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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)

NCT04165070 · Merck Sharp & Dohme LLC
In plain English

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Official title
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)
About this study
The master screening protocol is MK-3475-U01 (KEYMAKER-U01) - NCT04165798
Eligibility criteria
Inclusion Criteria: 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 Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * 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 before 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 (noninfectious) 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 human immunodeficiency virus (HIV) infection. Well-controlled HIV with anti-retroviral therapy (ART) is not excluded * Has a known history of Hepatitis B (HPV) or known active Hepatitis C virus infection. Hepatitis B surface antigen (HBsAg) positive is eligible if on HBV antiviral therapy for at least 4 weeks and HBV viral load is undetectable prior to randomization * Has had major surgery \<3 weeks before the first dose of study treatment * Is expected to require any other form of antineoplastic therapy while on study * 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 preexisting neuropathy that is moderate in intensity * Has received prior systemic cytotoxic chemotherapy or other targeted or biological antineoplastic therapy for metastatic disease * 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 before the first dose of study treatment. Any licensed COVID-19 vaccine (including for Emergency Use) in a particular country is allowed as long as they are messenger ribonucleic acid (mRNA) vaccines, adenoviral vaccines, or inactivated vaccines. Investigational vaccines (ie, those not licensed or approved for Emergency Use) are not allowed * Has received any prior immunotherapy and was discontinued from that treatment due to a severe or worse immune-related adverse event (irAE) * Has had chemotherapy or biological cancer therapy within 4 weeks before the first dose of study treatment or has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from the AEs due to cancer therapeutics administered more than 4 weeks before the first dose of study treatment (including participants who had previous immunomodulatory therapy with residual irAEs) * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before 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 * Has had an allogenic tissue/solid organ transplant
Study design
Enrollment target: 450 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2019-12-19
Estimated completion: 2032-02-13
Last updated: 2026-03-16
Interventions
Biological: PembrolizumabDrug: CarboplatinDrug: PaclitaxelDrug: PemetrexedBiological: VibostolimabBiological: BoserolimabBiological: MK-4830Biological: MK-0482Biological: Ifinatamab Deruxtecan (I-DXd)Biological: HER3-DXd
Primary outcomes
  • Part A: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) (Up to approximately 24 months)
  • Part B: Number of Participants Who Experience One or More Adverse Events (AEs) (Up to approximately 27 months)
  • Part B: Number of Participants Who Discontinue Study Intervention Due to an Adverse Event (AE) (Up to approximately 24 months)
Sponsor
Merck Sharp & Dohme LLC · industry
With: Daiichi Sankyo
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (46)
Banner MD Anderson Cancer Center ( Site 0001)Completed
Gilbert, Arizona, United States
City of Hope ( Site 0014)Completed
Duarte, California, United States
UCSF Medical Center at Mission Bay ( Site 0007)Completed
San Francisco, California, United States
Georgetown University ( Site 0036)Completed
Washington D.C., District of Columbia, United States
University of Kentucky Markey Cancer Center ( Site 0019)Completed
Lexington, Kentucky, United States
MedStar Franklin Square Medical Center ( Site 0033)Completed
Baltimore, Maryland, United States
Massachusetts General Hospital ( Site 0003)Completed
Boston, Massachusetts, United States
Dana Farber Cancer Institute ( Site 0002)Completed
Boston, Massachusetts, United States
Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)Completed
Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center ( Site 0016)Recruiting
Lebanon, New Hampshire, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037)Completed
Hackensack, New Jersey, United States
Laura and Isaac Perlmutter Cancer Center ( Site 0034)Completed
New York, New York, United States
Sanford Fargo Medical Center ( Site 0039)Recruiting
Fargo, North Dakota, United States
Cleveland Clinic Main ( Site 0006)Completed
Cleveland, Ohio, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0015)Recruiting
Columbus, Ohio, United States
Abramson Cancer Center of the University of Pennsylvania ( Site 0010)Recruiting
Philadelphia, Pennsylvania, United States
Sanford Cancer Center ( Site 0038)Recruiting
Sioux Falls, South Dakota, United States
The University of Texas MD Anderson Cancer Center ( Site 0009)Recruiting
Houston, Texas, United States
Petz Aladar Megyei Oktato Korhaz ( Site 0062)Completed
Győr, Győr-Moson-Sopron, Hungary
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061)Completed
Szolnok, Jász-Nagykun-Szolnok, Hungary
Orszagos Koranyi Pulmonologiai Intezet ( Site 0060)Completed
Budapest, Hungary
Soroka Medical Center ( Site 0072)Completed
Beersheba, Israel
Rambam Health Care Campus-Oncology ( Site 0076)Completed
Haifa, Israel
Shaare Zedek Medical Center ( Site 0075)Recruiting
Jerusalem, Israel
Meir Medical Center ( Site 0071)Completed
Kfar Saba, Israel
Rabin Medical Center ( Site 0074)Completed
Petah Tikva, Israel
Chaim Sheba Medical Center ( Site 0070)Recruiting
Ramat Gan, Israel
Sourasky Medical Center ( Site 0077)Completed
Tel Aviv, Israel
Azienda Ospedaliera Universitaria Careggi ( Site 0173)Completed
Florence, Firenze, Italy
IRCCS Ospedale San Raffaele ( Site 0171)Completed
Milan, Italy
Policlinico Gemelli di Roma ( Site 0174)Completed
Roma, Italy
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151)Completed
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)Completed
Gdansk, Pomeranian Voivodeship, Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152)Completed
Koszalin, West Pomeranian Voivodeship, Poland
Seoul National University Bundang Hospital ( Site 0081)Completed
Seongnam-si, Kyonggi-do, South Korea
Severance Hospital ( Site 0080)Completed
Seoul, South Korea
Samsung Medical Center ( Site 0082)Completed
Seoul, South Korea
ICO L Hospitalet ( Site 0090)Completed
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Quiron Madrid ( Site 0091)Completed
Madrid, Spain
Changhua Christian Hospital ( Site 0181)Recruiting
Changhua, Taiwan
Taipei Medical University Hospital ( Site 0180)Recruiting
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 0182)Recruiting
Taoyuan District, Taiwan
COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0463)Recruiting
Cherkasy, Cherkasy Oblast, Ukraine
Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Surgery department #2 ( Site 0460)Recruiting
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0461)Recruiting
Rivne, Rivne Oblast, Ukraine
Uzhhorod Multispecialty City Clinical Hospital ( Site 0462)Recruiting
Uzhhorod, Zakarpattia Oblast, Ukraine
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) · TrialPath