TriangleNCT03370276 · STUDY IN CONTEXT
Cetuximab & Nivolumab in Patients With Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma
Draft scope assessment: unclear. Attached because the study's own record describes recurrent 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 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
Maximum Tolerated Dose (MTD).. The target Dose Limiting Toxicity (DLT) rate is \<25%. The MTD will be defined as the dose of cetuximab and nivolumab in which \<1 of 3 patients experience a DLT or \<2 of 6 patients experience a DLT with the next higher dose having at least 2 patients experiencing a DLT. The MTD is the highest dose at which at most 1 of 6 patients has a DLT. This study will utilize the Cancer Therapy Evaluation Program CTCAE version 4.1 for toxicity and event reporting. Dose-limiting toxicities will be observed until patients have completed Cycle 1 (4 weeks).
One year overall survival of concurrent cetuximab and nivolumab in patients with recurrent and/or metastatic HNSCC. OS: The length of time from the start of treatment until death by any cause.
Complete Response (CR): The disappearance of all measurable lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameters of measureable lesions, taking as reference the baseline sum longest diameter. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s). Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval of 6 weeks.
Progressive Disease (PD): At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).
Related adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) V4.1. An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. A serious adverse event (SAE) is defined as any AE that results in death, is immediately life-threatening, results in persistent or significant disability/incapacity, requires or prolongs patient hospitalization, is a congenital anomaly/birth defect, or is to be deemed serious for any other reason if it is an important medical event when based on appropriate medical judgement that may jeopardize the patient and may require medical or surgical intervention to prevent one of the other outcomes listed in the above definitions.
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-hypopharyngeal-cancer-recurrent-58d713f9
- nct id
- NCT03370276
- trial label
- Cetuximab & Nivolumab in Patients With Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma
- applicability
- unclear
- applicability note
- Attached because the study's own record describes recurrent 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
- 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
- 5
- harms Count
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-hypopharyngeal-cancer-recurrent-58d713f9
- nct id
- NCT03370276
- outcome key
- om-0000
- source section id
- NCT03370276-om-0000
- source outcome index
- 0
- endpoint
- Phase I: Maximum Tolerated Dose
- endpoint definition
- Maximum Tolerated Dose (MTD).. The target Dose Limiting Toxicity (DLT) rate is \<25%. The MTD will be defined as the dose of cetuximab and nivolumab in which \<1 of 3 patients experience a DLT or \<2 of 6 patients experience a DLT with the next higher dose having at least 2 patients experiencing a DLT. The MTD is the highest dose at which at most 1 of 6 patients has a DLT. This study will utilize the Cancer Therapy Evaluation Program CTCAE version 4.1 for toxicity and event reporting. Dose-limiting toxicities will be observed until patients have completed Cycle 1 (4 weeks).
- time origin
- Up to 12 months
- analysis role
- primary
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-hypopharyngeal-cancer-recurrent-58d713f9
- nct id
- NCT03370276
- outcome key
- om-0001
- source section id
- NCT03370276-om-0001
- source outcome index
- 1
- endpoint
- Phase II: Overall Survival (OS)
- endpoint definition
- One year overall survival of concurrent cetuximab and nivolumab in patients with recurrent and/or metastatic HNSCC. OS: The length of time from the start of treatment until death by any cause.
- time origin
- Up to 24 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Evaluable 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-hypopharyngeal-cancer-recurrent-58d713f9
- nct id
- NCT03370276
- outcome key
- om-0002
- source section id
- NCT03370276-om-0002
- source outcome index
- 2
- endpoint
- Overall Response Rate (ORR)
- endpoint definition
- Complete Response (CR): The disappearance of all measurable lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameters of measureable lesions, taking as reference the baseline sum longest diameter. Progressive Disease (PD): At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s). Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval of 6 weeks.
- time origin
- Up to 48 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants evaluable for response
- 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-hypopharyngeal-cancer-recurrent-58d713f9
- nct id
- NCT03370276
- outcome key
- om-0003
- source section id
- NCT03370276-om-0003
- source outcome index
- 3
- endpoint
- Progression Free Survival (PFS)
- endpoint definition
- Progressive Disease (PD): At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).
- time origin
- at 12 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Evaluable 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-hypopharyngeal-cancer-recurrent-58d713f9
- nct id
- NCT03370276
- outcome key
- om-0004
- source section id
- NCT03370276-om-0004
- source outcome index
- 4
- endpoint
- Number of Study Treatment Related Adverse Events
- endpoint definition
- Related adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) V4.1. An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. A serious adverse event (SAE) is defined as any AE that results in death, is immediately life-threatening, results in persistent or significant disability/incapacity, requires or prolongs patient hospitalization, is a congenital anomaly/birth defect, or is to be deemed serious for any other reason if it is an important medical event when based on appropriate medical judgement that may jeopardize the patient and may require medical or surgical intervention to prevent one of the other outcomes listed in the above definitions.
- time origin
- Up to 48 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Evaluable 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-hypopharyngeal-cancer-recurrent-58d713f9
- nct id
- NCT03370276
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Phase I - Lead in
- regimen
- Nivolumab and dose lead in of Cetuximab. Lead-in Day -14 before Cycle 1 only: Cetuximab 500 mg/m\^2; Nivolumab - none. Cycle 1 Day 1 and all subsequent doses every 2 weeks (Q2W): Cetuximab 500 mg/m\^2; Nivolumab 240 mg. Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\^2 or 250 mg/m\^2 as outlined in the treatment arms.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03370276-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hypopharyngeal-cancer-recurrent-58d713f9
- nct id
- NCT03370276
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Phase I Lead in + Phase II: Cohort A
- regimen
- Patients who had progressed on at least one prior line of treatment for their recurrent and/or metastatic HNSCC Participants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\^2 or 250 mg/m\^2 as outlined in the treatment arms.
- analyzed count
- 45
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03370276-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hypopharyngeal-cancer-recurrent-58d713f9
- nct id
- NCT03370276
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Phase II - Cohort B
- regimen
- Patients who have not had any prior treatment for their recurrent and/or metastatic HNSCC Participants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\^2 or 250 mg/m\^2 as outlined in the treatment arms.
- analyzed count
- 43
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03370276-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-hypopharyngeal-cancer-recurrent-58d713f9
- nct id
- NCT03370276
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Phase I Lead in + Phase II: Cohort A
- regimen
- Patients who had progressed on at least one prior line of treatment for their recurrent and/or metastatic HNSCC Participants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\^2 or 250 mg/m\^2 as outlined in the treatment arms.
- analyzed count
- 43
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03370276-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hypopharyngeal-cancer-recurrent-58d713f9
- nct id
- NCT03370276
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Phase II - Cohort B
- regimen
- Patients who have not had any prior treatment for their recurrent and/or metastatic HNSCC Participants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\^2 or 250 mg/m\^2 as outlined in the treatment arms.
- analyzed count
- 42
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03370276-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-hypopharyngeal-cancer-recurrent-58d713f9
- nct id
- NCT03370276
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Phase I Lead in + Phase II: Cohort A
- regimen
- Patients who had progressed on at least one prior line of treatment for their recurrent and/or metastatic HNSCC Participants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\^2 or 250 mg/m\^2 as outlined in the treatment arms.
- analyzed count
- 45
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03370276-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hypopharyngeal-cancer-recurrent-58d713f9
- nct id
- NCT03370276
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Phase II - Cohort B
- regimen
- Patients who have not had any prior treatment for their recurrent and/or metastatic HNSCC Participants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\^2 or 250 mg/m\^2 as outlined in the treatment arms.
- analyzed count
- 43
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03370276-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-hypopharyngeal-cancer-recurrent-58d713f9
- nct id
- NCT03370276
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Phase I Lead in + Phase II: Cohort A
- regimen
- Patients who had progressed on at least one prior line of treatment for their recurrent and/or metastatic HNSCC Participants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\^2 or 250 mg/m\^2 as outlined in the treatment arms.
- analyzed count
- 45
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03370276-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hypopharyngeal-cancer-recurrent-58d713f9
- nct id
- NCT03370276
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Phase II - Cohort B
- regimen
- Patients who have not had any prior treatment for their recurrent and/or metastatic HNSCC Participants were treated with Nivolumab and Cetuximab at recommended Phase II dose (RP2D). Nivolumab: Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms. Cetuximab: Cetuximab intravenously (IV) at 500 mg/m\^2 or 250 mg/m\^2 as outlined in the treatment arms.
- analyzed count
- 43
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03370276-om-0004#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-hypopharyngeal-cancer-recurrent-58d713f9
- nct id
- NCT03370276
- harm key
- EG000
- source section id
- NCT03370276-ae
- event group key
- EG000
- event group label
- Phase I - Lead in
- serious affected
- 3
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- Adverse events collected from on study date to 30 days after completion of study therapy, approximately 2 years. All participants were followed for events, whether or not evaluable.
- 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-hypopharyngeal-cancer-recurrent-58d713f9
- nct id
- NCT03370276
- harm key
- EG001
- source section id
- NCT03370276-ae
- event group key
- EG001
- event group label
- Phase II- Cohort A
- serious affected
- 19
- serious at risk
- 44
- other affected
- 43
- other at risk
- 44
- frequency threshold
- 0
- collection period
- Adverse events collected from on study date to 30 days after completion of study therapy, approximately 2 years. All participants were followed for events, whether or not evaluable.
- 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-hypopharyngeal-cancer-recurrent-58d713f9
- nct id
- NCT03370276
- harm key
- EG002
- source section id
- NCT03370276-ae
- event group key
- EG002
- event group label
- Phase II - Cohort B
- serious affected
- 19
- serious at risk
- 48
- other affected
- 45
- other at risk
- 48
- frequency threshold
- 0
- collection period
- Adverse events collected from on study date to 30 days after completion of study therapy, approximately 2 years. All participants were followed for events, whether or not evaluable.
- 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