TriangleNCT03146650 · STUDY IN CONTEXT
Nivolumab and Ipilimumab in Treating Patients With Metastatic/Recurrent ACC of All Sites and Non-ACC Salivary Gland Cancer
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Progression-Free Survival assessed per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria at time of first study treatment. PFS defined as absence of death and of progressive disease. Progressive disease per RECIST v. 1.1 defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (0.5 cm). The appearance of one or more new lesions is also considered progression. Response rates and 95% confidence intervals will be calculated using exact binomial probability distributions for discrete outcomes. Efficacy will be evaluated in all patients who receive at least one dose of study treatment and have had their disease re-evaluated.
Progression-Free Survival assessed per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria at time of first study treatment. PFS defined as absence of death and of progressive disease. Progressive disease per RECIST v. 1.1 defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (0.5 cm). The appearance of one or more new lesions is also considered progression. Response rates and 95% confidence intervals will be calculated using exact binomial probability distributions for discrete outcomes. Efficacy will be evaluated in all patients who receive at least one dose of study treatment and have had their disease re-evaluated.
Response rate (RR) is percentage of patients whose cancer shrinks or disappears after treatment. Patients with adenoid cystic carcinoma who have a complete response (CR) or partial response (PR) per RECIST criteria v. 1.1 will be included in the results. Per RECIST v. 1.1, CR is defined as "disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10mm." A PR is defined as "At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters."
Clinical Benefit Rate (CBR) is defined as the percentage of patients with Complete Response (CR), Partial Response (PR), and Stable Disease (SD) and will be assessed by RECIST 1.1 in patients with adenoid cystic carcinoma (ACC). Per RECIST v. 1.1, CR is defined as, "Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10mm." PR is defined as, "At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters." SD is defined as, "Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."
Overall survival (OS) is defined as time in months from the date of first study treatment to the date of death or withdrawal from study, whichever comes first. The percentage of patients alive at 6 months, 12 months, and 24 months will be reported. All patients who receive at least one dose of nivolumab will be included in the secondary analyses of OS.
Toxicity, both frequency and severity, will continue to be measured by monitoring the occurrence of adverse events. Adverse events will be defined as those included in CTCAE v 4.03. AEs that were determined to be at least possibly related to study drug and graded 3, 4, 5 are included here. Grade 1 (mild): the event causes discomfort without disruption of normal daily activities. Grade 2 (moderate): the event causes discomfort that affects normal daily activities. Grade 3 (severe): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status. Grade 4 (Life-threatening): the patient was at risk of death at the time of the event. Grade 5 (fatal): the event caused death.
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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT03146650
- trial label
- Nivolumab and Ipilimumab in Treating Patients With Metastatic/Recurrent ACC of All Sites and Non-ACC Salivary Gland Cancer
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT03146650
- outcome key
- om-0000
- source section id
- NCT03146650-om-0000
- source outcome index
- 0
- endpoint
- Progression-Free Survival
- endpoint definition
- Progression-Free Survival assessed per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria at time of first study treatment. PFS defined as absence of death and of progressive disease. Progressive disease per RECIST v. 1.1 defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (0.5 cm). The appearance of one or more new lesions is also considered progression. Response rates and 95% confidence intervals will be calculated using exact binomial probability distributions for discrete outcomes. Efficacy will be evaluated in all patients who receive at least one dose of study treatment and have had their disease re-evaluated.
- time origin
- From the start of treatment and every 12 weeks during treatment, for up to two years, where 1 cycle =12 weeks/84 days, and range of cycles attempted was 1-11.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients with recurrent or metastatic Adenoid cystic carcinoma (ACC).
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT03146650
- outcome key
- om-0001
- source section id
- NCT03146650-om-0001
- source outcome index
- 1
- endpoint
- Median Progression-free Survival
- endpoint definition
- Progression-Free Survival assessed per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria at time of first study treatment. PFS defined as absence of death and of progressive disease. Progressive disease per RECIST v. 1.1 defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (0.5 cm). The appearance of one or more new lesions is also considered progression. Response rates and 95% confidence intervals will be calculated using exact binomial probability distributions for discrete outcomes. Efficacy will be evaluated in all patients who receive at least one dose of study treatment and have had their disease re-evaluated.
- time origin
- From the start of treatment and every 12 weeks during treatment, for up to two years, where 1 cycle =12 weeks/84 days, and range of cycles attempted was 1-11.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients with adenoid cystic carcinoma only.
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT03146650
- outcome key
- om-0002
- source section id
- NCT03146650-om-0002
- source outcome index
- 2
- endpoint
- Response Rate (RR)
- endpoint definition
- Response rate (RR) is percentage of patients whose cancer shrinks or disappears after treatment. Patients with adenoid cystic carcinoma who have a complete response (CR) or partial response (PR) per RECIST criteria v. 1.1 will be included in the results. Per RECIST v. 1.1, CR is defined as "disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10mm." A PR is defined as "At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters."
- time origin
- On Cycle 2 Day 1, and every cycle thereafter (1 cycle = 12 weeks), about 27 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Adenoid Cystic Carcinoma (ACC) patient only.
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT03146650
- outcome key
- om-0003
- source section id
- NCT03146650-om-0003
- source outcome index
- 3
- endpoint
- Clinical Benefit Rate (CBR)
- endpoint definition
- Clinical Benefit Rate (CBR) is defined as the percentage of patients with Complete Response (CR), Partial Response (PR), and Stable Disease (SD) and will be assessed by RECIST 1.1 in patients with adenoid cystic carcinoma (ACC). Per RECIST v. 1.1, CR is defined as, "Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10mm." PR is defined as, "At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters." SD is defined as, "Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."
- time origin
- On Cycle 2 Day 1, and every cycle thereafter (1 cycle = 12 weeks), about 27 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients with Adenoid cystic carcinoma only.
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT03146650
- outcome key
- om-0004
- source section id
- NCT03146650-om-0004
- source outcome index
- 4
- endpoint
- Overall Survival (OS)
- endpoint definition
- Overall survival (OS) is defined as time in months from the date of first study treatment to the date of death or withdrawal from study, whichever comes first. The percentage of patients alive at 6 months, 12 months, and 24 months will be reported. All patients who receive at least one dose of nivolumab will be included in the secondary analyses of OS.
- time origin
- Up to 2 years from start of treatment
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients with Adenoid Cystic Carcinoma only.
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT03146650
- outcome key
- om-0005
- source section id
- NCT03146650-om-0005
- source outcome index
- 5
- endpoint
- Number of Adverse Events Possibly Related to Study Drugs Graded 3, 4, and 5
- endpoint definition
- Toxicity, both frequency and severity, will continue to be measured by monitoring the occurrence of adverse events. Adverse events will be defined as those included in CTCAE v 4.03. AEs that were determined to be at least possibly related to study drug and graded 3, 4, 5 are included here. Grade 1 (mild): the event causes discomfort without disruption of normal daily activities. Grade 2 (moderate): the event causes discomfort that affects normal daily activities. Grade 3 (severe): the event makes the patient unable to perform normal daily activities or significantly affects his/her clinical status. Grade 4 (Life-threatening): the patient was at risk of death at the time of the event. Grade 5 (fatal): the event caused death.
- time origin
- Up to 30 days after discontinuation, where range of cycles attempted was 1-11, where 1 Cycle = 84 days/12 weeks
- analysis role
- secondary
- reporting status
- 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT03146650
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Nivolumab + Ipilimumab
- regimen
- Nivolumab and ipilimumab combination will be administered intravenously until disease progression or intolerable toxicity. Nivolumab: Given at 240mg over 30 minutes (-5 / +15 minutes) every 2 weeks starting with Cycle 1 Day 1 for the first 16 weeks (1 cycle = 12 weeks). Starting with Cycle 2 Day 29, nivolumab will be given at 480mg IV over 60 minutes (-10 / +15 minutes) every 4 weeks. Ipilimumab: Given at 1mg/Kg every 6 weeks starting with Cycle 1 Day 1 over approximately 90 minutes (-5 / +15 minutes). On days when both nivolumab and ipilimumab are administered, nivolumab should be given first, followed by ipilimumab about 30 minutes after completion of nivolumab. Patients will be assessed for response every 12 weeks (±7 days).
- analyzed count
- 19
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03146650-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT03146650
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Nivolumab + Ipilimumab
- regimen
- Nivolumab and ipilimumab combination will be administered intravenously until disease progression or intolerable toxicity. Nivolumab: Given at 240mg over 30 minutes (-5 / +15 minutes) every 2 weeks starting with Cycle 1 Day 1 for the first 16 weeks (1 cycle = 12 weeks). Starting with Cycle 2 Day 29, nivolumab will be given at 480mg IV over 60 minutes (-10 / +15 minutes) every 4 weeks. Ipilimumab: Given at 1mg/Kg every 6 weeks starting with Cycle 1 Day 1 over approximately 90 minutes (-5 / +15 minutes). On days when both nivolumab and ipilimumab are administered, nivolumab should be given first, followed by ipilimumab about 30 minutes after completion of nivolumab. Patients will be assessed for response every 12 weeks (±7 days).
- analyzed count
- 19
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03146650-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT03146650
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Nivolumab + Ipilimumab
- regimen
- Nivolumab and ipilimumab combination will be administered intravenously until disease progression or intolerable toxicity. Nivolumab: Given at 240mg over 30 minutes (-5 / +15 minutes) every 2 weeks starting with Cycle 1 Day 1 for the first 16 weeks (1 cycle = 12 weeks). Starting with Cycle 2 Day 29, nivolumab will be given at 480mg IV over 60 minutes (-10 / +15 minutes) every 4 weeks. Ipilimumab: Given at 1mg/Kg every 6 weeks starting with Cycle 1 Day 1 over approximately 90 minutes (-5 / +15 minutes). On days when both nivolumab and ipilimumab are administered, nivolumab should be given first, followed by ipilimumab about 30 minutes after completion of nivolumab. Patients will be assessed for response every 12 weeks (±7 days).
- analyzed count
- 18
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03146650-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT03146650
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Nivolumab + Ipilimumab
- regimen
- Nivolumab and ipilimumab combination will be administered intravenously until disease progression or intolerable toxicity. Nivolumab: Given at 240mg over 30 minutes (-5 / +15 minutes) every 2 weeks starting with Cycle 1 Day 1 for the first 16 weeks (1 cycle = 12 weeks). Starting with Cycle 2 Day 29, nivolumab will be given at 480mg IV over 60 minutes (-10 / +15 minutes) every 4 weeks. Ipilimumab: Given at 1mg/Kg every 6 weeks starting with Cycle 1 Day 1 over approximately 90 minutes (-5 / +15 minutes). On days when both nivolumab and ipilimumab are administered, nivolumab should be given first, followed by ipilimumab about 30 minutes after completion of nivolumab. Patients will be assessed for response every 12 weeks (±7 days).
- analyzed count
- 18
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03146650-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT03146650
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Nivolumab + Ipilimumab
- regimen
- Nivolumab and ipilimumab combination will be administered intravenously until disease progression or intolerable toxicity. Nivolumab: Given at 240mg over 30 minutes (-5 / +15 minutes) every 2 weeks starting with Cycle 1 Day 1 for the first 16 weeks (1 cycle = 12 weeks). Starting with Cycle 2 Day 29, nivolumab will be given at 480mg IV over 60 minutes (-10 / +15 minutes) every 4 weeks. Ipilimumab: Given at 1mg/Kg every 6 weeks starting with Cycle 1 Day 1 over approximately 90 minutes (-5 / +15 minutes). On days when both nivolumab and ipilimumab are administered, nivolumab should be given first, followed by ipilimumab about 30 minutes after completion of nivolumab. Patients will be assessed for response every 12 weeks (±7 days).
- analyzed count
- 19
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03146650-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT03146650
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Nivolumab + Ipilimumab
- regimen
- Nivolumab and ipilimumab combination will be administered intravenously until disease progression or intolerable toxicity. Nivolumab: Given at 240mg over 30 minutes (-5 / +15 minutes) every 2 weeks starting with Cycle 1 Day 1 for the first 16 weeks (1 cycle = 12 weeks). Starting with Cycle 2 Day 29, nivolumab will be given at 480mg IV over 60 minutes (-10 / +15 minutes) every 4 weeks. Ipilimumab: Given at 1mg/Kg every 6 weeks starting with Cycle 1 Day 1 over approximately 90 minutes (-5 / +15 minutes). On days when both nivolumab and ipilimumab are administered, nivolumab should be given first, followed by ipilimumab about 30 minutes after completion of nivolumab. Patients will be assessed for response every 12 weeks (±7 days).
- analyzed count
- 24
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03146650-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
- nct id
- NCT03146650
- harm key
- EG000
- source section id
- NCT03146650-ae
- event group key
- EG000
- event group label
- Nivolumab + Ipilimumab
- serious affected
- 16
- serious at risk
- 25
- other affected
- 24
- other at risk
- 24
- frequency threshold
- 0
- collection period
- Adverse Events (AEs) were collected over a 3 year period, and is still continuing (2 patients still on treatment). For other AEs, each patient was followed from the time of treatment, during treatment at the beginning of each cycle through 30 days post last treatment. For Serious AEs, each patient was followed at time of consent and 100 days post last treatment. 1 Cycle = 84 days/12 weeks and the range of cycles attempted was 1-11.
- event definition
- A patient who was registered and signed consent but did not initiate treatment is included as at risk for SAE but not at risk for other AEs. This patient never received treatment on study. All cause mortality and other adverse events are assessed from first dose of study treatment. Only patients that received at least 1 dose of study drug are included in all cause mortality and other adverse events. SAEs are assessed from patient signing consent.
- 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