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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Pembrolizumab (+) Berahyaluronidase alfa: SC injection
Study summary
The primary purpose of the study is to assess the pharmacokinetics (PK) profile of pembrolizumab following subcutaneous (SC) injection of pembrolizumab coformulated with hyaluronidase, and to evaluate the objective response rate (ORR) of pembrolizumab (+) berahyaluronidase alfa SC in adult participants with Relapsed or Refractory Classical Hodgkin Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL). There is no formal hypothesis to be tested for this study.
Eligibility
Primary outcome measure(s)
- Objective Response Rate (ORR) per Lugano Classification Criteria as Assessed by Investigator — Up to approximately 48 months
ORR is defined as the percentage of the participants who had complete response (CR) or partial response (PR) and will be evaluated using computed tomography (CT) and positron emission tomography (PET)-CT. Response was assessed based on the International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal fluorodeoxyglucose \[FDG\] uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). The percentage of participants who experience CR or PR as assessed by investigator will be presented. - Maximum Concentration (Cmax) of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase — At designated time points (up to ~6 weeks)
Blood samples will be collected at designated timepoints for the determination of Cmax. Cmax is defined as the peak concentration of pembrolizumab after administration of SC pembrolizumab coformulated with hyaluronidase. - Lowest Plasma Concentration (Ctrough) of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase — At designated time points (up to ~6 weeks)
Blood samples will be collected at designated timepoints for the determination of Ctrough. Ctrough is defined as the lowest concentration of pembrolizumab after administration of SC pembrolizumab coformulated with hyaluronidase. - Area Under the Concentration-Time Curve of Pembrolizumab After Administration of SC Pembrolizumab Coformulated with Hyaluronidase from Week 0-Week 6 (AUC0-6weeks) — At designated time points (up to ~6 weeks)
Blood samples will be collected at designated timepoints for the determination of AUC0-6weeks. AUC0-6 weeks is defined as area under concentration time curve over a 6-week dosing interval of pembrolizumab after administration of SC pembrolizumab coformulated with hyaluronidase.
Trial sites (29)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Iowa-Holden Comprehensive Cancer Center ( Site 0115) | Iowa City | Iowa | |
| University of Iowa - Waukee ( Site 0111) | Waukee | Iowa | |
| Comprehensive Cancer Centers of Nevada ( Site 0114) | Las Vegas | Nevada | |
| Clinical Research Alliance ( Site 0101) | Westbury | New York | |
| Westmead Hospital ( Site 0901) | Westmead | New South Wales | |
| Biocenter ( Site 0203) | Concepción | Biobio | |
| IC La Serena Research ( Site 0204) | La Serena | Coquimbo Region | |
| FALP ( Site 0207) | Santiago | Region M. de Santiago | |
| Clínica Inmunocel ( Site 0201) | Santiago | Region M. de Santiago | |
| Bradfordhill-Clinical Area ( Site 0202) | Santiago | Region M. de Santiago | |
| Universitaetsklinikum Essen ( Site 1302) | Essen | North Rhine-Westphalia | |
| Health Pharma Professional Research S.A. de C.V: ( Site 0403) | Mexico City | Mexico City | |
| Centro de Investigacion Clinica de Oaxaca ( Site 0405) | Oaxaca City | Mexico | |
| Auckland City Hospital ( Site 1001) | Auckland | New Zealand | |
| Pratia MCM Krakow ( Site 0503) | Krakow | Lesser Poland Voivodeship | |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site 0501) | Warsaw | Masovian Voivodeship | |
| Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0502) | Gdansk | Pomeranian Voivodeship | |
| Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0504) | Gliwice | Silesian Voivodeship | |
| Seoul National University Hospital-Oncology ( Site 1101) | Seoul | South Korea | |
| Institut Català d'Oncologia - L'Hospitalet-Haematology Department ( Site 0703) | L'Hospitalet Del Llobregat | Barcelona | |
| Hospital Universitario de Salamanca ( Site 0702) | Salamanca | Castille and León | |
| Hospital Universitario 12 de Octubre-Hemathology and hemotherapy ( Site 0701) | Madrid | Spain | |
| Ankara Universitesi Tıp Fakultesi Hastanesi ( Site 0801) | Ankara | Turkey (Türkiye) | |
| Hacettepe Universite Hastaneleri ( Site 0802) | Ankara | Turkey (Türkiye) | |
| Ondokuz Mayıs Universitesi ( Site 0803) | Samsun | Turkey (Türkiye) | |
| Glan Clwyd Hospital ( Site 0602) | Bodelwyddan | Denbighshire | |
| University College London Hospital ( Site 0605) | London | London, City of | |
| Churchill Hospital ( Site 0604) | Oxford | Oxfordshire | |
| The Christie NHS Foundation Trust ( Site 0603) | Manchester | United Kingdom |
More Merck Sharp & Dohme LLC trials in South Korea
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06504394 on ClinicalTrials.gov ↗ ← All trials in South Korea