NCT02526017 · STUDY IN CONTEXT
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
Draft scope assessment: unclear. Attached because the study's own record describes locally advanced 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
A DLT was defined as a study drug-related ≥ Grade 3 AE (using National Cancer Institute Common Terminology Criteria for Adverse Events v 4.03) occurring during the first 28-days, excluding Grade 3 tumor flare (defined as local pain, irritation, or rash localized at sites of known or suspected tumor), rash, immune-related adverse event (irAE) that resolved to ≤ Grade 1 by 14 days or a transient (resolving within 6 hours of onset) Grade 3 infusion-related AE. Any recurrence of Grade 3 rash, irAE or infusion-related AE was considered a DLT. The protocol was amended such that in the absence of clinical symptoms and other accompanying changes in bilirubin or alanine aminotransferase (ALT), serum elevation of aspartate aminotransferase (AST)/ALT \> 12 × upper limit of normal (ULN) and ≤ 20 × ULN that lasted for \< 7 days and serum elevation of creatine kinase (CK) and/or lactate dehydrogenase (LDH) \> 15 × ULN and ≤ 20 × ULN that lasted for \< 7 days were not considered DLTs.
Using both the incidence of dose limiting toxicities (first 28 days on therapy) as well as overall tolerability and toxicities observed beyond 28 days, the RD was chosen as 4 mg/kg of cabiralizumab + 3 mg/kg nivolumab every 2 weeks to be the dose used in the Phase 1b (dose expansion). No maximum tolerated dose was identified.
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation, patient-administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or causes prolongation of existing hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly/birth defect; * Was an important medical event that may jeopardize the patient or may require intervention (e.g., medical, surgical) to prevent one of the other serious outcomes listed in the definition above.
Safety: In the Phase 1b only, the incidence of treatment discontinuations, modifications, and interruptions due to adverse events.
Objective response rate (ORR) is defined as the percentage of participants with confirmed responses of either complete response (CR) or partial response (PR). Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 by investigator review. Complete Response: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Overall survival (OS) was defined as the time from first dose of study drug to death due to any cause. OS was calculated using the Kaplan-Meier method. Participants who did not die while on study were censored on the date they were last known to be alive.
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-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- trial label
- Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
- applicability
- unclear
- applicability note
- Attached because the study's own record describes locally advanced 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
- 6
- harms Count
- 8
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- outcome key
- om-0000
- source section id
- NCT02526017-om-0000
- source outcome index
- 0
- endpoint
- Safety: Number of Participants With Grade 3 or Grade 4 Adverse Events (AEs) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT) (Phase 1a)
- endpoint definition
- A DLT was defined as a study drug-related ≥ Grade 3 AE (using National Cancer Institute Common Terminology Criteria for Adverse Events v 4.03) occurring during the first 28-days, excluding Grade 3 tumor flare (defined as local pain, irritation, or rash localized at sites of known or suspected tumor), rash, immune-related adverse event (irAE) that resolved to ≤ Grade 1 by 14 days or a transient (resolving within 6 hours of onset) Grade 3 infusion-related AE. Any recurrence of Grade 3 rash, irAE or infusion-related AE was considered a DLT. The protocol was amended such that in the absence of clinical symptoms and other accompanying changes in bilirubin or alanine aminotransferase (ALT), serum elevation of aspartate aminotransferase (AST)/ALT \> 12 × upper limit of normal (ULN) and ≤ 20 × ULN that lasted for \< 7 days and serum elevation of creatine kinase (CK) and/or lactate dehydrogenase (LDH) \> 15 × ULN and ≤ 20 × ULN that lasted for \< 7 days were not considered DLTs.
- time origin
- 28 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants enrolled in the dose escalation phase who received at least 2 doses of study drug during the 28-day evaluation interval or who discontinued study treatment for drug-related adverse events before receiving 2 doses of study drug were considered evaluable for DLT determination.
- 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-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- outcome key
- om-0001
- source section id
- NCT02526017-om-0001
- source outcome index
- 1
- endpoint
- Recommended Dose (RD) of Cabiralizumab in Combination With Nivolumab (Phase 1a)
- endpoint definition
- Using both the incidence of dose limiting toxicities (first 28 days on therapy) as well as overall tolerability and toxicities observed beyond 28 days, the RD was chosen as 4 mg/kg of cabiralizumab + 3 mg/kg nivolumab every 2 weeks to be the dose used in the Phase 1b (dose expansion). No maximum tolerated dose was identified.
- time origin
- 28 days
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Participants enrolled in the dose escalation phase who received at least 2 doses of study drug during the 28-day evaluation interval or who discontinued study treatment for drug-related adverse events before receiving 2 doses of study drug were considered evaluable for DLT determination.
- 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-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- outcome key
- om-0002
- source section id
- NCT02526017-om-0002
- source outcome index
- 2
- endpoint
- Safety: Number of Participants With Adverse Events and Serious Adverse Events (Phase 1a and 1b)
- endpoint definition
- An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation, patient-administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or causes prolongation of existing hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly/birth defect; * Was an important medical event that may jeopardize the patient or may require intervention (e.g., medical, surgical) to prevent one of the other serious outcomes listed in the definition above.
- time origin
- From first dose of study drug up to 100 days after last dose. Median (range) duration of exposure was 6 (2-32) weeks in the monotherapy cohorts and 8 (2-108) weeks for cabiralizumab and 8 (2-156) weeks for nivolumab in the combination groups.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who received at least 1 dose of cabiralizumab and/or nivolumab. Safety results are grouped by participants who received the same treatment regimen.
- 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-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- outcome key
- om-0003
- source section id
- NCT02526017-om-0003
- source outcome index
- 3
- endpoint
- Safety: Number of Participants With Treatment Discontinuations, Modifications, or Interruptions Due to Adverse Events (Phase 1b)
- endpoint definition
- Safety: In the Phase 1b only, the incidence of treatment discontinuations, modifications, and interruptions due to adverse events.
- time origin
- From first dose of study drug up to last dose; median (range) duration of exposure was 8 (2-108) weeks for cabiralizumab and 8 (2-156) weeks for nivolumab.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All participants who received at least 1 dose of cabiralizumab and/or nivolumab at the RD of 4 mg/kg cabiralizumab + 3 mg/kg nivolumab.
- 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-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- outcome key
- om-0004
- source section id
- NCT02526017-om-0004
- source outcome index
- 4
- endpoint
- Efficacy: Objective Response Rate - Investigator Assessment (Phase 1b)
- endpoint definition
- Objective response rate (ORR) is defined as the percentage of participants with confirmed responses of either complete response (CR) or partial response (PR). Response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 by investigator review. Complete Response: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- time origin
- Tumor response was assessed every 8 weeks from first dose for the first 12 months and then every 12 weeks thereafter until end of treatment; maximum duration of treatment was 156 weeks.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Response-evaluable population based on investigator assessment included all participants who had a measurable lesion at baseline and had at least 1 post-baseline tumor assessment, or clinical progression, or death. Efficacy endpoints were specified to be analyzed by disease type for Phase 1b participants 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-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- outcome key
- om-0005
- source section id
- NCT02526017-om-0005
- source outcome index
- 5
- endpoint
- Efficacy: Overall Survival (Phase 1b)
- endpoint definition
- Overall survival (OS) was defined as the time from first dose of study drug to death due to any cause. OS was calculated using the Kaplan-Meier method. Participants who did not die while on study were censored on the date they were last known to be alive.
- time origin
- From first dose of study drug up to the end of study; maximum time on study in Phase 1b was 35.9 months.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All treated participants in Phase 1b; Efficacy endpoints were specified to be analyzed by disease type for phase 1b participants only.
- 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-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Cabiralizumab 2 mg/kg Q2W
- regimen
- Participants received 2 mg/kg cabiralizumab administered intravenously (IV) once every 2 weeks (Q2W).
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02526017-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Cabiralizumab 4 mg/kg Q2W
- regimen
- Participants received 4 mg/kg cabiralizumab IV Q2W
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02526017-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Cabiralizumab 6 mg/kg Q2W
- regimen
- Participants received 6 mg/kg cabiralizumab IV Q2W.
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02526017-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W
- regimen
- Participants received 1 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02526017-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- outcome key
- om-0000
- arm key
- OG004
- arm label
- Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W
- regimen
- Participants received 2 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02526017-om-0000#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- outcome key
- om-0000
- arm key
- OG005
- arm label
- Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W
- regimen
- Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02526017-om-0000#groups/OG005
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- outcome key
- om-0000
- arm key
- OG006
- arm label
- Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W
- regimen
- Participants received 6 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02526017-om-0000#groups/OG006
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Overall Phase 1a Dose Escalation
- regimen
- Participants received escalating doses of cabiralizumab monotherapy or cabiralizumab in combination with nivolumab.
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02526017-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Cabiralizumab 2 mg/kg Q2W
- regimen
- Participants received 2 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02526017-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Cabiralizumab 4 mg/kg Q2W
- regimen
- Participants received 4 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02526017-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- outcome key
- om-0002
- arm key
- OG002
- arm label
- Cabiralizumab 6 mg/kg Q2W
- regimen
- Participants received 6 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02526017-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- outcome key
- om-0002
- arm key
- OG003
- arm label
- Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W
- regimen
- Participants received 1 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02526017-om-0002#groups/OG003
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- harm key
- EG000
- source section id
- NCT02526017-ae
- event group key
- EG000
- event group label
- Phase 1a: Cabiralizumab 2 mg/kg Q2W
- serious affected
- 1
- serious at risk
- 3
- other affected
- 2
- other at risk
- 3
- frequency threshold
- 0
- collection period
- From first dose of study drug up to 100 days after last dose. Median (range) duration of exposure was 6 (2-32) weeks in the monotherapy cohorts and 8 (2-108) weeks for cabiralizumab and 8 (2-156) weeks for nivolumab in the combination groups.
- event definition
- All participants who received at least 1 dose of cabiralizumab and/or nivolumab. Safety results are grouped by participants who received the same treatment regimen.
- 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-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- harm key
- EG001
- source section id
- NCT02526017-ae
- event group key
- EG001
- event group label
- Phase 1a: Cabiralizumab 4 mg/kg Q2W
- serious affected
- 1
- serious at risk
- 10
- other affected
- 10
- other at risk
- 11
- frequency threshold
- 0
- collection period
- From first dose of study drug up to 100 days after last dose. Median (range) duration of exposure was 6 (2-32) weeks in the monotherapy cohorts and 8 (2-108) weeks for cabiralizumab and 8 (2-156) weeks for nivolumab in the combination groups.
- event definition
- All participants who received at least 1 dose of cabiralizumab and/or nivolumab. Safety results are grouped by participants who received the same treatment regimen.
- 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-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- harm key
- EG002
- source section id
- NCT02526017-ae
- event group key
- EG002
- event group label
- Phase 1a: Cabiralizumab 6 mg/kg Q2W
- serious affected
- 6
- serious at risk
- 11
- other affected
- 10
- other at risk
- 10
- frequency threshold
- 0
- collection period
- From first dose of study drug up to 100 days after last dose. Median (range) duration of exposure was 6 (2-32) weeks in the monotherapy cohorts and 8 (2-108) weeks for cabiralizumab and 8 (2-156) weeks for nivolumab in the combination groups.
- event definition
- All participants who received at least 1 dose of cabiralizumab and/or nivolumab. Safety results are grouped by participants who received the same treatment regimen.
- 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-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- harm key
- EG003
- source section id
- NCT02526017-ae
- event group key
- EG003
- event group label
- Phase 1a: Cabiralizumab 1mg/kg + Nivolumab 3 mg/kg Q2W
- serious affected
- 2
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 0
- collection period
- From first dose of study drug up to 100 days after last dose. Median (range) duration of exposure was 6 (2-32) weeks in the monotherapy cohorts and 8 (2-108) weeks for cabiralizumab and 8 (2-156) weeks for nivolumab in the combination groups.
- event definition
- All participants who received at least 1 dose of cabiralizumab and/or nivolumab. Safety results are grouped by participants who received the same treatment regimen.
- 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-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- harm key
- EG004
- source section id
- NCT02526017-ae
- event group key
- EG004
- event group label
- Phase 1a: Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W
- serious affected
- 1
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- From first dose of study drug up to 100 days after last dose. Median (range) duration of exposure was 6 (2-32) weeks in the monotherapy cohorts and 8 (2-108) weeks for cabiralizumab and 8 (2-156) weeks for nivolumab in the combination groups.
- event definition
- All participants who received at least 1 dose of cabiralizumab and/or nivolumab. Safety results are grouped by participants who received the same treatment regimen.
- 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-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- harm key
- EG005
- source section id
- NCT02526017-ae
- event group key
- EG005
- event group label
- Phase 1a+1b: Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W
- serious affected
- 138
- serious at risk
- 265
- other affected
- 264
- other at risk
- 265
- frequency threshold
- 0
- collection period
- From first dose of study drug up to 100 days after last dose. Median (range) duration of exposure was 6 (2-32) weeks in the monotherapy cohorts and 8 (2-108) weeks for cabiralizumab and 8 (2-156) weeks for nivolumab in the combination groups.
- event definition
- All participants who received at least 1 dose of cabiralizumab and/or nivolumab. Safety results are grouped by participants who received the same treatment regimen.
- 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-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- harm key
- EG006
- source section id
- NCT02526017-ae
- event group key
- EG006
- event group label
- Phase 1a: Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W
- serious affected
- 3
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 0
- collection period
- From first dose of study drug up to 100 days after last dose. Median (range) duration of exposure was 6 (2-32) weeks in the monotherapy cohorts and 8 (2-108) weeks for cabiralizumab and 8 (2-156) weeks for nivolumab in the combination groups.
- event definition
- All participants who received at least 1 dose of cabiralizumab and/or nivolumab. Safety results are grouped by participants who received the same treatment regimen.
- 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-pancreatic-cancer-locally-advanced-06747430
- nct id
- NCT02526017
- harm key
- EG007
- source section id
- NCT02526017-ae
- event group key
- EG007
- event group label
- Phase 1a: Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W
- serious affected
- 5
- serious at risk
- 10
- other affected
- 9
- other at risk
- 10
- frequency threshold
- 0
- collection period
- From first dose of study drug up to 100 days after last dose. Median (range) duration of exposure was 6 (2-32) weeks in the monotherapy cohorts and 8 (2-108) weeks for cabiralizumab and 8 (2-156) weeks for nivolumab in the combination groups.
- event definition
- All participants who received at least 1 dose of cabiralizumab and/or nivolumab. Safety results are grouped by participants who received the same treatment regimen.
- 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
Triangle