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)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 147
- 试验地点
- 45
- 主要终点
- Percentage of Participants Who Prefer Pembrolizumab (+) Berahyaluronidase alfa Subcutaneous (SC) on Patient Preference Questionnaire (PPQ) Question 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Arm A: Pembrolizumab (+) Berahyaluronidase alfa SC →Pembrolizumab IV
In the treatment crossover period, participants will receive pembrolizumab (+) berahyaluronidase alfa SC followed by pembrolizumab IV. After completion of the treatment crossover period, participants will enter the treatment continuation period, where they will receive their preferred intervention for up to ~1 year for renal cell carcinoma (RCC) and melanoma and for up to ~2 years for non-small cell lung cancer (NSCLC).
干预措施: Pembrolizumab (+) Berahyaluronidase alfa (Biological)
Arm A: Pembrolizumab (+) Berahyaluronidase alfa SC →Pembrolizumab IV
In the treatment crossover period, participants will receive pembrolizumab (+) berahyaluronidase alfa SC followed by pembrolizumab IV. After completion of the treatment crossover period, participants will enter the treatment continuation period, where they will receive their preferred intervention for up to ~1 year for renal cell carcinoma (RCC) and melanoma and for up to ~2 years for non-small cell lung cancer (NSCLC).
干预措施: Pembrolizumab (Biological)
Arm B: Pembrolizumab IV→pembrolizumab (+) berahyaluronidase alfa SC
In the treatment crossover period, participants will receive pembrolizumab IV followed by pembrolizumab (+) berahyaluronidase alfa SC. After completion of the treatment crossover period, participants will enter the treatment continuation period, where they will receive their preferred intervention for up to ~1 year for RCC and melanoma and for up to ~2 years for NSCLC.
干预措施: Pembrolizumab (+) Berahyaluronidase alfa (Biological)
Arm B: Pembrolizumab IV→pembrolizumab (+) berahyaluronidase alfa SC
In the treatment crossover period, participants will receive pembrolizumab IV followed by pembrolizumab (+) berahyaluronidase alfa SC. After completion of the treatment crossover period, participants will enter the treatment continuation period, where they will receive their preferred intervention for up to ~1 year for RCC and melanoma and for up to ~2 years for NSCLC.
干预措施: Pembrolizumab (Biological)
结局指标
主要结局
Percentage of Participants Who Prefer Pembrolizumab (+) Berahyaluronidase alfa Subcutaneous (SC) on Patient Preference Questionnaire (PPQ) Question 1
时间窗: ~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. 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.
次要结局
- Percentage of Responses From Participants to the Two Main Reasons for Their Preferred Method of Administration as Assessed on PPQ Question 3(~Day 106)
- 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(Up to ~Day 106)
- 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(Up to ~Day 106)
- Percentage of Participants Who Choose Pembrolizumab (+) Berahyaluronidase alfa SC for the Study Treatment Continuation Period(~Day 106)
- Number of Participants Who Experience an Adverse Event (AE)(Up to ~27 months)
- Number of participants who discontinue study drug due to an AE(Up to ~24 months)