NCT05017012CompletedPhase 1
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)
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
Source: ClinicalTrials.gov · Last updated 5 Jun 2026
Brief summary (registry, in English)
This is a study to assess the pharmacokinetics, safety, and tolerability of pembrolizumab formulated with berahyaluronidase when administered as a SC injection to participants with advanced solid tumors. Participants will receive SC injections of pembrolizumab (+) berahyaluronidase alfa containing one of 2 different concentrations (Conc) of pembrolizumab, Conc1 and Conc2, corresponding to a pembrolizumab dose level of dose 1 for Arms 1, 2, and 3 and dose 2 for Arm 4.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 142 (actual)
- First submitted
- 18 Aug 2021
- Start date
- 21 Sept 2021
- Primary completion date
- 19 May 2026
- Lead sponsor
- Merck Sharp & Dohme LLC
- NCT number
- NCT05017012
- EU CT number
- 2023-505340-19-00
- EudraCT number
- 2021-001569-18
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 142
- From 21 Sept 2021 to the primary completion date, 19 May 2026
- 22 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
Other illness
- Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
- 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 not fully recovered from any effects of major surgery without significant detectable infection.
- 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.
Lab values
- 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.
Other
- Has clinically active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Is pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study.
- 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.
Who the study is looking for
- Has a histologically- or cytologically-confirmed advanced/metastatic solid tumor.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| FALP-UIDO ( Site 0101) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Bradfordhill ( Site 0100) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| James Lind Centro de Investigación del Cáncer ( Site 0102) Coordinator of this site? Confirm its status | Temuco | Chile | Unknown status |
| HOSPITAL CLÍNIC DE BARCELONA-Department of Medical Oncology ( Site 0043) Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 0040) Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Virgen de la Victoria-Phase I Trials Unit ( Site 0042) Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Magyar Honvedseg Egeszsegugyi Kozpont-Onkologiai Osztaly ( Site 0020) Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Országos Onkológiai Intézet-Urogenital Tumors Department and Clinical Pharmacology ( Site 0021) Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| National Hospital Organization Kyushu Cancer Center ( Site 0114) Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Kansai Medical University Hospital ( Site 0112) Coordinator of this site? Confirm its status | Hirakata | Japan | Unknown status |
| Saitama Prefectural Cancer Center ( Site 0110) Coordinator of this site? Confirm its status | Ina-machi | Japan | Unknown status |
| Shizuoka Cancer Center ( Site 0111) Coordinator of this site? Confirm its status | Nagaizumi-cho,Sunto-gun | Japan | Unknown status |
| Osaka International Cancer Institute ( Site 0113) Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Samsung Medical Center ( Site 0063) Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System ( Site 0062) Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Cape Town Oncology Trials ( Site 0050) Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Medical Oncology Centre of Rosebank ( Site 0058) Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 0051) Coordinator of this site? Confirm its status | Port Elizabeth | South Africa | Unknown status |
| Steve Biko Academic Hospital-Medical Oncology ( Site 0057) Coordinator of this site? Confirm its status | Pretoria | South Africa | Unknown status |
| LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0052) Coordinator of this site? Confirm its status | Pretoria | South Africa | Unknown status |
| Cancercare Rondebosch Oncology-Clinical trials ( Site 0055) Coordinator of this site? Confirm its status | Rondebosch | South Africa | Unknown status |
| Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 0053) Coordinator of this site? Confirm its status | Sandton | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.