Clinical Trials in Italy / NCT02393625
Active, not recruiting
Phase 1
Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer
NCT02393625 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
ALK-positive NSCLC
Investigational drug(s) / intervention(s)
Study summary
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
Eligibility
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of NSCLC that carries an ALK rearrangement
* Stage IIIB or IV NSCLC or relapsed locally advanced or metastatic NSCLC
* Presence of at least one measurable lesion as defined by RECIST 1.1
* Patients who have received prior chemotherapy, other ALK inhibitors, biologic therapy, or other investigational agents, must have recovered from all toxicities related to prior anticancer therapies to grade ≤1 (CTCAE v 4.03). Patients with grade ≤ 2 peripheral neuropathy or any grade of alopecia, fatigue, nail changes or skin changes are allowed to enter the study
* Patient has a WHO performance status 0-1
Exclusion Criteria:
* Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years
* Patients with an active, known or suspected autoimmune disease
* Unable or unwilling to swallow tablets or capsules
* Patient has other severe, acute, or chronic medical conditions including uncontrolled diabetes mellitus or psychiatric conditions or laboratory abnormalities that in the opinion of the Investigator may increase the risk associated with study participation, or that may interfere with the interpretation of study results
Primary outcome measure(s)
- Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion — Study Day 42 (6 weeks)
- Overall response rate (ORR) — 24 Weeks
ORR (complete response (CR)+ partial response (PR)) per RECIST 1.1 as assessed by investigator
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic - Arizona | Scottsdale | Arizona | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Massachusetts General Hospital Thoracic Oncolgoy | Boston | Massachusetts | |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | |
| Novartis Investigative Site | Heidelberg | Victoria | |
| Novartis Investigative Site | Leuven | Vlaams Brabant | |
| Novartis Investigative Site | Toronto | Ontario | |
| Novartis Investigative Site | Hong Kong | Hong Kong | |
| Novartis Investigative Site | Milan | MI | |
| Novartis Investigative Site | Modena | MO | |
| Novartis Investigative Site | Singapore | Singapore | |
| Novartis Investigative Site | Barcelona | Spain |
On this site
📄 Opdivo (nivolumab) drug profile →More Novartis Pharmaceuticals trials in Italy
Phase 3 Study of Pelabresib (CPI-0610) in Myelofibrosis (MF) (MANIFEST-2)
Active, not recruiting
Study of PIT565 in Relapsed and/or Refractory B-cell Malignancies
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02393625 on ClinicalTrials.gov ↗ ← All trials in Italy