- Male participants must agree to follow contraceptive guidance.

- Female participants are not pregnant or breastfeeding, not a woman of child-bearing

potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance.

- Adequate organ function.

Exclusion Criteria:

- History of a second malignancy, unless potentially curative treatment has been

completed with no evidence of malignancy for 3 years.

- Prior therapy with anti-programmed cell-death (PD-1), anti-PD-L1, anti-PD-L2, or

anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT) agent.

- Prior systemic anticancer therapy including investigational agents within 4 weeks

before randomization/allocation.

- Received a live or live-attenuated vaccine within 30 days before the first dose of

study intervention. Administration of killed vaccines are allowed.

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

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

medication.

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

- Active infection requiring systemic therapy.

- Concurrent active hepatitis B and hepatitis C virus infection.

- History of allogenic tissue/solid organ transplant.

- Previous treatment with lenvatinib (for participants who will receive lenvatinib in

their assigned treatment arm).

- Has clinically significant cardiovascular disease within 12 months from first dose of

study intervention.

Studien-Rationale

Primary outcome:

1. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR) (Time Frame - Up to approximately 2 years):
ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented.

2. Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR (Time Frame - Up to approximately 2 years):
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, 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.

3. ORR per RECIST 1.1 as Assessed by Investigator in Participants with Selected Solid Tumors (Time Frame - Up to approximately 2 years):
ORR is defined as the percentage of participants who have a CR (Disappearance of all target lesions) or a PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by investigator based on RECIST 1.1 will be presented.

4. PFS per RECIST 1.1 as Assessed by Investigator at 9 months (Time Frame - 9 months):
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, 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.

5. PFS per RECIST 1.1 as Assessed by Investigator at 12 months (Time Frame - 12 months):
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, 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.

Secondary outcome:

1. Overall Survival (OS) (Time Frame - Up to approximately 5.5 years):
OS is defined as the time from randomization to death due to any cause.

2. PFS per RECIST 1.1 as Assessed by Investigator (Time Frame - Up to approximately 2 years):
PFS is defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, 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 investigator will be presented.

3. Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR (Time Frame - Up to approximately 2 years):
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or confirmed 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 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 have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by BICR will be presented.

4. DOR per RECIST 1.1 as Assessed by Investigator (Time Frame - Up to approximately 2 years):
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or confirmed 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 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 have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by investigator will be presented.

5. ORR per RECIST 1.1 as Assessed by Investigator (Time Frame - Up to approximately 2 years):
ORR is defined as the percentage of participants who have a CR (Disappearance of all target lesions) or a PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by investigator based on RECIST 1.1 will be presented.

6. PFS per RECIST 1.1 as Assessed by Investigator in Participants with Cervical Cancer (Time Frame - Up to approximately 2 years):
PFS is defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, 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 investigator will be presented.

7. Change from Baseline in Global Health Status/Quality of Life Score (European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 [EORTC QLQ-C30] Items 29 and 30) (Time Frame - Baseline and up to approximately 2 years):
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.

8. Change from Baseline in Physical Functioning Score (EORTC QLQ-C30 Items 1-5) (Time Frame - Baseline and up to approximately 2 years):
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) score will be presented.

9. Number of Participants Who Experienced One or More Adverse Events (AEs) (Time Frame - Up to approximately 2 years):
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

10. Number of Participants Who Discontinued Study Intervention Due to an AE (Time Frame - Up to approximately 2 years):
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

Studien-Arme

  • Experimental: Pembrolizumab/Vibostolimab Co-Formulation
    Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous (IV) infusion every 3 weeks (Q3W) up to 35 cycles.
  • Experimental: Pembrolizumab
    Participants receive pembrolizumab 200 mg via IV infusion Q3W up to 35 cycles.
  • Experimental: Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Endometrial Cancer Cohort)
    Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion Q3W up to 35 cycles, plus lenvatinib 20 mg once daily (qd) until meeting discontinuation criteria.
  • Experimental: Pembrolizumab/Vibostolimab Co-Formulation + Lenvatinib (Hepatocellular Cancer Cohort)
    Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion Q3W up to 35 cycles, plus lenvatinib 12 mg (body weight [BW] ≥60 kg) or lenvatinib 8 mg (BW <60 kg) qd until meeting discontinuation criteria.
  • Experimental: Pembrolizumab/Vibostolimab + 5-Fluorouracil + Cisplatin
    Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W, plus 5-fluorouracil (5-FU), plus Cisplatin as background therapy.
  • Experimental: Pembrolizumab/Vibostolimab Co-Formulation + Paclitaxel
    Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus paclitaxel as background therapy until meeting discontinuation criteria.
  • Experimental: Pembrolizumab/Vibostolimab Co-Formulation + Gemcitabine/Cisplatin
    Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus gemcitabine (until disease progression or unacceptable toxicity) and cisplatin (up to 8 cycles) as background therapy.
  • Experimental: Pembrolizumab/Vibostolimab Co-Formulation+ Carboplatin/Paclitaxel/Bevacizumab
    Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus carboplatin, paclitaxel, and bevacizumab as background therapy.
  • Experimental: Pembrolizumab/Vibostolimab Co-Formulation + Capecitabine/Oxaliplatin
    Participants receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via IV infusion Q3W up to 35 cycles, plus capecitabine and oxaliplatin as background therapy.

Geprüfte Regime

  • Pembrolizumab/Vibostolimab Co-Formulation (MK-7684A):
    Pembrolizumab 200 mg plus vibostolimab 200 mg administered via IV infusion Q3W
  • Pembrolizumab (MK-3475 / KEYTRUDA® / ):
    Pembrolizumab 200 mg administered via IV infusion Q3W.
  • Lenvatinib (Lenvima / E7080 / MK-7902 / ):
    Lenvatinib 20 mg, 12 mg, or 8 mg (dependent on cancer type and body weight) administered via oral capsule QD
  • 5-Fluorouracil (5-FU / Fluracil / ):
    5-FU 800 mg/m^2/day administered via continuous IV infusion on each of days 1 to 5 Q3W for up to 35 cycles
  • Cisplatin (Platinol / cis Platinum / ):
    Cisplatin administered via IV infusion
  • Paclitaxel (Taxol / Abraxane / Anzatax / ):
    Paclitaxel administered via IV infusion at investigator's choice of dose
  • Gemcitabine:
    Gemcitabine administered via IV infusion on Day 1 and Day 8 of each 3-week cycle, until PD or unacceptable toxicity
  • Carboplatin:
    Carboplatin administered via IV infusion at investigator's choice of dose and frequency
  • Docetaxel:
    For participants who cannot receive paclitaxel due to hypersensitivity or adverse event (AE), docetaxel administered via IV infusion Q3W, Day 1 of each cycle for up to 5 cycles
  • Bevacizumab:
    Bevacizumab (or biosimilars such as MVASI®, Zirabev®, Aybintio®, ALYMSYS®, Abevmy®, Onbevezy®, Vegzelma®) administered via IV infusion Q3W; Day 1 of each 3-week cycle for up to 15 cycles
  • Capecitabine:
    Capecitabine administered via oral tablet twice daily on Days 1 to 14 of each cycle (Q3W) for up to 35 cycles
  • Oxaliplatin:
    Oxaliplatin administered via IV infusion Q3W up to 35 cycles

Quelle: ClinicalTrials.gov


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