Pembrolizumab in advanced renal cell carcinoma

Phase 1

• Conditions: Renal cell carcinoma (clear cell & non-clear cell), or kidney cancer; MedDRA version: 20.1Level: LLTClassification code 10023400Term: Kidney cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-000589-47-GB
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-20
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 255

Inclusion Criteria

- Be willing and able to provide written informed consent for the trial
- Be =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 nonclear 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: 0
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

Exclusion Criteria

- 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