Trial · NCT02526017
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
NCT02526017, Phase 1, Completed, Five Prime Therapeutics, Inc.; results first posted 2022-03-09
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers. Trials, record NCT02526017. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02526017
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
- NCT number
- NCT02526017
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 313 participants, actual
- Lead sponsor
- Five Prime Therapeutics, Inc.
- Conditions
- Advanced Solid Tumors, Head and Neck Cancer, Pancreatic Cancer, Ovarian Cancer, Renal Cell Carcinoma, Malignant Glioma, Non-small Cell Lung Cancer
- Interventions
- Cabiralizumab, Nivolumab
- First posted
- 2015-08-18
- Last updated
- 2022-03-09
- Results first posted
- 2022-03-09
- Limitations and caveats
- Inclusion of multiple tumor types and several dose levels in monotherapy and combination with nivolumab limits the ability to accurately evaluate the incidence of off-target effects adverse events.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety: Number of Participants With Grade 3 or Grade 4 Adverse Events (AEs) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT) (Phase 1a) | 28 days | 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. |
| Primary | Recommended Dose (RD) of Cabiralizumab in Combination With Nivolumab (Phase 1a) | 28 days | 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 | Safety: Number of Participants With Adverse Events and Serious Adverse Events (Phase 1a and 1b) | 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. | 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. |
| Primary | Safety: Number of Participants With Treatment Discontinuations, Modifications, or Interruptions Due to Adverse Events (Phase 1b) | 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. | Safety: In the Phase 1b only, the incidence of treatment discontinuations, modifications, and interruptions due to adverse events. |
| Primary | Efficacy: Objective Response Rate - Investigator Assessment (Phase 1b) | 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. | 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. |
| Secondary | Efficacy: Overall Survival (Phase 1b) | From first dose of study drug up to the end of study; maximum time on study in Phase 1b was 35.9 months. | 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. |
| Secondary | Efficacy: Overall Survival (OS) at One Year (Phase 1b) | 52 weeks | Overall survival at one-year is defined as the percentage of participants who were alive one year after receiving their first dose of study drug. |
| Secondary | Efficacy: Duration of Response (Phase 1b) | From first dose of study drug up to the end of study; maximum time on study in Phase 1b was 35.9 months. | Duration of response (DOR) is defined as the time from the date of the first documentation of confirmed response (CR or PR) to the first objective documentation of progressive disease (PD) per RECIST v1.1 per Investigator assessment or to death due to any cause in the absence of documented PD. DOR was analyzed using Kaplan-Meier methods. Participants who discontinued from the study, did not die or have disease progression, or who received new anticancer therapy were censored on the date of last evaluable assessment prior to initiation of subsequent therapy. Participants with no evaluable baseline or post-baseline assessments were censored on the date of first dose. Progressive Disease (PD): The appearance of one or more new lesions or at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Efficacy: Progression Free Survival (Phase 1b) | From first dose of study drug up to the end of study; maximum time on study in phase 1b was 35.9 months. | Progression-free survival (PFS) was defined as as the time from the first dose to the first objectively documented disease progression per RECIST v1.1 per Investigator assessment or death due to any cause in the absence of documented progressive disease (PD). PFS was analyzed using Kaplan-Meier methods. Participants who discontinued from the study, did not die or have disease progression, or who received new anticancer therapy were censored on the date of last evaluable assessment prior to initiation of subsequent therapy. Participants with no evaluable baseline or post-baseline assessments were censored on the date of first dose. |
| Secondary | Efficacy: Objective Response Rate - Central Review Assessment (Phase 1b) | 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. | Objective response rate 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 independent central 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety: Number of Participants With Grade 3 or Grade 4 Adverse Events (AEs) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT) (Phase 1a) | 28 days | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Recommended Dose (RD) of Cabiralizumab in Combination With Nivolumab (Phase 1a) | 28 days | 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. | mg/kg Q2W | NUMBER |
| PRIMARY | Safety: Number of Participants With Adverse Events and Serious Adverse Events (Phase 1a and 1b) | 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. | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Safety: Number of Participants With Treatment Discontinuations, Modifications, or Interruptions Due to Adverse Events (Phase 1b) | 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. | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Efficacy: Objective Response Rate - Investigator Assessment (Phase 1b) | 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. | 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. | percentage of participants | NUMBER |
| SECONDARY | Efficacy: Overall Survival (Phase 1b) | From first dose of study drug up to the end of study; maximum time on study in Phase 1b was 35.9 months. | All treated participants in Phase 1b; Efficacy endpoints were specified to be analyzed by disease type for phase 1b participants only. | months | MEDIAN |
| SECONDARY | Efficacy: Overall Survival (OS) at One Year (Phase 1b) | 52 weeks | All treated participants in Phase 1b; Efficacy endpoints were specified to be analyzed by disease type for phase 1b participants only. | percentage of participants | NUMBER |
| SECONDARY | Efficacy: Duration of Response (Phase 1b) | From first dose of study drug up to the end of study; maximum time on study in Phase 1b was 35.9 months. | Phase 1b response-evaluable population based on investigator assessment with documented CR or PR.~Efficacy endpoints were specified to be analyzed by disease type for Phase 1b participants only. | months | MEDIAN |
| SECONDARY | Efficacy: Progression Free Survival (Phase 1b) | From first dose of study drug up to the end of study; maximum time on study in phase 1b was 35.9 months. | All treated participants in Phase 1b; Efficacy endpoints were specified to be analyzed by disease type for phase 1b participants only. | months | MEDIAN |
| SECONDARY | Efficacy: Objective Response Rate - Central Review Assessment (Phase 1b) | 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. | Response-evaluable population based on central review assessment included all participants who 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. | percentage of participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group210
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety: Number of Participants With Grade 3 or Grade 4 Adverse Events (AEs) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT) (Phase 1a) | Cabiralizumab 2 mg/kg Q2W | Grade 3 CK increase | 0 | Participants | |
| Safety: Number of Participants With Grade 3 or Grade 4 Adverse Events (AEs) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT) (Phase 1a) | Cabiralizumab 4 mg/kg Q2W | Grade 3 CK increase | 0 | Participants | |
| Safety: Number of Participants With Grade 3 or Grade 4 Adverse Events (AEs) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT) (Phase 1a) | Cabiralizumab 6 mg/kg Q2W | Grade 3 CK increase | 1 | Participants | |
| Safety: Number of Participants With Grade 3 or Grade 4 Adverse Events (AEs) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT) (Phase 1a) | Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W | Grade 3 CK increase | 0 | Participants | |
| Safety: Number of Participants With Grade 3 or Grade 4 Adverse Events (AEs) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT) (Phase 1a) | Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W | Grade 3 CK increase | 0 | Participants | |
| Safety: Number of Participants With Grade 3 or Grade 4 Adverse Events (AEs) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT) (Phase 1a) | Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W | Grade 3 CK increase | 0 | Participants | |
| Safety: Number of Participants With Grade 3 or Grade 4 Adverse Events (AEs) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT) (Phase 1a) | Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W | Grade 3 CK increase | 0 | Participants | |
| Safety: Number of Participants With Grade 3 or Grade 4 Adverse Events (AEs) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT) (Phase 1a) | Cabiralizumab 2 mg/kg Q2W | Grade 3 AST increase | 0 | Participants | |
| Safety: Number of Participants With Grade 3 or Grade 4 Adverse Events (AEs) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT) (Phase 1a) | Cabiralizumab 4 mg/kg Q2W | Grade 3 AST increase | 2 | Participants | |
| Safety: Number of Participants With Grade 3 or Grade 4 Adverse Events (AEs) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT) (Phase 1a) | Cabiralizumab 6 mg/kg Q2W | Grade 3 AST increase | 1 | Participants |
1 to 10 of 210Source ClinicalTrials.gov
See all 210 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1a: Cabiralizumab 2 mg/kg Q2W | 3 | |
| Overall Study | STARTED | Phase 1a: Cabiralizumab 4 mg/kg Q2W | 10 | |
| Overall Study | STARTED | Phase 1a: Cabiralizumab 6 mg/kg Q2W | 11 | |
| Overall Study | STARTED | Phase 1a: Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W | 4 | |
| Overall Study | STARTED | Phase 1a: Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W | 4 | |
| Overall Study | STARTED | Phase 1a: Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W | 3 | |
| Overall Study | STARTED | Phase 1a: Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W | 6 | |
| Overall Study | STARTED | Phase 1a: Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W | 10 | |
| Overall Study | STARTED | Phase 1b: Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W | 262 | |
| Overall Study | Received Study Treatment | Phase 1a: Cabiralizumab 2 mg/kg Q2W | 3 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events6,208
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Phase 1a: Cabiralizumab 2 mg/kg Q2W | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1a: Cabiralizumab 4 mg/kg Q2W | 3 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1a: Cabiralizumab 6 mg/kg Q2W | 0 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1a: Cabiralizumab 1mg/kg + Nivolumab 3 mg/kg Q2W | 2 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1a: Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1a+1b: Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W | 88 | 265 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1a: Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W | 3 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1a: Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W | 1 | 10 | |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Phase 1a: Cabiralizumab 2 mg/kg Q2W | 0 | 3 | |
| other | Anaemia of chronic disease | Blood and lymphatic system disorders | Phase 1a: Cabiralizumab 4 mg/kg Q2W | 0 | 11 |
1 to 10 of 6,208Source ClinicalTrials.gov
See all 6,208 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1a: Cabiralizumab 2 mg/kg Q2W | 2 | 3 |
| Total, all-cause mortality | Phase 1a: Cabiralizumab 4 mg/kg Q2W | 6 | 10 |
| Total, all-cause mortality | Phase 1a: Cabiralizumab 6 mg/kg Q2W | 6 | 11 |
| Total, all-cause mortality | Phase 1a: Cabiralizumab 1mg/kg + Nivolumab 3 mg/kg Q2W | 2 | 4 |
| Total, all-cause mortality | Phase 1a: Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W | 3 | 4 |
| Total, all-cause mortality | Phase 1a+1b: Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W | 172 | 265 |
| Total, all-cause mortality | Phase 1a: Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W | 4 | 6 |
| Total, all-cause mortality | Phase 1a: Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W | 7 | 10 |
| Total, other adverse events | Phase 1a: Cabiralizumab 2 mg/kg Q2W | 2 | 3 |
| Total, other adverse events | Phase 1a: Cabiralizumab 4 mg/kg Q2W | 10 | 11 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02526017
GET https://conductscience.org/api/trials/v1/NCT02526017/results?page=2