EUCTR2014-005614-29-ESActive, not recruitingPhase 1
A Phase 2 multicenter, randomized, placebo controlled, double-blind study to assess the safety and efficacy of CC-486 (oral azacitidine) in combination with pembrolizumab (MK-3475) versus pembrolizumab plus placebo in subjects with previously treated locally advanced or metastatic non-small cell lung cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Celgene Corporation
- Enrollment
- 90
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •-Subject is >= 18 years of age at the time of signing the informed consent form.
- •-Subject has histologically or cytologically confirmed squamous or non-squamous NSCLC.
- •-Subject has stage IIIB or IV NSCLC and was pretreated with 1 prior systemic platinum based chemotherapy.
- •-Subject has provided a formalin fixed tumor tissue sample from a biopsy of a tumor lesion either at the time of or after the diagnosis of metastatic disease has been made AND from a site not previously irradiated to assess for PD-L1 status.
- •-Subject has radiographically-documented measurable disease, as per RECIST 1.1.
- •-Subject has an ECOG performance status of 0 to 1.
- •-Subject has adequate organ and bone marrow functions
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
Exclusion Criteria
- •-Subject has known sensitizing EGFR and/or positive ALK mutation
- •-Subject has received prior therapy with any other anti-PD-1, or PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanism
- •-Subject has had radiotherapy <=4 weeks or limited field radiation for palliation <= 2 weeks prior to starting IP, and/or from whom >= 30% of the bone marrow was irradiated.
- •-Subject has received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted
- •-Subject has active autoimmune disease that has required systemic treatment within the past 2 years
- •-Subject with uncontrolled or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
Investigators
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