KEYMAKER-U01 Substudy 01A: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents With Pembrolizumab With or Without Chemotherapy in Treatment-Naive Participants With Stage IV Non-small Cell Lung Cancer (NSCLC)
Who is this study for? Treatment-naïve participants with advanced squamous or non-squamous NSCLC
Status: Recruiting
Location: See all (39) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) with or without chemotherapy in combination with vibostolimab (MK-7684), boserolimab (MK-5890), MK-4830, MK-0482, I-DXd, or HER3-DXd in treatment-naïve participants with advanced squamous or non-squamous NSCLC. This study is one of the pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ The main inclusion criteria include but are not limited to the following:
• 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 collected either within 5 years or within the interval from completion of last treatment but before entering the screening period or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated obtained within 90 days of treatment initiation
• Has not received prior systemic treatment for their metastatic NSCLC
• Is able to complete all screening procedures within the 35-day screening window for Part A and 28-day screening window for Part B
Locations
United States
Arizona
Banner MD Anderson Cancer Center ( Site 0001)
RECRUITING
Gilbert
California
City of Hope ( Site 0014)
COMPLETED
Duarte
UCSF Medical Center at Mission Bay ( Site 0007)
COMPLETED
San Francisco
Washington, D.c.
Georgetown University ( Site 0036)
COMPLETED
Washington D.c.
Kentucky
University of Kentucky Markey Cancer Center ( Site 0019)
RECRUITING
Lexington
Massachusetts
Dana Farber Cancer Institute ( Site 0002)
RECRUITING
Boston
Massachusetts General Hospital ( Site 0003)
RECRUITING
Boston
Maryland
MedStar Franklin Square Medical Center ( Site 0033)
COMPLETED
Baltimore
North Dakota
Sanford Fargo Medical Center ( Site 0039)
RECRUITING
Fargo
Nebraska
Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)
COMPLETED
Omaha
New Hampshire
Dartmouth Hitchcock Medical Center ( Site 0016)
RECRUITING
Lebanon
New Jersey
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037)
COMPLETED
Hackensack
New York
Laura and Isaac Perlmutter Cancer Center ( Site 0034)
ACTIVE_NOT_RECRUITING
New York
Ohio
Cleveland Clinic Main ( Site 0006)
COMPLETED
Cleveland
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0015)
RECRUITING
Columbus
Pennsylvania
Abramson Cancer Center of the University of Pennsylvania ( Site 0010)
RECRUITING
Philadelphia
South Dakota
Sanford Cancer Center ( Site 0038)
RECRUITING
Sioux Falls
Texas
The University of Texas MD Anderson Cancer Center ( Site 0009)
RECRUITING
Houston
Other Locations
Hungary
Orszagos Koranyi Pulmonologiai Intezet ( Site 0060)
RECRUITING
Budapest
Petz Aladar Megyei Oktato Korhaz ( Site 0062)
RECRUITING
Győr
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061)
RECRUITING
Szolnok
Israel
Soroka Medical Center ( Site 0072)
COMPLETED
Beersheba
Rambam Health Care Campus-Oncology ( Site 0076)
RECRUITING
Haifa
Shaare Zedek Medical Center ( Site 0075)
RECRUITING
Jerusalem
Meir Medical Center ( Site 0071)
RECRUITING
Kfar Saba
Rabin Medical Center ( Site 0074)
RECRUITING
Petah Tikva
Chaim Sheba Medical Center ( Site 0070)
RECRUITING
Ramat Gan
Sourasky Medical Center ( Site 0077)
RECRUITING
Tel Aviv
Italy
Azienda Ospedaliera Universitaria Careggi ( Site 0173)
COMPLETED
Florence
IRCCS Ospedale San Raffaele ( Site 0171)
COMPLETED
Milan
Policlinico Gemelli di Roma ( Site 0174)
ACTIVE_NOT_RECRUITING
Roma
Poland
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)
RECRUITING
Gdansk
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152)
ACTIVE_NOT_RECRUITING
Koszalin
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151)
ACTIVE_NOT_RECRUITING
Warsaw
Republic of Korea
Seoul National University Bundang Hospital ( Site 0081)
ACTIVE_NOT_RECRUITING
Seongnam-si
Samsung Medical Center ( Site 0082)
ACTIVE_NOT_RECRUITING
Seoul
Severance Hospital ( Site 0080)
ACTIVE_NOT_RECRUITING
Seoul
Spain
ICO L Hospitalet ( Site 0090)
RECRUITING
L'hospitalet De Llobregat
Hospital Universitario Quiron Madrid ( Site 0091)
RECRUITING
Madrid
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2019-12-19
Estimated Completion Date: 2032-02-13
Participants
Target number of participants: 450
Treatments
Experimental: Part A: 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: Part A: Pembrolizumab+Vibostolimab+Carboplatin + 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).
Experimental: Part A: Pembrolizumab+Boserolimab+Carboplatin+Paclitaxel
On Day 1 of each 3-week cycle, participants with squamous NSCLC receive pembrolizumab 200 mg IV PLUS carboplatin AUC 6 IV PLUS paclitaxel 200 mg/m\^2 IV PLUS boserolimab IV on Day 1 every 6 weeks (every other 3-week cycle) (Q6W) in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV Q3W PLUS boserolimab IV Q6W from Cycles 5 up to Cycle 35 (total treatment duration: up to approximately 2 years).
Experimental: Part A: Pembrolizumab+Boserolimab+Carboplatin+Pemetrexed
On Day 1 of each 3-week cycle, participants with nonsquamous NSCLC receive pembrolizumab 200 mg IV PLUS carboplatin AUC 5 IV PLUS pemetrexed 500 mg/m\^2 IV PLUS boserolimab IV on Day 1 every 6 weeks (every other 3-week cycle) (Q6W) in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV Q3W PLUS pemetrexed 500 mg/m\^2 IV Q3W PLUS boserolimab IV Q6W from Cycles 5 up to Cycle 35 (total treatment duration: up to approximately 2 years).
Experimental: Part A: Pembrolizumab+MK-4830+Carboplatin+Paclitaxel
On Day 1 of each 3-week cycle, participants with squamous NSCLC receive pembrolizumab 200 mg IV PLUS MK-4830 IV PLUS carboplatin AUC 6 IV PLUS paclitaxel 200 mg/m\^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS MK-4830 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).
Experimental: Part A: Pembrolizumab+MK-4830+Carboplatin+Pemetrexed
On Day 1 of each 3-week cycle, participants with nonsquamous NSCLC receive pembrolizumab 200 mg IV PLUS MK-4830 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 MK-4830 IV PLUS pemetrexed 500 mg/m\^2 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).
Experimental: Part A: Pembrolizumab+MK-0482+Carboplatin+Paclitaxel
On Day 1 of each 3-week cycle, participants with squamous NSCLC receive pembrolizumab 200 mg IV PLUS MK-0482 IV PLUS carboplatin AUC 6 IV PLUS paclitaxel 200 mg/m\^2 IV in Cycles 1-4, followed by maintenance treatment of pembrolizumab 200 mg IV PLUS MK-0482 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).
Experimental: Part A: Pembrolizumab+MK-0482+Carboplatin+Pemetrexed
On Day 1 of each 3-week cycle, participants with nonsquamous NSCLC receive pembrolizumab 200 mg IV PLUS MK-0482 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 MK-0482 IV PLUS pemetrexed 500 mg/m\^2 IV in Cycles 5-35 (total treatment duration: up to approximately 2 years).
Experimental: Part B: Pembrolizumab + I-DXd
On Day 1 of each 3-week cycle, participants with squamous and nonsquamous NSCLC will receive pembrolizumab 200 mg IV for up to 2 years, PLUS I-DXd in escalating doses until progressive disease or toxicity.
Experimental: Part B: Pembrolizumab + Carboplatin + I-DXd
On Day 1 of each 3-week cycle, participants will receive pembrolizumab 200 mg IV for up to 2 years, PLUS carboplatin AUC 5-6 up to 4 cycles PLUS I-DXd IV in escalating doses until PD or toxicity.
Experimental: Part B: Pembrolizumab + Carboplatin + HER3-DXd
On Day 1 of each 3-week cycle, participants will receive pembrolizumab 200 mg IV for up to 2 years, PLUS carboplatin AUC 5-6 up to 4 cycles PLUS HER3-DXd IV in escalating doses until PD or toxicity.
Related Therapeutic Areas
Sponsors
Collaborators: Daiichi Sankyo
Leads: Merck Sharp & Dohme LLC