Trial Title:
A Study of Participant Reported Preference for Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Over Intravenous Pembrolizumab (MK-3475) Formulation in Multiple Tumor Types (MK-3475A-F11)
NCT ID:
NCT06099782
Condition:
Non-Small Cell Lung Cancer
Renal Cell Carcinoma
Melanoma
Conditions: Official terms:
Carcinoma, Renal Cell
Pembrolizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Pembrolizumab co-formulated with hyaluronidase
Description:
Fixed dose coformulated product of hyaluronidase/pembrolizumab adminstered via SC
injection.
Arm group label:
Arm A: MK-3475A SC →Pembrolizumab IV
Arm group label:
Arm B: Pembrolizumab IV→MK-3475A SC
Other name:
MK-3475A
Intervention type:
Biological
Intervention name:
Pembrolizumab
Description:
Administered via IV infusion
Arm group label:
Arm A: MK-3475A SC →Pembrolizumab IV
Arm group label:
Arm B: Pembrolizumab IV→MK-3475A SC
Other name:
MK-3475, KEYTRUDA®
Summary:
The purpose of this study is to evaluate participant preference for coformulated
hyaluronidase/pembrolizumab (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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Has a histologically- or cytologically-confirmed early stage or advanced/ metastatic
solid tumor by pathology report and meet the following conditions based on tumor
type:
- Surgically resected Stage IIB and IIC (pathological or clinical), or III
cutaneous melanoma per American Joint Committee on Cancer (AJCC) eighth
edition.
- Surgically resected renal cell carcinoma (RCC) with intermediate-high or high
risk of recurrence as defined by the Fuhrman grading status.
- Stage IV non-small cell lung cancer (NSCLC) per AJCC eight edition, with an
anti-programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%
determined using the Dako PD-L1 immunohistochemistry (IHC) 22C3 pharmDx
diagnostic kit, and confirmation that epidermal growth factor receptor (EGFR-),
anaplastic lymphoma kinase (ALK-), or c-ros oncogene 1 (ROS1)- directed therapy
is not indicated as primary therapy.
- Has a life expectancy of at least 3 months.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled
HIV on antiretroviral therapy (ART).
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if
they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks,
and have undetectable HBV viral load before randomization.
- Participants with history of hepatitis C virus (HCV) infection are eligible if have
completed curative antiviral therapy at least 4 weeks before randomization and HCV
viral load is undetectable at screening.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
assessed within 3 days before the start of study intervention.
Exclusion Criteria:
- Non-small cell lung cancer (NSCLC) participants with a diagnosis of small cell lung
cancer or, for mixed tumors, presence of small cell elements.
- Melanoma participants with ocular, mucosal, or conjunctival melanoma.
- Renal Cell Carcinoma (RCC) participants who have had major surgery, other than
nephrectomy, within 12 weeks before randomization.
- Has received prior radiotherapy for RCC.
- RCC participants who have residual thrombus post nephrectomy in the vena renalis or
vena cava.
- Has received prior therapy with an anti-programmed cell death 1 protein (PD-1),
PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or
coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4
(CTLA-4), OX-40, CD137).
- Has received prior systemic anticancer therapy including investigational agents
within 4 weeks before randomization.
- Has received a live or live-attenuated vaccine within 30 days before the first dose
of study intervention. Administration of killed vaccines is allowed.
- Received prior radiotherapy within 2 weeks of start of study intervention, or has
radiation-related toxicities, requiring corticosteroids.
- Received prior systemic anticancer therapy for their metastatic NSCLC. Note: Prior
treatment with neoadjuvant or adjuvant therapy for nonmetastatic NSCLC is allowed as
long as therapy was completed at least 12 months before diagnosis of metastatic
NSCLC.
- Received radiation therapy to the lung that is >30 Gray within 6 months of start of
study intervention.
- Has received an investigational agent or has used an investigational device within 4
weeks prior to study intervention administration.
- Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
or any other form of immunosuppressive therapy within 7 days prior the first dose of
study medication.
- Has known additional malignancy that is progressing or has required active treatment
within the past 3 years.
- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis.
- Has active autoimmune disease that has required systemic treatment in the past 2
years.
- Has history of (noninfectious) pneumonitis/interstitial lung disease that required
steroids or has current pneumonitis/interstitial lung disease.
- Has active infection requiring systemic therapy.
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric
Castleman's Disease.
- Has history of allogeneic tissue/solid organ transplant corticosteroids.
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its
excipients.
- Has not adequately recovered from major surgery or have ongoing surgical
complications.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Russell Medical ( Site 0160)
Address:
City:
Alexander City
Zip:
35010
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
256-329-7633
Facility:
Name:
Alaska Oncology and Hematology ( Site 0121)
Address:
City:
Anchorage
Zip:
99508
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
907-257-9851
Facility:
Name:
Highlands Oncology Group-Research Department ( Site 0133)
Address:
City:
Springdale
Zip:
72762
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
479-587-1700
Facility:
Name:
Marin Cancer Care ( Site 0148)
Address:
City:
Greenbrae
Zip:
94904
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
415-925-5040
Facility:
Name:
Holy Cross Hospital-Clinical Research ( Site 0159)
Address:
City:
Fort Lauderdale
Zip:
33308
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
954-267-7742
Facility:
Name:
Mid Florida Hematology and Oncology Center ( Site 0113)
Address:
City:
Orange City
Zip:
32763
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
407-353-1915
Facility:
Name:
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0112)
Address:
City:
Marietta
Zip:
30060
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
770-281-5100
Facility:
Name:
Kadlec Clinic Hematology and Oncology ( Site 0103)
Address:
City:
Kennewick
Zip:
99336
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
509-942-2540
Facility:
Name:
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300)
Address:
City:
Mar del Plata
Zip:
B7600FZO
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+5492235937663
Facility:
Name:
Fundación Respirar ( Site 0302)
Address:
City:
Buenos Aires
Zip:
C1426ABP
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+541151082017
Facility:
Name:
Instituto San Marcos ( Site 0305)
Address:
City:
San Juan
Zip:
J5400EBB
Country:
Argentina
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+54 9 264 5017141
Facility:
Name:
Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 1001)
Address:
City:
Port Macquarie
Zip:
2444
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
61265814053
Facility:
Name:
Frankston Hospital-Oncology and Haematology ( Site 1007)
Address:
City:
Frankston
Zip:
3199
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0417129607
Facility:
Name:
Centro Investigacion Cancer James Lind ( Site 0408)
Address:
City:
Temuco
Zip:
4800827
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+56994443272
Facility:
Name:
Clínica Puerto Montt ( Site 0404)
Address:
City:
Puerto Montt
Zip:
5500243
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
56998634501
Facility:
Name:
FALP-UIDO ( Site 0401)
Address:
City:
Santiago
Zip:
7500921
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
56224457254
Facility:
Name:
Oncovida ( Site 0403)
Address:
City:
Santiago
Zip:
7510032
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
5624205100
Facility:
Name:
Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0407)
Address:
City:
Santiago
Zip:
8330032
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
56223546919
Facility:
Name:
Bradfordhill-Clinical Area ( Site 0402)
Address:
City:
Santiago
Zip:
8420383
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+56998744662
Facility:
Name:
ONCOCENTRO APYS-ACEREY ( Site 0400)
Address:
City:
Viña del Mar
Zip:
2520598
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+56992369820
Facility:
Name:
Centre Hospitalier Universitaire de Caen Normandie-DERMATOLOGY ( Site 0604)
Address:
City:
Caen
Zip:
14000
Country:
France
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
33231065227
Facility:
Name:
Clinique Francois Chenieux ( Site 0603)
Address:
City:
Limoges
Zip:
87039
Country:
France
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
33555454800
Facility:
Name:
Hôpital Bichat - Claude-Bernard ( Site 0605)
Address:
City:
Paris
Zip:
75018
Country:
France
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0679854698
Facility:
Name:
CENTRE LEON BERARD-onco dermatology ( Site 0600)
Address:
City:
Lyon Cedex08
Zip:
69373
Country:
France
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+33478785996
Facility:
Name:
HIA Sainte Anne-Pneumology ( Site 0601)
Address:
City:
Toulon
Zip:
83800 Cedex 9
Country:
France
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0033483162937
Facility:
Name:
Bell Land General Hospital ( Site 1101)
Address:
City:
Sakai
Zip:
599-8247
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+81-72-234-2001
Facility:
Name:
Tokyo Women's Medical University ( Site 1100)
Address:
City:
Tokyo
Zip:
162-8666
Country:
Japan
Status:
Active, not recruiting
Facility:
Name:
Auckland City Hospital-Cancer & Blood Research ( Site 1051)
Address:
City:
Auckland
Zip:
1023
Country:
New Zealand
Status:
Active, not recruiting
Facility:
Name:
Bowen Hospital ( Site 1050)
Address:
City:
Wellington
Zip:
6035
Country:
New Zealand
Status:
Active, not recruiting
Facility:
Name:
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0701)
Address:
City:
Bydgoszcz
Zip:
85-796
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
48501446778
Facility:
Name:
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier
Address:
City:
Warszawa
Zip:
02-781
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
48225463066
Facility:
Name:
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0702)
Address:
City:
Koszalin
Zip:
75-581
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
48502204953
Facility:
Name:
Zachodniopomorskie Centrum Onkologii ( Site 0703)
Address:
City:
Szczecin
Zip:
71-730
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
48914251502
Facility:
Name:
Cancer Care Langenhoven Drive Oncology Centre ( Site 0808)
Address:
City:
Port Elizabeth
Zip:
6045
Country:
South Africa
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
27413630581
Facility:
Name:
Medical Oncology Centre of Rosebank ( Site 0805)
Address:
City:
Johannesburg
Zip:
2196
Country:
South Africa
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
0824445473
Facility:
Name:
Nosworthy Oncology ( Site 0807)
Address:
City:
Johannesburg
Zip:
2196
Country:
South Africa
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+27114823593
Facility:
Name:
Steve Biko Academic Hospital-Medical Oncology ( Site 0804)
Address:
City:
Pretoria
Zip:
0001
Country:
South Africa
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
27123541054
Facility:
Name:
LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0800)
Address:
City:
Pretoria
Zip:
0181
Country:
South Africa
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
27123466701
Facility:
Name:
Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 0801)
Address:
City:
Sandton
Zip:
2196
Country:
South Africa
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
27118830900
Facility:
Name:
Cape Town Oncology Trials ( Site 0802)
Address:
City:
Cape Town
Zip:
7570
Country:
South Africa
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
27219443832
Facility:
Name:
CANCERCARE RONDEBOSCH ONCOLOGY-Cancercare Rondebosch Oncology ( Site 0806)
Address:
City:
Cape Town
Zip:
7700
Country:
South Africa
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
27219443700
Facility:
Name:
Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 0903)
Address:
City:
Adana
Zip:
01140
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
905056166338
Facility:
Name:
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0900)
Address:
City:
Ankara
Zip:
06230
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
+905334318506
Facility:
Name:
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0901)
Address:
City:
Ankara
Zip:
06800
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
905052933234
Facility:
Name:
Ege Universitesi Hastanesi ( Site 0902)
Address:
City:
İzmir
Zip:
35100
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
905332117153
Start date:
December 26, 2023
Completion date:
November 16, 2026
Lead sponsor:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Source:
Merck Sharp & Dohme LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06099782
https://www.merckclinicaltrials.com/
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3475A-F11&&kw=3475A-F11
