RecruitingPhase 1Phase 2NCT04165070

KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)

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)

Sponsor

Merck Sharp & Dohme LLC

Enrollment

450 participants

Start Date

Dec 19, 2019

Study Type

INTERVENTIONAL

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding new investigational drugs to pembrolizumab (Keytruda) — with or without chemotherapy — can improve outcomes for patients with advanced (stage IV) non-small cell lung cancer (NSCLC) who have not yet received any systemic treatment. Pembrolizumab is an immunotherapy drug that helps the immune system attack cancer cells. This is a substudy within a larger umbrella clinical trial. **You may be eligible if...** - You have confirmed stage IV squamous or non-squamous non-small cell lung cancer - You have not received any prior systemic treatment for your metastatic lung cancer - You do not have an actionable genetic mutation (like EGFR or ALK) that has an approved targeted therapy (for non-squamous patients) - You can provide a tumor tissue sample **You may NOT be eligible if...** - You have already received systemic treatment for your metastatic lung cancer - You have certain driver mutations that qualify for targeted therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPembrolizumab

IV infusion

DRUGCarboplatin

IV infusion

DRUGPaclitaxel

IV infusion

DRUGPemetrexed

IV infusion

BIOLOGICALVibostolimab

IV infusion

BIOLOGICALBoserolimab

IV infusion

BIOLOGICALMK-4830

IV infusion

BIOLOGICALMK-0482

IV Infusion

BIOLOGICALIfinatamab Deruxtecan (I-DXd)

IV infusion

BIOLOGICALHER3-DXd

IV Infusion

Locations(46)

Banner MD Anderson Cancer Center ( Site 0001)

Gilbert, Arizona, United States

City of Hope ( Site 0014)

Duarte, California, United States

UCSF Medical Center at Mission Bay ( Site 0007)

San Francisco, California, United States

Georgetown University ( Site 0036)

Washington D.C., District of Columbia, United States

University of Kentucky Markey Cancer Center ( Site 0019)

Lexington, Kentucky, United States

MedStar Franklin Square Medical Center ( Site 0033)

Baltimore, Maryland, United States

Massachusetts General Hospital ( Site 0003)

Boston, Massachusetts, United States

Dana Farber Cancer Institute ( Site 0002)

Boston, Massachusetts, United States

Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)

Omaha, Nebraska, United States

Dartmouth Hitchcock Medical Center ( Site 0016)

Lebanon, New Hampshire, United States

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037)

Hackensack, New Jersey, United States

Laura and Isaac Perlmutter Cancer Center ( Site 0034)

New York, New York, United States

Sanford Fargo Medical Center ( Site 0039)

Fargo, North Dakota, United States

Cleveland Clinic Main ( Site 0006)

Cleveland, Ohio, United States

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0015)

Columbus, Ohio, United States

Abramson Cancer Center of the University of Pennsylvania ( Site 0010)

Philadelphia, Pennsylvania, United States

Sanford Cancer Center ( Site 0038)

Sioux Falls, South Dakota, United States

The University of Texas MD Anderson Cancer Center ( Site 0009)

Houston, Texas, United States

Petz Aladar Megyei Oktato Korhaz ( Site 0062)

Győr, Győr-Moson-Sopron, Hungary

Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061)

Szolnok, Jász-Nagykun-Szolnok, Hungary

Orszagos Koranyi Pulmonologiai Intezet ( Site 0060)

Budapest, Hungary

Soroka Medical Center ( Site 0072)

Beersheba, Israel

Rambam Health Care Campus-Oncology ( Site 0076)

Haifa, Israel

Shaare Zedek Medical Center ( Site 0075)

Jerusalem, Israel

Meir Medical Center ( Site 0071)

Kfar Saba, Israel

Rabin Medical Center ( Site 0074)

Petah Tikva, Israel

Chaim Sheba Medical Center ( Site 0070)

Ramat Gan, Israel

Sourasky Medical Center ( Site 0077)

Tel Aviv, Israel

Azienda Ospedaliera Universitaria Careggi ( Site 0173)

Florence, Firenze, Italy

IRCCS Ospedale San Raffaele ( Site 0171)

Milan, Italy

Policlinico Gemelli di Roma ( Site 0174)

Roma, Italy

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151)

Warsaw, Masovian Voivodeship, Poland

Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)

Gdansk, Pomeranian Voivodeship, Poland

Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152)

Koszalin, West Pomeranian Voivodeship, Poland

Seoul National University Bundang Hospital ( Site 0081)

Seongnam-si, Kyonggi-do, South Korea

Severance Hospital ( Site 0080)

Seoul, South Korea

Samsung Medical Center ( Site 0082)

Seoul, South Korea

ICO L Hospitalet ( Site 0090)

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario Quiron Madrid ( Site 0091)

Madrid, Spain

Changhua Christian Hospital ( Site 0181)

Changhua, Taiwan

Taipei Medical University Hospital ( Site 0180)

Taipei, Taiwan

Chang Gung Medical Foundation-Linkou Branch ( Site 0182)

Taoyuan, Taiwan

COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0463)

Cherkasy, Cherkasy Oblast, Ukraine

Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Surgery department #2 ( Site 0460)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0461)

Rivne, Rivne Oblast, Ukraine

Uzhhorod Multispecialty City Clinical Hospital ( Site 0462)

Uzhhorod, Zakarpattia Oblast, Ukraine

View Full Details on ClinicalTrials.gov

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NCT04165070