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
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
| Drug | Synonyms | Arms |
|---|
| Nivolumab | BMS-936558, Opdivo | Flat-Dose |
| Ipilimumab | BMS-734016, Yervoy | Flat-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
| Name | Type | Description | Interventions |
|---|
| Flat-Dose | Experimental | Nivolumab flat dose + Ipilimumab | |
| Weight-Based Dose | Experimental | Nivolumab weight-based dose + 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: | Withdrawn |
| Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
April 17, 2018
