NCT02526017 (FPA008-003) is a Phase 1 clinical trial of Cabiralizumab in Advanced Solid Tumors, sponsored by Five Prime Therapeutics, Inc..

Who is sponsoring NCT02526017?

NCT02526017 is sponsored by Five Prime Therapeutics, Inc..

What drugs are being tested in NCT02526017?

Interventions in NCT02526017: Cabiralizumab, Nivolumab.

What condition does NCT02526017 study?

NCT02526017 studies Advanced Solid Tumors, Head and Neck Cancer, Pancreatic Cancer, Ovarian Cancer, Renal Cell Carcinoma, Malignant Glioma, Non-small Cell Lung Cancer.

Is NCT02526017 still recruiting?

NCT02526017 is currently completed. Last updated 9 March 2022.

Are results published for NCT02526017?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-03-09 · How we verify

NCT02526017: FPA008-003

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Results posted Last updated 9 March 2022

What this trial tests

Phase 1 trial testing Cabiralizumab in Advanced Solid Tumors in 313 participants. Completed in 18 November 2019.

Timeline

8 September 2015

Primary endpoint
18 November 2019

18 November 2019

Quick facts

Lead sponsor	Five Prime Therapeutics, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	313
Start date	8 September 2015
Primary completion	18 November 2019
Estimated completion	18 November 2019
Sites	39 locations across United States

Drugs / interventions tested

Cabiralizumab — full drug profile →
Nivolumab (nivolumab) — full drug profile →

Conditions studied

Advanced Solid Tumors — all drugs for Advanced Solid Tumors →
Head and Neck Cancer — all drugs for Head and Neck Cancer →
Pancreatic Cancer — all drugs for Pancreatic Cancer →
Ovarian Cancer — all drugs for Ovarian Cancer →

Sponsor

Five Prime Therapeutics, Inc. — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Tumors or Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Safety: Number of Participants With Grade 3 or Grade 4 Adverse Events (AEs) and Laboratory Abnormalities Defined as Dose Limiting Toxicities (DLT) (Phase 1a) Primary · 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 cl

Grade 3 CK increase

Group	Value	95% CI
Cabiralizumab 2 mg/kg Q2W	0
Cabiralizumab 4 mg/kg Q2W	0
Cabiralizumab 6 mg/kg Q2W	1
Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W	0
Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W	0
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W	0
Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W	0

Grade 3 AST increase

Group	Value	95% CI
Cabiralizumab 2 mg/kg Q2W	0
Cabiralizumab 4 mg/kg Q2W	2
Cabiralizumab 6 mg/kg Q2W	1
Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W	0
Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W	0
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W	0
Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W	0

Recommended Dose (RD) of Cabiralizumab in Combination With Nivolumab (Phase 1a) Primary · 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.

Group	Value	95% CI
Overall Phase 1a Dose Escalation	4

Safety: Number of Participants With Adverse Events and Serious Adverse Events (Phase 1a and 1b) Primary · 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; * R

Any adverse event

Group	Value	95% CI
Cabiralizumab 2 mg/kg Q2W	2
Cabiralizumab 4 mg/kg Q2W	10
Cabiralizumab 6 mg/kg Q2W	10
Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W	4
Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W	3
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W	264
Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W	6
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W	10

Serious adverse events

Group	Value	95% CI
Cabiralizumab 2 mg/kg Q2W	1
Cabiralizumab 4 mg/kg Q2W	1
Cabiralizumab 6 mg/kg Q2W	6
Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W	2
Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W	1
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W	138
Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W	3
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W	5

Safety: Number of Participants With Treatment Discontinuations, Modifications, or Interruptions Due to Adverse Events (Phase 1b) Primary · 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.

Cabiralizumab infusion interruptions

Group	Value	95% CI
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W	0

Cabiralizumab infusion modifications

Group	Value	95% CI
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W	12

Nivolumab infusion interruptions

Group	Value	95% CI
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W	4

Nivolumab infusion modifications

Group	Value	95% CI
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W	8

AEs leading to discontinuation of cabiralizumab or nivolumab

Group	Value	95% CI
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W	54

Efficacy: Objective Response Rate - Investigator Assessment (Phase 1b) Primary · 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.

Group	Value	95% CI
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve)	6.9	0.8 – 22.8
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant)	3.2	0.1 – 16.7
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN	13.8	3.9 – 31.7
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer	5.9	1.6 – 14.4
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer	13.3	3.8 – 30.7
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC	6.7	0.8 – 22.1
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Malignant Glioma	0	0.0 – 11.6
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma	9.1	0.2 – 41.3

Efficacy: Overall Survival (Phase 1b) Secondary · 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.

Group	Value	95% CI
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve)	12.3	6.1 – 19.1
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant)	4.7	2.6 – 10.3
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN	6.4	3.4 – NA
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer	5.6	4.0 – 8.0
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer	13.9	6.9 – 16.4
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC	NA	16.8 – NA
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM	8.1	5.7 – 12.8
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma	5.3	1.1 – 24.8

Efficacy: Overall Survival (OS) at One Year (Phase 1b) Secondary · 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.

Group	Value	95% CI
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve)	51.1	31.7 – 67.6
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant)	29.2	13.7 – 46.6
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN	42.5	23.0 – 60.7
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer	27.2	15.8 – 39.9
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer	52.9	30.6 – 71.0
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC	77.8	57.1 – 89.3
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM	35.0	16.2 – 54.6
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma	36.4	9.0 – 65.4

Efficacy: Duration of Response (Phase 1b) Secondary · 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 base

Group	Value	95% CI
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve)	8.9	7.6 – 10.2
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant)	16.2	NA – NA
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN	NA	NA – NA
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer	12.7	8.0 – 16.4
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer	7.3	3.8 – NA
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC	NA	3.7 – NA
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma	NA	NA – NA

Efficacy: Progression Free Survival (Phase 1b) Secondary · 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 we

Group	Value	95% CI
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve)	2.8	1.7 – 4.8
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant)	1.9	1.7 – 3.4
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN	1.8	1.4 – 3.8
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer	1.7	1.6 – 1.9
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer	2.0	1.7 – 3.6
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC	2.9	1.8 – 5.5
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM	1.8	1.3 – 3.4
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma	1.8	1.1 – 4.9

Efficacy: Objective Response Rate - Central Review Assessment (Phase 1b) Secondary · 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.

Group	Value	95% CI
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve)	3.4	0.1 – 17.8
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant)	0	0.0 – 11.2
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN	10.7	2.3 – 28.2
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer	6.0	1.7 – 14.6
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer	6.7	0.8 – 22.1
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC	16.7	5.6 – 34.7
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM	0	0.0 – 11.6
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma	9.1	0.2 – 41.3

Pharmacokinetics (PK) of Cabiralizumab: Area Under the Concentration Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) Normalized by Dose (Phase 1a and 1b) Secondary · Cycles 1 and 8, Day 1 predose, and at 0.25, 4, 24, 72, 168, and 336 hours after the end of infusion.

Cabiralizumab serum concentration was determined using a validated enzyme-linked immunosorbent assay (ELISA) method.

Cycle 1

Group	Value	95% CI
Cabiralizumab 2 mg/kg Q2W	1.26	± 0.588
Cabiralizumab 4 mg/kg Q2W	1.70	± 0.444
Cabiralizumab 6 mg/kg Q2W	1.84	± 0.684
Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W	0.66	± 0.346
Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W	1.22	± 0.970
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W	1.66	± 0.737
Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W	2.14	± 0.509
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W	1.75	± 0.982
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve)	1.74	± 0.769
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant)	1.46	± 0.562
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN	1.42	± 0.404
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer	1.52	± 0.494

Cycle 8

Group	Value	95% CI
Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W	3.65	± 0.696
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve)	2.83	± 1.602
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant)	3.52	± 1.290
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN	2.63	± 1.128
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer	2.32	± 0.694
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer	2.69	± 1.307
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC	2.67	± 2.120
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM	4.69	± 2.058
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma	4.43	± 1.126

PK of Cabiralizumab: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) Secondary · Cycles 1 and 8, Day 1 predose, and at 0.25, 4, 24, 72, 168, and 336 hours after the end of infusion.

Cabiralizumab serum concentration was determined using a validated enzyme-linked immunosorbent assay method. Cmax is the maximum observed serum concentration of cabiralizumab during the dosing period. Cmin is the minimum observed serum concentration of cabiralizumab during a dosing interval (excluding pre-dose concentration before the first dose).

Cmax Cycle 1

Group	Value	95% CI
Cabiralizumab 2 mg/kg Q2W	52.11	± 10.663
Cabiralizumab 4 mg/kg Q2W	104.82	± 21.543
Cabiralizumab 6 mg/kg Q2W	142.83	± 38.528
Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W	21.93	± 7.651
Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W	49.00	± 17.314
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W	104.47	± 6.890
Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W	124.36	± 8.825
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W	85.45	± 16.750
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve)	93.41	± 25.708
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant)	93.69	± 23.406
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN	83.01	± 37.646
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer	81.40	± 17.451

Cmin Cycle 1

Group	Value	95% CI
Cabiralizumab 2 mg/kg Q2W	2.68	± 2.223
Cabiralizumab 4 mg/kg Q2W	28.61	± 17.127
Cabiralizumab 6 mg/kg Q2W	37.08	± 18.490
Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W	3.29	± 4.414
Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W	3.96	± 2.711
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W	25.57	± 16.098
Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W	28.76	± 5.307
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W	10.34	± 8.351
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve)	16.22	± 10.176
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant)	17.82	± 10.054
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN	13.65	± 6.959
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer	15.45	± 9.663

Cmax Cycle 8

Group	Value	95% CI
Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W	187.27	± 63.438
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve)	126.01	± 39.937
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant)	142.85	± 44.856
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN	97.24	± 25.252
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer	108.76	± 24.249
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer	130.17	± 29.845
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC	121.06	± 40.392
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM	167.66	± 47.960
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma	164.47	± 15.283

Cmin Cycle 8

Group	Value	95% CI
Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W	109.66	± 58.420
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve)	38.79	± 20.999
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant)	52.26	± 6.642
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN	37.05	± 13.674
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer	40.63	± 11.189
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer	36.95	± 15.291
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC	40.15	± 16.612
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM	85.33	± 30.039
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma	82.00	± 12.572

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase 1a: Cabiralizumab 2 mg/kg Q2W

Serious: 1/3 (33%)

Deaths: 2/3

Phase 1a: Cabiralizumab 4 mg/kg Q2W

Serious: 1/10 (10%)

Deaths: 6/10

Phase 1a: Cabiralizumab 6 mg/kg Q2W

Serious: 6/11 (55%)

Deaths: 6/11

Phase 1a: Cabiralizumab 1mg/kg + Nivolumab 3 mg/kg Q2W

Serious: 2/4 (50%)

Deaths: 2/4

Phase 1a: Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W

Serious: 1/3 (33%)

Deaths: 3/4

Phase 1a+1b: Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W

Serious: 138/265 (52%)

Deaths: 172/265

Phase 1a: Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W

Serious: 3/6 (50%)

Deaths: 4/6

Phase 1a: Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W

Serious: 5/10 (50%)

Deaths: 7/10

Serious adverse events (162 terms)

Reaction	System	Phase 1a: Cabiralizumab 2 …	Phase 1a: Cabiralizumab 4 …	Phase 1a: Cabiralizumab 6 …	Phase 1a: Cabiralizumab 1m…	Phase 1a: Cabiralizumab 2 …	Phase 1a+1b: Cabiralizumab…	Phase 1a: Cabiralizumab 6 …	Phase 1a: Cabiralizumab 4 …
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—	—	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Seizure	Nervous system disorders	—	—	—	—	—	—	—	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Gait disturbance	General disorders	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Mental status changes	Psychiatric disorders	—	—	—	—	—	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Bacteraemia	Infections and infestations	—	—	—	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—

Other adverse events (614 terms — click to expand)

Reaction	System	Phase 1a: Cabiralizumab 2 …	Phase 1a: Cabiralizumab 4 …	Phase 1a: Cabiralizumab 6 …	Phase 1a: Cabiralizumab 1m…	Phase 1a: Cabiralizumab 2 …	Phase 1a+1b: Cabiralizumab…	Phase 1a: Cabiralizumab 6 …	Phase 1a: Cabiralizumab 4 …
Fatigue	General disorders	—	—	—	—	—	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—	—	—	—	—	—
Periorbital oedema	Eye disorders	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—
Peripheral swelling	General disorders	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—
Amylase increased	Investigations	—	—	—	—	—	—	—	—
Lipase increased	Investigations	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—
Blood lactate dehydrogenase increased	Investigations	—	—	—	—	—	—	—	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—

Most-reported serious reactions: Abdominal pain, Sepsis, Dyspnoea, Blood creatine phosphokinase increased, Colitis, Seizure, Pneumonitis, Acute respiratory failure.

Data from ClinicalTrials.gov NCT02526017 adverse events section.

Sponsor's own description

Phase 1a/1b does-escalation study of cabiralizumab alone and with nivolumab in advanced solid tumors.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Macrophages as regulators of tumour immunity and immunotherapy.
DeNardo DG, Ruffell B. · · 2019 · cited 1903× · PMID 30718830 · DOI 10.1038/s41577-019-0127-6
Enhancing cancer immunotherapy using antiangiogenics: opportunities and challenges.
Fukumura D, Kloepper J, Amoozgar Z, Duda DG, et al · · 2018 · cited 1560× · PMID 29508855 · DOI 10.1038/nrclinonc.2018.29
Colony-stimulating factor 1 receptor (CSF1R) inhibitors in cancer therapy.
Cannarile MA, Weisser M, Jacob W, Jegg AM, et al · · 2017 · cited 796× · PMID 28716061 · DOI 10.1186/s40425-017-0257-y
Targeting tumor-associated macrophages to synergize tumor immunotherapy.
Xiang X, Wang J, Lu D, Xu X. · · 2021 · cited 712× · PMID 33619259 · DOI 10.1038/s41392-021-00484-9
Myeloid-derived suppressor cells as immunosuppressive regulators and therapeutic targets in cancer.
Li K, Shi H, Zhang B, Ou X, et al · · 2021 · cited 687× · PMID 34620838 · DOI 10.1038/s41392-021-00670-9
Progress in tumor-associated macrophage (TAM)-targeted therapeutics.
Ngambenjawong C, Gustafson HH, Pun SH. · · 2017 · cited 659× · PMID 28449873 · DOI 10.1016/j.addr.2017.04.010
Targeting macrophages in cancer immunotherapy.
Duan Z, Luo Y. · · 2021 · cited 462× · PMID 33767177 · DOI 10.1038/s41392-021-00506-6
Pancreatic Ductal Adenocarcinoma: Current and Evolving Therapies.
Adamska A, Domenichini A, Falasca M. · · 2017 · cited 429× · PMID 28640192 · DOI 10.3390/ijms18071338

Verify or expand the search:

Other trials of Cabiralizumab

Trials testing the same drug.

NCT04331067 — Neoadjuvant Nivolumab and Chemotherapy in Patients With Localized Triple-negative Breast Cancer · Phase 1, PHASE2 · active not recruiting
NCT03697564 — Nivolumab + Cabiralizumab + Gemcitabine in Patients With Stage IV Pancreatic Cancer · Phase 2 · completed
NCT03502330 — APX005M With Nivolumab and Cabiralizumab in Advanced Melanoma, Non-small Cell Lung Cancer or Renal Cell Carcinoma · Phase 1 · completed
NCT03335540 — An Adaptive Study to Match Patients With Solid Tumors to Various Immunotherapy Combinations Based Upon a Broad Biomarker · Phase 1 · completed
NCT03431948 — Stereotactic Body Radiotherapy (SBRT) Plus Immunotherapy for Cancer · Phase 1 · completed

Other recruiting trials for Advanced Solid Tumors

Currently open trials in the same condition.

NCT07504445 — Clinical Study on the Efficacy and Safety of CAR-DC in the Treatment of Advanced Solid Tumors · EARLY_PHASE1 · recruiting
NCT07589530 — Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07360314 — Anti-Ly6E Exatecan ADC M7437 in Advanced Solid Tumors · Phase 1 · recruiting
NCT07414316 — A Single-Arm, Open-Label Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors. · EARLY_PHASE1 · recruiting
NCT07222969 — A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors · Phase 1, PHASE2 · recruiting

Other Five Prime Therapeutics, Inc. trials

Trials by the same sponsor.

NCT04074759 — FPT155 in Patients With Advanced Solid Tumors · Phase 1 · terminated
NCT03694522 — A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer · Phase 2 · completed
NCT03514121 — FPA150 in Patients With Advanced Solid Tumors · EARLY_PHASE1 · terminated
NCT03343301 — A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 in Gastric/Gastroesophageal Cancer · Phase 1 · completed
NCT03801278 — An Expanded Access Study of Bemarituzumab (FPA144) for a Single Patient With Recurrent Bladder Cancer · no longer available

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02526017 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Five Prime Therapeutics, Inc.
Last refreshed: 9 March 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02526017.

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