Not provided
Not provided
Not provided
Not provided
Not provided
Business objectives have changed
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and tolerability of BMS-986183 in patients with liver cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation Monotherapy | Experimental |
| |
| Dose Expansion Monotherapy | Experimental |
| |
| Dose Escalation Combination Therapy | Experimental |
| |
| Dose Expansion Combination Therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986183 | Biological | specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events at Its Worst Grade | Evaluated by comparing the incidence of Adverse Events (AEs) among subjects using their assigned treatment for at least one day. | First dose up to approximately 24 months |
| Incidence of Serious Adverse Events at Its Worst Grade | Evaluated by comparing the incidence of Serious Adverse Events (SAEs) among subjects using their assigned treatment for at least one day. | First dose up to approximately 24 months |
| Incidence of Adverse Events Leading to Discontinuation | Evaluated by comparing the incidence of Adverse Events leading to discontinuation among subjects using their assigned treatment for at least one day. | First dose up to approximately 24 months |
| Incidence of Adverse Events Leading to Death | Evaluated by comparing the incidence of Adverse Events leading to death among subjects using their assigned treatment for at least one day. | First dose up to approximately 24 months |
| Incidence of Laboratory Test Toxicity Grade Shifting From Baseline | First dose up to approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Best Overall Response (BOR) | Defined as BOR designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy. CR or PR determinations included in the BOR assessment must be confirmed by a second scan performed no less than 4 weeks after the criteria for response are first met. | First dose up to 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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Ottawa | Ontario | K1H 8L6 | Canada | ||
| Local Institution |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
Not provided
There were 10 subjects were treated in this study. All 10 subjects were enrolled in BMS-986183 escalation (Part 1)
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BMS-986183 3 mg | Dose escalation in combination with Nivolumab |
| FG001 | BMS-986183 9 mg | Dose escalation in combination with Nivolumab |
| FG002 | BMS-986183 18 mg | Dose escalation in combination with Nivolumab |
| FG003 | BMS-986183 36 mg | Dose escalation in combination with Nivolumab |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All treated paritcipants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BMS-986183 3 mg | Dose escalation in combination with Nivolumab |
| BG001 | BMS-986183 9 mg | Dose escalation in combination with Nivolumab |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | All treated participants |
| 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 | Incidence of Adverse Events at Its Worst Grade | Evaluated by comparing the incidence of Adverse Events (AEs) among subjects using their assigned treatment for at least one day. | The study was terminated and data is not reported for privacy reasons. | Posted | First dose up to approximately 24 months |
|
First dose up to approximately 24 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BMS-986183 ESC 3 mg | Dose escalation in combination with Nivolumab | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Phase 1/2 Study of BMS-986183 in Subjects with Advanced Hepatocellular Carcinoma | 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 |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 3, 2017 | Jan 7, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 21, 2017 | Jan 7, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nivolumab | Biological | specified dose on specified days |
|
|
| Overall Response Rate (ORR) | Defined as the total number of subjects whose BOR is either a CR or PR divided by the total number of subjects in the population of interest | First dose up to approximately 24 months |
| Duration of Response (DoR) | Defined as the time between the date of first response and the subsequent date of objectively documented disease progression or death, whichever occurs first. For those subjects who remain alive and have not progressed or received subsequent therapy, DoR will be censored on the date of last tumor assessment | First dose up to approximately 24 months |
| Progression Free Survival (PFS) | Defined as the time from the first dose of study drug to the date of the first objective documentation of tumor progression or death due to any cause. Subjects who did not progress nor died will be censored on the date of their last tumor assessment. Subjects who did not have any on-study tumor assessments will be censored on the date of the first dose of study drug. | First dose up to approximately 24 months |
| PFS Rate at Week 't' | Defined as the proportion of subjects who remain progression free and surviving at 't' weeks (t=12, 24, 36, etc). The proportion will be calculated by the product-limit method (Kaplan-Meier [K-M] estimate) which takes into account censored data | First dose up to approximately 24 months |
| Maximum Observed Concentration (Cmax) | To characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by Cmax | From first does up to approximately 24 months |
| Time of Maximum Observed Concentration (Tmax) | to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by Tmax. | First dose up to approximately 24 months |
| Area Under the Concentration-time Curve From Time 0 to T of the Last Quantifiable Concentration [AUC(0-T)] | to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by AUC(0-T)] | First does up to appromimately 24 months |
| Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] | To characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by AUC(TAU). | First dose up to approximately 24 months |
| Concentration at the End of a Dosing Interval (Ctau) | To characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by | First dose up to approximately 24 months |
| Trough Observed Concentration, Including Predose Concentrations and Ctau (Ctrough) | to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by (Ctrough) | First dose up to approximately 24 months |
| Total Body Clearance (CLT) | to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by CLT | First dose to approximately 24 months |
| Apparent Volume of Distribution at Steady-state (Vss) | to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by Vss | First dose up to approximately 24 months |
| Volume of Distribution of Terminal Phase (Vz) | (to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by Vz. | First dose up to approximately 24 months |
| Accumulation Index; Ratio of Cmax at Steady-state to Cmax After the First Dose (AI_Cmax) | to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by AI_Cmax. | First dose up to approximately 24 months |
| Accumulation Index; Ratio of Ctau at Steady-state to Ctau After the First Dose (AI_Ctau) | to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by AI_Ctau. | First dose up to approximately 24 months |
| Accumulation Index; Ratio of AUC(TAU) at Steady-state to AUC(TAU) After the First Dose [AI_AUC(TAU)] | To characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by AI_AUC(TAU). | First dose up to approximately 24 months |
| Average Concentration Over a Dosing Interval Calculated by Dividing AUC(TAU) at Steady State by Tau (Css,Ave) | To characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by Css,avg. | First dose up to approximately 24 months |
| Terminal Half-life (T-HALF) | to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by T-HALF. | First dose up to approximately 24 months |
| Changes in QTcF (ΔQTcF) From Baseline | To assess the effect of dosage regimen and exposure [active ADC and unconjugated tubulysin] of BMS-986183 as monotherapy on the QT interval. | Baseline up to approximately 24 months |
| Incidence of Positive Anti-drug Antibody (ADA) | The immunogenicity of BMS-986183 (as monotherapy and in combination with nivolumab) will be measured by assessment of the presence or absence of specific ADA to BMS-986183. The incidence of positive ADA will be calculated. | First dose up to approximately 24 months |
| Singapore |
| 169610 |
| Singapore |
| Local Institution | Seoul | 05505 | South Korea |
| Local Institution | Taipei | 10048 | Taiwan |
| AE Unrelated to Study Drug |
|
| Subject Withdrew Consent |
|
| BG002 | BMS-986183 18 mg | Dose escalation in combination with Nivolumab |
| BG003 | BMS-986183 36 mg | Dose escalation in combination with Nivolumab |
| BG004 | Total | Total of all reporting groups |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | All treated participants | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | All treated participants | Count of Participants | Participants |
|
Dose escalation in combination with Nivolumab |
| OG003 | BMS-986183 36 mg | Dose escalation in combination with Nivolumab |
|
| Primary | Incidence of Serious Adverse Events at Its Worst Grade | Evaluated by comparing the incidence of Serious Adverse Events (SAEs) among subjects using their assigned treatment for at least one day. | The study was terminated and data is not reported for privacy reasons. | Posted | First dose up to approximately 24 months |
|
|
| Primary | Incidence of Adverse Events Leading to Discontinuation | Evaluated by comparing the incidence of Adverse Events leading to discontinuation among subjects using their assigned treatment for at least one day. | The study was terminated and data is not reported for privacy reasons. | Posted | First dose up to approximately 24 months |
|
|
| Primary | Incidence of Adverse Events Leading to Death | Evaluated by comparing the incidence of Adverse Events leading to death among subjects using their assigned treatment for at least one day. | The study was terminated and data is not reported for privacy reasons. | Posted | First dose up to approximately 24 months |
|
|
| Primary | Incidence of Laboratory Test Toxicity Grade Shifting From Baseline | The study was terminated and data is not reported for privacy reasons. | Posted | First dose up to approximately 24 months |
|
|
| Secondary | Best Overall Response (BOR) | Defined as BOR designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy. CR or PR determinations included in the BOR assessment must be confirmed by a second scan performed no less than 4 weeks after the criteria for response are first met. | The study was terminated and data is not reported for privacy reasons. | Posted | First dose up to approximately 24 months |
|
|
| Secondary | Overall Response Rate (ORR) | Defined as the total number of subjects whose BOR is either a CR or PR divided by the total number of subjects in the population of interest | The study was terminated and data is not reported for privacy reasons. | Posted | First dose up to approximately 24 months |
|
|
| Secondary | Duration of Response (DoR) | Defined as the time between the date of first response and the subsequent date of objectively documented disease progression or death, whichever occurs first. For those subjects who remain alive and have not progressed or received subsequent therapy, DoR will be censored on the date of last tumor assessment | The study was terminated and data is not reported for privacy reasons. | Posted | First dose up to approximately 24 months |
|
|
| Secondary | Progression Free Survival (PFS) | Defined as the time from the first dose of study drug to the date of the first objective documentation of tumor progression or death due to any cause. Subjects who did not progress nor died will be censored on the date of their last tumor assessment. Subjects who did not have any on-study tumor assessments will be censored on the date of the first dose of study drug. | The study was terminated and data is not reported for privacy reasons. | Posted | First dose up to approximately 24 months |
|
|
| Secondary | PFS Rate at Week 't' | Defined as the proportion of subjects who remain progression free and surviving at 't' weeks (t=12, 24, 36, etc). The proportion will be calculated by the product-limit method (Kaplan-Meier [K-M] estimate) which takes into account censored data | The study was terminated and data is not reported for privacy reasons. | Posted | First dose up to approximately 24 months |
|
|
| Secondary | Maximum Observed Concentration (Cmax) | To characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by Cmax | The study was terminated and data is not reported for privacy reasons. | Posted | From first does up to approximately 24 months |
|
|
| Secondary | Time of Maximum Observed Concentration (Tmax) | to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by Tmax. | The study was terminated and data is not reported for privacy reasons. | Posted | First dose up to approximately 24 months |
|
|
| Secondary | Area Under the Concentration-time Curve From Time 0 to T of the Last Quantifiable Concentration [AUC(0-T)] | to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by AUC(0-T)] | The study was terminated and data is not reported for privacy reasons. | Posted | First does up to appromimately 24 months |
|
|
| Secondary | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] | To characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by AUC(TAU). | The study was terminated and data is not reported for privacy reasons. | Posted | First dose up to approximately 24 months |
|
|
| Secondary | Concentration at the End of a Dosing Interval (Ctau) | To characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by | The study was terminated and data is not reported for privacy reasons. | Posted | First dose up to approximately 24 months |
|
|
| Secondary | Trough Observed Concentration, Including Predose Concentrations and Ctau (Ctrough) | to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by (Ctrough) | The study was terminated and data is not reported for privacy reasons. | Posted | First dose up to approximately 24 months |
|
|
| Secondary | Total Body Clearance (CLT) | to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by CLT | The study was terminated and data is not reported for privacy reasons. | Posted | First dose to approximately 24 months |
|
|
| Secondary | Apparent Volume of Distribution at Steady-state (Vss) | to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by Vss | The study was terminated and data is not reported for privacy reasons. | Posted | First dose up to approximately 24 months |
|
|
| Secondary | Volume of Distribution of Terminal Phase (Vz) | (to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by Vz. | The study was terminated and data is not reported for privacy reasons. | Posted | First dose up to approximately 24 months |
|
|
| Secondary | Accumulation Index; Ratio of Cmax at Steady-state to Cmax After the First Dose (AI_Cmax) | to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by AI_Cmax. | The study was terminated and data is not reported for privacy reasons. | Posted | First dose up to approximately 24 months |
|
|
| Secondary | Accumulation Index; Ratio of Ctau at Steady-state to Ctau After the First Dose (AI_Ctau) | to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by AI_Ctau. | The study was terminated and data is not reported for privacy reasons. | Posted | First dose up to approximately 24 months |
|
|
| Secondary | Accumulation Index; Ratio of AUC(TAU) at Steady-state to AUC(TAU) After the First Dose [AI_AUC(TAU)] | To characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by AI_AUC(TAU). | The study was terminated and data is not reported for privacy reasons. | Posted | First dose up to approximately 24 months |
|
|
| Secondary | Average Concentration Over a Dosing Interval Calculated by Dividing AUC(TAU) at Steady State by Tau (Css,Ave) | To characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by Css,avg. | The study was terminated and data is not reported for privacy reasons. | Posted | First dose up to approximately 24 months |
|
|
| Secondary | Terminal Half-life (T-HALF) | to characterize the PK of the total antibody [unconjugated antibody + antibody conjugated to tubulysin or antibody conjugated to any tubulysin metabolites], active ADC [antibody conjugated to tubulysin], and unconjugated tubulysin) of BMS-986183 as monotherapy and in combination with nivolumab will be measured by T-HALF. | The study was terminated and data is not reported for privacy reasons. | Posted | First dose up to approximately 24 months |
|
|
| Secondary | Changes in QTcF (ΔQTcF) From Baseline | To assess the effect of dosage regimen and exposure [active ADC and unconjugated tubulysin] of BMS-986183 as monotherapy on the QT interval. | The study was terminated and data is not reported for privacy reasons. | Posted | Baseline up to approximately 24 months |
|
|
| Secondary | Incidence of Positive Anti-drug Antibody (ADA) | The immunogenicity of BMS-986183 (as monotherapy and in combination with nivolumab) will be measured by assessment of the presence or absence of specific ADA to BMS-986183. The incidence of positive ADA will be calculated. | The study was terminated and data is not reported for privacy reasons. | Posted | First dose up to approximately 24 months |
|
|
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | BMS-986183 ESC 9 mg | Dose escalation in combination with Nivolumab | 2 | 2 | 1 | 2 | 2 | 2 |
| EG002 | BMS-986183 ESC 18 mg | Dose escalation in combination with Nivolumab | 0 | 1 | 1 | 1 | 1 | 1 |
| EG003 | BMS-986183 ESC 36 mg | Dose escalation in combination with Nivolumab | 5 | 6 | 2 | 6 | 5 | 6 |
| Hepatic failure | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Lung infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Portal hypertension | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |