Trial · NCT02341625
A Study of BMS-986148 in Patients With Select Advanced Solid Tumors
NCT02341625, Phase 1, Phase 2, Terminated, Bristol-Myers Squibb; results first posted 2022-08-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of BMS-986148 in Patients With Select Advanced Solid Tumors. Trials, record NCT02341625. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02341625
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of BMS-986148 in Patients With Select Advanced Solid Tumors
- NCT number
- NCT02341625
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 126 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Advanced Cancer
- Interventions
- BMS-986148, Nivolumab
- First posted
- 2015-01-19
- Last updated
- 2022-08-18
- Other registries' IDs
- eudract:2014-002485-70
- Results first posted
- 2022-08-18
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events at Worst CTC Grade | From first dose to up to 100 days post last dose (Up to 6 months) | Number of participants with adverse events at worst CTC grade including any grade adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuations, and deaths grouped by dose + dose regimen. |
| Primary | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | From first dose to up to 100 days post last dose (Up to 6 months) | Number of participants with laboratory test toxicity grade (Grade 0, 1, 2, 3, and 4) in hematology and chemistry shifting from baseline. An increase in baseline indicates a shift of participant to a greater toxicity grade. A decrease in baseline indicates a shift of participant to a lesser toxicity grade. Participants are grouped by dose + dose regimen assessed by NCT CTCAE V 4.03. |
| Secondary | Maximum Observed Serum Concentration (Cmax) | PK blood assessed on cycle 1, day 1 | Maximum observed serum concentration (Cmax) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead. |
| Secondary | Time of Maximum Observed Serum Concentration (Tmax) | PK blood assessed on cycle 1, day 1 | Time of maximum observed serum concentration (Tmax) of BMS-986148 grouped by dose + dose regimen. |
| Secondary | Concentration at the End of a Dosing Interval (Ctau) | PK blood assessed on cycle 1, day 1 | Concentration at the end of a dosing interval (Ctau) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead. |
| Secondary | Trough Observed Serum Concentration (Ctrough) | PK blood assessment include cycle 2-day 1 and cycle 1-day 8 | Trough observed serum concentration (Ctrough) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead. |
| Secondary | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | PK blood assessment include cycle 1-day 1 | Area under the concentration-time curve from time Zero to time T (AUC(0-t)) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead. |
| Secondary | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | PK blood assessment include cycle 1-day 1 | Area under the concentration-time curve in one dosing interval (AUC\[TAU\]) of BMS-986148 grouped by dose + dose regimen Note: The geometric CV was not calculated. Arithmetic % CV is reported instead |
| Secondary | Best Overall Response (BOR) | Up to 58 months | Best overall response is defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Secondary | Objective Response Rate (ORR) | Up to 58 months | Objective response rate is defined as the total percentage of participants whose best overall response (BOR) is either a complete response or partial response divided by the total percentage of participants who are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events at Worst CTC Grade | From first dose to up to 100 days post last dose (Up to 6 months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline | From first dose to up to 100 days post last dose (Up to 6 months) | All treated participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Observed Serum Concentration (Cmax) | PK blood assessed on cycle 1, day 1 | All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data | ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Time of Maximum Observed Serum Concentration (Tmax) | PK blood assessed on cycle 1, day 1 | All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data | Hours | MEDIAN |
| SECONDARY | Concentration at the End of a Dosing Interval (Ctau) | PK blood assessed on cycle 1, day 1 | All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data | ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Trough Observed Serum Concentration (Ctrough) | PK blood assessment include cycle 2-day 1 and cycle 1-day 8 | All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data | ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) | PK blood assessment include cycle 1-day 1 | All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data | h*ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) | PK blood assessment include cycle 1-day 1 | All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data | h*ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Best Overall Response (BOR) | Up to 58 months | Per-protocol, data for this Outcome Measure was collected by disease irrespective of dose. All treated participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung Cancer (NSCLC), and Gastric) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate (ORR) | Up to 58 months | Per-protocol, data for this Outcome Measure was collected by disease irrespective of dose. All treated participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung Cancer (NSCLC), and Gastric) | Percentage of participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group748
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events at Worst CTC Grade | BMS-986148 0.1MG/KG Q3W | Adverse Events (AEs) | 1 | Participants | |
| Number of Participants With Adverse Events at Worst CTC Grade | BMS-986148 0.2MG/KG Q3W | Adverse Events (AEs) | 2 | Participants | |
| Number of Participants With Adverse Events at Worst CTC Grade | BMS-986148 0.4MG/KG Q3W | Adverse Events (AEs) | 3 | Participants | |
| Number of Participants With Adverse Events at Worst CTC Grade | BMS-986148 0.8MG/KG Q3W | Adverse Events (AEs) | 8 | Participants | |
| Number of Participants With Adverse Events at Worst CTC Grade | BMS-986148 1.6MG/KG Q3W | Adverse Events (AEs) | 10 | Participants | |
| Number of Participants With Adverse Events at Worst CTC Grade | BMS-986148 1.2MG/KG Q3W Es | Adverse Events (AEs) | 59 | Participants | |
| Number of Participants With Adverse Events at Worst CTC Grade | BMS-986148 0.4MG/KG QW | Adverse Events (AEs) | 8 | Participants | |
| Number of Participants With Adverse Events at Worst CTC Grade | BMS-986148 0.6MG/KG QW | Adverse Events (AEs) | 4 | Participants | |
| Number of Participants With Adverse Events at Worst CTC Grade | BMS-986148 0.8MG/KG Q3W+Nivolumab | Adverse Events (AEs) | 30 | Participants | |
| Number of Participants With Adverse Events at Worst CTC Grade | BMS-986148 0.1MG/KG Q3W | Serious Adverse Events (SAEs) | 1 | Participants |
1 to 10 of 748Source ClinicalTrials.gov
See all 748 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BMS-986148 0.1MG/KG Q3W | 2 | |
| Overall Study | STARTED | BMS-986148 0.2MG/KG Q3W | 2 | |
| Overall Study | STARTED | BMS-986148 0.4MG/KG Q3W | 3 | |
| Overall Study | STARTED | BMS-986148 0.8MG/KG Q3W | 8 | |
| Overall Study | STARTED | BMS-986148 1.2MG/KG Q3W Es | 8 | |
| Overall Study | STARTED | BMS-986148 1.6MG/KG Q3W | 10 | |
| Overall Study | STARTED | BMS-986148 1.2MG/KG Q3W Ex | 51 | |
| Overall Study | STARTED | BMS-986148 0.4MG/KG QW | 8 | |
| Overall Study | STARTED | BMS-986148 0.6MG/KG QW | 4 | |
| Overall Study | STARTED | BMS-986148 0.8MG/KG Q3W+Nivolumab | 30 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events2,079
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | BMS-986148 0.1MG/KG Q3W | 0 | 2 | |
| other | Anaemia | Blood and lymphatic system disorders | BMS-986148 0.2MG/KG Q3W | 0 | 2 | |
| other | Anaemia | Blood and lymphatic system disorders | BMS-986148 0.4MG/KG Q3W | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | BMS-986148 0.8MG/KG Q3W | 0 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | BMS-986148 1.6MG/KG Q3W | 1 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | BMS-986148 1.2MG/KG Q3W | 5 | 59 | |
| other | Anaemia | Blood and lymphatic system disorders | BMS-986148 0.4MG/KG QW | 2 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | BMS-986148 0.6MG/KG QW | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | BMS-986148 0.8MG/KG Q3W+Nivolumab | 2 | 30 | |
| other | Lymphopenia | Blood and lymphatic system disorders | BMS-986148 0.1MG/KG Q3W | 0 | 2 |
1 to 10 of 2,079Source ClinicalTrials.gov
See all 2,079 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BMS-986148 0.1MG/KG Q3W | 1 | 2 |
| Total, all-cause mortality | BMS-986148 0.2MG/KG Q3W | 2 | 2 |
| Total, all-cause mortality | BMS-986148 0.4MG/KG Q3W | 3 | 3 |
| Total, all-cause mortality | BMS-986148 0.8MG/KG Q3W | 5 | 8 |
| Total, all-cause mortality | BMS-986148 1.6MG/KG Q3W | 7 | 10 |
| Total, all-cause mortality | BMS-986148 1.2MG/KG Q3W | 38 | 59 |
| Total, all-cause mortality | BMS-986148 0.4MG/KG QW | 7 | 8 |
| Total, all-cause mortality | BMS-986148 0.6MG/KG QW | 4 | 4 |
| Total, all-cause mortality | BMS-986148 0.8MG/KG Q3W+Nivolumab | 22 | 30 |
| Total, other adverse events | BMS-986148 0.1MG/KG Q3W | 1 | 2 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34615718 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02341625
GET https://conductscience.org/api/trials/v1/NCT02341625/results?page=2