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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003603-21 | EudraCT Number |
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Inability to meet protocol objectives
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The purpose of this study is to investigate safety of experimental medication BMS-986242 and Nivolumab in patients with advanced cancers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | BMS-986242 administered in combination with Nivolumab |
|
| Dose Expansion | Experimental | BMS-986242 administered in combination with Nivolumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986242 | Drug | Specified dose on specified days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AE) | The primary objective to establish safety to be measured by the primary endpoint of AEs | From initiation of study treatment until 100 days after discontinuation of study treatment |
| Number of Participants With Serious Adverse Events (SAE) | The primary objective to establish safety to be measured by the primary endpoint of SAEs | From the date of participant's written consent until 100 days after discontinuation of nivolumab or participation in the study |
| Number of Participants With Dose Limiting Toxicities (DLT) | The primary objective to establish safety to be measured by the primary endpoint of dose limiting toxicities | Approximately 2 years |
| Number of Participants With AEs Leading to Discontinuation | The primary objective to establish safety to be measured by the primary endpoint of AEs leading to discontinuation | Approximately 2 years |
| Number of Deaths | The primary objective to establish safety to be measured by the primary endpoint of deaths | Approximately 2 years |
| Number of Participants With Laboratory Abnormalities | The primary objective to establish safety to be measured by the primary endpoint of clinical laboratory test abnormalities | Approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0 | Approximately 2 years |
| Time of Maximum Observed Plasma Concentration (Tmax) |
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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 |
|---|---|---|---|---|---|---|
| University Of Alabama At Birmingham | Birmingham | Alabama | 35294-3300 | United States | ||
| Hoag Memorial Hospital Presbyterian |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| Investigator Inquiry Form |
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7 participants were enrolled and 5 of those participants entered treatment; reasons for 2 participants not entering treatment were due to: 1 death; 1 participant no longer met study criteria. Note: study terminated following starting dose of BMS-986242 12.5 mg; dosing did not escalate.
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| ID | Title | Description |
|---|---|---|
| FG000 | BMS-986242 12.5 mg + Nivolumab 480 mg | 2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Combination Therapy Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 31, 2017 |
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| Nivolumab |
| Biological |
Specified dose on specified days |
|
|
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0 |
| Approximately 2 years |
| Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] | The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0 | Approximately 2 years |
| Area Under the Concentration-time Curve From Time Zero to Infinity [AUC(INF)] | The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0 | Approximately 2 years |
| Trough Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) | The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0 | Approximately 2 years |
| Apparent Elimination Half-life (T-HALF) | The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0 | Approximately 2 years |
| Apparent Total Body Clearance (CLT/F) | The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0 | Approximately 2 years |
| Apparent Volume of Distribution at Steady State (Vss/F) | The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0 | Approximately 2 years |
| Accumulation Index (AI) | The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0. Accumulation index, calculated based on ratio of area under the curve (AUC) and Cmax at steady state to after the first dose. | Approximately 2 years |
| Percent Urinary Recovery Over 24 Hours (%UR24) | The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0 | Approximately 2 years |
| Percent Urinary Recovery Over 72 Hours (%UR72) | The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0 | Approximately 2 years |
| Incidence of Anti-drug Antibody (ADA) to Nivolumab in Combination With BMS-986242 | 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. | Approximately 2 years |
| Overall Response Rate (ORR) | ORR in participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for solid tumors | Approximately 2 years |
| Los Angeles |
| California |
| 90033 |
| United States |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| Local Institution | Baltimore | Maryland | 21287 | United States |
| FDA Safety Alerts and Recalls | View source |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Safety Follow-Up Period |
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All treated participants; Note: study terminated following starting dose of BMS-986242 12.5 mg; dosing did not escalate.
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| ID | Title | Description |
|---|---|---|
| BG000 | BMS-986242 12.5 mg + Nivolumab 480 mg | 2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Number of Participants With Adverse Events (AE) | The primary objective to establish safety to be measured by the primary endpoint of AEs | Study terminated, data not reported due to privacy reasons | Posted | Number | Number of participants | From initiation of study treatment until 100 days after discontinuation of study treatment |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Participants With Serious Adverse Events (SAE) | The primary objective to establish safety to be measured by the primary endpoint of SAEs | Study terminated, data not reported due to privacy reasons | Posted | Number | Number of participants | From the date of participant's written consent until 100 days after discontinuation of nivolumab or participation in the study |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Dose Limiting Toxicities (DLT) | The primary objective to establish safety to be measured by the primary endpoint of dose limiting toxicities | Study terminated, data not reported due to privacy reasons | Posted | Number | Number of participants | Approximately 2 years |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With AEs Leading to Discontinuation | The primary objective to establish safety to be measured by the primary endpoint of AEs leading to discontinuation | Study terminated, data not reported due to privacy reasons | Posted | Number | Number of participants | Approximately 2 years |
|
| |||||||||||||||||||||||||||
| Primary | Number of Deaths | The primary objective to establish safety to be measured by the primary endpoint of deaths | Study terminated, data not reported due to privacy reasons | Posted | Number | Number of deaths | Approximately 2 years |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Laboratory Abnormalities | The primary objective to establish safety to be measured by the primary endpoint of clinical laboratory test abnormalities | Study terminated, data not reported due to privacy reasons | Posted | Number | Number of participants | Approximately 2 years |
|
| |||||||||||||||||||||||||||
| Secondary | Maximum Observed Plasma Concentration (Cmax) | The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0 | Study terminated, data not reported due to privacy reasons | Posted | Approximately 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Time of Maximum Observed Plasma Concentration (Tmax) | The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0 | Study terminated, data not reported due to privacy reasons | Posted | Approximately 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] | The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0 | Study terminated, data not reported due to privacy reasons | Posted | Approximately 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-time Curve From Time Zero to Infinity [AUC(INF)] | The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0 | Study terminated, data not reported due to privacy reasons | Posted | Approximately 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Trough Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) | The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0 | Study terminated, data not reported due to privacy reasons | Posted | Approximately 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Apparent Elimination Half-life (T-HALF) | The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0 | Study terminated, data not reported due to privacy reasons | Posted | Approximately 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Apparent Total Body Clearance (CLT/F) | The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0 | Study terminated, data not reported due to privacy reasons | Posted | Approximately 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Apparent Volume of Distribution at Steady State (Vss/F) | The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0 | Study terminated, data not reported due to privacy reasons | Posted | Approximately 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Accumulation Index (AI) | The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0. Accumulation index, calculated based on ratio of area under the curve (AUC) and Cmax at steady state to after the first dose. | Study terminated, data not reported due to privacy reasons | Posted | Approximately 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Percent Urinary Recovery Over 24 Hours (%UR24) | The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0 | Study terminated, data not reported due to privacy reasons | Posted | Approximately 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Percent Urinary Recovery Over 72 Hours (%UR72) | The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0 | Study terminated, data not reported due to privacy reasons | Posted | Approximately 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Incidence of Anti-drug Antibody (ADA) to Nivolumab in Combination With BMS-986242 | 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. | Study terminated, data not reported due to privacy reasons | Posted | Approximately 2 years |
|
| |||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) | ORR in participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for solid tumors | Study terminated, data not reported due to privacy reasons | Posted | Approximately 2 years |
|
|
Adverse Events (AEs) are monitored from initiation of study treatment (monitored from participant's written consent for Serious Adverse Events) up through 100 days post-End of Treatment (EOT); Study Start of December 2017 and Study End of August 2018 (assessed approximately 1 year)
The study will not be reported due to privacy reasons
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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 | BMS-986242 12.5 mg + Nivolumab 480 mg | 2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments | 0 | 5 | 0 | 5 | 0 | 5 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | please email | Clinical.Trials@bms.com |
| Sep 19, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| C000711728 | spartalizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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