Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01)

KEYMAKER-U01 Substudy 01E: A Phase 2 Umbrella Study With Rolling Arms of Investigational Agents With or Without Chemotherapy in Combination With Pembrolizumab in Treatment of Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)

The main goals are after treatment given before surgery, to measure the number of people who have no signs of cancer cells in tumors and lymph nodes removed during surgery; and to learn about whether the cancer gets smaller or goes away by measuring the number of people with a certain number of living cancer cells in the tumor removed during surgery.

Study Overview

• Status: Recruiting
• Conditions: Lung Neoplasm Malignant
• Intervention / Treatment: Biological: Pembrolizumab (neoadjuvant); Drug: Cisplatin; Drug: Gemcitabine; Drug: Pemetrexed; Drug: Carboplatin; Biological: Pembrolizumab (adjuvant); Drug: Paclitaxel; Drug: Sacituzumab tirumotecan; Drug: H2 receptor antagonist; Drug: Acetaminophen (or equivalent); Drug: Dexamethasone (or equivalent); Drug: Steroid mouthwash (dexamethasone or equivalent); Drug: H1 receptor antagonist

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Toll Free Number; Phone Number: 1-888-577-8839; Email: Trialsites@msd.com

Study Locations

• Chile
  • Region M. de Santiago
    • Santiago, Region M. de Santiago, Chile, 7500653
      • Recruiting
      • Centro de Estudios Clínicos SAGA ( Site 0162)
      • Contact: Study Coordinator; Phone Number: +56991612199
    • Santiago, Region M. de Santiago, Chile, 7500921
      • Recruiting
      • FALP ( Site 0161)
      • Contact: Study Coordinator; Phone Number: +56224205098
    • Santiago, Region M. de Santiago, Chile, 8420383
      • Recruiting
      • Bradfordhill ( Site 0160)
      • Contact: Study Coordinator; Phone Number: +56229490970
• Greece
  • Attica
    • Athens, Attica, Greece, 185 47
      • Recruiting
      • Metropolitan Hospital-4th Oncology Dept ( Site 0201)
      • Contact: Study Coordinator; Phone Number: 0030 2104807106
    • Athens, Attica, Greece, 115 28
      • Recruiting
      • Alexandra General Hospital of Athens Oncology-Hematology Unit ( Site 0203)
      • Contact: Study Coordinator; Phone Number: 0030 2132142545
    • Athens, Attica, Greece, 12462
      • Recruiting
      • ATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 0202)
      • Contact: Study Coordinator; Phone Number: 0030 2313301848
  • Irakleio
    • Heraklion, Irakleio, Greece, 71110
      • Recruiting
      • University General Hospital of Heraklion ( Site 0200)
      • Contact: Study Coordinator; Phone Number: 0030 2810392091
• Hungary
  • Budapest, Hungary, 1121
    • Recruiting
    • Országos Korányi Pulmonológiai Intézet ( Site 0060)
    • Contact: Study Coordinator; Phone Number: +3613913200
  • Győr-Moson-Sopron
    • Győr, Győr-Moson-Sopron, Hungary, 9024
      • Recruiting
      • Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 0062)
      • Contact: Study Coordinator; Phone Number: +3696507900
  • Jász-Nagykun-Szolnok
    • Szolnok, Jász-Nagykun-Szolnok, Hungary, 5000
      • Recruiting
      • Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 0061)
      • Contact: Study Coordinator; Phone Number: +3656503603
• Italy
  • Milan, Italy, 20132
    • Recruiting
    • Ospedale San Raffaele. ( Site 0171)
    • Contact: Study Coordinator; Phone Number: 390223903829
  • Milan, Italy, 20133
    • Recruiting
    • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)
    • Contact: Study Coordinator; Phone Number: 390223902190
  • Roma, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174)
    • Contact: Study Coordinator; Phone Number: +390630154844
  • Tuscany
    • Florence, Tuscany, Italy, 50134
      • Recruiting
      • Azienda Ospedaliera Universitaria Careggi ( Site 0173)
      • Contact: Study Coordinator; Phone Number: +393209225506
• Poland
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 60-569
      • Recruiting
      • Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 0153)
      • Contact: Study Coordinator; Phone Number: +48616654242
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-781
      • Recruiting
      • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151)
      • Contact: Study Coordinator; Phone Number: 48225463066
  • Pomeranian Voivodeship
    • Gdansk, Pomeranian Voivodeship, Poland, 80-952
      • Recruiting
      • Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)
      • Contact: Study Coordinator; Phone Number: +48 58 584 44 66
• Spain
  • Barcelona, Spain, 08008
    • Recruiting
    • Hospital Clinic de Barcelona ( Site 0092)
    • Contact: Study Coordinator; Phone Number: 34 932275402
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01250
    • Recruiting
    • Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 0702)
    • Contact: Study Coordinator; Phone Number: 903223272727
  • Ankara, Turkey (Türkiye), 06230
    • Recruiting
    • Hacettepe Universite Hastaneleri-oncology hospital ( Site 0700)
    • Contact: Study Coordinator; Phone Number: +903123052941
  • Izmir, Turkey (Türkiye), 35110
    • Recruiting
    • İzmir Suat Seren Chest Disease Training & Research Hospital ( Site 0701)
    • Contact: Study Coordinator; Phone Number: 902324587262
  • Samsun, Turkey (Türkiye), 55139
    • Recruiting
    • Ondokuz Mayıs Universitesi-Oncology department ( Site 0706)
    • Contact: Study Coordinator; Phone Number: 903624576041
• Ukraine
  • Kyiv, Ukraine, 03126
    • Recruiting
    • Shalimov Institute of Surgery and Transplantation ( Site 0138)
    • Contact: Study Coordinator; Phone Number: 093 33 33 911
  • Cherkasy Oblast
    • Cherkasy, Cherkasy Oblast, Ukraine, 18009
      • Recruiting
      • CNE CC of Oncology Hematol ( Site 0130)
      • Contact: Study Coordinator; Phone Number: +38(0472)31-94-18
  • Chernivetska Oblast
    • Chernivtsi, Chernivetska Oblast, Ukraine, 58013
      • Recruiting
      • Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 0139)
      • Contact: Study Coordinator; Phone Number: +380955077568
  • Ivano-Frankivsk Oblast
    • Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76018
      • Recruiting
      • CNCE Precarpathian Clinical Oncologic Center ( Site 0131)
      • Contact: Study Coordinator; Phone Number: +380978411455
  • Lviv Oblast
    • Lviv, Lviv Oblast, Ukraine, 79059
      • Recruiting
      • MNPE LTMU Multidisc. Clin. Hosp. of Emerg. and Intens. Care ( Site 0132)
      • Contact: Study Coordinator; Phone Number: 380977453295
  • Rivne Oblast
    • Rivne, Rivne Oblast, Ukraine, 33010
      • Recruiting
      • ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0460)
      • Contact: Study Coordinator; Phone Number: 380503802915
  • Vinnytsia Oblast
    • Vinnytsia, Vinnytsia Oblast, Ukraine, 21029
      • Recruiting
      • Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 0135)
      • Contact: Study Coordinator; Phone Number: 0988936318
• United States
  • Alabama
    • Daphne, Alabama, United States, 36526
      • Recruiting
      • Southern Cancer Center (SCC) ( Site 8004)
      • Contact: Study Coordinator; Phone Number: 251-607-5281
  • California
    • Santa Barbara, California, United States, 93105
      • Recruiting
      • Sansum Clinic (Ridley Tree) ( Site 8012)
      • Contact: Study Coordinator; Phone Number: 805-879-0643
  • Colorado
    • Lone Tree, Colorado, United States, 80124
      • Recruiting
      • Rocky Mountain Cancer Centers (RMCC) ( Site 8011)
      • Contact: Study Coordinator; Phone Number: 303-285-5051
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Recruiting
      • MedStar Franklin Square Medical Center ( Site 0033)
      • Contact: Study Coordinator; Phone Number: 443-777-7147
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Recruiting
      • Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8006)
      • Contact: Study Coordinator; Phone Number: 541-683-5001
  • Texas
    • Austin, Texas, United States, 78705
      • Recruiting
      • Texas Oncology - Central/South Texas ( Site 8009)
      • Contact: Study Coordinator; Phone Number: 254-399-0741
    • Tyler, Texas, United States, 75702
      • Recruiting
      • Texas Oncology - Northeast Texas ( Site 8005)
      • Contact: Study Coordinator; Phone Number: 903-579-9800
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • Virginia Cancer Specialists (VCS) ( Site 8002)
      • Contact: Study Coordinator; Phone Number: 215-706-2034

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

• Has previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC)
• Able to undergo protocol therapy, including necessary surgery
• Confirmation that epidermal growth factor receptor (EGFR) -directed therapy is not indicated as primary therapy
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 as assessed within 10 days before initiation of study intervention.
• Is able to provide archival or newly obtained core/excisional biopsy of the primary lung tumor or lymph node metastasis.

Exclusion Criteria:

• Has one of the following tumor locations/types: NSCLC involving the superior sulcus, large-cell neuro-endocrine cancer, mixed tumors containing small cell and non-small cell elements, or sarcomatoid tumor.
• Has Grade ≥2 peripheral neuropathy.
• Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
• Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
• Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
• Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
• Received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids.
• 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 intervention.
• Known additional malignancy that is progressing or has required active treatment within the past 5 years.
• Severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
• Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid) is allowed.
• History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
• Active infection requiring systemic therapy.
• Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or Hepatitis C virus (defined as detectable hepatitis C virus (HCV) ribonucleic acid (RNA) [qualitative]) infection.
• Known history of human immunodeficiency virus (HIV) infection.
• History of allogeneic tissue/solid organ transplant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pembrolizumab + Sacituzumab tirumotecan; Neoadjuvant: Prior to surgery pembrolizumab 200 mg Q3W for 4 cycles (each cycle is 21 days); sacituzumab tirumotecan 4 mg/kg Q2W for 6 cycles (each cycle is 14 days), followed by surgery. Adjuvant: After surgery pembrolizumab 200 mg Q3W for 13 cycles (each cycle is 21 days). Optional adjuvant platinum-based doublet chemotherapy up to 4 cycles may be given at the investigator's discretion.	Biological: Pembrolizumab (neoadjuvant); Before surgery neoadjuvant Pembrolizumab 200 mg by intravenous (IV) infusion on day 1 of each 21-day cycle for 4 cycles; Other Names: MK-3475; KEYTRUDA®; Drug: Cisplatin; Cisplatin 75 mg/m^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles; Other Names: PLATINOL®; Drug: Gemcitabine; In squamous tumors Gemcitabine 1000 mg/m^2 by IV infusion on day 1 and day 8 of each 21-day cycle for 4 cycles.; Other Names: GEMZAR®; Drug: Pemetrexed; In nonsquamous tumors Pemetrexed 500 mg/m^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles; Other Names: Alimta®; Drug: Carboplatin; AUC 5 mg/mL min or AUC 6 mg/mL min by IV infusion on day 1 of each 21-day cycle for 4 cycles; Other Names: PARAPLATIN®; Biological: Pembrolizumab (adjuvant); After surgery adjuvant Pembrolizumab 200 mg by IV infusion on day 1 of each 21-day cycle for 13 cycles; Other Names: MK-3475; KEYTRUDA®; Drug: Paclitaxel; Paclitaxel 175 or 200 mg/m^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles.; Drug: Sacituzumab tirumotecan; Sacituzumab tirumotecan 4 mg/kg by IV infusion on day 1 of each 14-day cycle for up to 6 cycles; Other Names: SKB264; MK-2870; Drug: H2 receptor antagonist; Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label; Drug: Acetaminophen (or equivalent); Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label; Drug: Dexamethasone (or equivalent); Administered as rescue medication 8 -10 mg before Sacituzumab tirumotecan infusion per approved product label; Drug: Steroid mouthwash (dexamethasone or equivalent); Administered orally as rescue medication 2-5 mL 4 times daily; Drug: H1 receptor antagonist; Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label
Active Comparator: Pembrolizumab + Platinum; Neoadjuvant: Prior to surgery pembrolizumab 200 mg every three weeks (Q3W) for 4 cycles (each cycle is 21 days); Cisplatin 75 mg/m^2 Q3W with gemcitabine 1000 mg/m^2 on Day 1 and Day 8 Q3W (squamous tumors), pemetrexed 500 mg/m^2 Q3W (nonsquamous tumors), or paclitaxel 175 mg/m^2 or 200 mg/m^2 q3w (any histology) OR Carboplatin AUC 5 mg/mL• min or AUC 6 mg/mL• min with paclitaxel 175 mg/m^2 or 200 mg/m^2 Q3W (any histology), pemetrexed 500 mg/m^2 Q3W (nonsquamous tumors), or gemcitabine 1000 mg/m^2 on Day 1 and Day 8 Q3W (squamous tumors); followed by surgery. Adjuvant: After surgery pembrolizumab 200 mg Q3W for 13 cycles (each cycle is 21 days).	Biological: Pembrolizumab (neoadjuvant); Before surgery neoadjuvant Pembrolizumab 200 mg by intravenous (IV) infusion on day 1 of each 21-day cycle for 4 cycles; Other Names: MK-3475; KEYTRUDA®; Drug: Cisplatin; Cisplatin 75 mg/m^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles; Other Names: PLATINOL®; Drug: Gemcitabine; In squamous tumors Gemcitabine 1000 mg/m^2 by IV infusion on day 1 and day 8 of each 21-day cycle for 4 cycles.; Other Names: GEMZAR®; Drug: Pemetrexed; In nonsquamous tumors Pemetrexed 500 mg/m^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles; Other Names: Alimta®; Drug: Carboplatin; AUC 5 mg/mL min or AUC 6 mg/mL min by IV infusion on day 1 of each 21-day cycle for 4 cycles; Other Names: PARAPLATIN®; Biological: Pembrolizumab (adjuvant); After surgery adjuvant Pembrolizumab 200 mg by IV infusion on day 1 of each 21-day cycle for 13 cycles; Other Names: MK-3475; KEYTRUDA®; Drug: Paclitaxel; Paclitaxel 175 or 200 mg/m^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological Complete Response (pCR)	pCR is defined as absence of residual viable invasive cancer on hematoxylin- and eosin-stained slides of the resected lung specimen and lymph nodes.	Up to approximately 20 weeks
Percent Residual Viable Tumor (%RVT)	%RVT is defined as the percentage of residual tumor estimated by comparing the estimated cross-sectional area of viable tumor with estimated cross-sectional areas of remainder of tumor bed. The tumor bed is defined as the area of tissue occupied by viable tumor or tumoral regression (includes areas of necrosis, foamy macrophages, giant cell reaction, cholesterol cleft granuloma, and inflammation.)	Up to approximately 20 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from randomization to death due to any cause.	Up to approximately 5 years
Percentage of Participants Who Report at Least 1 Adverse Event (AE)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.	Up to approximately 5 years
Percentage of Participants Who Discontinue Study Treatment Due to an AE	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.	Up to approximately 1 year
Event-free Survival (EFS)	EFS is defined as the time from randomization to any of the following events: radiographic disease progression per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) (for participants who have not had or will not have surgery, or participants who have gross residual disease after an incomplete resection [R2 resection]); local progression (primary tumor or regional lymph nodes) or distant metastasis precluding planned surgery; tumor determined to be unresectable in the operating room; local or distant recurrence (for participants who are disease free after surgery or participants with microscopic positive margins [R1 resection]); occurrence of new primary NCSLC; death due to any cause.	Up to approximately 5 years
Distant Metastasis-Free Survival (DMFS)	DMFS is defined as the time from randomization to the date of diagnosis of distant metastasis or death, whichever occurs first.	Up to approximately 5 years
Objective Response Rate (ORR)	OR is defined as a complete response or partial response with or without confirmation per RECIST 1.1 as assessed by the investigator during the Neoadjuvant Phase.	Up to approximately 12 weeks
Percentage of Participants Who Experience a Perioperative Complication	Perioperative Complications include both intraoperative and postoperative complications.	Up to approximately 20 weeks
Mean Length of Hospital Stay	Hospital Stay is the length of inpatient time spent in hospital.	Up to approximately 20 weeks
Percentage of Participants Who Require Hospital Readmission after Discharge	In participants previously discharged from hospital, the percentage requiring readmission to hospital.	Up to approximately 20 weeks
Mean Length of Surgery	Length of surgery is the time spent in surgery.	Up to approximately 20 weeks
Percentage of Participants Who Require a Blood Transfusion	Blood transfusion is the transfer of donated blood into the vein of a recipient.	Up to approximately 20 weeks

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2025
• Primary Completion (Estimated): February 6, 2032
• Study Completion (Estimated): February 6, 2032

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: January 17, 2025
• First Posted (Actual): January 23, 2025

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Programmed Cell Death-1 (PD1, PD-1); Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2); Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Parkinson Disease 4, Autosomal Dominant Lewy Body; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Histamine Agents; Neurotransmitter Agents; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pharmaceutical Preparations; Therapeutics; Pharmacologic Actions; Chemical Actions and Uses; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Polycyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Diterpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Specialty Uses of Chemicals; Pharmaceutic Aids; Pregnadienetriols; Platinum Compounds; Combined Modality Therapy; Pemetrexed; Gemcitabine; Dexamethasone; Acetaminophen; Carboplatin; Paclitaxel; Cisplatin; Histamine Antagonists; Histamine H2 Antagonists; Adjuvants, Pharmaceutic; pembrolizumab; Neoadjuvant Therapy
• Other Study ID Numbers: 3475-01E; KEYMAKER-U01 (Other Identifier: MSD); MK-3475-01E (Other Identifier: MSD Protocol Number); U1111-1299-6753 (Registry Identifier: UTN); 2023-509234-19-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No