JOURNAL ONKOLOGIE – STUDIE
Substudy 1: Efficacy and Safety Study of Pembrolizumab (MK-3475) Plus Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYNOTE-01A)
Rekrutierend
NCT-Nummer:
NCT04165070
Studienbeginn:
Dezember 2019
Letztes Update:
14.01.2021
Wirkstoff:
Pembrolizumab, Carboplatin, Paclitaxel, Pemetrexed, Vibostolimab
Indikation (Clinical Trials):
Carcinoma, Non-Small-Cell Lung
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
Phase 2
Sponsor:
Merck Sharp & Dohme Corp.
Collaborator:
-
Studienleiter
Study Director
Merck Sharp & Dohme Corp.
Kontakt
Kontakt:
Phone: 1-888-577-8839
E-Mail: Trialsites@merck.com» Kontaktdaten anzeigen
Studienlocations (3 von 21)
Banner MD Anderson Cancer Center ( Site 0001)
85234 Gilbert
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 480-256-3425» Ansprechpartner anzeigenCity of Hope ( Site 0014)
91010 Duarte
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 626-218-9200» Ansprechpartner anzeigenUniversity of Kentucky Markey Cancer Center ( Site 0019)
40536-0293 Lexington
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 859-218-0131» Ansprechpartner anzeigen
85234 Gilbert
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 480-256-3425» Ansprechpartner anzeigenCity of Hope ( Site 0014)
91010 Duarte
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 626-218-9200» Ansprechpartner anzeigenUniversity of Kentucky Markey Cancer Center ( Site 0019)
40536-0293 Lexington
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 859-218-0131» Ansprechpartner anzeigen
MedStar Franklin Square Medical Center ( Site 0033)
21237 Baltimore
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 443-777-7364» Ansprechpartner anzeigenMassachusetts General Hospital ( Site 0003)
02114 Boston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 617-724-4000» Ansprechpartner anzeigenDana Farber Cancer Institute ( Site 0002)
02215 Boston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 617-632-4767» Ansprechpartner anzeigenOncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)
68130 Omaha
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 402-691-6971» Ansprechpartner anzeigenDartmouth Hitchcock Medical Center ( Site 0016)
03756 Lebanon
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 603-650-4428» Ansprechpartner anzeigenCleveland Clinic ( Site 0006)
44195 Cleveland
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 216-636-6888» Ansprechpartner anzeigenOhio State University Comprehensive Cancer Center ( Site 0015)
43210 Columbus
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 614-366-0233» Ansprechpartner anzeigenAbramson Cancer Center of the University of Pennsylvania ( Site 0010)
19104 Philadelphia
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 215-220-9703» Ansprechpartner anzeigenThe University of Texas MD Anderson Cancer Center ( Site 0009)
77030 Houston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 713-792-6363» Ansprechpartner anzeigenJasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0061)
5000 Szolnok
HungaryRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +36209323256» Ansprechpartner anzeigenShaare Zedek Medical Center ( Site 0075)
9103102 Jerusalem
IsraelRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +972587040620» Ansprechpartner anzeigenMeir Medical Center ( Site 0071)
4428132 Kfar-Saba
IsraelRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +97297472414» Ansprechpartner anzeigenRabin Medical Center ( Site 0074)
4941492 Petah Tikva
IsraelRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +97239378101» Ansprechpartner anzeigenChaim Sheba Medical Center ( Site 0070)
5262000 Ramat Gan
IsraelRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +97235307096» Ansprechpartner anzeigenSeoul National University Bundang Hospital ( Site 0081)
13620 Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +82215883369» Ansprechpartner anzeigenSeverance Hospital ( Site 0080)
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 82022281004» Ansprechpartner anzeigenICO L Hospitalet ( Site 0090)
08907 Hospitalet de Llobregat
SpainRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +34605431976» Ansprechpartner anzeigenHospital Universitario Quiron Madrid ( Site 0091)
28223 Pozuelo de Alarcon
SpainRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +34914521987» Ansprechpartner anzeigen
Alle anzeigen 21237 Baltimore
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 443-777-7364» Ansprechpartner anzeigenMassachusetts General Hospital ( Site 0003)
02114 Boston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 617-724-4000» Ansprechpartner anzeigenDana Farber Cancer Institute ( Site 0002)
02215 Boston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 617-632-4767» Ansprechpartner anzeigenOncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)
68130 Omaha
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 402-691-6971» Ansprechpartner anzeigenDartmouth Hitchcock Medical Center ( Site 0016)
03756 Lebanon
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 603-650-4428» Ansprechpartner anzeigenCleveland Clinic ( Site 0006)
44195 Cleveland
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 216-636-6888» Ansprechpartner anzeigenOhio State University Comprehensive Cancer Center ( Site 0015)
43210 Columbus
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 614-366-0233» Ansprechpartner anzeigenAbramson Cancer Center of the University of Pennsylvania ( Site 0010)
19104 Philadelphia
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 215-220-9703» Ansprechpartner anzeigenThe University of Texas MD Anderson Cancer Center ( Site 0009)
77030 Houston
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 713-792-6363» Ansprechpartner anzeigenJasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0061)
5000 Szolnok
HungaryRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +36209323256» Ansprechpartner anzeigenShaare Zedek Medical Center ( Site 0075)
9103102 Jerusalem
IsraelRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +972587040620» Ansprechpartner anzeigenMeir Medical Center ( Site 0071)
4428132 Kfar-Saba
IsraelRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +97297472414» Ansprechpartner anzeigenRabin Medical Center ( Site 0074)
4941492 Petah Tikva
IsraelRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +97239378101» Ansprechpartner anzeigenChaim Sheba Medical Center ( Site 0070)
5262000 Ramat Gan
IsraelRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +97235307096» Ansprechpartner anzeigenSeoul National University Bundang Hospital ( Site 0081)
13620 Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +82215883369» Ansprechpartner anzeigenSeverance Hospital ( Site 0080)
03722 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: 82022281004» Ansprechpartner anzeigenICO L Hospitalet ( Site 0090)
08907 Hospitalet de Llobregat
SpainRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +34605431976» Ansprechpartner anzeigenHospital Universitario Quiron Madrid ( Site 0091)
28223 Pozuelo de Alarcon
SpainRekrutierend» Google-Maps
Ansprechpartner:
Study Coordinator
Phone: +34914521987» Ansprechpartner anzeigen
Studien-Informationen
Detailed Description:The Master screening protocol is MK-3475-U01 - NCT04165798
Ein-/Ausschlusskriterien
Inclusion Criteria:- Has histologically- or cytologically-confirmed diagnosis of Stage IV squamous or
nonsquamous NSCLC
- Participants with nonsquamous NSCLC who are not eligible for an approved targeted
therapy
- Is able to provide archival tumor tissue sample or newly obtained core or excisional
biopsy of a tumor lesion not previously irradiated
- Has not received prior systemic treatment for their metastatic NSCLC
- Is able to complete all screening procedures within the 28-day screening window
- Has adequate organ function within 10 days of initiation of study treatment
- Male participants must agree to use contraception and should refrain from donating
sperm during the treatment period and for at least 120 days after the last dose of
pembrolizumab and for at least 180 days after the last dose of chemotherapy
- Female participants must not be pregnant or breastfeeding, and at least one of the
following conditions apply:
1. Not a woman of childbearing potential (WOCBP), OR
2. A WOCBP who agrees to use contraception during the treatment period and for at
least 120 days after the last dose of pembrolizumab and for at least 180 days
after the last dose of chemotherapy
Exclusion Criteria:
- Has a diagnosis of small cell lung cancer
- 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 to the first dose of study treatment
- Has a known additional malignancy that is progressing or has required active treatment
within the past 2 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis
- Has an active autoimmune disease that has required systemic treatment in the past 2
years
- Has a history of (non-infectious) pneumonitis that required steroids or has current
pneumonitis
- Has an active infection requiring systemic therapy
- Has clinically significant cardiac disease, including unstable angina, acute
myocardial infarction within 6 months from Day 1 of study treatment administration, or
New York Heart Association Class III or IV congestive heart failure
- Has a known history of HIV infection
- Has a known history of Hepatitis B or known active Hepatitis C virus infection
- Has had major surgery <3 weeks prior to first dose of study treatment
- Is expected to require any other form of antineoplastic therapy while on study
- Has symptomatic ascites or pleural effusion (if receiving pemetrexed; Alimta®, Eli
Lilly)
- Has a history or current evidence of a gastrointestinal (GI) condition (e.g.
inflammatory bowel disease, Crohn's disease, ulcerative colitis) or impaired liver
function or diseases that in the opinion of the investigator may significantly alter
the absorption or metabolism of oral medications
- Is getting chemotherapy and has clinically active diverticulitis, intra-abdominal
abscess, GI obstruction, or peritoneal carcinomatosis
- Has pre-existing neuropathy that is moderate in intensity
- Has received prior systemic cytotoxic chemotherapy or other targeted or biological
antineoplastic therapy for metastatic disease
- Has received prior therapy with an anti-programmed cell death-1 (PD-1),
anti-programmed cell death-ligand 1 (PD-L1), or anti-PD-L2 agent or prior therapy
targeting other immunoregulatory receptors or mechanisms
- Is currently receiving either strong or moderate inhibitors of cytochrome P450 3A4
(CYP3A4) or cytochrome P450 2C8 (CYP2C8) that cannot be discontinued for the duration
of the study
- Is currently receiving strong or moderate inducers of CYP3A4 or CYP2C8 that cannot be
discontinued for the duration of the study
- Is unable to interrupt aspirin or other non-steroidal anti-inflammatory drugs
(NSAIDs), other than aspirin dose less than or equal to 1.3 gm/day for a 5-day period
(8-day period for long acting agents such as peroxicam), for participants who will
receive pemetrexed
- Is unable or unwilling to take folic acid or vitamin B12 supplementation, for
participants who will receive pemetrexed
- Has a known sensitivity to any component of carboplatin, paclitaxel, pemetrexed or any
of their excipients
- Has received prior radiation therapy to the lung that is >30 Gray (Gy) within 6 months
of the first dose of study treatment
- Has received a live vaccine within 30 days prior to the first dose of study treatment
- Has received any prior immunotherapy and was discontinued from that treatment due to a
severe or worse immune-related adverse event (irAE)
- Is currently 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 treatment
- Previously had a severe hypersensitivity reaction to treatment with monoclonal
antibodies (including pembrolizumab) and/or any of their excipients
- Is pregnant or breastfeeding or expecting to conceive or father children within the
projected duration of the study, starting with the screening visit through 120 days
after the last dose of study treatment
- Has had an allogenic tissue/solid organ transplant
Studien-Rationale
Primary outcome:1. Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (Time Frame - Up to approximately 24 months):
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1.
Secondary outcome:
1. Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (Time Frame - Up to approximately 24 months):
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.
2. Number of Participants Who Experience One or More Adverse Events (AEs) (Time Frame - Up to approximately 27 months):
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
3. Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) (Time Frame - Up to approximately 24 months):
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Studien-Arme
- Experimental: Pembrolizumab + Vibostolimab + Carboplatin + Paclitaxel
On Day 1 of each 3-week cycle, participants with squamous NSCLC receive pembrolizumab 200 mg intravenously (IV) PLUS vibostolimab IV PLUS carboplatin Area Under the Concentration-Time Curve (AUC) 6 IV PLUS paclitaxel 200 mg/m^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS vibostolimab IV in Cycles 5-35 (total treatment duration: up to approximately 2 years). - Experimental: Pembrolizumab + Vibostolimab + Pemetrexed
On Day 1 of each 3-week cycle, participants with nonsquamous NSCLC receive pembrolizumab 200 mg IV PLUS vibostolimab IV PLUS carboplatin AUC 5 IV PLUS pemetrexed 500 mg/m^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS vibostolimab IV PLUS pemetrexed 500 mg/m^2 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).
Geprüfte Regime
- Pembrolizumab (MK-3475 / SCH 900475 / KEYTRUDA® / ):
IV infusion - Carboplatin (PARAPLATIN®):
IV infusion - Paclitaxel (ABRAXANE®):
IV infusion - Pemetrexed (ALIMTA®):
IV infusion - Vibostolimab (MK-7684):
IV infusion
Quelle: ClinicalTrials.gov