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NCT02819518 · CITED IN SOURCE DOCUMENTS

Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs. Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (MK-3475-355/KEYNOTE-355)

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2024-11-27

The study will consist of two parts. In Part 1, the safety of pembrolizumab (MK-3475) in combination with one of three different chemotherapies will be assessed in the treatment of locally recurrent inoperable or metastatic triple negative breast cancer (TNBC), which has not been previously treated with chemotherapy. In Part 2, the safety and efficacy of pembrolizumab plus background chemotherapy will be assessed compared to the safety and efficacy of placebo plus background chemotherapy in the treatment of locally recurrent inoperable or metastatic TNBC, which has not been previously treated with chemotherapy. The primary hypotheses are that: 1. the combination of pembrolizumab and chemotherapy prolongs Progression-Free Survival (PFS) compared to placebo and chemotherapy in: * all participants, * participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 tumors, and * participants with PD-L1 CPS ≥10 tumors, and 2. the combination of pembrolizumab and chemotherapy prolongs Overall Survival (OS) compared to placebo and chemotherapy in: * all participants, * participants with PD-L1 CPS ≥1 tumors, and * participants with PD-L1 CPS ≥10 tumors.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Part 1: Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants

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outcome · POSTED

Part 1: Percentage of Participants Who Discontinued Study Drug Due to an AE - All Participants

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outcome · POSTED

Part 2: Progression-Free Survival (PFS) - All Participants

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outcome · POSTED

Part 2: PFS - Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 Tumors

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outcome · POSTED

Part 2: PFS - Participants With PD-L1 CPS ≥10 Tumors

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outcome · POSTED

Part 2: Overall Survival (OS) - All Participants

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outcome · POSTED

Part 2: OS - Participants With PD-L1 CPS ≥1 Tumors

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outcome · POSTED

Part 2: OS - Participants With PD-L1 CPS ≥10 Tumors

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outcome · POSTED

Part 2: Objective Response Rate (ORR) - All Participants

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outcome · POSTED

Part 2: ORR - Participants With PD-L1 CPS ≥1 Tumors

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outcome · POSTED

Part 2: ORR - Participants With PD-L1 CPS ≥10 Tumors

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outcome · POSTED

Part 2: Duration of Response (DOR) - All Participants

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outcome · POSTED

Part 2: DOR - Participants With PD-L1 CPS ≥1 Tumors

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outcome · POSTED

Part 2: DOR - Participants With PD-L1 CPS ≥10 Tumors

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outcome · POSTED

Part 2: Disease Control Rate (DCR) - All Participants

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outcome · POSTED

Part 2: DCR - Participants With PD-L1 CPS ≥1 Tumors

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outcome · POSTED

Part 2: DCR - Participants With PD-L1 CPS ≥10 Tumors

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outcome · POSTED

Part 2: Percentage of Participants Who Experienced an AE- All Participants

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outcome · POSTED

Part 2: Percentage of Participants Who Discontinued Study Drug Due to an AE- All Participants

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outcome · POSTED

Part 2: Change From Baseline to Week 15 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score- All Participants

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outcome · POSTED

Part 2: Change From Baseline to Week 15 in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score - Participants With PD-L1 CPS ≥1 Tumors

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outcome · POSTED

Part 2: Change From Baseline to Week 15 in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score-Participants With PD-L1 CPS ≥10 Tumors

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outcome · POSTED

Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC Breast Cancer-Specific Quality of Life Questionnaire (QLQ-BR23)-All Participants

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outcome · POSTED

Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC QLQ-BR23 - Participants With PD-L1 CPS ≥1 Tumors

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outcome · POSTED

Part 2: Change From Baseline to Week 15 in Systemic Therapy Side Effects Using the EORTC QLQ-BR23- Participants With PD-L1 CPS ≥10 Tumors

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Has locally recurrent inoperable breast cancer not previously treated with chemotherapy and which cannot be treated with curative intent OR has metastatic breast cancer not previously treated with chemotherapy. * Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology/college of American Pathologists (ASCO/CAP) guidelines. * Has completed treatment for Stage I-III breast cancer, if indicated, and ≥6 months elapsed between the completion of treatment with curative intent (e.g., date of primary breast tumor surgery or date of last adjuvant chemotherapy administration, whichever occurred last) and first documented local or distant disease recurrence. * Has been treated with (neo)adjuvant anthracycline, if they received systemic treatment in the (neo)adjuvant setting, unless anthracycline was contraindicated or not considered the best treatment option for the participant in the opinion of the treating physician. * Has measurable disease based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by local radiology review. * Has provided recently or newly obtained core or excisional biopsy from a locally recurrent inoperable or metastatic tumor lesion for central determination of TNBC status and PD-L1 expression, unless contraindicated due to site inaccessibility and/or participant safety concerns. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 10 days prior to the start of study drug. * Has a life expectancy ≥12 weeks from randomization. * Demonstrates adequate organ function, within 10 days prior to the start of study drug. * Female participants are eligible to participate if they are not pregnant or breastfeeding AND they are not a woman of childbearing potential (WOCBP) OR is a WOCBP using a contraceptive method that is highly effective or is abstinent from heterosexual intercourse during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention AND has a negative highly-sensitive pregnancy test (\[urine or serum\] as required by local regulations) within 24 hours (urine) or 72 hours (serum) before the first dose of study intervention. * Male participants are eligible to participate if they agree to refrain from donating sperm during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention PLUS be abstinent from heterosexual intercourse OR must agree to use contraception unless confirmed to be azoospermic. Exclusion Criteria: * Is currently participating in a clinical study and receiving an investigational agent and/or using an investigational device, or has participated in a clinical study and received an investigational agent and/or used an investigational device within 4 weeks prior to randomization. * Has not recovered (e.g., to ≤ Grade 1 or to baseline) from AEs due to a previously administered therapy. * Has neuropathy ≥ Grade 2. * Has an active autoimmune disease that has required systemic treatment in the past 2 years (e.g., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to randomization. * Has a known additional malignancy that progressed or required active treatment within the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, and in situ cervical cancer. * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they have stable brain metastases and did not receive chemotherapy for metastatic breast cancer. * Has history of (non-infectious) pneumonitis that required steroids or current pneumonitis. * Has active, or a history of, interstitial lung disease. * Has a known history of active tuberculosis (TB). * Has an active infection requiring systemic therapy. * Has a history of Class II-IV congestive heart failure or myocardial infarction within 6 months of randomization. * Has a known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days (or longer as specified by local institutional guidelines) after the last dose of study drug. * Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T cell receptor (such as cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX-40, CD137) or has previously participated in Merck pembrolizumab (MK-3475) clinical studies. * Has a known history of human immunodeficiency virus (HIV). * Has known active hepatitis B or hepatitis C. * Has received a live vaccine within 30 days prior to randomization. * Has a known history of hypersensitivity or allergy to pembrolizumab and any of its components and/or to any of the study chemotherapies (e.g., nab-paclitaxel, paclitaxel, gemcitabine, or carboplatin) and any of their components. * Is receiving any medication prohibited in combination with study chemotherapies as described in the respective product labels, unless medication was stopped within 7 days prior to randomization.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle.
    intervention Names
    1. Biological: Pembrolizumab
    2. Drug: Nab-paclitaxel
    label
    Part 1: Pembrolizumab + Nab-paclitaxel
    type
    EXPERIMENTAL
  2. description
    Participants receive pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle.
    intervention Names
    1. Biological: Pembrolizumab
    2. Drug: Paclitaxel
    label
    Part 1: Pembrolizumab + Paclitaxel
    type
    EXPERIMENTAL
  3. description
    Participants receive pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS gemcitabine/carboplatin 1000 mg/m\^2 (gemcitabine) and an Area Under the Curve (AUC) 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
    intervention Names
    1. Biological: Pembrolizumab
    2. Drug: Gemcitabine
    3. Drug: Carboplatin
    label
    Part 1: Pembrolizumab + Gemcitabine/Carboplatin
    type
    EXPERIMENTAL
  4. description
    Participants receive pembrolizumab 200 mg IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m\^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
    intervention Names
    1. Biological: Pembrolizumab
    2. Drug: Nab-paclitaxel
    3. Drug: Paclitaxel
    4. Drug: Gemcitabine
    5. Drug: Carboplatin
    label
    Part 2: Pembrolizumab + Chemotherapy
    type
    EXPERIMENTAL
  5. description
    Participants receive placebo (normal saline) IV on Day 1 of each 21-day cycle PLUS one of three background chemotherapy regimens at investigator's discretion: 1) nab-paclitaxel 100 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle, 2) paclitaxel 90 mg/m\^2 IV on Days 1, 8 and 15 of each 28-day cycle, OR 3) gemcitabine/carboplatin 1000 mg/m\^2 (gemcitabine) and an AUC 2 (carboplatin) on Days 1 and 8 of each 21-day cycle.
    intervention Names
    1. Drug: Nab-paclitaxel
    2. Drug: Paclitaxel
    3. Drug: Gemcitabine
    4. Drug: Carboplatin
    5. Drug: Normale Saline Solution
    label
    Part 2: Placebo + Chemotherapy
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Part 1: Pembrolizumab + Gemcitabine/Carboplatin
    2. Part 1: Pembrolizumab + Nab-paclitaxel
    3. Part 1: Pembrolizumab + Paclitaxel
    4. Part 2: Pembrolizumab + Chemotherapy
    description
    IV infusion
    name
    Pembrolizumab
    other Names
    1. MK-3475
    2. KEYTRUDA®
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Part 1: Pembrolizumab + Nab-paclitaxel
    2. Part 2: Pembrolizumab + Chemotherapy
    3. Part 2: Placebo + Chemotherapy
    description
    IV infusion
    name
    Nab-paclitaxel
    other Names
    1. ABRAXANE®
    type
    DRUG
  3. arm Group Labels
    1. Part 1: Pembrolizumab + Paclitaxel
    2. Part 2: Pembrolizumab + Chemotherapy
    3. Part 2: Placebo + Chemotherapy
    description
    IV infusion
    name
    Paclitaxel
    other Names
    1. TAXOL®
    type
    DRUG
  4. arm Group Labels
    1. Part 1: Pembrolizumab + Gemcitabine/Carboplatin
    2. Part 2: Pembrolizumab + Chemotherapy
    3. Part 2: Placebo + Chemotherapy
    description
    IV infusion
    name
    Gemcitabine
    other Names
    1. GEMZAR®
    type
    DRUG
  5. arm Group Labels
    1. Part 1: Pembrolizumab + Gemcitabine/Carboplatin
    2. Part 2: Pembrolizumab + Chemotherapy
    3. Part 2: Placebo + Chemotherapy
    description
    IV infusion
    name
    Carboplatin
    other Names
    1. PARAPLATIN®
    type
    DRUG
  6. arm Group Labels
    1. Part 2: Placebo + Chemotherapy
    description
    IV infusion
    name
    Normale Saline Solution
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
QUADRUPLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
  4. OUTCOMES_ASSESSOR
primary Purpose
TREATMENT
Enrollment
count
882
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. 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.
    measure
    Part 1: Percentage of Participants Who Experienced an Adverse Event (AE) - All Participants
    time Frame
    Up to approximately 39 months
  2. 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.
    measure
    Part 1: Percentage of Participants Who Discontinued Study Drug Due to an AE - All Participants
    time Frame
    Up to approximately 39 months
  3. description
    Progression-free survival was defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on assessments by blinded independent central review (BICR) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.
    measure
    Part 2: Progression-Free Survival (PFS) - All Participants
    time Frame
    Up to approximately 53 months
  4. description
    Progression-free survival was defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.
    measure
    Part 2: PFS - Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 Tumors
    time Frame
    Up to approximately 53 months
  5. description
    Progression-free survival was defined as the time from randomization to the first documented PD per RECIST 1.1 based on assessments by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD.
    measure
    Part 2: PFS - Participants With PD-L1 CPS ≥10 Tumors
    time Frame
    Up to approximately 53 months
  6. description
    Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.
    measure
    Part 2: Overall Survival (OS) - All Participants
    time Frame
    Up to approximately 53 months
  7. description
    Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.
    measure
    Part 2: OS - Participants With PD-L1 CPS ≥1 Tumors
    time Frame
    Up to approximately 53 months
  8. description
    Overall survival is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.
    measure
    Part 2: OS - Participants With PD-L1 CPS ≥10 Tumors
    time Frame
    Up to approximately 53 months
secondary Outcomes
  1. description
    Objective response rate is defined as the percentage of participants in the analysis population who have a 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). The percentage of participants who experienced a CR or PR as assessed by BICR based on RECIST 1.1 is presented.
    measure
    Part 2: Objective Response Rate (ORR) - All Participants
    time Frame
    Up to approximately 53 months
  2. description
    Objective response rate is defined as the percentage of participants in the analysis population who have a 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). The percentage of participants who experienced a CR or PR as assessed by BICR based on RECIST 1.1 is presented.
    measure
    Part 2: ORR - Participants With PD-L1 CPS ≥1 Tumors
    time Frame
    Up to approximately 53 months
  3. description
    Objective response rate is defined as the percentage of participants in the analysis population who have a 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). The percentage of participants who experienced a CR or PR as assessed by BICR based on RECIST 1.1 is presented.
    measure
    Part 2: ORR - Participants With PD-L1 CPS ≥10 Tumors
    time Frame
    Up to approximately 53 months
  4. description
    For participants who demonstrate a confirmed CR (Disappearance of all target lesions) or confirmed PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death due to any cause, whichever occurs first, based on assessments by BICR per RECIST 1.1. Per RECIST 1.1, PD was 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 have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.
    measure
    Part 2: Duration of Response (DOR) - All Participants
    time Frame
    Up to approximately 53 months
  5. description
    For participants who demonstrate a confirmed CR (Disappearance of all target lesions) or confirmed PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death due to any cause, whichever occurs first, based on assessments by BICR per RECIST 1.1. Per RECIST 1.1, PD was 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 have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.
    measure
    Part 2: DOR - Participants With PD-L1 CPS ≥1 Tumors
    time Frame
    Up to approximately 53 months
  6. description
    For participants who demonstrate a confirmed CR (Disappearance of all target lesions) or confirmed PR (At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death due to any cause, whichever occurs first, based on assessments by BICR per RECIST 1.1. Per RECIST 1.1, PD was 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 have demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.
    measure
    Part 2: DOR - Participants With PD-L1 CPS ≥10 Tumors
    time Frame
    Up to approximately 53 months
  7. description
    Disease control rate is defined as the percentage of participants who have achieved CR (disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions) or have demonstrated stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\]) for at least 24 weeks, based on assessments by BICR per RECIST 1.1.
    measure
    Part 2: Disease Control Rate (DCR) - All Participants
    time Frame
    Up to approximately 53 months
  8. description
    Disease control rate is defined as the percentage of participants who have achieved CR (disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions) or have demonstrated stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\]) for at least 24 weeks, based on assessments by BICR per RECIST 1.1.
    measure
    Part 2: DCR - Participants With PD-L1 CPS ≥1 Tumors
    time Frame
    Up to approximately 53 months
  9. description
    Disease control rate is defined as the percentage of participants who have achieved CR (disappearance of all target lesions) or PR (At least a 30% decrease in the sum of diameters of target lesions) or have demonstrated stable disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\]) for at least 24 weeks, based on assessments by BICR per RECIST 1.1.
    measure
    Part 2: DCR - Participants With PD-L1 CPS ≥10 Tumors
    time Frame
    Up to approximately 53 months
  10. 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.
    measure
    Part 2: Percentage of Participants Who Experienced an AE- All Participants
    time Frame
    Up to approximately 81 months
  11. 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.
    measure
    Part 2: Percentage of Participants Who Discontinued Study Drug Due to an AE- All Participants
    time Frame
    Up to approximately 81 months
  12. 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?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores were 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 are presented.
    measure
    Part 2: Change From Baseline to Week 15 in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score- All Participants
    time Frame
    Baseline and Week 15
Full study description
brief Summary
The study will consist of two parts. In Part 1, the safety of pembrolizumab (MK-3475) in combination with one of three different chemotherapies will be assessed in the treatment of locally recurrent inoperable or metastatic triple negative breast cancer (TNBC), which has not been previously treated with chemotherapy. In Part 2, the safety and efficacy of pembrolizumab plus background chemotherapy will be assessed compared to the safety and efficacy of placebo plus background chemotherapy in the treatment of locally recurrent inoperable or metastatic TNBC, which has not been previously treated with chemotherapy. The primary hypotheses are that: 1. the combination of pembrolizumab and chemotherapy prolongs Progression-Free Survival (PFS) compared to placebo and chemotherapy in: * all participants, * participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 tumors, and * participants with PD-L1 CPS ≥10 tumors, and 2. the combination of pembrolizumab and chemotherapy prolongs Overall Survival (OS) compared to placebo and chemotherapy in: * all participants, * participants with PD-L1 CPS ≥1 tumors, and * participants with PD-L1 CPS ≥10 tumors.
Source references
references
  1. citation
    Rugo HS, Cescon DW, Schmid P, Nowecki Z, Im SA, Md Yusof M, Gallardo C, Iwata H, Lipatov O, Cruz F, Barrios CH, Hegg R, Loi S, Gion M, Otero MT, Arkosy P, Tarnawski R, Yao L, Mejia J, Pan W, Cortes J. Outcomes in KEYNOTE-355 after chemotherapy discontinuation before pembrolizumab discontinuation and with immune-mediated adverse events. NPJ Breast Cancer. 2026 Jun 26. doi: 10.1038/s41523-026-00971-8. Online ahead of print.
    pmid
    42362563
    type
    DERIVED
  2. citation
    Im SA, Cortes J, Cescon DW, Yusof MM, Iwata H, Masuda N, Takano T, Huang CS, Chung CF, Tsugawa K, Park YH, Matsumoto K, Inoue K, Kwong A, Loi S, Fu W, Pan W, Karantza V, Rugo HS, Schmid P. Results from the randomized KEYNOTE-355 study of pembrolizumab plus chemotherapy for Asian patients with advanced TNBC. NPJ Breast Cancer. 2024 Sep 12;10(1):79. doi: 10.1038/s41523-024-00679-7.
    pmid
    39266535
    type
    DERIVED
  3. citation
    Cortes J, Rugo HS, Cescon DW, Im SA, Yusof MM, Gallardo C, Lipatov O, Barrios CH, Perez-Garcia J, Iwata H, Masuda N, Torregroza Otero M, Gokmen E, Loi S, Guo Z, Zhou X, Karantza V, Pan W, Schmid P; KEYNOTE-355 Investigators. Pembrolizumab plus Chemotherapy in Advanced Triple-Negative Breast Cancer. N Engl J Med. 2022 Jul 21;387(3):217-226. doi: 10.1056/NEJMoa2202809.
    pmid
    35857659
    type
    DERIVED
  4. citation
    Cortes J, Cescon DW, Rugo HS, Nowecki Z, Im SA, Yusof MM, Gallardo C, Lipatov O, Barrios CH, Holgado E, Iwata H, Masuda N, Otero MT, Gokmen E, Loi S, Guo Z, Zhao J, Aktan G, Karantza V, Schmid P; KEYNOTE-355 Investigators. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE-355): a randomised, placebo-controlled, double-blind, phase 3 clinical trial. Lancet. 2020 Dec 5;396(10265):1817-1828. doi: 10.1016/S0140-6736(20)32531-9.
    pmid
    33278935
    type
    DERIVED
see Also Links
  1. label
    Merck Clinical Trial Information
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-14d4a6ef53571a7d296e
      requested nct id
      NCT02819518
      primary nct id
      NCT02819518
      source kind
      fda_spl_label
      source url
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      source file sha256
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      payload sha256
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      payload
      application numbers
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      clinical indication matching status
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      end exclusive
      true
      id
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      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
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      occurrences
      1. context exact
        L1 (CPS ≥10) The efficacy of KEYTRUDA in combination with paclitaxel, paclitaxel protein-bound, or gemcitabine and carboplatin was investigated in KEYNOTE-355 (NCT02819518), a multicenter, double-blind, randomized, placebo-controlled trial conducted in 847 patients with locally recurrent unresectable or metastatic TNBC, regardles
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      source file sha256
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      source json pointer
      /results/20/clinical_studies/0
      source kind
      fda_spl_label
      source record id
      228e1e3f-d207-481f-8e14-9fdcbd0470e9
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      8363db34593bf3be5a99cd9f3132c716fc77e783f32263bb73a3910d5da525da
      source url
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      spl effective time
      20260710
      spl set id
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    2. release id
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      edge id
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      requested nct id
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      primary nct id
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      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source file sha256
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      payload sha256
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      payload
      clinical indication matching status
      not_inferred
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      true
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      nct-edge-46cb219bd8b25cb34976
      link basis
      explicit_NCT_identifier_in_acquired_source
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      occurrences
      1. context exact
        ">Pembrolizumab</h5> <p id="_2479" tabindex="-1">The phase III, randomized, placebo-controlled, double-blind, multinational <a href="/clinicaltrials/NCT02819518">KEYNOTE-355</a> trial (NCT02819518) evaluated the addition of pembrolizumab to first-line chemotherapy in patients with metastatic TNBC. This combination was
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        exact text
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      2. context exact
        ="_2479" tabindex="-1">The phase III, randomized, placebo-controlled, double-blind, multinational <a href="/clinicaltrials/NCT02819518">KEYNOTE-355</a> trial (NCT02819518) evaluated the addition of pembrolizumab to first-line chemotherapy in patients with metastatic TNBC. This combination was approved for use in this patient pop
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      source kind
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      source retrieved at
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      source string basis
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      source string sha256
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      source title
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      1. context
        Updated: April 25, 2025
        datetime
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        display
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    3. release id
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      primary nct id
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      source kind
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      source url
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      source file sha256
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      payload sha256
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      payload
      application numbers
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      clinical indication matching status
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      link basis
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      occurrences
      1. context exact
        efficacy of intravenous pembrolizumab in combination with paclitaxel, paclitaxel protein-bound, or gemcitabine and carboplatin was investigated in KEYNOTE-355 (NCT02819518), a multicenter, double-blind, randomized, placebo-controlled trial conducted in 847 patients with locally recurrent unresectable or metastatic TNBC, regardles
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      source json pointer
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      source string basis
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      source string sha256
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      source url
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      spl effective time
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      spl set id
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    Preserved source evidence · Not medical advice