TriangleNCT02320058 · STUDY IN CONTEXT
An Investigational Immuno-therapy Study to Evaluate Safety and Effectiveness in Patients With Melanoma That Has Spread to the Brain, Treated With Nivolumab in Combination With Ipil
Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
Intracranial Clinical Benefit Rate (CBR) is defined as the percentage of all treated participants whose best overall response is either a complete response (CR) or partial response (PR) or whose best overall response was Stable Disease (SD) with duration of \>6 months, as determined by modified RECIST 1.1 criteria for index intracranial lesions based on investigator review.
Investigator-Assessed Intracranial Objective Response Rate (ORR) per modified RECIST 1.1 criteria is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants.
Intracranial progression-free survival (PFS) per modified RECIST 1.1 criteria is defined as the time between the date of first dose of study drug and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Participant who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die will be censored on the date of first dose of study drug. Participants who started anti-cancer therapy without a prior reported progression will be censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.
Extracranial Clinical Benefit Rate (CBR) is defined as the percentage of all treated participants whose best overall response is either a complete response (CR) or partial response (PR) or whose best overall response was Stable Disease (SD) with duration of \>6 months, as determined by RECIST 1.1 criteria for index extracranial lesions based on investigator review.
Extracranial Objective Response Rate (ORR) per RECIST 1.1 criteria is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants.
Extracranial progression-free survival (PFS) per RECIST 1.1 criteria is defined as the time between the date of first dose of study drug and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Participant who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die will be censored on the date of first dose of study drug. Participants who started anti-cancer therapy without a prior reported progression will be censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-keytruda-b5e1d696
- nct id
- NCT02320058
- trial label
- An Investigational Immuno-therapy Study to Evaluate Safety and Effectiveness in Patients With Melanoma That Has Spread to the Brain, Treated With Nivolumab in Combination With Ipil
- applicability
- unclear
- applicability note
- Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-keytruda-b5e1d696
- nct id
- NCT02320058
- outcome key
- om-0000
- source section id
- NCT02320058-om-0000
- source outcome index
- 0
- endpoint
- Intracranial Clinical Benefit Rate (CBR)
- endpoint definition
- Intracranial Clinical Benefit Rate (CBR) is defined as the percentage of all treated participants whose best overall response is either a complete response (CR) or partial response (PR) or whose best overall response was Stable Disease (SD) with duration of \>6 months, as determined by modified RECIST 1.1 criteria for index intracranial lesions based on investigator review.
- time origin
- Up to 66 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All treated participants
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-keytruda-b5e1d696
- nct id
- NCT02320058
- outcome key
- om-0001
- source section id
- NCT02320058-om-0001
- source outcome index
- 1
- endpoint
- Intracranial Objective Response Rate (ORR)
- endpoint definition
- Investigator-Assessed Intracranial Objective Response Rate (ORR) per modified RECIST 1.1 criteria is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants.
- time origin
- Up to 66 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All treated participants
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-keytruda-b5e1d696
- nct id
- NCT02320058
- outcome key
- om-0002
- source section id
- NCT02320058-om-0002
- source outcome index
- 2
- endpoint
- Intracranial Progression Free Survival (PFS)
- endpoint definition
- Intracranial progression-free survival (PFS) per modified RECIST 1.1 criteria is defined as the time between the date of first dose of study drug and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Participant who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die will be censored on the date of first dose of study drug. Participants who started anti-cancer therapy without a prior reported progression will be censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.
- time origin
- Up to 66 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All treated participants
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-keytruda-b5e1d696
- nct id
- NCT02320058
- outcome key
- om-0003
- source section id
- NCT02320058-om-0003
- source outcome index
- 3
- endpoint
- Extracranial Clinical Benefit Rate (CBR)
- endpoint definition
- Extracranial Clinical Benefit Rate (CBR) is defined as the percentage of all treated participants whose best overall response is either a complete response (CR) or partial response (PR) or whose best overall response was Stable Disease (SD) with duration of \>6 months, as determined by RECIST 1.1 criteria for index extracranial lesions based on investigator review.
- time origin
- Up to 66 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All treated participants
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-keytruda-b5e1d696
- nct id
- NCT02320058
- outcome key
- om-0004
- source section id
- NCT02320058-om-0004
- source outcome index
- 4
- endpoint
- Extracranial Objective Response Rate (ORR)
- endpoint definition
- Extracranial Objective Response Rate (ORR) per RECIST 1.1 criteria is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants.
- time origin
- Up to 66 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All treated participants
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-keytruda-b5e1d696
- nct id
- NCT02320058
- outcome key
- om-0005
- source section id
- NCT02320058-om-0005
- source outcome index
- 5
- endpoint
- Extracranial Progression Free Survival (PFS)
- endpoint definition
- Extracranial progression-free survival (PFS) per RECIST 1.1 criteria is defined as the time between the date of first dose of study drug and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Participant who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die will be censored on the date of first dose of study drug. Participants who started anti-cancer therapy without a prior reported progression will be censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.
- time origin
- Up to 66 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All treated participants
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-keytruda-b5e1d696
- nct id
- NCT02320058
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Cohort A
- regimen
- Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
- analyzed count
- 101
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02320058-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-keytruda-b5e1d696
- nct id
- NCT02320058
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Cohort B
- regimen
- Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
- analyzed count
- 18
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02320058-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-keytruda-b5e1d696
- nct id
- NCT02320058
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Cohort A
- regimen
- Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
- analyzed count
- 101
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02320058-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-keytruda-b5e1d696
- nct id
- NCT02320058
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Cohort B
- regimen
- Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
- analyzed count
- 18
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02320058-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-keytruda-b5e1d696
- nct id
- NCT02320058
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Cohort A
- regimen
- Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
- analyzed count
- 101
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02320058-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-keytruda-b5e1d696
- nct id
- NCT02320058
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Cohort B
- regimen
- Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
- analyzed count
- 18
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02320058-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-keytruda-b5e1d696
- nct id
- NCT02320058
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Cohort A
- regimen
- Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
- analyzed count
- 101
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02320058-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-keytruda-b5e1d696
- nct id
- NCT02320058
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Cohort B
- regimen
- Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
- analyzed count
- 18
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02320058-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-keytruda-b5e1d696
- nct id
- NCT02320058
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Cohort A
- regimen
- Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
- analyzed count
- 101
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02320058-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-keytruda-b5e1d696
- nct id
- NCT02320058
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Cohort B
- regimen
- Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
- analyzed count
- 18
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02320058-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-keytruda-b5e1d696
- nct id
- NCT02320058
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Cohort A
- regimen
- Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
- analyzed count
- 101
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02320058-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-keytruda-b5e1d696
- nct id
- NCT02320058
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Cohort B
- regimen
- Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
- analyzed count
- 18
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02320058-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-keytruda-b5e1d696
- nct id
- NCT02320058
- harm key
- EG000
- source section id
- NCT02320058-ae
- event group key
- EG000
- event group label
- Cohort A
- serious affected
- 50
- serious at risk
- 101
- other affected
- 97
- other at risk
- 101
- frequency threshold
- 5
- collection period
- From first dose to 100 days post last dose (Up to 68 months)
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-keytruda-b5e1d696
- nct id
- NCT02320058
- harm key
- EG001
- source section id
- NCT02320058-ae
- event group key
- EG001
- event group label
- Cohort B
- serious affected
- 14
- serious at risk
- 18
- other affected
- 18
- other at risk
- 18
- frequency threshold
- 5
- collection period
- From first dose to 100 days post last dose (Up to 68 months)
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice