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Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)

Status
Active
Cancer Type
Solid Tumor
Trial Phase
Phase II
Eligibility
18+, Male and Female
Study Type
Treatment
NCD ID
NCT02628067
Protocol IDs
NCT02628067 (primary)
3475-158
2015-002067-41
163196
Study Sponsor
Merck Sharp & Dohme Corp.

Summary

Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)
A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects With Advanced Solid Tumors (KEYNOTE 158)
In this study, participants with multiple types of advanced (unresectable and/or metastatic) solid tumors that have progressed on standard of care therapy will be treated with pembrolizumab.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Cancer
Biological: pembrolizumab
intravenous infusion
Other Names:
  • MK-3475
  • KEYTRUDA®
Experimental: Pembrolizumab
Participants receive pembrolizumab 200 mg intravenously every 3 weeks (Q3W) for up to 35 administrations (approximately 2 years of treatment)
Intervention: Biological: pembrolizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1100
May 2019
September 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically-documented, advanced solid tumor of one of the following types:

    • Anal Carcinoma
    • Biliary Adenocarcinoma (gallbladder or biliary tree (intrahepatic or extrahepatic cholangiocarcinoma) except Ampulla of Vater cancers)
    • Neuroendocrine Tumors (well- and moderately-differentiated) of the lung, appendix, small intestine, colon, rectum, or pancreas
    • Endometrial Carcinoma (sarcomas and mesenchymal tumors are excluded)
    • Cervical Carcinoma
    • Vulvar Carcinoma
    • Small Cell Lung Carcinoma
    • Mesothelioma
    • Thyroid Carcinoma
    • Salivary Gland Carcinoma (sarcomas and mesenchymal tumors are excluded)
    • OR
    • Any advanced solid tumor, with the exception of colorectal carcinoma (CRC), which is Microsatellite Instability (MSI)-High (MSI-H)
  • Progression of tumor or intolerance to therapies known to provide clinical benefit. There is no limit to the number of prior treatment regimens
  • Can supply tumor tissue for study analyses (dependent on tumor type)
  • Radiologically-measurable disease
  • Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
  • Life expectancy of at least 3 months
  • Adequate organ function
  • Female participants of childbearing potential must be willing to use adequate contraception for the course of the study through 120 days after the last dose of study medication
  • Male participants with partners of must childbearing potential must be willing to use adequate contraception for the course of the study through 120 days after the last dose of study medication

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 medication
  • 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 medication
  • Active autoimmune disease that has required systemic treatment in the past 2 years
  • 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
  • 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
  • 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
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has known glioblastoma multiforme of the brainstem
  • History of non-infectious pneumonitis that required steroids or current pneumonitis
  • Active infection requiring systemic therapy
  • Known psychiatric or substance abuse disorders that would interfere with cooperation 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 medication
  • 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-L2, or any other immunomodulating mAb or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Known history of Human Immunodeficiency Virus (HIV)
  • Known active Hepatitis B or C
  • Received live vaccine within 30 days of planned start of study medication

 

Objectives

Objective Response Rate (ORR) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Objective Response Rate (ORR) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT02628067 on ClinicalTrials.gov Archive Site

 

Treatment Sites in Georgia

Georgia Cancer Center of Excellence at Grady Memorial Hospital


80 Jesse Hill Jr. Drive, SE
Atlanta, GA 30303
404-489-9000
www.gradyhealth.org

South Atlanta Hematology Oncology - Riverdale


253 Upper Riverdale Rd
Suite C
Riverdale, GA 30274


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