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| Name | Class |
|---|---|
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
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The purpose of this study is to determine whether an investigational immuno-therapy, cabiralizumab in combination with nivolumab, is safe and tolerable in the treatment of advanced malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monotherapy | Experimental | Cabiralizumab administered as a single agent intravenous formulation |
|
| Combination Therapy | Experimental | Cabiralizumab will be administered in combination with Nivolumab as an intravenous formulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabiralizumab | Biological | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) - Carbiralizumab Monotherapy | The number of participants that experienced an AE during the course of the study while participating in cabiralizumab monotherapy treatment. | From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months |
| Number of Participants With Serious Adverse Events (SAEs) - Carbiralizumab Monotherapy | The number of participants that experienced a SAE during the course of the study while participating in cabiralizumab monotherapy treatment. | From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months |
| Number of Participants With AEs Meeting Protocol-defined Dose-Limiting Toxicity (DLT) Criteria - Carbiralizumab Monotherapy | The number of participants that experienced an AE meeting protocol-defined DLT criteria during the course of the study while participating in cabiralizumab monotherapy treatment. | 28 days (from first day of treatment) |
| Number of Participants With AEs Leading to Discontinuation - Carbiralizumab Monotherapy | The number of participants that experienced an AE leading to discontinuation during the course of the study while participating in cabiralizumab monotherapy treatment. | From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months |
| Number of Participants Who Died - Carbiralizumab Monotherapy | The number of participants that died during the course of the study while participating in cabiralizumab monotherapy treatment. | From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) - Carbiralizumab and Nivolumab Combo Therapy | The number of participants that experienced an AE during the course of the study while participating in cabiralizumab and nivolumab combination therapy. | From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months |
Not provided
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Nagoya | Aichi-ken | 4678602 | Japan | ||
| Local Institution |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
Not provided
19 participants entered the treatment period, and 19 were treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | M1 Cohort | 2 mg/kg cabiralizumab monotherapy |
| FG001 | M2 Cohort | 4 mg/kg cabiralizumab monotherapy |
| FG002 | C1 Cohort | Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor |
| FG003 | C2 Cohort | Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | M1 Cohort | 2 mg/kg cabiralizumab monotherapy |
| BG001 | M2 Cohort | 4 mg/kg cabiralizumab monotherapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) - Carbiralizumab Monotherapy | The number of participants that experienced an AE during the course of the study while participating in cabiralizumab monotherapy treatment. | All treated participants participating in carbiralizumab monotherapy | Posted | Number | Number of participants | From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months |
|
From first dose to 100 days post last dose for SAEs and AEs, assessed up to July 2019, approximately 24 months. Note: Specifically for mortality data, assessment was performed up to end of study (Apr2020 data base lock).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | M1 Cohort | 2 mg/kg cabiralizumab monotherap | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email: | Clinical.Trials@bms.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 10, 2019 | Oct 9, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Mar 22, 2018 | Oct 9, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| C000722457 | cabiralizumab |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Parallel assignment will only in combination therapy arm.
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| Nivolumab | Biological | Specified dose on specified days |
|
|
| Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy |
The number of participants that experienced a laboratory abnormality during the course of the study while participating in cabiralizumab monotherapy treatment. |
| From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months |
| Number of Participants With Serious Adverse Events (SAEs) - Carbiralizumab and Nivolumab Combo Therapy |
The number of participants that experienced an SAE during the course of the study while participating in cabiralizumab and nivolumab combination therapy. |
| From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months |
| Number of Participants With AEs Leading to Discontinuation - Carbiralizumab and Nivolumab Combo Therapy | The number of participants that experienced an AE leading to discontinuation during the course of the study while participating in cabiralizumab and nivolumab combination therapy. | From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months |
| Number of Participants Who Died - Carbiralizumab and Nivolumab Combo Therapy | The number of participants that died during the course of the study while participating in cabiralizumab and nivolumab combination therapy. | From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months |
| Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy | The number of participants that experienced a laboratory abnormality during the course of the study while participating in carbiralizumab and nivolumab combination therapy | From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months |
| AI_Ctrough | Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data. Ctrough Accumulation Index; ratio of Ctrough at steady-state (i.e. Cycle 8) to Ctrough after the first dose Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy. AI = Ctrough on cycle 8 / Ctrough on Cycle 2 | Cycle 2 (pre-dose), Cycle 8 (pre-dose) |
| AUC(0-T) | Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data. AUC(0-T) is defined as the area under the serum concentration-time curve from time zero to time of last quantifiable concentration after the first dose. Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy. | Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour) |
| AUC(TAU) | Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data. AUC(TAU) is defined as the area under the serum concentration-time curve in one dosing interval. Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy. | Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour) |
| Cmax | Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data. Cmax is defined as the maximum observed serum concentration. Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy. | Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour) |
| Ctrough | Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data. Ctrough is defined as the Trough observed serum concentration (predose at each cycle). Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy. | Cycles 1, 2, 3, 4, 5, 6, 7, 8, 9 |
| T-HALFeff_Ctrough | Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data. T-HALFeff_Ctrough is defined as the effective elimination half-life that explains the degree of Ctrough accumulation observed. Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy. | Cycle 2 (pre-dose), Cycle 8 (pre-dose) |
| Tmax | Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data. Tmax is defined as the time of maximum observed serum concentration. Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy. | Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour) |
| Incidence of Anti-drug Antibodies (ADA) | To characterize the immunogenicity of cabiralizumab and nivolumab. Baseline ADA-positive participant is defined as a participant who has a ADA detected sample at baseline. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment. Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy. | Day 1 pre-dose for cycles 2, 3, 5, 9, 13, 21 |
| Best Overall Response (BOR) | To assess the preliminary anti-tumor activity of cabiralizumab administered alone and in combination with nivolumab per RECIST 1.1 (M1, M2, C1 cohorts: participants with advanced solid tumors) and per IMWG criteria (Cohort C2: participants with hematologic malignancies). IMWG: International Myeloma Working Group RECIST: Response Evaluation Criteria in Solid Tumors | From first dose to end of follow-up, assessed up to July 2019, approximately 24 months |
| Duration of Response (DOR) | To assess the preliminary anti-tumor activity of cabiralizumab administered alone and in combination with nivolumab per RECIST 1.1 (M1, M2, C1 cohorts: participants with advanced solid tumors) and per IMWG criteria (Cohort C2: participants with hematologic malignancies). IMWG: International Myeloma Working Group RECIST: Response Evaluation Criteria in Solid Tumors Duration of response (DOR) was listed for participants with a BOR of complete response (CR) or partial response (PR). | From first dose to end of follow-up |
| Kamogawa-shi |
| Chiba |
| 2968602 |
| Japan |
| Local Institution | Kashiwa-shi | Chiba | 2778577 | Japan |
| Local Institution | Chuo-ku | Tokyo | 1040045 | Japan |
| FDA Safety Alerts and Recalls | View source |
| Death |
|
| Other reasons |
|
| Adverse event unrelated to the drug |
|
| BG002 |
| C1 Cohort |
Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor |
| BG003 | C2 Cohort | Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Age, Customized | Age categorization | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Participants With Serious Adverse Events (SAEs) - Carbiralizumab Monotherapy | The number of participants that experienced a SAE during the course of the study while participating in cabiralizumab monotherapy treatment. | All treated participants participating in carbiralizumab monotherapy | Posted | Number | Number of participants | From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months |
|
|
|
| Primary | Number of Participants With AEs Meeting Protocol-defined Dose-Limiting Toxicity (DLT) Criteria - Carbiralizumab Monotherapy | The number of participants that experienced an AE meeting protocol-defined DLT criteria during the course of the study while participating in cabiralizumab monotherapy treatment. | All treated participants participating in carbiralizumab monotherapy | Posted | Number | Number of participants | 28 days (from first day of treatment) |
|
|
|
| Primary | Number of Participants With AEs Leading to Discontinuation - Carbiralizumab Monotherapy | The number of participants that experienced an AE leading to discontinuation during the course of the study while participating in cabiralizumab monotherapy treatment. | All treated participants participating in carbiralizumab monotherapy | Posted | Number | Number of participants | From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months |
|
|
|
| Primary | Number of Participants Who Died - Carbiralizumab Monotherapy | The number of participants that died during the course of the study while participating in cabiralizumab monotherapy treatment. | All treated participants participating in carbiralizumab monotherapy | Posted | Number | Number of participants | From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months |
|
|
|
| Primary | Number of Participants With Laboratory Abnormalities - Carbiralizumab Monotherapy | The number of participants that experienced a laboratory abnormality during the course of the study while participating in cabiralizumab monotherapy treatment. | All treated participants participating in carbiralizumab monotherapy | Posted | Number | Number of participants | From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs) - Carbiralizumab and Nivolumab Combo Therapy | The number of participants that experienced an AE during the course of the study while participating in cabiralizumab and nivolumab combination therapy. | All treated participants participating in carbiralizumab and nivolumab combo therapy | Posted | Number | Number of participants | From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months |
|
|
|
| Secondary | Number of Participants With Serious Adverse Events (SAEs) - Carbiralizumab and Nivolumab Combo Therapy | The number of participants that experienced an SAE during the course of the study while participating in cabiralizumab and nivolumab combination therapy. | All treated participants participating in carbiralizumab and nivolumab combo therapy | Posted | Number | Number of participants | From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months |
|
|
|
| Secondary | Number of Participants With AEs Leading to Discontinuation - Carbiralizumab and Nivolumab Combo Therapy | The number of participants that experienced an AE leading to discontinuation during the course of the study while participating in cabiralizumab and nivolumab combination therapy. | All treated participants participating in carbiralizumab and nivolumab combo therapy | Posted | Number | Number of participants | From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months |
|
|
|
| Secondary | Number of Participants Who Died - Carbiralizumab and Nivolumab Combo Therapy | The number of participants that died during the course of the study while participating in cabiralizumab and nivolumab combination therapy. | All treated participants participating in carbiralizumab and nivolumab combo therapy | Posted | Number | Number of participants | From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months |
|
|
|
| Secondary | Number of Participants With Laboratory Abnormalities - Carbiralizumab and Nivolumab Combination Therapy | The number of participants that experienced a laboratory abnormality during the course of the study while participating in carbiralizumab and nivolumab combination therapy | All treated participants participating in carbiralizumab and nivolumab combo therapy | Posted | Number | Number of participants | From first dose to 30 days post last dose, assessed up to July 2019, approximately 24 months |
|
|
|
| Secondary | AI_Ctrough | Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data. Ctrough Accumulation Index; ratio of Ctrough at steady-state (i.e. Cycle 8) to Ctrough after the first dose Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy. AI = Ctrough on cycle 8 / Ctrough on Cycle 2 | All treated participants who completed through cycle 8 visit | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio of Ctrough: cycle 8 to cycle 2 | Cycle 2 (pre-dose), Cycle 8 (pre-dose) |
|
|
|
| Secondary | AUC(0-T) | Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data. AUC(0-T) is defined as the area under the serum concentration-time curve from time zero to time of last quantifiable concentration after the first dose. Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy. | All treated participants | Posted | Geometric Mean | Geometric Coefficient of Variation | h*µg/mL | Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour) |
|
|
|
| Secondary | AUC(TAU) | Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data. AUC(TAU) is defined as the area under the serum concentration-time curve in one dosing interval. Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy. | All treated participants | Posted | Geometric Mean | Geometric Coefficient of Variation | h*µg/mL | Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour) |
|
|
|
| Secondary | Cmax | Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data. Cmax is defined as the maximum observed serum concentration. Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy. | All treated participants | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour) |
|
|
|
| Secondary | Ctrough | Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data. Ctrough is defined as the Trough observed serum concentration (predose at each cycle). Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy. | All treated participants for all cohorts for Cabiralizumab; All treated participants for Cohorts C1 and C2 for Nivolumab. Note: Data reported for the cycles that were reached. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Cycles 1, 2, 3, 4, 5, 6, 7, 8, 9 |
|
|
|
| Secondary | T-HALFeff_Ctrough | Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data. T-HALFeff_Ctrough is defined as the effective elimination half-life that explains the degree of Ctrough accumulation observed. Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy. | All treated participants who completed through cycle 8 visit | Posted | Median | Full Range | hour | Cycle 2 (pre-dose), Cycle 8 (pre-dose) |
|
|
|
| Secondary | Tmax | Pharmacokinetics of cabiralizumab and nivolumab were derived from serum concentration versus time data. Tmax is defined as the time of maximum observed serum concentration. Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy. | All treated participants | Posted | Median | Full Range | h (Hour) | Cycle 1 (from Day 1 pre-dose to Day 8, 168 hour) |
|
|
|
| Secondary | Incidence of Anti-drug Antibodies (ADA) | To characterize the immunogenicity of cabiralizumab and nivolumab. Baseline ADA-positive participant is defined as a participant who has a ADA detected sample at baseline. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment. Data collected from participants participating in cabiralizumab monotherapy, as well as cabiralizumab and nivolumab combination therapy. | All treated participants | Posted | Number | Number of participants | Day 1 pre-dose for cycles 2, 3, 5, 9, 13, 21 |
|
|
|
| Secondary | Best Overall Response (BOR) | To assess the preliminary anti-tumor activity of cabiralizumab administered alone and in combination with nivolumab per RECIST 1.1 (M1, M2, C1 cohorts: participants with advanced solid tumors) and per IMWG criteria (Cohort C2: participants with hematologic malignancies). IMWG: International Myeloma Working Group RECIST: Response Evaluation Criteria in Solid Tumors | All treated participants | Posted | Number | Number of participants | From first dose to end of follow-up, assessed up to July 2019, approximately 24 months |
|
|
|
| Secondary | Duration of Response (DOR) | To assess the preliminary anti-tumor activity of cabiralizumab administered alone and in combination with nivolumab per RECIST 1.1 (M1, M2, C1 cohorts: participants with advanced solid tumors) and per IMWG criteria (Cohort C2: participants with hematologic malignancies). IMWG: International Myeloma Working Group RECIST: Response Evaluation Criteria in Solid Tumors Duration of response (DOR) was listed for participants with a BOR of complete response (CR) or partial response (PR). | All treated participants Note: there is no DOR data to report as no participant had a BOR of CR or PR or better. | Posted | From first dose to end of follow-up |
|
|
| 3 |
| 2 |
| 3 |
| 3 |
| 3 |
| EG001 | M2 Cohort | 4 mg/kg cabiralizumab monotherapy | 1 | 4 | 3 | 4 | 4 | 4 |
| EG002 | C1 Cohort | Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with solid tumor | 2 | 6 | 2 | 6 | 6 | 6 |
| EG003 | C2 Cohort | Cabiralizumab in combination with nivolumab: 4 mg/kg cabiralizumab and 3 mg/kg nivolumab in participants with hematologic malignancies | 2 | 6 | 3 | 6 | 6 | 6 |
| Anorectal disorder | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Cholangitis infective | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Gastritis bacterial | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
|
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Bladder disorder | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Bundle branch block left | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Periorbital oedema | Eye disorders | MedDRA 22.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Parotid gland enlargement | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Retroperitoneal haemorrhage | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Generalised oedema | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Escherichia bacteraemia | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Infected dermal cyst | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
Not provided
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| HYPERKALEMIA - grade 1 |
|
| HYPERNATREMIA - grade 0 |
|
| HYPOCALCEMIA - grade 0 |
|
| HYPOCALCEMIA - grade 1 |
|
| HYPOKALEMIA - grade 0 |
|
| HYPOKALEMIA -grade 1 |
|
| HYPONATREMIA - grade 0 |
|
| HYPONATREMIA - grade 1 |
|
| HEMOGLOBIN - grade 1 |
|
| HEMOGLOBIN - grade 2 |
|
| PLATELET COUNT - grade 0 |
|
| LEUKOCYTES - grade 0 |
|
| LEUKOCYTES - grade 2 |
|
| ABSOLUTE NEUTROPHIL COUNT - grade 0 |
|
| ABSOLUTE NEUTROPHIL COUNT - grade 2 |
|
| LYMPHOCYTES (ABSOLUTE) - grade 0 |
|
| LYMPHOCYTES (ABSOLUTE) - grade 2 |
|
| LYMPHOCYTES (ABSOLUTE) - grade 3 |
|
| NEUTROPHILS (ABSOLUTE) - grade 0 |
|
| NEUTROPHILS (ABSOLUTE) - grade 1 |
|
| NEUTROPHILS (ABSOLUTE) - grade 2 |
|
| CREATININE - grade 0 |
|
| CREATININE - grade 1 |
|
| ALKALINE PHOSPHATASE (ALP) - grade 0 |
|
| ALKALINE PHOSPHATASE (ALP) - grade 1 |
|
| ALKALINE PHOSPHATASE (ALP) - grade 2 |
|
| ALANINE AMINOTRANSFERASE (ALT) - grade 0 |
|
| ALANINE AMINOTRANSFERASE (ALT) - grade 1 |
|
| ASPARTATE AMINOTRANSFERASE (AST) - grade 0 |
|
| ASPARTATE AMINOTRANSFERASE (AST) - grade 1 |
|
| ASPARTATE AMINOTRANSFERASE (AST) - grade 2 |
|
| ASPARTATE AMINOTRANSFERASE (AST) - grade 3 |
|
| BILIRUBIN, TOTAL - grade 0 |
|
| HYPERKALEMIA - grade 1 |
|
| HYPERNATREMIA - grade 0 |
|
| HYPERNATREMIA - grade 1 |
|
| HYPOCALCEMIA - grade 0 |
|
| HYPOCALCEMIA - grade 1 |
|
| HYPOCALCEMIA - grade 2 |
|
| HYPOCALCEMIA - grade 3 |
|
| HYPOKALEMIA - grade 0 |
|
| HYPOKALEMIA -grade 1 |
|
| HYPOKALEMIA - grade 3 |
|
| HYPONATREMIA - grade 0 |
|
| HYPONATREMIA - grade 1 |
|
| HEMOGLOBIN - grade 1 |
|
| HEMOGLOBIN - grade 2 |
|
| HEMOGLOBIN - grade 3 |
|
| PLATELET COUNT - grade 0 |
|
| PLATELET COUNT - grade 1 |
|
| PLATELET COUNT - grade 2 |
|
| PLATELET COUNT - grade 3 |
|
| PLATELET COUNT - grade 4 |
|
| LEUKOCYTES - grade 0 |
|
| LEUKOCYTES - grade 1 |
|
| LEUKOCYTES - grade 2 |
|
| LEUKOCYTES - grade 3 |
|
| LEUKOCYTES - grade 4 |
|
| ABSOLUTE NEUTROPHIL COUNT - grade 0 |
|
| ABSOLUTE NEUTROPHIL COUNT - grade 1 |
|
| ABSOLUTE NEUTROPHIL COUNT - grade 2 |
|
| ABSOLUTE NEUTROPHIL COUNT - grade 3 |
|
| ABSOLUTE NEUTROPHIL COUNT - grade 4 |
|
| LYMPHOCYTES (ABSOLUTE) - grade 1 |
|
| LYMPHOCYTES (ABSOLUTE) - grade 2 |
|
| LYMPHOCYTES (ABSOLUTE) - grade 3 |
|
| NEUTROPHILS (ABSOLUTE) - grade 0 |
|
| NEUTROPHILS (ABSOLUTE) - grade 1 |
|
| NEUTROPHILS (ABSOLUTE) - grade 2 |
|
| NEUTROPHILS (ABSOLUTE) - grade 3 |
|
| NEUTROPHILS (ABSOLUTE) - grade 4 |
|
| CREATININE - grade 0 |
|
| CREATININE - grade 1 |
|
| CREATININE - grade 2 |
|
| CREATININE - grade 3 |
|
| ALKALINE PHOSPHATASE (ALP) - grade 0 |
|
| ALKALINE PHOSPHATASE (ALP) - grade 1 |
|
| ALKALINE PHOSPHATASE (ALP) - grade 2 |
|
| ALKALINE PHOSPHATASE (ALP) - grade 3 |
|
| ALANINE AMINOTRANSFERASE (ALT) - grade 0 |
|
| ALANINE AMINOTRANSFERASE (ALT) - grade 1 |
|
| ALANINE AMINOTRANSFERASE (ALT) - grade 2 |
|
| ASPARTATE AMINOTRANSFERASE (AST) - grade 1 |
|
| ASPARTATE AMINOTRANSFERASE (AST) - grade 2 |
|
| ASPARTATE AMINOTRANSFERASE (AST) - grade 3 |
|
| BILIRUBIN, TOTAL - grade 0 |
|
| BILIRUBIN, TOTAL - grade 2 |
|
|
| Cabiralizumab cycle 3 |
|
|
| Cabiralizumab cycle 4 |
|
|
| Cabiralizumab cycle 5 |
|
|
| Cabiralizumab cycle 6 |
|
|
| Cabiralizumab cycle 7 |
|
|
| Cabiralizumab cycle 8 |
|
|
| Cabiralizumab cycle 9 |
|
|
| Nivolumab cycle 2 |
|
|
| Nivolumab cycle 3 |
|
|
| Nivolumab cycle 5 |
|
|
| Nivolumab cycle 9 |
|
|
| Nivolumab data |
|
| Progression |
|
| Not evaluable |
|