Health Trials

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)

ConditionCarcinoma, Non-Small-Cell Lung
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pembrolizumab

    Biological/Vaccine

    IV infusion

  • Carboplatin

    Drug

    IV infusion

  • Paclitaxel

    Drug

    IV infusion

  • Pemetrexed

    Drug

    IV infusion

  • Vibostolimab

    Biological/Vaccine

    IV infusion

  • Boserolimab

    Biological/Vaccine

    IV infusion

  • MK-4830

    Biological/Vaccine

    IV infusion

  • MK-0482

    Biological/Vaccine

    IV Infusion

  • Ifinatamab Deruxtecan (I-DXd)

    Biological/Vaccine

    IV infusion

  • HER3-DXd

    Biological/Vaccine

    IV Infusion

Treatment groups

450 Participants
are divided into 11 treatment groups

11

Treatment groups

See each treatment group below.

Group A: Part A: Pembrolizumab+Vibostolimab+Carboplatin + PaclitaxelExperimental treatment 4 interventions
Group B: Part A: Pembrolizumab+Vibostolimab+Carboplatin + PemetrexedExperimental treatment 4 interventions
Group C: Part A: Pembrolizumab+Boserolimab+Carboplatin+PaclitaxelExperimental treatment 4 interventions
Group D: Part A: Pembrolizumab+Boserolimab+Carboplatin+PemetrexedExperimental treatment 4 interventions
Group E: Part A: Pembrolizumab+MK-4830+Carboplatin+PaclitaxelExperimental treatment 4 interventions
Group F: Part A: Pembrolizumab+MK-4830+Carboplatin+PemetrexedExperimental treatment 4 interventions
Group G: Part A: Pembrolizumab+MK-0482+Carboplatin+PaclitaxelExperimental treatment 3 interventions
Group H: Part A: Pembrolizumab+MK-0482+Carboplatin+PemetrexedExperimental treatment 3 interventions
Group I: Part B: Pembrolizumab + I-DXdExperimental treatment 2 interventions
Group J: Part B: Pembrolizumab + Carboplatin + I-DXdExperimental treatment 3 interventions
Group K: Part B: Pembrolizumab + Carboplatin + HER3-DXdExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Part 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
2

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
3

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
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Merck Sharp & Dohme LLC

Lead sponsor

Daiichi Sankyo

Collaborator

Source ClinicalTrials.gov
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