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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Pembrolizumab (+) Berahyaluronidase alfa: Fixed dose coformulated product of hyaluronidase/pembrolizumab adminstered via SC injection.
Pembrolizumab: Administered via IV infusion
Study 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.
Eligibility
Primary outcome measure(s)
- Percentage of Participants Who Prefer Pembrolizumab Plus Berahyaluronidase Alfa Subcutaneous (SC) As Assessed By Patient Preference Questionnaire (PPQ) Question 1 — Day 106
The PPQ is an instrument that has been developed from participant interviews and includes questions to evaluate directly from participants their preference regarding mode of administration, as well as the strength of the preference, and the reason for the preference. The PPQ does not have any pre-defined scale or associated numerical scoring and answer choices are qualitative. Question 1 in the PPQ evaluates participants' preferred method of administration with response options of IV, SC or "no preference". As pre-specified by the protocol, the percentage of participants who preferred SC administration (participant preference rate \[PPR\]) was reported out of all randomized participants who received all 3 doses of Pembrolizumab IV and Pembrolizumab SC during treatment crossover period and answered at least question 1 of the PPQ on Cycle 6 Day 1 (Day 106).
Trial sites (45)
| Facility | City | Region | Status |
|---|---|---|---|
| Russell Medical ( Site 0160) | Alexander City | Alabama | |
| Alaska Oncology and Hematology ( Site 0121) | Anchorage | Alaska | |
| Highlands Oncology Group-Research Department ( Site 0133) | Springdale | Arkansas | |
| Marin Cancer Care ( Site 0148) | Greenbrae | California | |
| Holy Cross Hospital-Clinical Research ( Site 0159) | Fort Lauderdale | Florida | |
| Mid Florida Hematology and Oncology Center ( Site 0113) | Orange City | Florida | |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0112) | Marietta | Georgia | |
| Kadlec Clinic Hematology and Oncology ( Site 0103) | Kennewick | Washington | |
| Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300) | Mar del Plata | Buenos Aires | |
| Fundación Respirar ( Site 0302) | Buenos Aires | Buenos Aires F.D. | |
| Instituto San Marcos ( Site 0305) | San Juan | Argentina | |
| Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 1001) | Port Macquarie | New South Wales | |
| Frankston Hospital-Oncology and Haematology ( Site 1007) | Frankston | Victoria | |
| Centro Investigacion Cancer James Lind ( Site 0408) | Temuco | Araucania | |
| Clínica Puerto Montt ( Site 0404) | Port Montt | Los Lagos Region | |
| FALP-UIDO ( Site 0401) | Santiago | Region M. de Santiago | |
| Oncovida ( Site 0403) | Santiago | Region M. de Santiago | |
| Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0407) | Santiago | Region M. de Santiago | |
| Bradfordhill-Clinical Area ( Site 0402) | Santiago | Region M. de Santiago | |
| ONCOCENTRO APYS-ACEREY ( Site 0400) | Viña del Mar | Valparaiso | |
| CENTRE LEON BERARD-onco dermatology ( Site 0600) | Lyon Cedex08 | Auvergne-Rhône-Alpes | |
| Centre Hospitalier Universitaire de Caen Normandie-DERMATOLOGY ( Site 0604) | Caen | Calvados | |
| Clinique Francois Chenieux ( Site 0603) | Limoges | Haute-Vienne | |
| HIA Sainte Anne-Pneumology ( Site 0601) | Toulon | Var | |
| Hôpital Bichat - Claude-Bernard ( Site 0605) | Paris | Île-de-France Region | |
| Bell Land General Hospital ( Site 1101) | Sakai | Osaka | |
| Tokyo Women's Medical University ( Site 1100) | Tokyo | Japan | |
| Auckland City Hospital-Cancer & Blood Research ( Site 1051) | Auckland | New Zealand | |
| Bowen Hospital ( Site 1050) | Wellington | New Zealand | |
| Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0701) | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier | Warsaw | Masovian Voivodeship | |
| Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0702) | Koszalin | West Pomeranian Voivodeship | |
| Zachodniopomorskie Centrum Onkologii ( Site 0703) | Szczecin | West Pomeranian Voivodeship | |
| Cancer Care Langenhoven Drive Oncology Centre ( Site 0808) | Port Elizabeth | Eastern Cape | |
| Medical Oncology Centre of Rosebank ( Site 0805) | Johannesburg | Gauteng | |
| Nosworthy Oncology ( Site 0807) | Johannesburg | Gauteng | |
| Steve Biko Academic Hospital-Medical Oncology ( Site 0804) | Pretoria | Gauteng | |
| LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0800) | Pretoria | Gauteng | |
| Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 0801) | Sandton | Gauteng | |
| Cape Town Oncology Trials ( Site 0802) | Cape Town | Western Cape |
+ 5 more sites — see the full list on the official registry below.
On this site
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Other trials for the same condition
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 NCT06099782 on ClinicalTrials.gov ↗ ← All trials in Australia