Pembrolizumab in advanced renal cell carcinoma
- Conditions
- Renal cell carcinoma (clear cell & non-clear cell), or kidney cancerMedDRA version: 20.1Level: LLTClassification code 10023400Term: Kidney cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-000589-47-DE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 255
- Provide written informed consent/assent for the trial
- Be willing and able to provide written informed consent for the trial
- Be > or = 18 years of age on day of signing informed consent
- Cohort A (clear cell cohort) must have histologically confirmed diagnosis of clear cell RCC or RCC with clear cell component (with or without sarcomatoid features)
- Cohort B (non-clear cell cohort) must have histologically confirmed diagnosis of non-clear cell RCC (with or without sarcomatoid features) by the site pathologist. For Cohort B, sites will submit tissues for histologic confirmation of the diagnosis of non-clear cell RCC by central histology review during the screening phase. Sites should enroll subjects in Cohort B after receiving notice that the submitted tissue was adequate for central review. Confirmation of non-clear cell RCC histology by the central laboratory will be made available to the sites as a later date.
- Have locally advanced/metastatic disease, i.e., newly diagnosed Stage IV RCC per American Joint Committee on Cancer (AJCC) or have recurrent disease
- Have measurable disease per RECIST 1.1 as assessed by BICR. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
- Have received no prior systemic therapy for advanced RCC.
Note: Prior neoadjuvant/adjuvant therapy for RCC is acceptable if completed > 12 months prior to allocation.
- Provide adequate tissue for biomarker analysis for cohorts A and B
- Demonstrate adequate organ function
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 135
- Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks prior to allocation, has had major surgery within 4 weeks or radiation therapy within 2 weeks prior to allocation, or who has not recovered (i.e., < or = Grade 1 or at baseline) from adverse events due to prior treatment
- Had prior treatment with any anti-PD-1, or PD-L1, or PD-L2 agent or an antibody targeting any other immune-regulatory receptors or mechanisms. Examples of such antibodies include (but are not limited
to) antibodies against IDO, PD-L1, IL-2R, GITR
- Has a diagnosis of immunodeficiency OR is receiving a systemic steroid therapy exceeding 10 mg daily dose of prednisone or equivalent or any other form of immunosuppressive therapy within 7 days prior to allocation, except in the case of central nervous system (CNS) metastases
- Has an active autoimmune disease requiring systemic treatment within the past 2 years, (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs); OR a documented history of clinically severe autoimmune disease
- Has a known additional malignancy that has had progression or has required active treatment in the last 3 years. Note: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, such as breast cancer in situ, that has undergone potentially curative therapy are acceptable
- Has known CNS metastases and/or carcinomatous meningitis
- Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
- Has had a prior solid organ transplant
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method