Breast Cancer Clinical Trial

Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Adults With Advanced Solid Tumors (MK-5890-001)

Summary

The purpose of this study is to assess the safety and pharmacokinetics of MK-5890 when administered alone and in combination with pembrolizumab (MK-3475) in adults with advanced solid tumors. The initial course of MK-5890 monotherapy or MK-5890 plus pembrolizumab combination therapy will be for up to 35 administrations (approximately 2 years). The safety and pharmacokinetics of MK-5890 when administered with pembrolizumab, pemetrexed and carboplatin in adults with nonsquamous non-small cell lung cancer (NSCLC) and MK-5890 when administered with pembrolizumab and nab-paclitaxel in adults with triple-negative breast cancer (TNBC) will also be assessed.

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Full Description

Participants receiving MK-5890 monotherapy who experience disease progression may be eligible to switch to receiving MK-5890 plus pembrolizumab combination therapy for up to 35 cycles (approximately 2 years) at the discretion of the Investigator and approval of the Sponsor.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Arms 1 & 2: Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and has received or been intolerant to all treatment known to confer clinical benefit
Arm 3: Histologically or cytologically confirmed diagnosis of stage IV (M1a or M1b per current American Joint Committee on Cancer criteria) non-squamous NSCLC
Arm 4: Triple-negative breast cancer (TNBC) that is locally recurrent, inoperable, not previously treated with chemotherapy, and which cannot be treated with curative intent OR metastatic disease not previously treated with chemotherapy
Measurable disease by RECIST 1.1. as assessed by the local site investigator/radiologist. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
Adequate organ function
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Male participants must agree to use adequate contraception during the treatment period and for at least 120 days after the last dose of MK-5890 or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents and refrain from donating sperm during this period
Female participants must not be pregnant or breastfeeding and agree to follow use adequate contraception during the treatment period and for at least 120 days after the last dose of MK-5890 or pembrolizumab OR 180 days after the last dose of chemotherapeutic agents
Submit an evaluable baseline tumor sample for analysis (either a newly obtained or archival tumor sample)

Exclusion Criteria:

History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
Clinically active central nervous system metastases and/or carcinomatous meningitis
Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAb) and/or other components of the study treatment
Active infection requiring systemic treatment
History of interstitial lung disease
History of (noninfectious) pneumonitis that required steroids or current pneumonitis
Symptomatic ascites or pleural effusion
Previously had a stem cell or bone marrow transplant
Previously had a solid organ transplant
Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy
Known human immunodeficiency virus (HIV) and/or active and acute Hepatitis B or C infections
Not fully recovered from any effects of major surgery without significant detectable infection
Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study
Had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study treatment, or has not recovered to Grade ≤1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier
Expected to require any other form of antineoplastic therapy while participating in this study
On chronic systemic steroid therapy in excess of replacement doses (e.g., exceeding 10 mg/day of prednisone equivalent), or on any other form of immunosuppressive medication
Regular user (including "recreational use") of any illicit drugs at the time of signing informed consent, or has a recent history (within the last year) of substance abuse (including alcohol), as determined by the treating investigator. Participants who use cannabis for medicinal purposes or to treat specific symptoms will not be excluded unless it is being abused in the opinion of the treating investigator
Received a live-virus vaccine within 28 days before the first dose of study treatment
Currently participating and receiving study treatment in a study of an investigational agent or has participated and received study treatment in a study of an investigational agent or has used an investigational device within 28 days before the first dose of study treatment

Additional Exclusion Criteria for Participants in Arm 3:

Has received radiation therapy to the lung that is >30 Gray (Gy) within 6 months before the first dose of study treatment
Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
Is unable or unwilling to take folic acid or vitamin B12 supplementation

Additional Exclusion Criteria for Participants in Arm 4:

Has a known history of hypersensitivity or allergy to nab-paclitaxel or any of its components
Has neuropathy ≥Grade 2
Has a history of class II-IV congestive heart failure or myocardial infarction within 6 months of randomization
Has received previous treatment with immune checkpoint inhibitor(s) (eg, Programmed Cell Death Receptor 1 (PD-1)/PD-L1)

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

202

Study ID:

NCT03396445

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 18 Locations for this study

See Locations Near You

University of South Alabama, Mitchell Cancer Institute ( Site 0020)
Mobile Alabama, 36604, United States
Florida Cancer Specialists ( Site 0002)
Sarasota Florida, 34232, United States
The West Clinic, P.C. ( Site 0021)
Germantown Tennessee, 38138, United States
FALP-UIDO ( Site 0502)
Santiago Region M. De Santiago, 69009, Chile More Info
Study Coordinator
Contact
+56224205098
Bradfordhill-Clinical Area ( Site 0501)
Santiago Region M. De Santiago, 84203, Chile More Info
Study Coordinator
Contact
+56998744662
Soroka Medical Center-Oncology ( Site 0012)
Be'er Sheva , 84000, Israel More Info
Study Coordinator
Contact
97286244127
Hadassah Ein Kerem Medical Center ( Site 0010)
Jerusalem , 91120, Israel
The Chaim Sheba Medical Center - Oncology Institute ( Site 0001)
Ramat Gan , 52656, Israel
Seoul National University Hospital-Internal Medicine ( Site 0702)
Seoul , 03080, Korea, Republic of More Info
Study Coordinator
Contact
+82220720850
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 0701)
Seoul , 03722, Korea, Republic of More Info
Study Coordinator
Contact
+820222288135
Antoni van Leeuwenhoek Ziekenhuis ( Site 0003)
Amsterdam Noord-Holland, 1066 , Netherlands More Info
Study Coordinator
Contact
+31205122446
Erasmus MC ( Site 0031)
Rotterdam Zuid-Holland, 3015 , Netherlands More Info
Study Coordinator
Contact
+31107041733
Hospital Universitario Quiron Madrid ( Site 0043)
Pozuelo de Alarcon Madrid, 28223, Spain More Info
Study Coordinator
Contact
+34914521987
Instituto Catalan de Oncologia - ICO ( Site 0044)
Barcelona , 08916, Spain More Info
Study Coordinator
Contact
+34934978925
Hospital Universitario Fundacion Jimenez Diaz ( Site 0041)
Madrid , 28040, Spain More Info
Study Coordinator
Contact
+34 915504800x2486
Centro Integral Oncologico Clara Campal START Madrid ( Site 0040)
Madrid , 28050, Spain More Info
Study Coordinator
Contact
+34 917567825
National Taiwan University Hospital-Oncology ( Site 0801)
Taipei , 10002, Taiwan More Info
Study Coordinator
Contact
88623123456
Koo Foundation Sun Yat-Sen Cancer Center ( Site 0802)
Taipei , 112, Taiwan More Info
Study Coordinator
Contact
886228970011

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

202

Study ID:

NCT03396445

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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