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Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT02393625
Recruitment Status : Active, not recruiting
First Posted : March 19, 2015
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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

Condition or disease Intervention/treatment Phase
ALK-positive NSCLC Drug: Ceritinib (LDK378) Drug: Nivolumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Open-label Study to Assess the Safety and Efficacy of Combination Ceritinib (LDK378) and Nivolumab in Adult Patients With Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC)
Actual Study Start Date : May 27, 2015
Estimated Primary Completion Date : June 5, 2020
Estimated Study Completion Date : June 5, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose Escalation Drug: Ceritinib (LDK378)
Drug: Nivolumab
Experimental: Dose Expansion Drug: Ceritinib (LDK378)
Drug: Nivolumab



Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion [ Time Frame: Study Day 42 (6 weeks) ]
  2. Overall response rate (ORR) [ Time Frame: 24 Weeks ]
    ORR (complete response (CR)+ partial response (PR)) per RECIST 1.1 as assessed by investigator


Secondary Outcome Measures :
  1. Duration of Response (DOR) [ Time Frame: 24 weeks ]
  2. Disease Control Rate (DCR) [ Time Frame: 24 weeks ]
  3. Time to Response (TTR) [ Time Frame: 24 weeks ]
  4. Progression Free Survival (PFS) [ Time Frame: 24 weeks ]
  5. Overall survival (OS) [ Time Frame: 24 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02393625


Locations
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United States, Arizona
Mayo Clinic - Arizona
Scottsdale, Arizona, United States, 85259
United States, Massachusetts
Massachusetts General Hospital Thoracic Oncolgoy
Boston, Massachusetts, United States, 02115
United States, Pennsylvania
Fox Chase Cancer Center StudyCoordinator
Philadelphia, Pennsylvania, United States, 19111
Australia, Victoria
Novartis Investigative Site
Heidelberg, Victoria, Australia, 3084
Belgium
Novartis Investigative Site
Leuven, Belgium, 3000
Canada, Ontario
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 1Z6
Hong Kong
Novartis Investigative Site
Hong Kong, Hong Kong
Italy
Novartis Investigative Site
Milano, MI, Italy, 20133
Novartis Investigative Site
Modena, MO, Italy, 41124
Netherlands
Novartis Investigative Site
Amsterdam, Netherlands, 1066
Novartis Investigative Site
Rotterdam, Netherlands, 3015 GD
Singapore
Novartis Investigative Site
Singapore, Singapore, 169610
Spain
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02393625     History of Changes
Other Study ID Numbers: CLDK378A2120C
First Posted: March 19, 2015    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
NSCLC, ALK-positive
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Nivolumab
Ceritinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action