Pembrolizumab in advanced renal cell carcinoma

Phase 1

• Conditions: Renal cell carcinoma (clear cell & non-clear cell), or kidney cancer; MedDRA version: 19.0Level: LLTClassification code 10023400Term: Kidney cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-05
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

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

Inclusion Criteria

- Provide written informed consent/assent 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). Confirmation of the diagnosis of non-clear cell RCC by central histology review during the screening phase is required prior to allocation to Cohort B
- Have locally advanced/metastatic disease, i.e., 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. Target 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
- 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

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 prior to allocation 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 systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment, except in the case of central nervous system (CNS) metastases
- Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic or immunosuppressive agents
- Has a known additional malignancy that has had progression or has required active treatment in the last 3 years. Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or carcinoma in situ are not excluded
- Has known active central nervous system (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