TriangleNCT04514484 · STUDY IN CONTEXT
Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV
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
Dose-limiting toxicity (DLT) were defined as any treatment-related grade 3 or 4 nonhematologic toxicity during the first cycle of therapy, including grade 3 nausea and/or vomiting and grade 3 diarrhea despite prophylaxis and/or treatment or any of the following grade 4 hematologic toxicities during the first cycle of therapy: thrombocytopenia and neutropenia of more than 7 days duration, neutropenia of any duration with fever or documented infection; additionally, treatment delay of 14 days or greater during Cycle 1 due to unresolved toxicity will be considered a DLT.
Percentage of participants who experienced either a Complete Response (CR) or Partial Response (PR) to treatment. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Percentage of patients who experienced either a Complete Response (CR) or Partial Response (PR) to treatment. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Percentage of patients (who are off treatment) who experienced either a Complete Response (CR) or Partial Response (PR) during off treatment period. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
Percentage of patients without progressive disease at 12 months.
Percentage of patients without progressive disease at 24 months.
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-advanced-hepatocellular-carcinoma
- nct id
- NCT04514484
- trial label
- Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV
- 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-advanced-hepatocellular-carcinoma
- nct id
- NCT04514484
- outcome key
- om-0000
- source section id
- NCT04514484-om-0000
- source outcome index
- 0
- endpoint
- Incidence of Dose Limiting Toxicities (DLTs)
- endpoint definition
- Dose-limiting toxicity (DLT) were defined as any treatment-related grade 3 or 4 nonhematologic toxicity during the first cycle of therapy, including grade 3 nausea and/or vomiting and grade 3 diarrhea despite prophylaxis and/or treatment or any of the following grade 4 hematologic toxicities during the first cycle of therapy: thrombocytopenia and neutropenia of more than 7 days duration, neutropenia of any duration with fever or documented infection; additionally, treatment delay of 14 days or greater during Cycle 1 due to unresolved toxicity will be considered a DLT.
- time origin
- 28 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All treated patients
- 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-advanced-hepatocellular-carcinoma
- nct id
- NCT04514484
- outcome key
- om-0001
- source section id
- NCT04514484-om-0001
- source outcome index
- 1
- endpoint
- Objective Response Rate (ORR)
- endpoint definition
- Percentage of participants who experienced either a Complete Response (CR) or Partial Response (PR) to treatment. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- time origin
- Up to 24 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Treated patients who were evaluated for efficacy.
- 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-advanced-hepatocellular-carcinoma
- nct id
- NCT04514484
- outcome key
- om-0002
- source section id
- NCT04514484-om-0002
- source outcome index
- 2
- endpoint
- Best Overall Response
- endpoint definition
- Percentage of patients who experienced either a Complete Response (CR) or Partial Response (PR) to treatment. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
- time origin
- Up to 24 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Treated patients who were evaluated for efficacy.
- 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-advanced-hepatocellular-carcinoma
- nct id
- NCT04514484
- outcome key
- om-0003
- source section id
- NCT04514484-om-0003
- source outcome index
- 3
- endpoint
- Best Overall Response (Off Treatment)
- endpoint definition
- Percentage of patients (who are off treatment) who experienced either a Complete Response (CR) or Partial Response (PR) during off treatment period. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD):≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.
- time origin
- Up to 24 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Off treatment patients who were evaluated for efficacy.
- 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-advanced-hepatocellular-carcinoma
- nct id
- NCT04514484
- outcome key
- om-0004
- source section id
- NCT04514484-om-0004
- source outcome index
- 4
- endpoint
- 12-month Progression-free Survival (PFS)
- endpoint definition
- Percentage of patients without progressive disease at 12 months.
- time origin
- At 12 months (from start of treatment)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Treated patients who were evaluated for efficacy.
- 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-advanced-hepatocellular-carcinoma
- nct id
- NCT04514484
- outcome key
- om-0005
- source section id
- NCT04514484-om-0005
- source outcome index
- 5
- endpoint
- 24-month Progression-free Survival (PFS)
- endpoint definition
- Percentage of patients without progressive disease at 24 months.
- time origin
- At 24 months (from start of treatment)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Treated patients who were evaluated for efficacy.
- 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-advanced-hepatocellular-carcinoma
- nct id
- NCT04514484
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (Cabozantinib S-malate, Nivolumab)
- regimen
- Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
- analyzed count
- 7
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04514484-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-advanced-hepatocellular-carcinoma
- nct id
- NCT04514484
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (Cabozantinib S-malate, Nivolumab)
- regimen
- Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04514484-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-advanced-hepatocellular-carcinoma
- nct id
- NCT04514484
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment (Cabozantinib S-malate, Nivolumab)
- regimen
- Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04514484-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-advanced-hepatocellular-carcinoma
- nct id
- NCT04514484
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Treatment (Cabozantinib S-malate, Nivolumab)
- regimen
- Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04514484-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-advanced-hepatocellular-carcinoma
- nct id
- NCT04514484
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Treatment (Cabozantinib S-malate, Nivolumab)
- regimen
- Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04514484-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-advanced-hepatocellular-carcinoma
- nct id
- NCT04514484
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Treatment (Cabozantinib S-malate, Nivolumab)
- regimen
- Patients receive cabozantinib s-malate PO QD on days 1-28 of each cycle and nivolumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days for up to 1 year or 1 year after a partial response is achieved, or 6 months after a complete response is achieved in the absence of disease progression or unacceptable toxicity. Patients also undergo a CT scan and/or MRI as well as blood sample collection throughout the trial. Biospecimen Collection: Undergo blood sample collection Cabozantinib S-malate: Given PO Computed Tomography: Undergo CT Magnetic Resonance Imaging: Undergo MRI Nivolumab: Given IV
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04514484-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-advanced-hepatocellular-carcinoma
- nct id
- NCT04514484
- harm key
- EG000
- source section id
- NCT04514484-ae
- event group key
- EG000
- event group label
- Treatment (Cabozantinib S-malate, Nivolumab)
- serious affected
- 5
- serious at risk
- 7
- other affected
- 7
- other at risk
- 7
- frequency threshold
- 0
- collection period
- Adverse event data were collected for up to 23 months for the total population. Median exposure to treatment was 5 (28-day) cycles (range 1-14); up to 14 months for individuals. All-Cause Mortality data were collected for up to 26 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