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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Pembrolizumab: IV infusion
Carboplatin: IV infusion
Paclitaxel: IV infusion
Pemetrexed: IV infusion
Vibostolimab: IV infusion
Boserolimab: IV infusion
MK-4830: IV infusion
MK-0482: IV Infusion
Ifinatamab Deruxtecan (I-DXd): IV infusion
HER3-DXd: IV Infusion
Study 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
Primary outcome measure(s)
- 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
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. ORR will be reported. - Part B: Number of Participants Who Experience One or More Adverse Events (AEs) — 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. The number of participants who experience an AE will be reported. - Part B: Number of Participants Who Discontinue Study Intervention Due to an Adverse Event (AE) — 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. The number of participants who discontinue study intervention due to an AE will be reported. - Part B: Number of Participants Who Experience a Dose Limiting Toxicity (DLT) — Up to approximately 3 Weeks
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). Number of participants who experience a DLT per CTCAE 5.0 will be reported.
Trial sites (46)
| Facility | City | Region | Status |
|---|---|---|---|
| Banner MD Anderson Cancer Center ( Site 0001) | Gilbert | Arizona | Completed |
| City of Hope ( Site 0014) | Duarte | California | Completed |
| UCSF Medical Center at Mission Bay ( Site 0007) | San Francisco | California | Completed |
| Georgetown University ( Site 0036) | Washington D.C. | District of Columbia | Completed |
| University of Kentucky Markey Cancer Center ( Site 0019) | Lexington | Kentucky | Completed |
| MedStar Franklin Square Medical Center ( Site 0033) | Baltimore | Maryland | Completed |
| Massachusetts General Hospital ( Site 0003) | Boston | Massachusetts | Completed |
| Dana Farber Cancer Institute ( Site 0002) | Boston | Massachusetts | Completed |
| Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031) | Omaha | Nebraska | Completed |
| Dartmouth Hitchcock Medical Center ( Site 0016) | Lebanon | New Hampshire | Recruiting |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037) | Hackensack | New Jersey | Completed |
| Laura and Isaac Perlmutter Cancer Center ( Site 0034) | New York | New York | Completed |
| Sanford Fargo Medical Center ( Site 0039) | Fargo | North Dakota | Recruiting |
| Cleveland Clinic Main ( Site 0006) | Cleveland | Ohio | Completed |
| The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0015) | Columbus | Ohio | Recruiting |
| Abramson Cancer Center of the University of Pennsylvania ( Site 0010) | Philadelphia | Pennsylvania | Recruiting |
| Sanford Cancer Center ( Site 0038) | Sioux Falls | South Dakota | Recruiting |
| The University of Texas MD Anderson Cancer Center ( Site 0009) | Houston | Texas | Recruiting |
| Petz Aladar Megyei Oktato Korhaz ( Site 0062) | Győr | Győr-Moson-Sopron | Completed |
| Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061) | Szolnok | Jász-Nagykun-Szolnok | Completed |
| Orszagos Koranyi Pulmonologiai Intezet ( Site 0060) | Budapest | Hungary | Completed |
| Soroka Medical Center ( Site 0072) | Beersheba | Israel | Completed |
| Rambam Health Care Campus-Oncology ( Site 0076) | Haifa | Israel | Completed |
| Shaare Zedek Medical Center ( Site 0075) | Jerusalem | Israel | Recruiting |
| Meir Medical Center ( Site 0071) | Kfar Saba | Israel | Completed |
| Rabin Medical Center ( Site 0074) | Petah Tikva | Israel | Completed |
| Chaim Sheba Medical Center ( Site 0070) | Ramat Gan | Israel | Recruiting |
| Sourasky Medical Center ( Site 0077) | Tel Aviv | Israel | Completed |
| Azienda Ospedaliera Universitaria Careggi ( Site 0173) | Florence | Firenze | Completed |
| IRCCS Ospedale San Raffaele ( Site 0171) | Milan | Italy | Completed |
| Policlinico Gemelli di Roma ( Site 0174) | Roma | Italy | Completed |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151) | Warsaw | Masovian Voivodeship | Completed |
| Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150) | Gdansk | Pomeranian Voivodeship | Completed |
| Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152) | Koszalin | West Pomeranian Voivodeship | Active Not Recruiting |
| Seoul National University Bundang Hospital ( Site 0081) | Seongnam-si | Kyonggi-do | Completed |
| Severance Hospital ( Site 0080) | Seoul | South Korea | Completed |
| Samsung Medical Center ( Site 0082) | Seoul | South Korea | Completed |
| ICO L Hospitalet ( Site 0090) | L'Hospitalet de Llobregat | Barcelona | Completed |
| Hospital Universitario Quiron Madrid ( Site 0091) | Madrid | Spain | Completed |
| Changhua Christian Hospital ( Site 0181) | Changhua | Taiwan | Recruiting |
+ 6 more sites — see the full list on the official registry below.
On this site
📄 Keytruda (pembrolizumab) drug profile →More Merck Sharp & Dohme LLC trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04165070 on ClinicalTrials.gov ↗ ← All trials in Italy