Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
1100

Exclusion Criteria

Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study treatment
Known history of active tuberculosis (TB, Bacillus tuberculosis)
Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
...
Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study treatment
Known history of active tuberculosis (TB, Bacillus tuberculosis)
Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
Known additional malignancy within 2 years prior to enrollment with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cancers
Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or not recovered from an adverse event caused by mAbs administered more than 4 weeks earlier
Received live vaccine within 30 days of planned start of study treatment
Known psychiatric or substance abuse disorders that would interfere with the participant's ability to cooperate with the requirements of the study
Pregnant, 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
Previously participated in any other pembrolizumab (MK-3475) study, or received prior therapy with an anti-programmed cell death (PD)-1, anti-PD-Ligand 1 (anti-PD-L1), anti-PD-Ligand 2 (anti-PD-L2), or any other immunomodulating mAb or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
Has had an allogenic tissue/solid organ transplant.
Active autoimmune disease that has required systemic treatment in the past 2 years
Known active Hepatitis B or C
Has known glioblastoma multiforme of the brain stem
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks of study Day 1 or not recovered from adverse events caused by a previously administered agent
Active infection requiring systemic therapy
Known history of Human Immunodeficiency Virus (HIV)
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease.

Summary

Conditions
  • Anal Cancer
  • Advanced Cancer
  • Small Cell Lung Cancer ( SCLC )
  • Advanced Solid Tumors
  • Thyroid Carcinoma
  • Anal Carcinoma
  • Bile Duct Cancer
  • Biliary Cancer
  • Carcinoid Tumor
  • Vulvar Carcinoma
  • Vulvar Cancer
  • Cervical Cancer
  • Cervical Carcinoma
  • Thyroid Cancer
  • Endometrial Cancer
  • Neuroendocrine Tumor
  • Parotid Gland Cancer
  • Salivary Gland Carcinoma
  • Endometrial Carcinoma
  • Cholangiocarcinoma
  • Salivary Cancer
  • Small Cell Lung Carcinoma
  • Mesothelioma
  • Colorectal Carcinoma
  • Salivary Gland Cancer
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Exclusion Criteria

Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study treatment
Known history of active tuberculosis (TB, Bacillus tuberculosis)
Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
...
Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study treatment
Known history of active tuberculosis (TB, Bacillus tuberculosis)
Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
Known additional malignancy within 2 years prior to enrollment with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cancers
Prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or not recovered from an adverse event caused by mAbs administered more than 4 weeks earlier
Received live vaccine within 30 days of planned start of study treatment
Known psychiatric or substance abuse disorders that would interfere with the participant's ability to cooperate with the requirements of the study
Pregnant, 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
Previously participated in any other pembrolizumab (MK-3475) study, or received prior therapy with an anti-programmed cell death (PD)-1, anti-PD-Ligand 1 (anti-PD-L1), anti-PD-Ligand 2 (anti-PD-L2), or any other immunomodulating mAb or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
Has had an allogenic tissue/solid organ transplant.
Active autoimmune disease that has required systemic treatment in the past 2 years
Known active Hepatitis B or C
Has known glioblastoma multiforme of the brain stem
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks of study Day 1 or not recovered from adverse events caused by a previously administered agent
Active infection requiring systemic therapy
Known history of Human Immunodeficiency Virus (HIV)
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease.

Locations

Madrid
Baltimore, Maryland, 21231
Boston, Massachusetts, 02114
Taipei
Bogota
...
Madrid
Baltimore, Maryland, 21231
Boston, Massachusetts, 02114
Taipei
Bogota
Los Angeles, California, 90033
Sao Paulo
New Brunswick, New Jersey, 08903
Boston, Massachusetts, 02215
Boston, Massachusetts, 02215
Beijing
Midrand
North Ryde
Rome
Chiyoda-Ku, Tokyo, 102-8667
Houston, Texas, 77030
Hod Hasharon
Moscow
Haarlem
Rockville, Maryland, 20850
Kirkland, Quebec, H9H 4M7
Haar
Paris
Orlando, Florida, 32806
Seoul, 4130
Los Angeles, California, 90048
Drammen
Mexico City
Glostrup
Makati

Tracking Information

NCT #
NCT02628067
Collaborators
Not Provided
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.