Description:
The purpose of part 1 of this study is to determine the objective response rate (ORR) in
stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line
therapy.
The purpose of part 2 of this study is to determine the safety and tolerability of nivolumab
and ipilimumab combined with a short course of chemotherapy in first line stage IV NSCLC.
Title
- Brief Title: Nivolumab in Combination With Ipilimumab (Part 1); Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer
- Official Title: A Study of Nivolumab in Combination With Ipilimumab (Part 1); and Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer (NSCLC)
Clinical Trial IDs
- ORG STUDY ID:
CA209-568
- NCT ID:
NCT02659059
Conditions
- Non-Small-Cell Lung Cancer
Interventions
| Drug | Synonyms | Arms |
|---|
| Nivolumab | BMS-936558, Opdivo | Nivolumab+Ipilimumab |
| Ipilimumab | BMS-734016, Yervoy | Nivolumab+Ipilimumab |
| Platinum Doublet Chemotherapy | Carboplatin + Paclitaxel, Cisplatin + pemetrexed | Nivolumab+Ipilimumab + 2 cycles Platinum Doublet Chemotherapy |
Purpose
The purpose of part 1 of this study is to determine the objective response rate (ORR) in
stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line
therapy.
The purpose of part 2 of this study is to determine the safety and tolerability of nivolumab
and ipilimumab combined with a short course of chemotherapy in first line stage IV NSCLC.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Nivolumab+Ipilimumab | Experimental | Part 1
Specified Dose on Specified Days | |
| Nivolumab+Ipilimumab + 2 cycles Platinum Doublet Chemotherapy | Experimental | Part 2
Specified Dose on Specified Days | - Nivolumab
- Ipilimumab
- Platinum Doublet Chemotherapy
|
Eligibility Criteria
For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation,
please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Men and Women ≥ 18 years of age
- Diagnosed with stage IV Non-Small Cell Lung Cancer
- Diagnosed with recurrent stage IIIB non-small cell lung cancer and failed previous
concurrent chemoradiation with no further curative options.
Exclusion Criteria:
- Subjects with untreated CNS metastases are excluded.
- Subjects with carcinomatous meningitis
- Subjects with an active, known or suspected autoimmune disease.
- Subjects with a condition requiring systemic treatment with either corticosteroids ( >
10 mg daily prednisone
equivalent) or other immunosuppressive medications within 14 days of first treatment.
- Women who are pregnant, plan to become pregnant, and/or breastfeed during the study.
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: | Objective Response Rate (ORR) by PD-L1 Positive and Negative Levels - Part 1 |
| Time Frame: | From first dose to database lock (Up to 18 months) |
| Safety Issue: | |
| Description: | Objective response rate (ORR) in PD-L1 positive (PD-L1 ≥1%) and PD-L1 negative (PD-L1 <1%) participants was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment. |
Secondary Outcome Measures
| Measure: | Overall Survival (OS) |
| Time Frame: | Part 1 up to 18 months and Part 2 up to 24 months |
| Safety Issue: | |
| Description: | Overall survival (OS) was defined as the time from date of first treatment to the date of death for part 1 and part 2. A participant who has not died will be censored at the last known date alive. |
| Measure: | Progression Free Survival (PFS) - Part 1 |
| Time Frame: | Up to 18 months |
| Safety Issue: | |
| Description: | Progression Free Survival (PFS) was defined as the time between the date of first dose and the first date of documented progression, as determined by blinded independent central review (BICR), or death due to any cause, whichever occurred first. |
| Measure: | Progression Free Survival (PFS) - Part 2 |
| Time Frame: | Up to 24 months |
| Safety Issue: | |
| Description: | Progression Free Survival (PFS) was defined as the time between the date of first dose and the first date of documented progression, as determined by investigator (per RECIST 1.1), or death due to any cause, whichever occurred first. |
| Measure: | Objective Response Rate (ORR) - Part 1 |
| Time Frame: | Up to 18 months |
| Safety Issue: | |
| Description: | Objective response rate (ORR) was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment. |
| Measure: | Objective Response Rate (ORR) - Part 2 |
| Time Frame: | Up to 24 months |
| Safety Issue: | |
| Description: | Objective response rate (ORR) was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on investigator assessment. |
| Measure: | Overall Survival (OS) by PD-L1 Expression Levels - Part 1 |
| Time Frame: | Up to 18 months |
| Safety Issue: | |
| Description: | Overall survival (OS) by PD-L1 expression levels was defined as the time from date of first treatment to the date of death. A participant who has not died will be censored at the last known date alive. |
| Measure: | Progression Free Survival (PFS) by PD-L1 Expression Levels - Part 1 |
| Time Frame: | Up to 18 months |
| Safety Issue: | |
| Description: | Progression Free Survival (PFS) by PD-L1 expression levels was defined as the time between the date of first dose and the first date of documented progression, as determined by blinded independent central review (BICR), or death due to any cause, whichever occurred first. |
| Measure: | Objective Response Rate (ORR) by PD-L1 Expression Levels-Part 1 |
| Time Frame: | Up to 18 months |
| Safety Issue: | |
| Description: | Objective response rate (ORR) by PD-L1 expression levels was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment. |
| Measure: | Overall Survival (OS) by Tumor Mutation Burden (TMB) Levels - Part 1 |
| Time Frame: | Up to 18 months |
| Safety Issue: | |
| Description: | Overall survival (OS) by tumor mutational burden (TMB) using DNA derived from tumor specimens. High TMB is >= 10 mutations per megabase and Low TMB is < 10 mutations per megabase. |
| Measure: | Progression Free Survival (PFS) by Tumor Mutation Burden (TMB) Levels - Part 1 |
| Time Frame: | Up to 18 months |
| Safety Issue: | |
| Description: | Progression free survival (PFS) by tumor mutational burden (TMB) using DNA derived from tumor specimens. High TMB is >= 10 mutations per megabase and Low TMB is < 10 mutations per megabase. |
| Measure: | Objective Response Rate (ORR) by Tumor Mutation Burden (TMB) Levels - Part 1 |
| Time Frame: | Up to 18 months |
| Safety Issue: | |
| Description: | Objective response rate (ORR) by tumor mutational burden (TMB) using DNA derived from tumor specimens. High TMB is >= 10 mutations per megabase and Low TMB is < 10 mutations per megabase. |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
July 22, 2021
