Brief Summary
Researchers are looking for new ways to treat non-small cell lung cancer (NSCLC) that is metastatic, which means cancer has spread to other parts of the body.
Some people with metastatic NSCLC are treated with pembrolizumab, an immunotherapy treatment that is given into a vein as an intravenous (IV) infusion. Pembrolizumab (+) Berahyaluronidase alfa is pembrolizumab that is given under the skin as a subcutaneous (SC) injection. The goal of this study is to compare what happens to pembrolizumab in a person's body over time when it is given as an IV infusion or SC injection.
Some people with metastatic NSCLC are treated with pembrolizumab, an immunotherapy treatment that is given into a vein as an intravenous (IV) infusion. Pembrolizumab (+) Berahyaluronidase alfa is pembrolizumab that is given under the skin as a subcutaneous (SC) injection. The goal of this study is to compare what happens to pembrolizumab in a person's body over time when it is given as an IV infusion or SC injection.
Brief Title
A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84)
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
1-888-577-8839
Central Contact Email
Trialsites@msd.com
Completion Date
Completion Date Type
Estimated
Conditions
Lung Cancer
Non-Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC).
* Measurable disease as assessed by the local site investigator/radiology.
Exclusion Criteria:
* Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
* Received prior systemic anticancer therapy for their metastatic NSCLC.
* Known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Active autoimmune disease that has required systemic treatment in the past 2 years.
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* Active infection requiring systemic therapy.
* Histologically or cytologically confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC).
* Measurable disease as assessed by the local site investigator/radiology.
Exclusion Criteria:
* Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
* Received prior systemic anticancer therapy for their metastatic NSCLC.
* Known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Active autoimmune disease that has required systemic treatment in the past 2 years.
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* Active infection requiring systemic therapy.
Inclusion Criteria
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC).
* Measurable disease as assessed by the local site investigator/radiology.
* Histologically or cytologically confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC).
* Measurable disease as assessed by the local site investigator/radiology.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06698042
Org Class
Industry
Org Full Name
Merck Sharp & Dohme LLC
Org Study Id
3475A-F84
Overall Status
Recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS 50% or Greater
Primary Outcomes
Outcome Description
AUC is defined as area under curve exposure. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine AUC.
Outcome Measure
Area Under the Curve (AUC) of Pembrolizumab Measured After the First Dose
Outcome Time Frame
At designated time points (up to approximately 14 months)
Outcome Description
Ctrough is defined as the trough concentration at steady-state. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough
Outcome Measure
Trough Concentration (Ctrough) of Pembrolizumab Measured at Steady State
Outcome Time Frame
At designated time points (Up to ~18 months)
Secondary Ids
Secondary Id
MK-3475A-F84
Secondary Id
2024-513165-39-00
Secondary Id
U1111-1306-1214
Secondary Id
jRCT2031240445
Secondary Outcomes
Outcome Description
Cmax is defined as the peak concentration over the dosing interval. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmax.
Outcome Time Frame
At designated time points (Up to ~28 months)
Outcome Measure
Maximum Serum Concentration (Cmax) of Pembrolizumab Measured After the First Dose
Outcome Description
Ctrough is defined as the trough concentration. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough.
Outcome Time Frame
At designated time points (Up to ~28 months)
Outcome Measure
Trough Concentration (Ctrough) of Pembrolizumab Measured After the First Dose
Outcome Description
AUC is defined as area under curve exposure at steady state. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine AUC.
Outcome Time Frame
At designated time points (Up to ~28 months)
Outcome Measure
AUC of Pembrolizumab Measured at Steady State
Outcome Description
Cmax is defined as the peak concentration over the dosing interval in steady-state. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmax
Outcome Time Frame
At designated time points (Up to ~28 months)
Outcome Measure
Maximum Serum Concentration (Cmax) of Pembrolizumab Measured at Steady State
Outcome Description
Model-based Ctrough is defined as the value of trough concentration at the end of the dosing interval, as predicted by the population PK model.
Outcome Time Frame
At designated time points (Up to ~28 monhts
Outcome Measure
Model-based Ctrough of Pembrolizumab Measured After the First Dose
Outcome Description
Model-based steady-state Ctrough is defined as the value of trough concentration at the end of the dosing interval at steady-state, as predicted by the population PK model.
Outcome Time Frame
At designated time points (Up to ~28 months)
Outcome Measure
Model-based Ctrough of Pembrolizumab Measured at Steady State
Outcome Description
Blood samples are to be collected at designated time points for the determination of the presence or absence of anti-pembrolizumab antibodies. The percentage of participants who develop anti pembrolizumab antibodies will be reported.
Outcome Time Frame
Baseline and up to approximately 28 months
Outcome Measure
Number of participants with antipembrolizumab antibodies
Outcome Description
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Outcome Time Frame
Up to approximately 60 months
Outcome Measure
Objective Response Rate (ORR)
Outcome Description
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (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 as assessed by blinded independent central review (BICR) will be presented.
Outcome Time Frame
Up to approximately 60 months
Outcome Measure
Progression-free Survival (PFS)
Outcome Description
OS is defined as time from randomization to death due to any cause.
Outcome Time Frame
Up to approximately 60 months
Outcome Measure
Overall survival (OS)
Outcome Description
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1), DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 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 at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by Blinded Independent Central Review (BICR) will be presented
Outcome Time Frame
Up to approximately 60 months
Outcome Measure
Duration of Response (DOR)
Outcome Description
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.
Outcome Time Frame
Up to approximately 28 months
Outcome Measure
Number of Participants Who Experience an AE- All Participants
Outcome Description
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.
Outcome Time Frame
Up to approximately 25 months
Outcome Measure
Number of Participants Who Discontinue Study Intervention Due to an AE
Outcome Description
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7- point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.
Outcome Time Frame
Baseline and up to approximately 26 months
Outcome Measure
Change in Score from Baseline: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)Global Health Status/Quality of Life (QoL)- Items 29 and 30
Outcome Description
Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Outcome Time Frame
Baseline and up to approximately 26 months
Outcome Measure
Change in Score from Baseline: EORTC QLQ-C30 Physical Functioning (Items 1 to 5)
Outcome Description
Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Outcome Time Frame
Baseline and up to approximately 26 months
Outcome Measure
Change in Score from Baseline: EORTC QLQ-C30 Role functioning (Items 6 and 7)
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Balazs Halmos
Investigator Email
bahalmos@montefiore.org