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Trial record 1 of 1 for:    KEYNOTE 021
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A Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy or Immunotherapy in Participants With Lung Cancer (MK-3475-021/KEYNOTE-021)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT02039674
First received: January 16, 2014
Last updated: March 17, 2017
Last verified: March 2017
  Purpose
The purpose of this study is to determine 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

Condition Intervention Phase
Non-small Cell Lung Carcinoma Biological: Pembrolizumab Drug: Paclitaxel Drug: Carboplatin Biological: Bevacizumab Drug: Pemetrexed Biological: Ipilimumab Drug: Erlotinib Drug: Gefitinib Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase I/II Study of MK-3475 (SCH900475) in Combination With Chemotherapy or Immunotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Part II, Cohort G: Objective Response Rate [ Time Frame: Up to 2 years ]
  • Part II, Cohort H: Objective Response Rate [ Time Frame: Up to 2 years ]
  • Part I, All Cohorts: the recommended Phase II dose for pembrolizumab in combination with chemotherapy or immunotherapy [ Time Frame: Up to 2 years ]

Secondary Outcome Measures:
  • Part II, Cohort G: Overall survival (OS) [ Time Frame: Up to 2 years ]
  • Part II, Cohort G: Progression-Free Survival (PFS) [ Time Frame: up to 2 years ]
  • Part II, Cohort G: Duration of Response (DOR) [ Time Frame: up to 2 years ]

Estimated Enrollment: 308
Study Start Date: February 2014
Estimated Study Completion Date: October 2019
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part I, Cohort A (Pembro + Paclitaxel [Pa] + Carboplatin [C])
pembrolizumab (2 or 10 mg/kg) + paclitaxel (200 mg/m^2) + carboplatin (6 mg/mL/minute)
Biological: Pembrolizumab
intravenously (IV) every 3 weeks (Q3W) on Day 1 of each cycle prior to chemo/immunotherapy
Drug: Paclitaxel
IV Q3W on Day 1 of each cycle
Drug: Carboplatin
IV Q3W on Day 1 of each cycle
Experimental: Part I, Cohort B (Pembro + Pa + C+ Bevacizumab [B])
pembrolizumab (2 or 10 mg/kg) + paclitaxel (200 mg/m^2) + carboplatin (6 mg/mL/minute) + bevacizumab (15 mg/kg)
Biological: Pembrolizumab
intravenously (IV) every 3 weeks (Q3W) on Day 1 of each cycle prior to chemo/immunotherapy
Drug: Paclitaxel
IV Q3W on Day 1 of each cycle
Drug: Carboplatin
IV Q3W on Day 1 of each cycle
Biological: Bevacizumab
IV Q3W on Day 1 of each cycle
Experimental: Part I, Cohort C (Pembro + Pemetrexed [Pe] + C)
pembrolizumab (2 or 10 mg/kg) + pemetrexed (500 mgm^2) + carboplatin (5 mg/mL/min)
Biological: Pembrolizumab
intravenously (IV) every 3 weeks (Q3W) on Day 1 of each cycle prior to chemo/immunotherapy
Drug: Carboplatin
IV Q3W on Day 1 of each cycle
Drug: Pemetrexed
IV Q3W on Day 1 of each cycle
Experimental: Part I, Cohort D (Pembro + Ipilimumab [I])
pembrolizumab (2 mg/kg) + Ipilimumab (0.3, 1, or 3 mg/kg)
Biological: Pembrolizumab
intravenously (IV) every 3 weeks (Q3W) on Day 1 of each cycle prior to chemo/immunotherapy
Biological: Ipilimumab
IV Q3W on Day 1 of each cycle
Experimental: Part I, Cohort E (Pembro + Erlotinib)
pembrolizumab (2 mg/kg) + erlotinib (150 mg)
Biological: Pembrolizumab
intravenously (IV) every 3 weeks (Q3W) on Day 1 of each cycle prior to chemo/immunotherapy
Drug: Erlotinib
Orally (po) daily (QD)
Experimental: Part I, Cohort F (Pembro + Gefitinib)
pembrolizumab (2 mg/kg) + gefitinib (250 mg)
Biological: Pembrolizumab
intravenously (IV) every 3 weeks (Q3W) on Day 1 of each cycle prior to chemo/immunotherapy
Drug: Gefitinib
po QD
Experimental: Part II, Cohort G (C + Pe With/without Pembro)
Cohorts G1 and G2: carboplatin AUC 5 (5 mg/mL/min) + pemetrexed 500 mg/m^2, IV Q3W on Day 1 of each cycle; or carboplatin AUC 5 (5 mg/mL/min) + pemetrexed 500 mg/m^2 + pembrolizumab 200 mg, IV Q3W on Day 1 of each cycle
Biological: Pembrolizumab
intravenously (IV) every 3 weeks (Q3W) on Day 1 of each cycle prior to chemo/immunotherapy
Drug: Carboplatin
IV Q3W on Day 1 of each cycle
Drug: Pemetrexed
IV Q3W on Day 1 of each cycle
Experimental: Part II, Cohort H (Pembro + I)
Pembrolizumab + ipilimumab at recommended Phase II dose determined in Cohort D
Biological: Pembrolizumab
intravenously (IV) every 3 weeks (Q3W) on Day 1 of each cycle prior to chemo/immunotherapy
Biological: Ipilimumab
IV Q3W on Day 1 of each cycle

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02039674

Locations
United States, California
Call for Information (Investigational Site 0018)
La Jolla, California, United States, 92037
Call for Information (Investigational Site 0010)
San Francisco, California, United States, 94115
United States, Indiana
Call for Information (Investigational Site 0019)
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Call for Information (Investigational Site 0017)
Boston, Massachusetts, United States, 02114
Call for Information (Investigational Site 0002)
Boston, Massachusetts, United States, 02215
Call for Information (Investigational Site 0016)
Boston, Massachusetts, United States, 02215
United States, Nebraska
Call for Information (Investigational Site 0023)
Omaha, Nebraska, United States, 68130
United States, New Jersey
Call for Information (Investigational Site 0055)
Hackensack, New Jersey, United States, 07601
United States, New York
Call for Information (Investigational Site 0056)
Lake Success, New York, United States, 11042
United States, Pennsylvania
Call for Information (Investigational Site 0009)
Philadelphia, Pennsylvania, United States, 19104
Call for Information (Investigational Site 0015)
Philadelphia, Pennsylvania, United States, 19104
Call for Information (Investigational Site 0004)
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
Call for Information (Investigational Site 0007)
Houston, Texas, United States, 77030
Call for Information (Investigational Site 0003)
San Antonio, Texas, United States, 78229
Taiwan
Merck Sharp & Dohme (I.A.) Corp.
Taipei, Taiwan
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02039674     History of Changes
Other Study ID Numbers: 3475-021
Study First Received: January 16, 2014
Last Updated: March 17, 2017

Keywords provided by Merck Sharp & Dohme Corp.:
PD-1
PD1
Programmed Cell Death-1
Programmed Cell Death 1

Additional relevant MeSH terms:
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Pembrolizumab
Gefitinib
Albumin-Bound Paclitaxel
Bevacizumab
Carboplatin
Erlotinib Hydrochloride
Pemetrexed
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on July 24, 2017