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A Phase 1 Clinical Study to Evaluate the Bioavailability of Pembrolizumab via Subcutaneous Injection of MK-3475A, a Formulation of Pembrolizumab With MK-5180, in Participants with Advanced Solid Tumors

A Bioavailability Study of MK-3475A in Participants with Solid Tumors

Fujita Tomoko

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

msdjrct@msd.com

MSDJRCT inquiry mailbox

MSD K.K.

KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan

+81-3-6272-1957

msdjrct@msd.com

Not Recruiting

Dec. 23, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

-Has histologically- or cytologically-confirmed diagnosis of Non Small Cell Lung Cancer (NSCLC) (Arm 3).
-Can provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
-Has a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
-Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale.
-Demonstrates adequate organ function.

-Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication.
-Has had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) before the first dose of study intervention, or has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better from any adverse events (AEs) that were due to cancer therapeutics administered more than 4 weeks earlier (this includes participants with previous immunomodulatory therapy with residual immune-related AEs).
-Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
-Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis.
-Has severe hypersensitivity (>=Grade 3) to pembrolizumab and/or any of its excipients.
-Has an active infection requiring therapy.
-Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease.
-Has an active autoimmune disease that has required systemic treatment in the past 2 years.
-Has known hepatitis B or C infections or known to be positive for hepatitis B surface antigen (HBsAg)/hepatitis B virus deoxyribonucleic acid (DNA) or hepatitis C antibody or ribonucleic acid (RNA)
-Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
-Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
-Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study.
-Has not fully recovered from any effects of major surgery without significant detectable infection.
-Has symptomatic ascites or pleural effusion.
-Has preexisting peripheral neuropathy that is >Grade 2 by latest NCI CTCAE version 5.
-Has a known sensitivity to recombinant hyaluronidase or other form of hyaluronidase.
-Has a history of severe hypersensitivity reaction (eg, generalized rash/erythema, hypotension, bronchospasm, angioedema, or anaphylaxis) to pemetrexed, cisplatin, axitinib, carboplatin, paclitaxel, or nab-paclitaxel.
-Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.

Both

Arm 3: NSCLC

Arm 3:
-Cycle 1: MK-3475A subcutaneous (SC) treatment with standard of care (SOC) therapy
-Cycles 2 to 18: pembrolizumab 400 mg intravenous (IV) with SOC therapy

Arm 3:
-PK exposure measures in Cycle 1 including trough concentration (Ctrough), maximum plasma concentration (Cmax), time to maximum plasma concentration (Tmax), and area under the curve (AUC)
-Dose-limiting Toxicities (DLTs)
-AEs
-Discontinuing study intervention due to an AE
-Responses to a Subcutaneous Injection Site Signs and Symptoms questionnaire

Arm 3:
-Antidrug antibody levels
-PK parameter bioavailability (F)

+81-48-722-1111

Nov. 22, 2022

Yes

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Chile/Hungary/South Korea/South Africa/Spain