Non-Small Cell Lung Cancer Clinical Trial
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)
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.
| Status | Recruiting |
| Enrollment | 144 |
| Est. completion date | November 16, 2026 |
| Est. primary completion date | March 3, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Fundación Respirar ( Site 0302) | Buenos Aires | |
| Argentina | Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300) | Mar del Plata | Buenos Aires |
| Argentina | Instituto San Marcos ( Site 0305) | San Juan | |
| Australia | Frankston Hospital-Oncology and Haematology ( Site 1007) | Frankston | Victoria |
| Australia | Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 1001) | Port Macquarie | New South Wales |
| Chile | Clínica Puerto Montt ( Site 0404) | Puerto Montt | Los Lagos |
| Chile | Bradfordhill-Clinical Area ( Site 0402) | Santiago | Region M. De Santiago |
| Chile | FALP-UIDO ( Site 0401) | Santiago | Region M. De Santiago |
| Chile | Oncovida ( Site 0403) | Santiago | Region M. De Santiago |
| Chile | Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0407) | Santiago | Region M. De Santiago |
| Chile | ONCOCENTRO APYS-ACEREY ( Site 0400) | Viña del Mar | Valparaiso |
| France | Centre Hospitalier Universitaire de Caen Normandie-DERMATOLOGY ( Site 0604) | Caen | Calvados |
| France | Clinique Francois Chenieux ( Site 0603) | Limoges | Haute-Vienne |
| France | CENTRE LEON BERARD-onco dermatology ( Site 0600) | Lyon Cedex08 | Rhone-Alpes |
| France | Hôpital Bichat - Claude-Bernard ( Site 0605) | Paris | Ile-de-France |
| France | HIA Sainte Anne-Pneumology ( Site 0601) | Toulon | Var |
| Japan | Bell Land General Hospital ( Site 1101) | Sakai | Osaka |
| Japan | Tokyo Women's Medical University ( Site 1100) | Tokyo | |
| New Zealand | Auckland City Hospital-Cancer & Blood Research ( Site 1051) | Auckland | |
| New Zealand | Bowen Hospital ( Site 1050) | Wellington | |
| Poland | Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 0701) | Bydgoszcz | Kujawsko-pomorskie |
| Poland | Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0702) | Koszalin | Zachodniopomorskie |
| Poland | Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier | Warszawa | Mazowieckie |
| South Africa | Cape Town Oncology Trials ( Site 0802) | Cape Town | Western Cape |
| South Africa | Medical Oncology Centre of Rosebank ( Site 0805) | Johannesburg | Gauteng |
| South Africa | Nosworthy Oncology ( Site 0807) | Johannesburg | Gauteng |
| South Africa | LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 0800) | Pretoria | Gauteng |
| South Africa | Steve Biko Academic Hospital-Medical Oncology ( Site 0804) | Pretoria | Gauteng |
| Turkey | Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 0903) | Adana | |
| Turkey | Ankara Bilkent Sehir Hastanesi-Medical Oncology ( Site 0901) | Ankara | |
| Turkey | Hacettepe Universite Hastaneleri-oncology hospital ( Site 0900) | Ankara | |
| Turkey | Ege Universitesi Hastanesi ( Site 0902) | Izmir | |
| United States | Alaska Oncology and Hematology ( Site 0121) | Anchorage | Alaska |
| United States | Marin Cancer Care ( Site 0148) | Greenbrae | California |
| United States | Kadlec Clinic Hematology and Oncology ( Site 0103) | Kennewick | Washington |
| United States | Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0112) | Marietta | Georgia |
| United States | Mid Florida Hematology and Oncology Center ( Site 0113) | Orange City | Florida |
| United States | Highlands Oncology Group-Research Department ( Site 0133) | Springdale | Arkansas |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Argentina, Australia, Chile, France, Japan, New Zealand, Poland, South Africa, Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants Who Prefer MK-3475A Subcutaneous (SC) on Patient Preference Questionnaire (PPQ) Question 1 | 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. Question 1 in PPQ evaluates participants' preferred method of administration with response options of IV, SC or no preference. The percentage of participants who prefer SC will be reported. | ~Day 106 | |
| Secondary | Percentage of Responses From Participants to the Two Main Reasons for Their Preferred Method of Administration as Assessed on PPQ Question 3 | The PPQ is an instrument that has been developed from patient 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. Question 3 in PPQ evaluates two main reasons for participants' preference for one of the administration methods with response options of feels less emotionally distressing, requires less time in the clinic, lower level injection-site pain, among others. The percentage of responses from participants to the two main reasons for their preferred method of administration, as assessed on PPQ Question 3 will be reported. | ~Day 106 | |
| Secondary | 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 | The TASQ SC is a 12-item questionnaire that asks questions regarding different aspects of participants' satisfaction with SC administration, experiences related to administration, convenience, time. Question 1 in TASQ SC evaluates participants' satisfaction or dissatisfaction with SC administration. The percentage of participants by their level of satisfaction with the SC method of administration as assessed on TASQ-SC Question 1 will be reported. | Up to ~Day 106 | |
| Secondary | 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 | The TASQ IV is a 12-item questionnaire that asks questions regarding different aspects of participants' satisfaction with IV administration, experiences related to administration, convenience, time. Question 1 in TASQ IV evaluates participants' satisfaction or dissatisfaction with IV administration. The percentage of participants by their level of satisfaction with the IV method of administration as assessed on TASQ-IV Question 1 will be reported. | Up to ~Day 106 | |
| Secondary | Percentage of Participants Who Choose MK-3475A SC for the Study Treatment Continuation Period | The percentage of participants who choose SC treatment for the continuation period in the study will be reported. | ~Day 106 | |
| Secondary | Number of Participants Who Experience an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to ~27 months | |
| Secondary | Number of participants who discontinue study drug due to an AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to ~24 months |
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