Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced or Metastatic Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Axitinib | Drug | Axitinib | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pembrolizumab | Biological | Pembrolizumab | ALIAS |
| Pembrolizumab (+) Berahyaluronidase alfa | Biological | — | UNRESOLVED |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Pembrolizumab Conc1 [dose 1]/Berahyaluronidase alfa
- description
- 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.
- interventionNames
- Biological: Pembrolizumab (+) Berahyaluronidase alfa
- Biological: Pembrolizumab
- Drug: Pemetrexed
- Drug: Carboplatin
- Drug: Paclitaxel
- Drug: Nab-paclitaxel
- Drug: Axitinib
- Drug: Cisplatin
- type
- EXPERIMENTAL
- label
- Pembrolizumab Conc2 [dose 1]/Berahyaluronidase alfa
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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 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.
References
Publications (1)
- DERIVEDCohen 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 Nov 17;230:115709. doi: 10.1016/j.ejca.2025.115709. Epub 2025 Aug 9. PMID 40957773