TriangleNCT02224781 · STUDY IN CONTEXT
Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Mel
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
Overall Survival (OS) was defined as the time from randomization to death from any cause. Patients who have not died would be censored at the date of last known alive. 2-year OS rate was defined as a proportion of patients who are alive after two years of follow-up time among all cases who have died within 2 years or alive after 2-year follow-up time. Kaplan-Meier method was used to estimate 2-year OS.
Overall Survival (OS) was defined as the time from randomization to death from any cause. Patients who have not died would be censored at the date of last known alive. Median overall survival was estimated using Kaplan-Meier method.
Overall Survival (OS) was defined as the time from randomization to death from any cause. Patients who have not died would be censored at the date of last known alive. 3-year OS rate was defined as a proportion of patients who are alive after three years of follow-up time among all cases who have died within 3 years or alive after 3-year follow-up time. Kaplan-Meier method was used to estimate 3-year OS.
Progression-Free Survival (PFS) was defined as the time from randomization to disease progression or death (whichever occurs first). Cases without an event to date was censored at the date of last disease assessment documenting the patient was free of progression. Progression was evaluated based on international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Median PFS was estimated using Kaplan-Meier method.
Progression-Free Survival (PFS) was defined as the time from randomization (arm A) or crossover (arm D) to disease progression or death (whichever occurs first). Cases without an event to date was censored at the date of last disease assessment documenting the patient was free of progression. Progression was evaluated based on international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Median PFS was estimated using Kaplan-Meier method.
Progression-Free Survival (PFS) was defined as the time from randomization (arm B) or crossover (arm C) to disease progression or death (whichever occurs first). Cases without an event to date was censored at the date of last disease assessment documenting the patient was free of progression. Progression was evaluated based on international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Median PFS was estimated using Kaplan-Meier method.
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-qlex-b6745983
- nct id
- NCT02224781
- trial label
- Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Mel
- 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
- 4
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-keytruda-qlex-b6745983
- nct id
- NCT02224781
- outcome key
- om-0000
- source section id
- NCT02224781-om-0000
- source outcome index
- 0
- endpoint
- 2-year Overall Survival (OS)
- endpoint definition
- Overall Survival (OS) was defined as the time from randomization to death from any cause. Patients who have not died would be censored at the date of last known alive. 2-year OS rate was defined as a proportion of patients who are alive after two years of follow-up time among all cases who have died within 2 years or alive after 2-year follow-up time. Kaplan-Meier method was used to estimate 2-year OS.
- time origin
- assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized patients (ie, intent-to-treat population)
- 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-qlex-b6745983
- nct id
- NCT02224781
- outcome key
- om-0001
- source section id
- NCT02224781-om-0001
- source outcome index
- 1
- endpoint
- Median Overall Survival
- endpoint definition
- Overall Survival (OS) was defined as the time from randomization to death from any cause. Patients who have not died would be censored at the date of last known alive. Median overall survival was estimated using Kaplan-Meier method.
- time origin
- assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry
- analysis role
- secondary
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population 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-qlex-b6745983
- nct id
- NCT02224781
- outcome key
- om-0002
- source section id
- NCT02224781-om-0002
- source outcome index
- 2
- endpoint
- 3-year OS
- endpoint definition
- Overall Survival (OS) was defined as the time from randomization to death from any cause. Patients who have not died would be censored at the date of last known alive. 3-year OS rate was defined as a proportion of patients who are alive after three years of follow-up time among all cases who have died within 3 years or alive after 3-year follow-up time. Kaplan-Meier method was used to estimate 3-year OS.
- time origin
- assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry
- analysis role
- secondary
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population 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-qlex-b6745983
- nct id
- NCT02224781
- outcome key
- om-0003
- source section id
- NCT02224781-om-0003
- source outcome index
- 3
- endpoint
- Median Progression-free Survival (Arm A vs Arm B)
- endpoint definition
- Progression-Free Survival (PFS) was defined as the time from randomization to disease progression or death (whichever occurs first). Cases without an event to date was censored at the date of last disease assessment documenting the patient was free of progression. Progression was evaluated based on international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Median PFS was estimated using Kaplan-Meier method.
- time origin
- assessed at baseline and then every 12 weeks from start of treatment if patient is < 2 years from study entry (or < 2 years from crossover), then every 6 months until 5 years from study entry
- analysis role
- secondary
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population 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-qlex-b6745983
- nct id
- NCT02224781
- outcome key
- om-0004
- source section id
- NCT02224781-om-0004
- source outcome index
- 4
- endpoint
- Median Progression-free Survival (Arm A vs Arm D)
- endpoint definition
- Progression-Free Survival (PFS) was defined as the time from randomization (arm A) or crossover (arm D) to disease progression or death (whichever occurs first). Cases without an event to date was censored at the date of last disease assessment documenting the patient was free of progression. Progression was evaluated based on international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Median PFS was estimated using Kaplan-Meier method.
- time origin
- assessed at baseline and then every 12 weeks from start of treatment if patient is < 2 years from study entry (or < 2 years from crossover), then every 6 months until 5 years from study entry
- analysis role
- secondary
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population 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-qlex-b6745983
- nct id
- NCT02224781
- outcome key
- om-0005
- source section id
- NCT02224781-om-0005
- source outcome index
- 5
- endpoint
- Median Progression-free Survival (Arm B vs Arm C)
- endpoint definition
- Progression-Free Survival (PFS) was defined as the time from randomization (arm B) or crossover (arm C) to disease progression or death (whichever occurs first). Cases without an event to date was censored at the date of last disease assessment documenting the patient was free of progression. Progression was evaluated based on international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Median PFS was estimated using Kaplan-Meier method.
- time origin
- assessed at baseline and then every 12 weeks from start of treatment if patient is < 2 years from study entry (or < 2 years from crossover), then every 6 months until 5 years from study entry
- analysis role
- secondary
- reporting status
- NOT_POSTED
- data cutoff
- Source null
- population note
- Source null
- 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-qlex-b6745983
- nct id
- NCT02224781
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm A (Immunotherapy)
- regimen
- IMMUNOTHERAPY INDUCTION (CYCLES 1-2): Patients receive nivolumab IV over 30-60 minutes and ipilimumab IV over 30-90 minutes on days 1 and 22. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. IMMUNOTHERAPY MAINTENANCE (CYCLES 3-14): Patients receive nivolumab IV over 30-60 minutes on days 1, 15, and 29. Treatment repeats every 6 weeks for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm C. Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial. Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Echocardiography Test: Undergo ECHO Ipilimumab: Given IV Multigated Acquisition Scan: Undergo MUGA scan Nivolumab: Given IV Quality-of-Life Assessment: Ancillary studies
- analyzed count
- 135
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02224781-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-keytruda-qlex-b6745983
- nct id
- NCT02224781
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm B (BRAF Inhibitor Therapy)
- regimen
- Patients receive dabrafenib mesylate PO BID and trametinib dimethyl sulfoxide PO daily on days 1-42. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Upon disease progression (or before), patients re-register and cross over to Arm D. Patients also undergo CT, ECHO or MUGA, and collection of blood samples throughout the trial. Biospecimen Collection: Undergo collection of blood samples Computed Tomography: Undergo CT Dabrafenib Mesylate: Given PO Echocardiography Test: Undergo ECHO Multigated Acquisition Scan: Undergo MUGA scan Quality-of-Life Assessment: Ancillary studies Trametinib Dimethyl Sulfoxide: Given PO
- analyzed count
- 132
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02224781-om-0000#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-melanoma-keytruda-qlex-b6745983
- nct id
- NCT02224781
- harm key
- EG000
- source section id
- NCT02224781-ae
- event group key
- EG000
- event group label
- Arm A (Immunotherapy)
- serious affected
- 83
- serious at risk
- 131
- other affected
- 124
- other at risk
- 131
- frequency threshold
- 5
- collection period
- Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
- event definition
- All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
- 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-qlex-b6745983
- nct id
- NCT02224781
- harm key
- EG001
- source section id
- NCT02224781-ae
- event group key
- EG001
- event group label
- Arm B (BRAF Inhibitor Therapy)
- serious affected
- 75
- serious at risk
- 132
- other affected
- 129
- other at risk
- 132
- frequency threshold
- 5
- collection period
- Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
- event definition
- All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
- 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-qlex-b6745983
- nct id
- NCT02224781
- harm key
- EG002
- source section id
- NCT02224781-ae
- event group key
- EG002
- event group label
- Arm C (BRAF Inhibitor Therapy)
- serious affected
- 17
- serious at risk
- 29
- other affected
- 29
- other at risk
- 29
- frequency threshold
- 5
- collection period
- Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
- event definition
- All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
- 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-qlex-b6745983
- nct id
- NCT02224781
- harm key
- EG003
- source section id
- NCT02224781-ae
- event group key
- EG003
- event group label
- Arm D (Immunotherapy)
- serious affected
- 24
- serious at risk
- 52
- other affected
- 44
- other at risk
- 52
- frequency threshold
- 5
- collection period
- Assessed every cycle (1 cycle=42 days) while on treatment and for 30 days after the end of treatment, up to 8 years
- event definition
- All-cause mortality was assessed among all randomized patients, while serious adverse events and other adverse events were assessed among patients who received protocol therapy.
- 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