Trial · NCT02526017
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| 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 |
| SECONDARY | 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) | Cycles 1 and 8, Day 1 predose, and at 0.25, 4, 24, 72, 168, and 336 hours after the end of infusion. | The PK evaluable population included participants who received at least 1 dose of cabiralizumab, had at least 1 available serum concentration data, and adequate PK assessments which could be used to reliably derive at least 1 PK parameter. Not all participants completed 8 cycles.~PK data are reported by treatment regimen for Phase 1a participants and by disease type for Phase 1b participants. | days*µg/mL/mg | MEAN |
| SECONDARY | PK of Cabiralizumab: Maximum Observed Concentration (Cmax) and Minimum Observed Concentration (Cmin) | Cycles 1 and 8, Day 1 predose, and at 0.25, 4, 24, 72, 168, and 336 hours after the end of infusion. | The PK evaluable population included participants who received at least 1 dose of cabiralizumab, had at least 1 available serum concentration data, and adequate PK assessments which could be used to reliably derive at least 1 PK parameter. Not all participants completed 8 cycles.~PK data are reported by treatment regimen for Phase 1a participants and by disease type for Phase 1b participants. | µg/mL | MEAN |
| SECONDARY | Immunogenicity of Cabiralizumab: Number of Participants With Anti-Cabiralizumab Antibodies (Phase 1a and 1b) | Blood samples were collected before the infusion on Cycles 1 (Baseline), 2, 3, 4, 5, 9, 13, and 21, and at 28 days and 100 days after the end of treatment | All participants who received at least 1 dose of cabiralizumab and had available ADA data at baseline and post-baseline. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Immunogenicity of Nivolumab: Number of Participants With Anti-Nivolumab Antibodies (Phase 1a and 1b) | Blood samples were collected before the infusion on Cycles 1 (Baseline), 2, 3, 4, 5, 9, 13, and 21, and at 28 days and 100 days after the end of treatment | All participants who received at least 1 dose of nivolumab and had available ADA data at baseline and post-baseline. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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