Brief Summary
A study to evaluate the safety of Nivolumab given in combination with Ipilimumab in patients with advanced cancers. The initial group will enroll patients with newly diagnosed Stage 4 or non-small cell lung cancer that has come back.
Brief Title
An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers
Categories
Completion Date
Completion Date Type
Actual
Conditions
Lung Cancer
Eligibility Criteria
Inclusion Criteria:
* Histologically confirmed Stage 4 or recurrent non-small cell lung cancer
* Eastern Cooperative Oncology Group (ECOG) score 0-1 (Physically able to carry out light housework or office work through to being fully active as you were before cancer)
* No prior systemic anticancer therapy (including EGFR and ALK inhibitors)
* Tissue or Programmed death-ligand 1 (PD-L1) results available
Cohort 1A Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) score 2 or
* Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria as listed in the protocol
Cohort C Inclusion Criteria:
* High Tumor Mutation Burden
Exclusion Criteria:
* Untreated brain metastases
* An active malignancy that requires concurrent intervention
* Active, known or suspected autoimmune disease
* Carcinomatous meningitis, which means there is inflammation of the covering of the brain, caused by cancer
Other protocol-defined inclusion/exclusion criteria apply
* Histologically confirmed Stage 4 or recurrent non-small cell lung cancer
* Eastern Cooperative Oncology Group (ECOG) score 0-1 (Physically able to carry out light housework or office work through to being fully active as you were before cancer)
* No prior systemic anticancer therapy (including EGFR and ALK inhibitors)
* Tissue or Programmed death-ligand 1 (PD-L1) results available
Cohort 1A Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) score 2 or
* Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria as listed in the protocol
Cohort C Inclusion Criteria:
* High Tumor Mutation Burden
Exclusion Criteria:
* Untreated brain metastases
* An active malignancy that requires concurrent intervention
* Active, known or suspected autoimmune disease
* Carcinomatous meningitis, which means there is inflammation of the covering of the brain, caused by cancer
Other protocol-defined inclusion/exclusion criteria apply
Inclusion Criteria
Inclusion Criteria:
* Histologically confirmed Stage 4 or recurrent non-small cell lung cancer
* Eastern Cooperative Oncology Group (ECOG) score 0-1 (Physically able to carry out light housework or office work through to being fully active as you were before cancer)
* No prior systemic anticancer therapy (including EGFR and ALK inhibitors)
* Tissue or Programmed death-ligand 1 (PD-L1) results available
Cohort 1A Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) score 2 or
* Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria as listed in the protocol
Cohort C Inclusion Criteria:
* High Tumor Mutation Burden
inclusion/
* Histologically confirmed Stage 4 or recurrent non-small cell lung cancer
* Eastern Cooperative Oncology Group (ECOG) score 0-1 (Physically able to carry out light housework or office work through to being fully active as you were before cancer)
* No prior systemic anticancer therapy (including EGFR and ALK inhibitors)
* Tissue or Programmed death-ligand 1 (PD-L1) results available
Cohort 1A Inclusion Criteria:
* Eastern Cooperative Oncology Group (ECOG) score 2 or
* Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria as listed in the protocol
Cohort C Inclusion Criteria:
* High Tumor Mutation Burden
inclusion/
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02869789
Org Class
Industry
Org Full Name
Bristol-Myers Squibb
Org Study Id
CA209-817
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase 3b/4 Safety Trial of Flat Dose Nivolumab In Combination With Ipilimumab in Participants With Non-Small Cell Lung Cancer
Primary Outcomes
Outcome Description
Drug related AEs are those events with relationship to study drug. If the relationship to study drug is missing, the AE will be considered as drug-related. The select AEs of interest are the following: Pulmonary, Renal, Gastrointestinal, Hepatic, Skin, Endocrine, and hypersensitivity/infusion reaction events. AEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Grade 3= Prolonged severe reaction Grade 4= Life threatening Grade 5= Death
Grade 3= Prolonged severe reaction Grade 4= Life threatening Grade 5= Death
Outcome Measure
Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs)
Outcome Time Frame
From first dose to 30 days post last dose (Up to approximately 27 months)
Outcome Description
imAEs are specific events that include pneumonitis, diarrhea/colitis, hepatitis, nephritis/renal dysfunction, rash, and endocrine (adrenal insufficiency, hypothyroidism/thyroiditis, hyperthyroidism, diabetes mellitus, and hypophysitis). AEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.
Grade 3= Prolonged severe reaction Grade 4= Life threatening Grade 5= Death
Grade 3= Prolonged severe reaction Grade 4= Life threatening Grade 5= Death
Outcome Measure
Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs)
Outcome Time Frame
From first dose to 100 days post last dose (Up to approximately 29 months)
Secondary Ids
Secondary Id
2016-002621-10
Secondary Outcomes
Outcome Description
PFS is defined as the time from first dosing date to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first.
Progressive Disease (PD)= ≥ 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of ≥ 5 mm. The appearance of one or more new lesions is also considered progression.
Progressive Disease (PD)= ≥ 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of ≥ 5 mm. The appearance of one or more new lesions is also considered progression.
Outcome Time Frame
From first dosing date to the date of first documented tumor progression or, death due to any cause, whichever occurs first (Up to approximately 67 months)
Outcome Measure
Progression Free Survival (PFS)
Outcome Description
OS is defined as the time from first dosing date to the date of death. A participant who has not died will be censored at last known date alive.
Outcome Time Frame
From first dosing date to the date of death (Up to approximately 67 months)
Outcome Measure
Overall Survival (OS)
Outcome Description
ORR is defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR).
CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome Time Frame
From first dosing date up to approximately 67 months
Outcome Measure
Objective Response Rate (ORR)
Outcome Description
DoR is defined as the time between the date of first confirmed complete response (CR) or partial response (PR) to the date of the first documented tumor progression per RECIST 1.1, or death due to any cause, whichever occurs first.
CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD)= ≥ 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of ≥ 5 mm. The appearance of one or more new lesions is also considered progression.
CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm.
PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD)= ≥ 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of ≥ 5 mm. The appearance of one or more new lesions is also considered progression.
Outcome Time Frame
From first dosing date to the date of first documented tumor progression or, death due to any cause, whichever occurs first (Up to approximately 67 months)
Outcome Measure
Duration of Response (DoR)
Outcome Description
FACT-L is a quality-of-life questionnaire which includes Lung Cancer Subscale (LCS) that assesses the treatment impact on lung cancer related symptoms in 5 domains: Physical, social/family, emotional, and functional well-being using a 5-point scale (0=not at all; 1=a little bit, 2=somewhat; 3=quite a bit; 4=very much) added to obtain total score. The ranges of possible total scores are 0-136 for the FACT-L with a higher score representing better quality of life, improved symptomatology and enhanced physical/functional outcomes. According to Functional Assessment of Chronic Illness Therapy scoring guidelines, in the event of missing responses for some of the questions, scores will be prorated using the average of the other answers in that scale.
Baseline is defined as events that occur before the date/time of first dose. Post treatment visits include follow-up (FU) visit 1, FU visit 2, and subsequent survival FU visits to occur every 3 months up until survival FU visit 18.
Baseline is defined as events that occur before the date/time of first dose. Post treatment visits include follow-up (FU) visit 1, FU visit 2, and subsequent survival FU visits to occur every 3 months up until survival FU visit 18.
Outcome Time Frame
From baseline and up to subsequent survival follow-up visit 18 (Up to approximately 67 months)
Outcome Measure
Change From Baseline in Health-Related Quality of Life (HRQoL) Using Functional Assessment of Cancer Therapy-Lung (FACT-L)
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Balazs Halmos
Investigator Email
bahalmos@montefiore.org
Investigator Phone