Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer
Part of paid clinical trials in Scottsdale, Arizona.
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT02393625
- Phase
- PHASE1
- Status
- Active Not Recruiting
Conditions
- ALK-positive NSCLC
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Not accepted
Interventions
- Ceritinib (LDK378) — DRUG
- Nivolumab — DRUG
Study Details
This is an open label multi center trial to determine the safety and efficacy of ceritinib in combination with nivolumab in ALK-positive NSCLC patients
Key Dates
- Start date
- May 27, 2015
- Status verified
- Jun 2026
- Primary completion
- Apr 9, 2027
- Completion
- Apr 9, 2027
Study Design
- Enrollment
- 57 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Dose Escalation
- Experimental: Dose Expansion
Primary Outcome Measure
Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion [ Time Frame: Study Day 42 (6 weeks) ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Mayo Clinic - Arizona | Scottsdale | Arizona | 85259 | - |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | - |
| Massachusetts General Hospital Thoracic Oncolgoy | Boston | Massachusetts | 02115 | - |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | - |
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