NCT02526017 · STUDY IN CONTEXT

Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers

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

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

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.

→

primary · POSTED

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.

→

primary · POSTED

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.

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.

→

primary · POSTED

Safety: In the Phase 1b only, the incidence of treatment discontinuations, modifications, and interruptions due to adverse events.

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.

→

primary · POSTED

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.

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.

→

secondary · POSTED

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.

All treated participants in Phase 1b; Efficacy endpoints were specified to be analyzed by disease type for phase 1b participants only.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

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-renal-cell-cancer
nct id: NCT02526017
trial label: Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
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: 8
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer
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-renal-cell-cancer
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-renal-cell-cancer
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-renal-cell-cancer
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-renal-cell-cancer
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-renal-cell-cancer
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-renal-cell-cancer
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-renal-cell-cancer
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-renal-cell-cancer
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-renal-cell-cancer
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-renal-cell-cancer
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-renal-cell-cancer
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-renal-cell-cancer
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-renal-cell-cancer
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-renal-cell-cancer
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-renal-cell-cancer
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-renal-cell-cancer
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-renal-cell-cancer
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-renal-cell-cancer
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-renal-cell-cancer
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-renal-cell-cancer
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-renal-cell-cancer
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-renal-cell-cancer
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-renal-cell-cancer
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-renal-cell-cancer
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-renal-cell-cancer
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