This study is in progress, not accepting new patients

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)

a study on Lung Cancer

Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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).

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

Keywords

Non-small Cell Lung Carcinoma PD-1 PD1 Programmed Cell Death-1 Programmed Cell Death 1 Chemotherapy Pemetrexed Paclitaxel Bevacizumab Erlotinib Gefitinib Ipilimumab Carboplatin Carcinoma Lung Neoplasms Carcinoma, Non-Small-Cell Lung Pembrolizumab Albumin-Bound Paclitaxel Erlotinib Hydrochloride Antibodies, Monoclonal

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

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

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Merck Sharp & Dohme Corp.
ID
NCT02039674
Phase
Phase 1/2
Lead Scientist
Matthew Gubens
Study Type
Interventional
Last Updated
December 12, 2017

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