Trial · NCT03446040
An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread
NCT03446040, Phase 1, Phase 2, Terminated, Bristol-Myers Squibb; results first posted 2025-09-18
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread. Trials, record NCT03446040. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03446040
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread
- NCT number
- NCT03446040
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 92 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Advanced Cancer
- Interventions
- BMS-986258, Nivolumab, rHuPH20
- First posted
- 2018-02-26
- Last updated
- 2025-09-18
- Other registries' IDs
- eudract:2019-000442-35
- Results first posted
- 2025-09-18
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) | From first dose until 100 days after last dose of study therapy (up to approximately 78 weeks) | An Adverse Event (AE) is any new untoward medical occurrence or worsening of a preexisting medical condition in a study participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose: * Results in death * Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event) * Requires inpatient hospitalization or causes prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect. |
| Primary | Number of Participants Who Died During the Study | From first dose until death due to any cause (up to approximately 78 months) | The number of participants who died during the study. |
| Primary | Number of Participants With Dose Limiting Toxicities (DLTs) | From first dose (Cycle 1 Day 1) until day 28 (Cycle 1 Day 28) | Dose-limiting toxicity (DLT) refers to a side effect or adverse reaction caused by a drug that is severe enough to prevent an increase in dose or level of that drug. It is typically identified during clinical trials to determine the highest dose of a drug that can be given safely without causing unacceptable side effects. A participant was considered DLT evaluable if they received 1 dose of BMS-986258 in Part A or 1 dose of BMS-986258 and nivolumab 480mg in Part B and completed the DLT observation period. Participants who withdraw from the study during the 4-week DLT evaluation period for reasons other than a DLT may be replaced with a new participant at the same dose level. |
| Secondary | Objective Response Rate (ORR) | From first dose until disease progression or death, whichever occurred first (up to approximately 78 months) | Objective response rate (ORR) is defined as the percent of treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) per RECIST v1.1. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Median Duration of Response (mDOR) | From first dose until disease progression or death whichever occurred first (up to approximately 78 months) | Median duration of response (mDOR) for a participant with a best overall response (BOR) of complete response (CR) or partial response (PR) is defined as the time between the date of first response and the date of the first objectively documented disease progression (DP) per RECIST v1.1 or death, whichever occurred first. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Disease Progression (DP): At least a 20% increase in the sum of the diameters of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions. Based on Kaplan-Meier estimates. |
| Secondary | Progression-Free Survival (PFS) Rate at 6, 9, and 12 Months | At 6, 9, and 12 months after first dose | Progression free survival (PFS) for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurred first. Disease Progression (DP): At least a 20% increase in the sum of the diameters of target lesions, with an absolute increase of at least 5 mm, or the appearance of new lesions. |
| Secondary | Maximum Plasma Concentration (Cmax) of BMS-986258 | Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks) | Cmax (Maximum Concentration) is the highest level of a drug in the blood after it has been taken. It shows the peak level of the drug, which helps in understanding how much of the drug is absorbed and how strong its effects might be. |
| Secondary | Area Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258 | Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks) | AUC (0-T) is the total exposure to the drug over a specific period; from the time you take it until a specified time. It helps in understanding the overall amount of drug that has been in your body over that time period. |
| Secondary | Area Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258 | Part A and B: 0 to 28 days post-dose on Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: 0 to 28 days post-dose on Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks) | AUC(TAU) (Area Under the Curve over the Dosing Interval) is the total exposure to the drug over one complete dosing interval (the time between doses). It helps in understanding how much of the drug is in your body over the entire period between doses, which is important for determining the right dosing schedule. |
| Secondary | Concentration at the End of the Dosing Interval (Ctau) of BMS-986258 | Part A and B: On Cycle 1 Day 29 and Cycle 3 Day 29 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 29 and Cycle 2 Day 1 predose (1 cycle = 8 weeks) | Ctau (Concentration at the End of the Dosing Interval) is the level of the drug in the blood just before the next dose is due. It shows how much of the drug remains in your body before taking the next dose, which helps in ensuring that the drug levels stay effective without dropping too low. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
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 (AEs) | From first dose until 100 days after last dose of study therapy (up to approximately 78 weeks) | All treated participants. Participants who started in the Part A1 group but transitioned to Part B are accounted for in both treatment groups. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Who Died During the Study | From first dose until death due to any cause (up to approximately 78 months) | All treated participants. Participants who crossed over from part A1 are accounted for under their original arm assignment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Dose Limiting Toxicities (DLTs) | From first dose (Cycle 1 Day 1) until day 28 (Cycle 1 Day 28) | All treated participants who were evaluable for DLTs. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate (ORR) | From first dose until disease progression or death, whichever occurred first (up to approximately 78 months) | All treated participants. Prespecified to be reported collectively per Part. Participants who crossed over from part A1 to Part B are accounted for in both arms. | Percent of Participants | NUMBER |
| SECONDARY | Median Duration of Response (mDOR) | From first dose until disease progression or death whichever occurred first (up to approximately 78 months) | All treated participants witha complete or partial response. Prespecified to be reported collectively per Part. Response evaluable participants who crossed over from part A1 to Part B are accounted for in both arms. | Months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) Rate at 6, 9, and 12 Months | At 6, 9, and 12 months after first dose | All treated participants. Prespecified to be reported collectively per Part. Treated participants who crossed over from part A1 to Part B are accounted for in both arms. | Percent of Participants | NUMBER |
| SECONDARY | Maximum Plasma Concentration (Cmax) of BMS-986258 | Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks) | All treated participants with available PK results. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms. | ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Curve From Time 0 to T (AUC(0-T)) of BMS-986258 | Part A and B: On Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks) | All treated participants with available PK results. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms. | h*ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Curve Over the Dosing Interval AUC(TAU) of BMS-986258 | Part A and B: 0 to 28 days post-dose on Cycle 1 Day 1 and Cycle 3 Day 1 (1 cycle = 8 weeks); Part A1: 0 to 28 days post-dose on Cycle 1 Day 1 and Cycle 1 Day 29 (1 cycle = 8 weeks) | All treated participants with available PK results. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms. | h*ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Concentration at the End of the Dosing Interval (Ctau) of BMS-986258 | Part A and B: On Cycle 1 Day 29 and Cycle 3 Day 29 (1 cycle = 8 weeks); Part A1: On Cycle 1 Day 29 and Cycle 2 Day 1 predose (1 cycle = 8 weeks) | All treated participants with available PK results. PK evaluable participants who crossed over from Part A1 to Part B are accounted for in both arms. | ug/mL | GEOMETRIC_MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group206
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 (AEs) | Part A: BMS-986258 8 mg | Adverse Events (AEs) | 3 | Participants | |
| Number of Participants With Adverse Events (AEs) | Part A: BMS-986258 24 mg | Adverse Events (AEs) | 3 | Participants | |
| Number of Participants With Adverse Events (AEs) | Part A: BMS-986258 72 mg | Adverse Events (AEs) | 4 | Participants | |
| Number of Participants With Adverse Events (AEs) | Part A: BMS-986258 200 mg | Adverse Events (AEs) | 4 | Participants | |
| Number of Participants With Adverse Events (AEs) | Part A: BMS-986258 480 mg | Adverse Events (AEs) | 4 | Participants | |
| Number of Participants With Adverse Events (AEs) | Part A: BMS-986258 800 mg | Adverse Events (AEs) | 8 | Participants | |
| Number of Participants With Adverse Events (AEs) | Part A: BMS-986258 1200 mg | Adverse Events (AEs) | 2 | Participants | |
| Number of Participants With Adverse Events (AEs) | Part A: BMS-986258 1600 mg | Adverse Events (AEs) | 5 | Participants | |
| Number of Participants With Adverse Events (AEs) | Part A: BMS-986258 2400 mg | Adverse Events (AEs) | 8 | Participants | |
| Number of Participants With Adverse Events (AEs) | Part B: BMS-986258 480 mg + NIVO 480 mg | Adverse Events (AEs) | 4 | Participants |
1 to 10 of 206Source ClinicalTrials.gov
See all 206 results by groupParticipant flow56
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part A: BMS-986258 8 mg | 3 | |
| Overall Study | STARTED | Part A: BMS-986258 24 mg | 3 | |
| Overall Study | STARTED | Part A: BMS-986258 72 mg | 4 | |
| Overall Study | STARTED | Part A: BMS-986258 200 mg | 4 | |
| Overall Study | STARTED | Part A: BMS-986258 480 mg | 4 | |
| Overall Study | STARTED | Part A: BMS-986258 800 mg | 9 | |
| Overall Study | STARTED | Part A: BMS-986258 1200 mg | 3 | |
| Overall Study | STARTED | Part A: BMS-986258 1600 mg | 5 | |
| Overall Study | STARTED | Part A: BMS-986258 2400 mg | 8 | |
| Overall Study | STARTED | Part B: BMS-986258 480 mg + NIVO 480 mg | 4 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 participant flowAdverse events2,896
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 | Part A: BMS-986258 8 mg | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A: BMS-986258 24 mg | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A: BMS-986258 72 mg | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A: BMS-986258 200 mg | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A: BMS-986258 480 mg | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A: BMS-986258 800 mg | 0 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A: BMS-986258 1200 mg | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A: BMS-986258 1600 mg | 0 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A: BMS-986258 2400 mg | 2 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Part B: BMS-986258 480 mg + NIVO 480 mg | 0 | 4 |
1 to 10 of 2,896Source ClinicalTrials.gov
See all 2,896 adverse eventsAdverse event totals48
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: BMS-986258 8 mg | 3 | 3 |
| Total, all-cause mortality | Part A: BMS-986258 24 mg | 3 | 3 |
| Total, all-cause mortality | Part A: BMS-986258 72 mg | 3 | 4 |
| Total, all-cause mortality | Part A: BMS-986258 200 mg | 3 | 4 |
| Total, all-cause mortality | Part A: BMS-986258 480 mg | 3 | 4 |
| Total, all-cause mortality | Part A: BMS-986258 800 mg | 7 | 9 |
| Total, all-cause mortality | Part A: BMS-986258 1200 mg | 3 | 3 |
| Total, all-cause mortality | Part A: BMS-986258 1600 mg | 4 | 5 |
| Total, all-cause mortality | Part A: BMS-986258 2400 mg | 5 | 8 |
| Total, all-cause mortality | Part B: BMS-986258 480 mg + NIVO 480 mg | 3 | 4 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33277223 | 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/NCT03446040
GET https://conductscience.org/api/trials/v1/NCT03446040/results?page=2