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)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Renal Cell Carcinoma
Melanoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2023-10-25
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate participant preference for coformulated hyaluronidase/pembrolizumab pembrolizumab (+) berahyaluronidase alfa 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 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.

Primary outcomes:
measure: Percentage of Participants Who Prefer Pembrolizumab (+) Berahyaluronidase alfa Subcutaneous (SC) on Patient Preference Questionnaire (PPQ) Question 1
timeFrame: ~Day 106
Secondary outcomes:
measure: Percentage of Responses From Participants to the Two Main Reasons for Their Preferred Method of Administration as Assessed on PPQ Question 3
timeFrame: ~Day 106
measure: Percentage of Participants by Their Level of Satisfaction With the SC Method of Administration as assessed on Therapy Administration Satisfaction Questionnaire - Subcutaneous (TASQ-SC) Question 1
timeFrame: Up to ~Day 106
measure: Percentage of Participants by Their Level of Satisfaction With the IV Method of Administration as assessed on Therapy Administration Satisfaction Questionnaire -Intravenous (TASQ-IV) Question 1
timeFrame: Up to ~Day 106
measure: Percentage of Participants Who Choose Pembrolizumab (+) Berahyaluronidase alfa SC for the Study Treatment Continuation Period
timeFrame: ~Day 106
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to ~27 months
measure: Number of participants who discontinue study drug due to an AE
timeFrame: Up to ~24 months
Other outcomes:
Locations:
city: Alexander City
country: United States
facility: Russell Medical ( Site 0160)
state: Alabama
city: Anchorage
country: United States
facility: Alaska Oncology and Hematology ( Site 0121)
state: Alaska
city: Springdale
country: United States
facility: Highlands Oncology Group-Research Department ( Site 0133)
state: Arkansas
city: Greenbrae
country: United States
facility: Marin Cancer Care ( Site 0148)
state: California
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital-Clinical Research ( Site 0159)
state: Florida
city: Orange City
country: United States
facility: Mid Florida Hematology and Oncology Center ( Site 0113)
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0112)
state: Georgia
city: Kennewick
country: United States
facility: Kadlec Clinic Hematology and Oncology ( Site 0103)
state: Washington
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300)
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Fundación Respirar ( Site 0302)
state: Caba
city: San Juan
country: Argentina
facility: Instituto San Marcos ( Site 0305)
city: Port Macquarie
country: Australia
facility: Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 1001)
state: New South Wales
city: Frankston
country: Australia
facility: Frankston Hospital-Oncology and Haematology ( Site 1007)
state: Victoria
city: Temuco
country: Chile
facility: Centro Investigacion Cancer James Lind ( Site 0408)
state: Araucania
city: Puerto Montt
country: Chile
facility: Clínica Puerto Montt ( Site 0404)
state: Los Lagos
city: Santiago
country: Chile
facility: FALP-UIDO ( Site 0401)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Oncovida ( Site 0403)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0407)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill-Clinical Area ( Site 0402)
state: Region M. De Santiago
city: Viña del Mar
country: Chile
facility: ONCOCENTRO APYS-ACEREY ( Site 0400)
state: Valparaiso
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen Normandie-DERMATOLOGY ( Site 0604)
state: Calvados
city: Limoges
country: France
facility: Clinique Francois Chenieux ( Site 0603)
state: Haute-Vienne
city: Paris
country: France
facility: Hôpital Bichat - Claude-Bernard ( Site 0605)
state: Ile-de-France
city: Lyon Cedex08
country: France
facility: CENTRE LEON BERARD-onco dermatology ( Site 0600)
state: Rhone-Alpes
city: Toulon
country: France
facility: HIA Sainte Anne-Pneumology ( Site 0601)
state: Var
city: Sakai
country: Japan
facility: Bell Land General Hospital ( Site 1101)
state: Osaka
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University ( Site 1100)
city: Auckland
country: New Zealand
facility: Auckland City Hospital-Cancer & Blood Research ( Site 1051)
city: Wellington
country: New Zealand
facility: Bowen Hospital ( Site 1050)
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0701)
state: Kujawsko-pomorskie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier
state: Mazowieckie
city: Koszalin
country: Poland
facility: Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0702)
state: Zachodniopomorskie
city: Szczecin
country: Poland
facility: Zachodniopomorskie Centrum Onkologii ( Site 0703)
state: Zachodniopomorskie
city: Port Elizabeth
country: South Africa
facility: Cancer Care Langenhoven Drive Oncology Centre ( Site 0808)
state: Eastern Cape
city: Johannesburg
country: South Africa
facility: Medical Oncology Centre of Rosebank ( Site 0805)
state: Gauteng
city: Johannesburg
country: South Africa
facility: Nosworthy Oncology ( Site 0807)
state: Gauteng
city: Pretoria
country: South Africa
facility: Steve Biko Academic Hospital-Medical Oncology ( Site 0804)
state: Gauteng
city: Pretoria
country: South Africa
facility: LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0800)
state: Gauteng
city: Sandton
country: South Africa
facility: Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 0801)
state: Gauteng
city: Cape Town
country: South Africa
facility: Cape Town Oncology Trials ( Site 0802)
state: Western Cape
city: Cape Town
country: South Africa
facility: CANCERCARE RONDEBOSCH ONCOLOGY-Cancercare Rondebosch Oncology ( Site 0806)
state: Western Cape
city: Adana
country: Turkey
facility: Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 0903)
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri-oncology hospital ( Site 0900)
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0901)
city: İzmir
country: Turkey
facility: Ege Universitesi Hastanesi ( Site 0902)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: