Clinical Trials /

A Safety Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Non-small Cell Lung Cancer

NCT03048136

Description:

A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Withdrawn

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Safety Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Non-small Cell Lung Cancer
  • Official Title: A Phase Ib/II Safety Trial of Nivolumab in Combination With Ipilimumab Administered in Participants With Chemotherapy-naive Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC) (CheckMate 955: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 955)

Clinical Trial IDs

  • ORG STUDY ID: CA209-955
  • NCT ID: NCT03048136

Conditions

  • Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
NivolumabBMS-936558, OpdivoFlat-Dose
IpilimumabBMS-734016, YervoyFlat-Dose

Purpose

A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab

Detailed Description

      A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent
      Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab
    

Trial Arms

NameTypeDescriptionInterventions
Flat-DoseExperimentalNivolumab flat dose + Ipilimumab
  • Nivolumab
  • Ipilimumab
Weight-Based DoseExperimentalNivolumab weight-based dose + Ipilimumab
  • Nivolumab
  • Ipilimumab

Eligibility Criteria

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  1) Stage IV or recurrent non-Small cell lung cancer

          -  2) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

          -  3) Prior adjuvant or neoadjuvant chemotherapy for local, advanced disease allowed if
             completed at least 6 months prior to randomization

        Exclusion Criteria:

          -  1) Known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma
             syndrome(ALK) translocations that are sensitive to targeted inhibitor therapy

          -  2) Active, known or suspected autoimmune disease or HIV infection

          -  3) Prior treatment with any drug that targets T cell co-stimulation pathways (such as
             checkpoint inhibitors)

          -  4) Untreated Central Nervous System metastases

        Other protocol defined inclusion/exclusion criteria could apply
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence of high grade (Grade 3-4 and Grade 5) treatment-related select adverse events
Time Frame:Approximately 3 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Progression-free survival (PFS) as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Objective Response Rate (ORR) as assessed by the Investigator using tumor progression per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time Frame:Up to 24 months
Safety Issue:
Description:
Measure:Overall survival (OS) as defined as the time from first dosing to the date of death
Time Frame:Up to 5 years
Safety Issue:
Description:
Measure:Duration of Response (DOR) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time Frame:Up to 24 months
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Bristol-Myers Squibb

Last Updated

May 18, 2017