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).
The master screening protocol is MK-3475-U01 (KEYMAKER-U01) - NCT04165798
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
450
IV infusion
IV infusion
IV infusion
IV infusion
IV infusion
IV infusion
IV infusion
IV Infusion
IV infusion
IV Infusion
Banner MD Anderson Cancer Center ( Site 0001)
Gilbert, Arizona, United States
COMPLETEDCity of Hope ( Site 0014)
Duarte, California, United States
COMPLETEDUCSF Medical Center at Mission Bay ( Site 0007)
San Francisco, California, United States
COMPLETEDGeorgetown University ( Site 0036)
Washington D.C., District of Columbia, United States
COMPLETEDPart A: Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
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.
Time frame: Up to approximately 24 months
Part B: Number of Participants Who Experience One or More Adverse Events (AEs)
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.
Time frame: Up to approximately 27 months
Part B: Number of Participants Who Discontinue Study Intervention Due to an Adverse Event (AE)
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.
Time frame: Up to approximately 24 months
Part B: Number of Participants Who Experience a Dose Limiting Toxicity (DLT)
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.
Time frame: Up to approximately 3 Weeks
Part A: Progression-Free Survival (PFS) According to RECIST 1.1
PFS is defined as the time from first dose of study treatment until either the earliest date of documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS will be reported.
Time frame: Up to approximately 24 months
Part A: Number of Participants Who Experience One or More AEs
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.
Time frame: Up to approximately 27 months
Part A: Number of Participants Who Discontinue Study Treatment Due to an AE
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.
Time frame: Up to approximately 24 months
Part B: ORR per RECIST 1.1 as assessed by blinded independent central review (BICR)
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.
Time frame: Up to approximately 24 months
Part B: Duration of Response (DOR) per RECIST 1.1 as assessed by BICR
For participants who show confirmed CR or PR, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. DOR will be reported.
Time frame: Up to approximately 24 months
Part B: Cmax of I-DXd
Cmax is the maximum concentration of the drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of I-DXd.
Time frame: At designated time points up to approximately 2 years
Part B: Cmax of HER3-DXd
Cmax is the maximum concentration of the drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of HER3-DXd.
Time frame: At designated time points up to approximately 2 years
Part B: Cmax of pembrolizumab
Cmax is the maximum concentration of the drug observed in serum. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of pembrolizumab.
Time frame: At designated time points up to approximately 2 years
Part B: Ctrough of I-DXd
Ctrough is defined as the lowest observed concentration of drug in plasma at the end of the dosing interval. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Ctrough of I-DXd.
Time frame: At designated time points up to approximately 2 years
Part B: Ctrough of HER3-DXd
Ctrough is defined as the lowest observed concentration of drug in plasma at the end of the dosing interval. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Ctrough of HER3-DXd.
Time frame: At designated time points up to approximately 2 years
Part B: Ctrough of pembrolizumab
Ctrough is defined as the lowest observed concentration of drug in serum at the end of the dosing interval. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Ctrough of pembrolizumab.
Time frame: At designated time points up to approximately 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Kentucky Markey Cancer Center ( Site 0019)
Lexington, Kentucky, United States
COMPLETEDMedStar Franklin Square Medical Center ( Site 0033)
Baltimore, Maryland, United States
COMPLETEDMassachusetts General Hospital ( Site 0003)
Boston, Massachusetts, United States
COMPLETEDDana Farber Cancer Institute ( Site 0002)
Boston, Massachusetts, United States
COMPLETEDOncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)
Omaha, Nebraska, United States
COMPLETEDDartmouth Hitchcock Medical Center ( Site 0016)
Lebanon, New Hampshire, United States
RECRUITING...and 36 more locations