A Study to Evaluate the Bioavailability of Pembrolizumab (MK-3475) Via Subcutaneous (SC) Injection of Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180) [MK-3475A] In Advanced Solid Tumors (MK-3475A-C18)
NCT ID: NCT05017012
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
72 participants
INTERVENTIONAL
2021-09-21
2026-09-26
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Pembrolizumab Conc1 [dose 1]/Berahyaluronidase alfa
Participants receive pembrolizumab (+) berahyaluronidase alfa (pembrolizumab Conc1 \[dose 1\] + berahyaluronidase alfa) SC on Day 1 of Cycles 1 and 3 plus 400 mg pembrolizumab intravenously (IV) on Day 1 of Cycles 2 and 4 to 18, with or without background standard of care (SOC) chemotherapy as appropriate for the indication. A cycle is 42 days.
Pembrolizumab (+) Berahyaluronidase alfa
Pembrolizumab (+) Berahyaluronidase alfa is a fixed-dose formulation of pembrolizumab (either Conc1 or Conc2) and berahyaluronidase alfa for SC administration.
Pembrolizumab
Participants will receive pembrolizumab 400 mg IV.
Pemetrexed
Participants may receive 500 mg/m\^2 IV every 3 weeks (Q3W) Day 1 and Day 22 of Cycles 1 to 18 as background SOC treatment during the study, as applicable to their diagnosis.
Carboplatin
Participants may receive 5 mg/mL/min IV (nonsquamous) or 6 mg/mL/min IV (squamous) on Day 1 of each 21-day cycle for 4 cycles as background SOC treatment during the study, as applicable to their diagnosis.
Paclitaxel
Participants may receive 200 mg/m\^2 IV on Day 1 of each 21-day cycle for 4 cycles as background SOC treatment during the study, as applicable to their diagnosis.
Nab-paclitaxel
Participants may receive 100 mg/m2 IV on Day 1, 8, and 15 of each 21-day cycle for 4 cycles as background SOC treatment during the study, as applicable to their diagnosis.
Axitinib
Participants may receive 5 mg orally twice daily continuously as background SOC treatment during the study, as applicable to their diagnosis.
Cisplatin
Participants may receive 75 mg/m\^2 IV on Day 1 of each 21-day cycle for 4 cycles as background SOC treatment during the study, as applicable to their diagnosis.
Pembrolizumab Conc2 [dose 1]/Berahyaluronidase alfa
Participants receive pembrolizumab (+) berahyaluronidase alfa (pembrolizumab Conc2 \[dose 1\] + Berahyaluronidase alfa) SC on Day 1 of Cycles 1 and 3 plus 400 mg pembrolizumab IV on Day 1 of Cycles 2 and 4 to 18, with or without background SOC chemotherapy as appropriate for the indication. A cycle is 42 days.
Pembrolizumab (+) Berahyaluronidase alfa
Pembrolizumab (+) Berahyaluronidase alfa is a fixed-dose formulation of pembrolizumab (either Conc1 or Conc2) and berahyaluronidase alfa for SC administration.
Pembrolizumab
Participants will receive pembrolizumab 400 mg IV.
Pemetrexed
Participants may receive 500 mg/m\^2 IV every 3 weeks (Q3W) Day 1 and Day 22 of Cycles 1 to 18 as background SOC treatment during the study, as applicable to their diagnosis.
Carboplatin
Participants may receive 5 mg/mL/min IV (nonsquamous) or 6 mg/mL/min IV (squamous) on Day 1 of each 21-day cycle for 4 cycles as background SOC treatment during the study, as applicable to their diagnosis.
Paclitaxel
Participants may receive 200 mg/m\^2 IV on Day 1 of each 21-day cycle for 4 cycles as background SOC treatment during the study, as applicable to their diagnosis.
Nab-paclitaxel
Participants may receive 100 mg/m2 IV on Day 1, 8, and 15 of each 21-day cycle for 4 cycles as background SOC treatment during the study, as applicable to their diagnosis.
Axitinib
Participants may receive 5 mg orally twice daily continuously as background SOC treatment during the study, as applicable to their diagnosis.
Cisplatin
Participants may receive 75 mg/m\^2 IV on Day 1 of each 21-day cycle for 4 cycles as background SOC treatment during the study, as applicable to their diagnosis.
Pembrolizumab Conc1 [dose 1]/Berahyaluronidase alfa + SOC Chemotherapy
Participants in Japan receive pembrolizumab (+) berahyaluronidase alfa (pembrolizumab Conc1 \[dose 1\] + berahyaluronidase alfa) SC on Day 1 of Cycle 1, with background SOC chemotherapy, and then receive 400 mg pembrolizumab IV on Day 1 of Cycles 2 to 18, with background SOC chemotherapy. A cycle is 42 days.
Pembrolizumab (+) Berahyaluronidase alfa
Pembrolizumab (+) Berahyaluronidase alfa is a fixed-dose formulation of pembrolizumab (either Conc1 or Conc2) and berahyaluronidase alfa for SC administration.
Pembrolizumab
Participants will receive pembrolizumab 400 mg IV.
Pemetrexed
Participants may receive 500 mg/m\^2 IV every 3 weeks (Q3W) Day 1 and Day 22 of Cycles 1 to 18 as background SOC treatment during the study, as applicable to their diagnosis.
Carboplatin
Participants may receive 5 mg/mL/min IV (nonsquamous) or 6 mg/mL/min IV (squamous) on Day 1 of each 21-day cycle for 4 cycles as background SOC treatment during the study, as applicable to their diagnosis.
Paclitaxel
Participants may receive 200 mg/m\^2 IV on Day 1 of each 21-day cycle for 4 cycles as background SOC treatment during the study, as applicable to their diagnosis.
Nab-paclitaxel
Participants may receive 100 mg/m2 IV on Day 1, 8, and 15 of each 21-day cycle for 4 cycles as background SOC treatment during the study, as applicable to their diagnosis.
Cisplatin
Participants may receive 75 mg/m\^2 IV on Day 1 of each 21-day cycle for 4 cycles as background SOC treatment during the study, as applicable to their diagnosis.
Pembrolizumab Conc1 [dose 2]/Berahyaluronidase alfa
Participants receive pembrolizumab (+) berahyaluronidase alfa (pembrolizumab Conc1 \[dose 2\] + berahyaluronidase alfa) SC on Day 1 of Cycles 1 to 35 without background standard of care (SOC) chemotherapy. A cycle is 21 days.
Pembrolizumab (+) Berahyaluronidase alfa
Pembrolizumab (+) Berahyaluronidase alfa is a fixed-dose formulation of pembrolizumab (either Conc1 or Conc2) and berahyaluronidase alfa for SC administration.
Interventions
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Pembrolizumab (+) Berahyaluronidase alfa
Pembrolizumab (+) Berahyaluronidase alfa is a fixed-dose formulation of pembrolizumab (either Conc1 or Conc2) and berahyaluronidase alfa for SC administration.
Pembrolizumab
Participants will receive pembrolizumab 400 mg IV.
Pemetrexed
Participants may receive 500 mg/m\^2 IV every 3 weeks (Q3W) Day 1 and Day 22 of Cycles 1 to 18 as background SOC treatment during the study, as applicable to their diagnosis.
Carboplatin
Participants may receive 5 mg/mL/min IV (nonsquamous) or 6 mg/mL/min IV (squamous) on Day 1 of each 21-day cycle for 4 cycles as background SOC treatment during the study, as applicable to their diagnosis.
Paclitaxel
Participants may receive 200 mg/m\^2 IV on Day 1 of each 21-day cycle for 4 cycles as background SOC treatment during the study, as applicable to their diagnosis.
Nab-paclitaxel
Participants may receive 100 mg/m2 IV on Day 1, 8, and 15 of each 21-day cycle for 4 cycles as background SOC treatment during the study, as applicable to their diagnosis.
Axitinib
Participants may receive 5 mg orally twice daily continuously as background SOC treatment during the study, as applicable to their diagnosis.
Cisplatin
Participants may receive 75 mg/m\^2 IV on Day 1 of each 21-day cycle for 4 cycles as background SOC treatment during the study, as applicable to their diagnosis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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 and 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.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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FALP-UIDO ( Site 0101)
Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 0100)
Santiago, Region M. de Santiago, Chile
James Lind Centro de Investigación del Cáncer ( Site 0102)
Temuco, Región de la Araucanía, Chile
Országos Onkológiai Intézet-Urogenital Tumors Department and Clinical Pharmacology ( Site 0021)
Budapest, Pest County, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont-Onkologiai Osztaly ( Site 0020)
Budapest, , Hungary
Kansai Medical University Hospital ( Site 0112)
Hirakata, Osaka, Japan
Saitama Prefectural Cancer Center ( Site 0110)
Ina-machi, Saitama, Japan
Shizuoka Cancer Center ( Site 0111)
Nagaizumi-cho,Sunto-gun, Shizuoka, Japan
National Hospital Organization Kyushu Cancer Center ( Site 0114)
Fukuoka, , Japan
Osaka International Cancer Institute ( Site 0113)
Osaka, , Japan
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 0051)
Port Elizabeth, Eastern Cape, South Africa
Medical Oncology Centre of Rosebank ( Site 0058)
Johannesburg, Gauteng, South Africa
Steve Biko Academic Hospital-Medical Oncology ( Site 0057)
Pretoria, Gauteng, South Africa
LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0052)
Pretoria, Gauteng, South Africa
Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 0053)
Sandton, Gauteng, South Africa
Cape Town Oncology Trials ( Site 0050)
Cape Town, Western Cape, South Africa
Cancercare Rondebosch Oncology-Clinical trials ( Site 0055)
Rondebosch, Western Cape, South Africa
Severance Hospital, Yonsei University Health System ( Site 0062)
Seoul, , South Korea
Samsung Medical Center ( Site 0063)
Seoul, , South Korea
Hospital Universitario Virgen de la Victoria-Phase I Trials Unit ( Site 0042)
Málaga, Andalusia, Spain
HOSPITAL CLÍNIC DE BARCELONA-Department of Medical Oncology ( Site 0043)
Barcelona, Catalonia, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 0040)
Madrid, Madrid, Comunidad de, Spain
Countries
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References
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Cohen GL, Coetzee C, Walton CA, Reig Torras O, Chul Cho B, McAdam G, Rojas CI, Medina Rodriguez L, Papai Z, Chan SW, Rapoport BL, Caglevic C, Yanez Weber P, Takahashi T, Kurata T, Song G, Cohen JW, Akala OO, Khanyile R. Pharmacokinetics and bioavailability of pembrolizumab with berahyaluronidase alfa for subcutaneous administration in participants with advanced or metastatic solid tumors: The phase 1 study 3475A-C18. Eur J Cancer. 2025 Aug 9:115709. doi: 10.1016/j.ejca.2025.115709. Online ahead of print.
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-3475A-C18
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2031220507
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-001569-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3475A-C18
Identifier Type: -
Identifier Source: org_study_id