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Pembrolizumab (+) Berahyaluronidase alfa

BIOLOGICAL8 trials

Sponsors

Merck Sharp & Dohme LLC

Conditions

Advanced or Metastatic Solid TumorsClassical Hodgkin Lymphoma RecurrentClassical Hodgkin Lymphoma RefractoryHematologic MalignanciesLung CancerMelanomaMetastatic Non-small Cell Lung CancerNon-Small Cell Lung Cancer

Phase 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)
Active, not recruitingNCT05017012
Merck Sharp & Dohme LLCAdvanced or Metastatic Solid Tumors
Start: 2021-09-21End: 2026-05-19Target: 72Updated: 2026-03-27

Phase 2

A Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) (Pembrolizumab Formulated With Berahyaluronidase Alfa (MK-5180)) in Japanese Participants With Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC) or Locally Advanced (LA) Unresectable cSCC (MK-3475A-E39)
Active, not recruitingNCT06041802
Merck Sharp & Dohme LLCSquamous Cell Carcinoma
Start: 2023-10-20End: 2028-03-31Target: 19Updated: 2026-02-17
A Study of Participant Reported Preference for Subcutaneous Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) Over Intravenous Pembrolizumab (MK-3475) Formulation in Multiple Tumor Types (MK-3475A-F11)
Active, not recruitingNCT06099782
Merck Sharp & Dohme LLCMelanoma, Non-Small Cell Lung Cancer, Renal Cell Carcinoma
Start: 2023-12-26End: 2027-02-15Updated: 2026-04-08
A Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) Coformulated With Berahyaluronidase Alfa (MK-3475A) in Participants With Relapsed or Refractory Classical Hodgkin Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)(MK-3475A-F65)
Active, not recruitingNCT06504394
Merck Sharp & Dohme LLCClassical Hodgkin Lymphoma Recurrent, Classical Hodgkin Lymphoma Refractory, Primary Mediastinal Large B-cell Lymphoma Recurrent +1
Start: 2024-10-14End: 2028-11-08Target: 66Updated: 2026-02-09

Phase 3

Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)
RecruitingNCT03486873
Merck Sharp & Dohme LLCHematologic Malignancies, Solid Tumors
Start: 2018-08-21End: 2043-08-04Target: 3500Updated: 2026-05-18
A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)-Japan Extension
Active, not recruitingNCT06212752
Merck Sharp & Dohme LLCMetastatic Non-small Cell Lung Cancer
Start: 2023-06-13End: 2028-05-22Updated: 2025-11-12
A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84)
Active, not recruitingNCT06698042
Merck Sharp & Dohme LLCLung Cancer, Non-Small Cell Lung Cancer
Start: 2024-11-21End: 2030-02-11Updated: 2026-04-01
A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)
RecruitingNCT07190248
Merck Sharp & Dohme LLCNon-small Cell Lung Cancer
Start: 2025-10-08End: 2032-08-06Target: 675Updated: 2026-05-18

Related Papers

140TiP KANDLELIT-007: Phase III, open-label study of first-line calderasib with subcutaneous pembrolizumab (pembro SC) vs pembro SC plus chemotherapy (chemo) for KRAS G12C– mutant advanced/metastatic nonsquamous NSCLC
ESMO Open2026-03-17
Model-based dose selection and pharmacokinetic bridging of subcutaneous from intravenous pembrolizumab across indications.
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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.
2025-08-09
Phase 2 study of MK-3475A in relapsed or refractory classic Hodgkin lymphoma or primary mediastinal large B-cell lymphoma.
Journal of Clinical Oncology2025-05-28
Abstract CT036: Bioavailability of MK-3475A (pembrolizumab with berahyaluronidase alfa; “subcutaneous pembrolizumab”) in participants with advanced or metastatic solid tumors
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Abstract CT035: Pharmacokinetics (PK), safety, and tolerability of pembrolizumab with berahyaluronidase alfa administered subcutaneously Q3W in participants with advanced melanoma
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