A Study of Pembrolizumab (MK-3475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for Participants With Extensive Stage Small Cell Lung Cancer (MK-3475-604/KEYNOTE-604)

Description

The purpose of this study is to assess the safety and efficacy of pembrolizumab plus standard of care (SOC) chemotherapy (etoposide/platinum [EP]) in participants with newly diagnosed extensive stage small cell lung cancer (ES-SCLC) who have not previously received systemic therapy for this malignancy. The primary study hypotheses are that pembrolizumab+EP prolongs Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) and Overall Survival (OS) compared with placebo+EP in adult participants with ES-SCLC.

Study Start Date

May, 02 2017

Estimated Completion Date

October 2021

Interventions

  • Drug: Normal saline solution
  • Drug: Cisplatin
  • Biological: Pembrolizumab
  • Drug: Etoposide
  • Drug: Carboplatin

Study ID

Merck Sharp & Dohme Corp. -- 3475-604

Status

Recruiting

Trial ID

NCT03066778

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

430

Sponsor

Merck Sharp & Dohme Corp.

Inclusion Criteria

  • Has a documented new diagnosis of SCLC by histology or cytology from brushing, washing, or needle aspiration of a defined lesion. Participants who do not have histology samples (defined as core or excisional biopsy, or resections) will need to undergo a new biopsy to provide a tissue sample.
  • Has extensive-stage disease defined as Stage IV (T any, N any, M 1a/b) by the American Joint Committee on Cancer (AJCC), Seventh Edition
  • Has ?1 lesion that meets the criteria for measurable, as defined by RECIST 1.1, and is appropriate for selection as a target lesion, as determined by local site investigator/radiology assessment
  • Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
  • Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Has a life expectancy of ?3 months
  • Has adequate organ function
  • Female and male participants of childbearing potential must be willing to use an adequate method of contraception, starting with the first dose of study treatment through 120 days after the last dose of study treatment and up to 180 days after last dose of chemotherapeutic agents

Exclusion Criteria

  • Has received prior systemic therapy for the treatment of SCLC
  • Is currently participating and receiving study treatment or has participated in a study of an investigational agent and received study treatment or used an investigational device within 4 weeks of the first dose of treatment for another health-related problem
  • Is expected to require any other form of antineoplastic therapy for SCLC, including radiation therapy, while on study. (Prophylactic cranial irradiation will be possible for those participants with stable disease or better at the completion of the 4 cycles of chemotherapy with or without pembrolizumab.)
  • Has known central nervous system (CNS)(i.e., brain and/or spinal cord) metastases and/or carcinomatous meningitis. Participants with brain metastases may participate only if they satisfy all of the following:
  • Has completed treatment (eg, whole brain radiation treatment [WBRT], stereotactic radiosurgery, or equivalent) ?14 days prior to the first dose of study treatment,
  • Has no evidence of new or enlarging brain metastases confirmed by post-treatment repeat brain imaging performed ?3 weeks after pre-treatment brain imaging, and
  • Is neurologically stable without the need for steroids for ?7 days before first dose of study treatment.
  • Has had major surgery within 3 weeks prior to receiving the first dose of study treatment or has not recovered adequately from toxicity and/or complications from an intervention prior to receiving the first dose of study treatment.
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
  • Has a known history of interstitial lung disease
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic treatment.
  • Has a known history of, or active, neurologic paraneoplastic syndrome
  • Has clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, and/or abdominal carcinomatosis
  • Has a history of a severe hypersensitivity reaction to treatment with another monoclonal antibody
  • Is taking chronic systemic steroids (in doses exceeding 10 mg daily of prednisone equivalent) within 7 days prior to the first dose of study treatment
  • Has a diagnosis of immunodeficiency or is receiving any form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
  • Has received a live vaccine within 30 days prior to the first dose of study treatment
  • Has received prior therapy with an anti-programmed cell death protein-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-programmed cell death-ligand 2 (anti-PD-L2) agent or with an agent directed to another co-inhibitory T-cell receptor (i.e., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], tumor necrosis factor receptor superfamily member 9 [TNFRSF9, OX-40, CD137]) or has previously participated in a Merck pembrolizumab (MK-3475) clinical trial
  • Has severe hypersensitivity (Grade ?3) to pembrolizumab and/or any of its excipients
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Has a known history of Hepatitis B or known active Hepatitis C virus infection
  • Has a known history of active TB (Bacillus Tuberculosis)
  • Has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco
  • or paracentesis) is eligible.
  • 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 after the last dose of study treatment through and up to 180 days after last dose of chemotherapeutic agents

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (132)

Study Location Distance Name Phone Email
Beth Israel Deaconess Medical Center Site 1206 - Boston, Massachusetts 2.4 miles Study Coordinator 617-632-3468 None
DanaFarber Cancer Institute Boston Site 1201 - Boston, Massachusetts 2.4 miles Study Coordinator 617-632-3468 None
Beth Israel Deaconess Medical Center Site 1206 - Boston, Massachusetts 2.4 miles Study Coordinator 617-632-3468 None
DanaFarber Cancer Institute Boston Site 1201 - Boston, Massachusetts 2.4 miles Study Coordinator 617-632-3468 None
Beth Israel Deaconess Medical Center Site 1206 - Boston, Massachusetts 2.4 miles Study Coordinator 617-632-3468 None
Beth Israel Deaconess Medical Center Site 1206 - Boston, Massachusetts 2.4 miles Study Coordinator 617-632-3468 None
Beth Israel Deaconess Medical Center Site 1206 - Boston, Massachusetts 2.4 miles Study Coordinator 617-632-3468 None
DanaFarber Cancer Institute Boston Site 1201 - Boston, Massachusetts 2.4 miles Study Coordinator 617-632-3468 None
DanaFarber Cancer Institute Boston Site 1201 - Boston, Massachusetts 2.4 miles Study Coordinator 617-632-3468 None
Beth Israel Deaconess Medical Center Site 1206 - Boston, Massachusetts 2.4 miles Study Coordinator 617-632-3468 None
DanaFarber Cancer Institute Boston Site 1201 - Boston, Massachusetts 2.4 miles Study Coordinator 617-632-3468 None
DanaFarber Cancer Institute Boston Site 1201 - Boston, Massachusetts 2.4 miles Study Coordinator 617-632-3468 None
Massachusetts General Hospital Site 1203 - Boston, Massachusetts 2.8 miles Study Coordinator 617-632-3468 None
Massachusetts General Hospital Site 1203 - Boston, Massachusetts 2.8 miles Study Coordinator 617-632-3468 None
Massachusetts General Hospital Site 1203 - Boston, Massachusetts 2.8 miles Study Coordinator 617-632-3468 None
Massachusetts General Hospital Site 1203 - Boston, Massachusetts 2.8 miles Study Coordinator 617-632-3468 None
Massachusetts General Hospital Site 1203 - Boston, Massachusetts 2.8 miles Study Coordinator 617-632-3468 None
Massachusetts General Hospital Site 1203 - Boston, Massachusetts 2.8 miles Study Coordinator 617-632-3468 None
Memorial SloanKettering Cancer Center at Commack Site 1227 - Commack, New York 154.4 miles Study Coordinator 646-888-4527 None
Memorial SloanKettering Cancer Center at Commack Site 1227 - Commack, New York 154.4 miles Study Coordinator 646-888-4527 None
Memorial SloanKettering Cancer Center at Commack Site 1227 - Commack, New York 154.4 miles Study Coordinator 646-888-4527 None
Memorial SloanKettering Cancer Center at Commack Site 1227 - Commack, New York 154.4 miles Study Coordinator 646-888-4527 None
Memorial SloanKettering Cancer Center at Commack Site 1227 - Commack, New York 154.4 miles Study Coordinator 646-888-4527 None
Memorial SloanKettering Cancer Center at Commack Site 1227 - Commack, New York 154.4 miles Study Coordinator 646-888-4527 None
Memorial Sloan Kettering Cancer Center Site 1229 - Harrison, New York 164.7 miles Study Coordinator 646-888-4527 None
Memorial Sloan Kettering Cancer Center Site 1229 - Harrison, New York 164.7 miles Study Coordinator 646-888-4527 None
Memorial Sloan Kettering Cancer Center Site 1229 - Harrison, New York 164.7 miles Study Coordinator 646-888-4527 None
Memorial Sloan Kettering Cancer Center Site 1229 - Harrison, New York 164.7 miles Study Coordinator 646-888-4527 None
Memorial Sloan Kettering Cancer Center Site 1229 - Harrison, New York 164.7 miles Study Coordinator 646-888-4527 None
Memorial Sloan Kettering Cancer Center Site 1229 - Harrison, New York 164.7 miles Study Coordinator 646-888-4527 None
Memorial Sloan Kettering Cancer Center Rockville Centre Site 1228 - Rockville Center, New York 176.5 miles Study Coordinator 646-888-4527 None
Memorial Sloan Kettering Cancer Center Rockville Centre Site 1228 - Rockville Center, New York 176.5 miles Study Coordinator 646-888-4527 None
Memorial Sloan Kettering Cancer Center Rockville Centre Site 1228 - Rockville Center, New York 176.5 miles Study Coordinator 646-888-4527 None
Memorial Sloan Kettering Cancer Center Rockville Centre Site 1228 - Rockville Center, New York 176.5 miles Study Coordinator 646-888-4527 None
Memorial Sloan Kettering Cancer Center Rockville Centre Site 1228 - Rockville Center, New York 176.5 miles Study Coordinator 646-888-4527 None
Memorial Sloan Kettering Cancer Center Rockville Centre Site 1228 - Rockville Center, New York 176.5 miles Study Coordinator 646-888-4527 None
Montefiore Einstein Center for Cancer Care Main site Site 1204 - The Bronx, New York 176.6 miles Study Coordinator 718-405-8404 None
Montefiore Einstein Center for Cancer Care Main site Site 1204 - The Bronx, New York 176.6 miles Study Coordinator 718-405-8404 None
Montefiore Einstein Center for Cancer Care Main site Site 1204 - The Bronx, New York 176.6 miles Study Coordinator 718-405-8404 None
Montefiore Einstein Center for Cancer Care Main site Site 1204 - The Bronx, New York 176.6 miles Study Coordinator 718-405-8404 None
Montefiore Einstein Center for Cancer Care Main site Site 1204 - The Bronx, New York 176.6 miles Study Coordinator 718-405-8404 None
Montefiore Einstein Center for Cancer Care Main site Site 1204 - The Bronx, New York 176.6 miles Study Coordinator 718-405-8404 None
Montefiore Medical Center Site 1222 - The Bronx, New York 176.6 miles Study Coordinator 718-405-8404 None
Montefiore Medical Center Site 1222 - The Bronx, New York 176.6 miles Study Coordinator 718-405-8404 None
Montefiore Medical Center Site 1222 - The Bronx, New York 176.6 miles Study Coordinator 718-405-8404 None
Montefiore Medical Center Site 1222 - The Bronx, New York 176.6 miles Study Coordinator 718-405-8404 None
Montefiore Medical Center Site 1222 - The Bronx, New York 176.6 miles Study Coordinator 718-405-8404 None
Montefiore Medical Center Site 1222 - The Bronx, New York 176.6 miles Study Coordinator 718-405-8404 None
Memorial Sloan Kettering Cancer Center Site 1211 - New York, New York 187.1 miles Study Coordinator 646-888-4527 None
Memorial Sloan Kettering Cancer Center Site 1211 - New York, New York 187.1 miles Study Coordinator 646-888-4527 None
Memorial Sloan Kettering Cancer Center Site 1211 - New York, New York 187.1 miles Study Coordinator 646-888-4527 None
Memorial Sloan Kettering Cancer Center Site 1211 - New York, New York 187.1 miles Study Coordinator 646-888-4527 None
Memorial Sloan Kettering Cancer Center Site 1211 - New York, New York 187.1 miles Study Coordinator 646-888-4527 None
Memorial Sloan Kettering Cancer Center Site 1211 - New York, New York 187.1 miles Study Coordinator 646-888-4527 None
Memorial Sloan Kettering Cancer Center Monmouth Site 1225 - Middletown, New Jersey 207.4 miles Study Coordinator 646-888-4527 None
Memorial Sloan Kettering Cancer Center Monmouth Site 1225 - Middletown, New Jersey 207.4 miles Study Coordinator 646-888-4527 None
Memorial Sloan Kettering Cancer Center Monmouth Site 1225 - Middletown, New Jersey 207.4 miles Study Coordinator 646-888-4527 None
Memorial Sloan Kettering Cancer Center Monmouth Site 1225 - Middletown, New Jersey 207.4 miles Study Coordinator 646-888-4527 None
Memorial Sloan Kettering Cancer Center Monmouth Site 1225 - Middletown, New Jersey 207.4 miles Study Coordinator 646-888-4527 None
Memorial Sloan Kettering Cancer Center Monmouth Site 1225 - Middletown, New Jersey 207.4 miles Study Coordinator 646-888-4527 None
Memorial SloanKettering Cancer Center At Basking Ridge Site 1226 - Basking Ridge, New Jersey 214.0 miles Study Coordinator 646-888-4527 None
Memorial SloanKettering Cancer Center At Basking Ridge Site 1226 - Basking Ridge, New Jersey 214.0 miles Study Coordinator 646-888-4527 None
Memorial SloanKettering Cancer Center At Basking Ridge Site 1226 - Basking Ridge, New Jersey 214.0 miles Study Coordinator 646-888-4527 None
Memorial SloanKettering Cancer Center At Basking Ridge Site 1226 - Basking Ridge, New Jersey 214.0 miles Study Coordinator 646-888-4527 None
Memorial SloanKettering Cancer Center At Basking Ridge Site 1226 - Basking Ridge, New Jersey 214.0 miles Study Coordinator 646-888-4527 None
Memorial SloanKettering Cancer Center At Basking Ridge Site 1226 - Basking Ridge, New Jersey 214.0 miles Study Coordinator 646-888-4527 None
Weinberg Cancer Institute at Franklin Square Site 1210 - Baltimore, Maryland 352.0 miles Study Coordinator 443-777-7147 None
Weinberg Cancer Institute at Franklin Square Site 1210 - Baltimore, Maryland 352.0 miles Study Coordinator 443-777-7147 None
Weinberg Cancer Institute at Franklin Square Site 1210 - Baltimore, Maryland 352.0 miles Study Coordinator 443-777-7147 None
Weinberg Cancer Institute at Franklin Square Site 1210 - Baltimore, Maryland 352.0 miles Study Coordinator 443-777-7147 None
Weinberg Cancer Institute at Franklin Square Site 1210 - Baltimore, Maryland 352.0 miles Study Coordinator 443-777-7147 None
Weinberg Cancer Institute at Franklin Square Site 1210 - Baltimore, Maryland 352.0 miles Study Coordinator 443-777-7147 None
Henry Ford Health System Site 1221 - Detroit, Michigan 612.3 miles Study Coordinator 313-916-1784 None
Henry Ford Health System Site 1221 - Detroit, Michigan 612.3 miles Study Coordinator 313-916-1784 None
Henry Ford Health System Site 1221 - Detroit, Michigan 612.3 miles Study Coordinator 313-916-1784 None
Henry Ford Health System Site 1221 - Detroit, Michigan 612.3 miles Study Coordinator 313-916-1784 None
Henry Ford Health System Site 1221 - Detroit, Michigan 612.3 miles Study Coordinator 313-916-1784 None
Henry Ford Health System Site 1221 - Detroit, Michigan 612.3 miles Study Coordinator 313-916-1784 None
Bon Secours St Francis Health Sytem Site 1212 - Greenville, South Carolina 800.4 miles Study Coordinator 864-255-1591 None
Bon Secours St Francis Health Sytem Site 1212 - Greenville, South Carolina 800.4 miles Study Coordinator 864-255-1591 None
Bon Secours St Francis Health Sytem Site 1212 - Greenville, South Carolina 800.4 miles Study Coordinator 864-255-1591 None
Bon Secours St Francis Health Sytem Site 1212 - Greenville, South Carolina 800.4 miles Study Coordinator 864-255-1591 None
Bon Secours St Francis Health Sytem Site 1212 - Greenville, South Carolina 800.4 miles Study Coordinator 864-255-1591 None
Bon Secours St Francis Health Sytem Site 1212 - Greenville, South Carolina 800.4 miles Study Coordinator 864-255-1591 None
Community Hospital Site 1207 - Munster, Indiana 845.3 miles Study Coordinator 219-924-8178 None
Community Hospital Site 1207 - Munster, Indiana 845.3 miles Study Coordinator 219-924-8178 None
Community Hospital Site 1207 - Munster, Indiana 845.3 miles Study Coordinator 219-924-8178 None
Community Hospital Site 1207 - Munster, Indiana 845.3 miles Study Coordinator 219-924-8178 None
Community Hospital Site 1207 - Munster, Indiana 845.3 miles Study Coordinator 219-924-8178 None
Community Hospital Site 1207 - Munster, Indiana 845.3 miles Study Coordinator 219-924-8178 None
North Shore University Health System Site 1216 - Evanston, Illinois 850.4 miles Study Coordinator 847-570-2515 None
North Shore University Health System Site 1216 - Evanston, Illinois 850.4 miles Study Coordinator 847-570-2515 None
North Shore University Health System Site 1216 - Evanston, Illinois 850.4 miles Study Coordinator 847-570-2515 None
North Shore University Health System Site 1216 - Evanston, Illinois 850.4 miles Study Coordinator 847-570-2515 None
North Shore University Health System Site 1216 - Evanston, Illinois 850.4 miles Study Coordinator 847-570-2515 None
North Shore University Health System Site 1216 - Evanston, Illinois 850.4 miles Study Coordinator 847-570-2515 None
Mercy Hospital Saint Louis Site 1213 - Saint Louis, Missouri 1,048.4 miles Study Coordinator 314-251-7057 None
Mercy Hospital Saint Louis Site 1213 - Saint Louis, Missouri 1,048.4 miles Study Coordinator 314-251-7057 None
Mercy Hospital Saint Louis Site 1213 - Saint Louis, Missouri 1,048.4 miles Study Coordinator 314-251-7057 None
Mercy Hospital Saint Louis Site 1213 - Saint Louis, Missouri 1,048.4 miles Study Coordinator 314-251-7057 None
Mercy Hospital Saint Louis Site 1213 - Saint Louis, Missouri 1,048.4 miles Study Coordinator 314-251-7057 None
Mercy Hospital Saint Louis Site 1213 - Saint Louis, Missouri 1,048.4 miles Study Coordinator 314-251-7057 None
Minnesota Oncology Hematology PA Site 8001 - Minneapolis, Minnesota 1,121.3 miles Study Coordinator 612-884-6300 None
Minnesota Oncology Hematology PA Site 8001 - Minneapolis, Minnesota 1,121.3 miles Study Coordinator 612-884-6300 None
Minnesota Oncology Hematology PA Site 8001 - Minneapolis, Minnesota 1,121.3 miles Study Coordinator 612-884-6300 None
Minnesota Oncology Hematology PA Site 8001 - Minneapolis, Minnesota 1,121.3 miles Study Coordinator 612-884-6300 None
Minnesota Oncology Hematology PA Site 8001 - Minneapolis, Minnesota 1,121.3 miles Study Coordinator 612-884-6300 None
Minnesota Oncology Hematology PA Site 8001 - Minneapolis, Minnesota 1,121.3 miles Study Coordinator 612-884-6300 None
Hattiesburg Clinic Site 1205 - Hattiesburg, Mississippi 1,263.7 miles Study Coordinator 601-261-1700 None
Hattiesburg Clinic Site 1205 - Hattiesburg, Mississippi 1,263.7 miles Study Coordinator 601-261-1700 None
Hattiesburg Clinic Site 1205 - Hattiesburg, Mississippi 1,263.7 miles Study Coordinator 601-261-1700 None
Hattiesburg Clinic Site 1205 - Hattiesburg, Mississippi 1,263.7 miles Study Coordinator 601-261-1700 None
Hattiesburg Clinic Site 1205 - Hattiesburg, Mississippi 1,263.7 miles Study Coordinator 601-261-1700 None
Hattiesburg Clinic Site 1205 - Hattiesburg, Mississippi 1,263.7 miles Study Coordinator 601-261-1700 None
Baptist Health Medical Group Oncology LLC Site 8000 - Miami, Florida 1,271.8 miles Study Coordinator 305-595-2141 None
Baptist Health Medical Group Oncology LLC Site 8000 - Miami, Florida 1,271.8 miles Study Coordinator 305-595-2141 None
Baptist Health Medical Group Oncology LLC Site 8000 - Miami, Florida 1,271.8 miles Study Coordinator 305-595-2141 None
Baptist Health Medical Group Oncology LLC Site 8000 - Miami, Florida 1,271.8 miles Study Coordinator 305-595-2141 None
Baptist Health Medical Group Oncology LLC Site 8000 - Miami, Florida 1,271.8 miles Study Coordinator 305-595-2141 None
Baptist Health Medical Group Oncology LLC Site 8000 - Miami, Florida 1,271.8 miles Study Coordinator 305-595-2141 None
Texas OncologyBaylor Charles A Sammons Cancer Center Site 8003 - Dallas, Texas 1,549.2 miles Study Coordinator 214-370-1000 None
Texas OncologyBaylor Charles A Sammons Cancer Center Site 8003 - Dallas, Texas 1,549.2 miles Study Coordinator 214-370-1000 None
Texas OncologyBaylor Charles A Sammons Cancer Center Site 8003 - Dallas, Texas 1,549.2 miles Study Coordinator 214-370-1000 None
Texas OncologyBaylor Charles A Sammons Cancer Center Site 8003 - Dallas, Texas 1,549.2 miles Study Coordinator 214-370-1000 None
Texas OncologyBaylor Charles A Sammons Cancer Center Site 8003 - Dallas, Texas 1,549.2 miles Study Coordinator 214-370-1000 None
Texas OncologyBaylor Charles A Sammons Cancer Center Site 8003 - Dallas, Texas 1,549.2 miles Study Coordinator 214-370-1000 None
Texas Oncology Site 8002 - Austin, Texas 1,701.6 miles Study Coordinator 512-427-9400 None
Texas Oncology Site 8002 - Austin, Texas 1,701.6 miles Study Coordinator 512-427-9400 None
Texas Oncology Site 8002 - Austin, Texas 1,701.6 miles Study Coordinator 512-427-9400 None
Texas Oncology Site 8002 - Austin, Texas 1,701.6 miles Study Coordinator 512-427-9400 None
Texas Oncology Site 8002 - Austin, Texas 1,701.6 miles Study Coordinator 512-427-9400 None
Texas Oncology Site 8002 - Austin, Texas 1,701.6 miles Study Coordinator 512-427-9400 None

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