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A Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy or Immunotherapy in Participants With Non-small Cell Lung Cancer (MK-3475-021/KEYNOTE-021)

NCT ID: NCT02039674

Last Updated: 2022-11-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-21

Study Completion Date

2021-10-18

Brief Summary

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The purpose of this study is to determine the safety, tolerability, and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy or immunotherapy in participants with unresectable or metastatic non-small cell lung cancer (NSCLC).

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Detailed Description

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Conditions

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Non-small Cell Lung Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1 Cohort A2 (Pembro2mg/kg+Paclitaxel [Pa]+Carboplatin [C])

Cohort A participants receive pembrolizumab (2 mg/kg) via intravenous (IV) infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (Aare Under the Curve \[AUC\] 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type BIOLOGICAL

IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy

Paclitaxel

Intervention Type DRUG

IV on Day 1 of each 3-week cycle for a maximum of 4 administrations

Carboplatin

Intervention Type DRUG

IV on Day 1 of each 3-week cycle for a maximum of 4 administrations

Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])

Cohort B2 participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type BIOLOGICAL

IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy

Paclitaxel

Intervention Type DRUG

IV on Day 1 of each 3-week cycle for a maximum of 4 administrations

Carboplatin

Intervention Type DRUG

IV on Day 1 of each 3-week cycle for a maximum of 4 administrations

Bevacizumab

Intervention Type BIOLOGICAL

IV on Day 1 of each 3-week cycle

Part 1 Cohort C2 (Pembro 2mg/kg+Pemetrexed [Pe]+C)

Cohort C2 participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type BIOLOGICAL

IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy

Carboplatin

Intervention Type DRUG

IV on Day 1 of each 3-week cycle for a maximum of 4 administrations

Pemetrexed

Intervention Type DRUG

IV on Day 1 of each 3-week cycle

Part 1 Cohort D1 (Pembro 10mg/kg+Ipilimumab [I])

Cohort D1 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type BIOLOGICAL

IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy

Ipilimumab

Intervention Type BIOLOGICAL

IV on Day 1 of each 3-week cycle for a maximum of 4 administrations

Part 1 Cohort E (Pembro 2mg/kg+Erlotinib)

Cohort E participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (150 mg) via oral tablet once a day on every day of each 3-week cycle.

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type BIOLOGICAL

IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy

Erlotinib

Intervention Type DRUG

Orally tablet once daily

Part 1 Cohort F (Pembro 2mg/kg+Gefitinib)

Cohort F participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (250 mg) via oral tablet once a day on every day of each 3-week cycle.

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type BIOLOGICAL

IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy

Gefitinib

Intervention Type DRUG

Oral tablet once daily

Part 2 Cohort G+ (Pembro 200mg+C+Pe)

Cohort G+ participants receive pembrolizumab (200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle.

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type BIOLOGICAL

IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy

Carboplatin

Intervention Type DRUG

IV on Day 1 of each 3-week cycle for a maximum of 4 administrations

Pemetrexed

Intervention Type DRUG

IV on Day 1 of each 3-week cycle

Part 2 Cohort H (Pembro+I)

Cohort H participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase II dose determined in Cohort D).

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type BIOLOGICAL

IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy

Ipilimumab

Intervention Type BIOLOGICAL

IV on Day 1 of each 3-week cycle for a maximum of 4 administrations

Part 1 Cohort A10 (Pembro+Paclitaxel [Pa]+Carboplatin [C])

Cohort A10 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 6 \[mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type BIOLOGICAL

IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy

Paclitaxel

Intervention Type DRUG

IV on Day 1 of each 3-week cycle for a maximum of 4 administrations

Carboplatin

Intervention Type DRUG

IV on Day 1 of each 3-week cycle for a maximum of 4 administrations

Part 1 Cohort B10 (Pembro+Pa+C+Bevacizumab [B])

Cohort B10 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (200 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 6 \[6 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type BIOLOGICAL

IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy

Paclitaxel

Intervention Type DRUG

IV on Day 1 of each 3-week cycle for a maximum of 4 administrations

Carboplatin

Intervention Type DRUG

IV on Day 1 of each 3-week cycle for a maximum of 4 administrations

Bevacizumab

Intervention Type BIOLOGICAL

IV on Day 1 of each 3-week cycle

Part 1 Cohort C10 (Pembro 10mg/kg+Pemetrexed [Pe]+C)

Cohort C10 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle.

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type BIOLOGICAL

IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy

Carboplatin

Intervention Type DRUG

IV on Day 1 of each 3-week cycle for a maximum of 4 administrations

Pemetrexed

Intervention Type DRUG

IV on Day 1 of each 3-week cycle

Part 2 Cohort G- (Placebo+C+Pe)

Cohort G- participants receive placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (AUC 5 \[5 mg/mL/min\]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (500 mg/m\^2) via IV infusion on Day 1 of each 3-week cycle PLUS.

Group Type EXPERIMENTAL

Carboplatin

Intervention Type DRUG

IV on Day 1 of each 3-week cycle for a maximum of 4 administrations

Pemetrexed

Intervention Type DRUG

IV on Day 1 of each 3-week cycle

Part 1 Cohort D2 (Pembro 10mg/kg+Ipilimumab [I])

Cohort D2 participants receive pembrolizumab (10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type BIOLOGICAL

IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy

Ipilimumab

Intervention Type BIOLOGICAL

IV on Day 1 of each 3-week cycle for a maximum of 4 administrations

Part 1 Cohort D4 (Pembro 2mg/kg+Ipilimumab [I])

Cohort D1 participants receive pembrolizumab (2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type BIOLOGICAL

IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy

Ipilimumab

Intervention Type BIOLOGICAL

IV on Day 1 of each 3-week cycle for a maximum of 4 administrations

Interventions

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Pembrolizumab

IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy

Intervention Type BIOLOGICAL

Paclitaxel

IV on Day 1 of each 3-week cycle for a maximum of 4 administrations

Intervention Type DRUG

Carboplatin

IV on Day 1 of each 3-week cycle for a maximum of 4 administrations

Intervention Type DRUG

Bevacizumab

IV on Day 1 of each 3-week cycle

Intervention Type BIOLOGICAL

Pemetrexed

IV on Day 1 of each 3-week cycle

Intervention Type DRUG

Ipilimumab

IV on Day 1 of each 3-week cycle for a maximum of 4 administrations

Intervention Type BIOLOGICAL

Erlotinib

Orally tablet once daily

Intervention Type DRUG

Gefitinib

Oral tablet once daily

Intervention Type DRUG

Other Intervention Names

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MK-3475 KEYTRUDA® SCH 900475 ABRAXANE® PARAPLATIN® AVASTIN® ALIMTA® YERVOY® TARCEVA® IRESSA®

Eligibility Criteria

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Inclusion Criteria

* Stage IIIb/IV NSCLC
* Disease progression \>1 year after completing adjuvant therapy for Stage I-IIIA disease and no systemic therapy for the recurrent disease
* Resolution of any toxic effects (excepting alopecia) of the most recent therapy
* At least one radiographically measurable lesion
* Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status scale
* Female participants of reproductive potential must not be pregnant (negative urine or serum human chorionic gonadotropin test within 72 hours of study start)
* Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 120 days after the last dose of study therapy and for up to 180 days after the last dose of chemotherapeutic agents or tyrosine kinase inhibitors

Exclusion Criteria

* Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of administration of pembrolizumab
* Expected to require any other form of antineoplastic therapy while on study
* Is on chronic systemic steroid therapy or on any other form of immunosuppressive medication
* Has received a live-virus vaccination within 30 days of planned treatment start
* Clinically active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, or abdominal carcinomatosis (known risks factors for bowel perforation)
* History of a hematologic malignancy, primary brain tumor or sarcoma, or of another primary solid tumor, unless the participant has undergone potentially curative therapy with no evidence of that disease for 5 years
* Active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
* Active autoimmune disease that has required systemic treatment in the past 2 years (replacement therapies for hormone deficiencies are allowed)
* Prior treatment with any other anti-programmed cell death protein-1 (anti-PD-1), or PD Ligand-1 (PD-L1) or PD Ligand-2 (PD-L2) agent or an antibody targeting other immuno-regulatory receptors or mechanisms
* Systemic cytotoxic chemotherapy, antineoplastic biologic therapy, or major surgery within 3 weeks of the first dose of study medication
* Radiation therapy to lung \>30 Gy within 6 months of first dose of study medication
* Prior tyrosine kinase inhibitor therapy or palliative radiation within 7 days of first dose of study medication
* Active infection requiring therapy
* History of Human Immunodeficiency Virus (HIV)
* Active Hepatitis B or C
* Symptomatic ascites or pleural effusion
* Interstitial lung disease or pneumonitis requiring oral or IV glucocorticoids
* Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study
* Psychiatric disorders and substance (drug/alcohol) abuse
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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Langer CJ, Gadgeel SM, Borghaei H, Papadimitrakopoulou VA, Patnaik A, Powell SF, Gentzler RD, Martins RG, Stevenson JP, Jalal SI, Panwalkar A, Yang JC, Gubens M, Sequist LV, Awad MM, Fiore J, Ge Y, Raftopoulos H, Gandhi L; KEYNOTE-021 investigators. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol. 2016 Nov;17(11):1497-1508. doi: 10.1016/S1470-2045(16)30498-3. Epub 2016 Oct 10.

Reference Type RESULT
PMID: 27745820 (View on PubMed)

Borghaei H, Langer CJ, Gadgeel S, Papadimitrakopoulou VA, Patnaik A, Powell SF, Gentzler RD, Martins RG, Stevenson JP, Jalal SI, Panwalkar A, Yang JC, Gubens M, Sequist LV, Awad MM, Fiore J, Saraf S, Keller SM, Gandhi L. 24-Month Overall Survival from KEYNOTE-021 Cohort G: Pemetrexed and Carboplatin with or without Pembrolizumab as First-Line Therapy for Advanced Nonsquamous Non-Small Cell Lung Cancer. J Thorac Oncol. 2019 Jan;14(1):124-129. doi: 10.1016/j.jtho.2018.08.004. Epub 2018 Aug 21.

Reference Type RESULT
PMID: 30138764 (View on PubMed)

Cheng Y, Yang JC, Okamoto I, Zhang L, Hu J, Wang D, Hu C, Zhou J, Wu L, Cao L, Liu J, Zhang H, Sun H, Wang Z, Gao H, Yan Y, Xiao S, Lin J, Pietanza MC, Kurata T. Pembrolizumab plus chemotherapy for advanced non-small-cell lung cancer without tumor PD-L1 expression in Asia. Immunotherapy. 2023 Sep;15(13):1029-1044. doi: 10.2217/imt-2023-0043. Epub 2023 Jul 19.

Reference Type DERIVED
PMID: 37465924 (View on PubMed)

Yang JC, Gadgeel SM, Sequist LV, Wu CL, Papadimitrakopoulou VA, Su WC, Fiore J, Saraf S, Raftopoulos H, Patnaik A. Pembrolizumab in Combination With Erlotinib or Gefitinib as First-Line Therapy for Advanced NSCLC With Sensitizing EGFR Mutation. J Thorac Oncol. 2019 Mar;14(3):553-559. doi: 10.1016/j.jtho.2018.11.028. Epub 2018 Dec 4.

Reference Type DERIVED
PMID: 30529597 (View on PubMed)

Gadgeel SM, Stevenson JP, Langer CJ, Gandhi L, Borghaei H, Patnaik A, Villaruz LC, Gubens M, Hauke R, Yang JC, Sequist LV, Bachman R, Saraf S, Raftopoulos H, Papadimitrakopoulou V. Pembrolizumab and platinum-based chemotherapy as first-line therapy for advanced non-small-cell lung cancer: Phase 1 cohorts from the KEYNOTE-021 study. Lung Cancer. 2018 Nov;125:273-281. doi: 10.1016/j.lungcan.2018.08.019. Epub 2018 Aug 25.

Reference Type DERIVED
PMID: 30429032 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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http://merckoncologyclinicaltrials.com

Merck Oncology Clinical Trials Information

Other Identifiers

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MK-3475-021

Identifier Type: OTHER

Identifier Source: secondary_id

KEYNOTE-021

Identifier Type: OTHER

Identifier Source: secondary_id

3475-021

Identifier Type: -

Identifier Source: org_study_id

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