Phase
Condition
Neoplasm Metastasis
Treatment
MK-6837
Pembrolizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Histologically or cytologically confirmed solid tumor by pathology report that isadvanced or metastatic
Human Immunodeficiency Virus (HIV)-infected participants must have well controlledHIV on Antiretroviral Therapy (ART)
Participants who are Hepatitis B Surface Antigen (HBsAg) positive are eligible ifthey have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks,and have undetectable HBV viral load before allocation
Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCVviral load is undetectable at screening
Exclusion
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Has not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1or better from any Adverse Events (AEs) that were due to cancer therapeuticsadministered more than 4 weeks earlier
History of a second malignancy, unless potentially curative treatment has beencompleted with no evidence of malignancy for 2 years
Has clinically significant cardiovascular disease
HIV-infected participants with a history of Kaposi's sarcoma and/or MulticentricCastleman's Disease
Received prior systemic anticancer therapy including investigational agents within 4weeks before the first dose of study intervention
Has received any prior immunotherapy and was discontinued from that treatment due toa Grade 3 or higher immune-related AE (except endocrine disorders that can betreated with replacement therapy) or was discontinued from that treatment due toGrade 2 myocarditis or recurrent Grade 2 pneumonitis
Received prior radiotherapy within 2 weeks of start of study intervention, or hasradiation-related toxicities, requiring corticosteroids
Received a live or live-attenuated vaccine within 30 days before the first dose ofstudy intervention. Administration of killed vaccines is allowed
Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy orany other form of immunosuppressive therapy within 7 days before the first dose ofstudy intervention
Known additional malignancy that is progressing or has required active treatmentwithin the past 2 years
Known active Central Nervous System (CNS) metastases and/or carcinomatous meningitis
Active autoimmune disease that has required systemic treatment in the past 2 yearsexcept replacement therapy
History of (noninfectious) pneumonitis/interstitial lung disease that requiredsteroids or has current pneumonitis/interstitial lung disease
Active infection requiring systemic therapy
History of allogeneic tissue/solid organ transplant
Participants who have not adequately recovered from major surgery or have ongoingsurgical complications
Study Design
Connect with a study center
Westmead Hospital ( Site 1002)
Westmead, New South Wales 2145
AustraliaActive - Recruiting
The Alfred Hospital ( Site 1001)
Melbourne, Victoria 3004
AustraliaActive - Recruiting
Princess Margaret Cancer Centre ( Site 2001)
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
Sheba Medical Center-ONCOLOGY ( Site 3001)
Ramat Gan, 5265601
IsraelActive - Recruiting
Atlantic Health System Morristown Medical Center ( Site 4001)
Morristown, New Jersey 07960
United StatesActive - Recruiting
Providence Portland Medical Center ( Site 4002)
Portland, Oregon 97213
United StatesActive - Recruiting
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