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)

FacilityCityStateZIPSite coordinators
Mayo Clinic - ArizonaScottsdaleArizona85259-
Massachusetts General HospitalBostonMassachusetts02114-
Massachusetts General Hospital Thoracic OncolgoyBostonMassachusetts02115-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-

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