Clinical Trial: NCT06099782
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)
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 2| Lead Sponsor: | Merck Sharp & Dohme LLC |
| Information Provided By: | Merck Sharp & Dohme LLC |
| Last Update Posted: | 2026-04-08 |
Study Overview
Brief Summary
The purpose of this study is to evaluate participant preference for coformulated hyaluronidase/pembrolizumab pembrolizumab (+) berahyaluronidase alfa [MK-3475A] administered subcutaneously (SC) over pembrolizumab [MK-3475] administered intravenously (IV) in participants with multiple tumor types. There will be no hypothesis testing in this study.
Official Title
A Phase 2 Study to Evaluate Patient Reported Preference for Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Over Intravenous Pembrolizumab Formulation in Participants With Multiple Tumor Types (MK-3475A-F11)
Conditions
Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Melanoma
Intervention / Treatment
- Biological: Pembrolizumab (+) Berahyaluronidase alfa
- Biological: Pembrolizumab
Other Study ID Numbers
- 3475A-F11
- 2023-506017-22-00
- U1111-1293-0814
- MK-3475A-F11
- jRCT2051230147
- 2023
Start Date (Actual)
2023-12-26
Primary Completion Date (Actual)
2025-04-09
Study Completion Date (Estimated)
2027-02-15
Enrollment (Actual)
147
Study Type
Interventional
Phase
Phase 2
| Lead Sponsor: | Merck Sharp & Dohme LLC |
| Information Provided By: | Merck Sharp & Dohme LLC |
| Last Update Posted: | 2026-04-08 |
Study Overview
Brief Summary
The purpose of this study is to evaluate participant preference for coformulated hyaluronidase/pembrolizumab pembrolizumab (+) berahyaluronidase alfa [MK-3475A] administered subcutaneously (SC) over pembrolizumab [MK-3475] administered intravenously (IV) in participants with multiple tumor types. There will be no hypothesis testing in this study.
Official Title
A Phase 2 Study to Evaluate Patient Reported Preference for Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Over Intravenous Pembrolizumab Formulation in Participants With Multiple Tumor Types (MK-3475A-F11)
Conditions
Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Melanoma
Intervention / Treatment
- Biological: Pembrolizumab (+) Berahyaluronidase alfa
- Biological: Pembrolizumab
Other Study ID Numbers
- 3475A-F11
- 2023-506017-22-00
- U1111-1293-0814
- MK-3475A-F11
- jRCT2051230147
- 2023
Start Date (Actual)
2023-12-26
Primary Completion Date (Actual)
2025-04-09
Study Completion Date (Estimated)
2027-02-15
Enrollment (Actual)
147
Study Type
Interventional
Phase
Phase 2