Trial · NCT02658890
An Investigational Immuno-therapy Study of BMS-986205 Given in Combination With Nivolumab and in Combination With Both Nivolumab and Ipilimumab in Cancers That Are Advanced or Have Spread
NCT02658890, Phase 1, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2023-08-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Investigational Immuno-therapy Study of BMS-986205 Given in Combination With Nivolumab and in Combination With Both Nivolumab and Ipilimumab in Cancers That Are Advanced or Have Spread. Trials, record NCT02658890. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02658890
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Investigational Immuno-therapy Study of BMS-986205 Given in Combination With Nivolumab and in Combination With Both Nivolumab and Ipilimumab in Cancers That Are Advanced or Have Spread
- NCT number
- NCT02658890
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 627 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Advanced Cancer, Melanoma, Non-Small Cell Lung Cancer
- Interventions
- BMS-986205, Nivolumab, Ipilimumab
- First posted
- 2016-01-20
- Last updated
- 2023-08-28
- Other registries' IDs
- eudract:2015-004914-79
- Results first posted
- 2023-08-28
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | From first dose to 100 days after last dose (up to 15 months) | Number of participants with adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation and deaths. |
| Primary | Number of Treated Participant With Laboratory Abnormalities - Thyroid | From first dose to 100 days after last dose (up to 15 months) | The number of treated participants who experienced a laboratory abnormality of the thyroid during the course of the study. Free T3 (FT3) Free T4 (FT4) Thyroid stimulating hormone (TSH) Lower Limit of Normal (LLN) Upper limit of normal (ULN) Results reported in International System of Units (SI) |
| Primary | Number of Treated Participant With Laboratory Abnormalities - Liver | From first dose to 100 days after last dose (up to 15 months) | The number of treated participants who experienced a laboratory abnormality of the liver during the course of the study. Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN) Results reported in International System of Units (SI) |
| Primary | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks) | Best overall response (BOR) is defined as the best response designation over the study as a whole. Complete response (CR) or partial response (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. For those participants who have surgical resection, only pre-surgical tumor assessments will be considered in the determination of BOR. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Progressive Disease. (PD): At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Appearance of 1 or more new lesions is also considered progression. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
| Primary | Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3 | From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks) | Objective response rate (ORR) is defined as the percentage of all treated participants whose BOR is either a complete response (CR) or partial response (PR). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. |
| Primary | Median Duration of Response (DoR) - Parts 2 and 3 | From first dose to the date of disease progression, death, or until participants withdraw from the study, whichever occurs first (up to a maximum of 185 weeks) | Duration of response (DoR) was computed for all treated subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) and is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. |
| Primary | Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3 | At 24 weeks after first dose | Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 24 weeks. Reported values are estimates derived from Kaplan-Meier analyses. |
| Primary | Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3 | At 1 year | Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 1 year. Reported values are estimates derived from Kaplan-Meier analyses. |
| Primary | Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3 | At 2 years | Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 2 years. Reported values are estimates derived from Kaplan-Meier analyses. |
| Secondary | Cmax | At cycle 0 day 1 and day 14 [cycle 0= up to 2 weeks] | Cmax is defined as the maximum observed plasma concentration. Pharmacokinetic parameters measured here are for BMS-986205. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
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 AEs, SAEs, AEs Leading to Discontinuation and Deaths | From first dose to 100 days after last dose (up to 15 months) | All treated participants in parts 1, 2, and 3 | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Treated Participant With Laboratory Abnormalities - Thyroid | From first dose to 100 days after last dose (up to 15 months) | All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter in parts 1, 2, and 3 | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Treated Participant With Laboratory Abnormalities - Liver | From first dose to 100 days after last dose (up to 15 months) | All treated participants with at least one on-treatment measurement of the corresponding laboratory parameter in parts 1, 2, and 3 | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks) | All treated participants in parts 2 and 3 | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3 | From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks) | All treated participants in parts 2 and 3 | Percentage of participants | NUMBER |
| PRIMARY | Median Duration of Response (DoR) - Parts 2 and 3 | From first dose to the date of disease progression, death, or until participants withdraw from the study, whichever occurs first (up to a maximum of 185 weeks) | All treated participants in parts 2 and 3 who achieved a response (CR or PR) | Weeks | MEDIAN |
| PRIMARY | Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3 | At 24 weeks after first dose | All treated participants in parts 2 and 3 | Percentage of participants | NUMBER |
| PRIMARY | Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3 | At 1 year | All treated participants in parts 2 and 3 | Percentage of participants | NUMBER |
| PRIMARY | Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3 | At 2 years | All treated participants in parts 2 and 3 | Percentage of participants | NUMBER |
| SECONDARY | Cmax | At cycle 0 day 1 and day 14 [cycle 0= up to 2 weeks] | All treated participants with evaluable pharmacokinetic measurements in Part 1 | ng/mL | GEOMETRIC_MEAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group931
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 AEs, SAEs, AEs Leading to Discontinuation and Deaths | Part 1: BMS50 (ESC) | Adverse Events | 1 | Participants | |
| Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Part 1: BMS400 (ESC) | Adverse Events | 1 | Participants | |
| Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Unplanned - BMS50 | Adverse Events | 0 | Participants | |
| Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Part 1: BMS25+NIV240(ESC) | Adverse Events | 7 | Participants | |
| Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Part 1: BMS50+NIV240(ESC) | Adverse Events | 10 | Participants | |
| Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Part 1: BMS100+NIV240(ESC) | Adverse Events | 11 | Participants | |
| Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Part 1: BMS200+NIV240(ESC) | Adverse Events | 18 | Participants | |
| Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Part 1: BMS400+NIV240(ESC) | Adverse Events | 6 | Participants | |
| Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Part 2: Exp Cervical + (IDO 100) | Adverse Events | 18 | Participants | |
| Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | Part 2: Exp Cervical + (IDO 200) | Adverse Events | 17 | Participants |
1 to 10 of 931Source ClinicalTrials.gov
See all 931 results by groupParticipant flow162
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre-Treatment Phase | STARTED | Part 1: BMS25+NIV240(ESC) | 7 | |
| Pre-Treatment Phase | STARTED | Part 1: BMS50+NIV240(ESC) | 11 | |
| Pre-Treatment Phase | STARTED | Part 1: BMS100+NIV240(ESC) | 12 | |
| Pre-Treatment Phase | STARTED | Part 1: BMS200+NIV240(ESC) | 18 | |
| Pre-Treatment Phase | STARTED | Part 1: BMS400+NIV240(ESC) | 7 | |
| Pre-Treatment Phase | STARTED | Part 2: Exp Cervical + (IDO 100) | 18 | |
| Pre-Treatment Phase | STARTED | Part 2: Exp Cervical + (IDO 200) | 17 | |
| Pre-Treatment Phase | STARTED | Part 2: Exp Pancreatic | 22 | |
| Pre-Treatment Phase | STARTED | Part 2: Exp DLBCL | 36 | |
| Pre-Treatment Phase | STARTED | Part 2: Exp SCCHN + (IDO 100) | 15 |
1 to 10 of 162Source ClinicalTrials.gov
See all 162 participant flowAdverse events20,820
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 1: BMS50 (ESC) | 0 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: BMS400 (ESC) | 0 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | Unplanned - BMS50 | 0 | 1 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: BMS25+NIV240(ESC) | 1 | 7 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: BMS50+NIV240(ESC) | 2 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: BMS100+NIV240(ESC) | 6 | 12 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: BMS200+NIV240(ESC) | 7 | 18 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1: BMS400+NIV240(ESC | 2 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2: Exp Cervical + (IDO 100) | 5 | 18 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2: Exp Cervical + (IDO 200) | 4 | 17 |
1 to 10 of 20,820Source ClinicalTrials.gov
See all 20,820 adverse eventsAdverse event totals90
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: BMS50 (ESC) | 1 | 1 |
| Total, all-cause mortality | Part 1: BMS400 (ESC) | 1 | 1 |
| Total, all-cause mortality | Unplanned - BMS50 | 0 | 1 |
| Total, all-cause mortality | Part 1: BMS25+NIV240(ESC) | 6 | 7 |
| Total, all-cause mortality | Part 1: BMS50+NIV240(ESC) | 8 | 10 |
| Total, all-cause mortality | Part 1: BMS100+NIV240(ESC) | 9 | 12 |
| Total, all-cause mortality | Part 1: BMS200+NIV240(ESC) | 15 | 18 |
| Total, all-cause mortality | Part 1: BMS400+NIV240(ESC | 4 | 6 |
| Total, all-cause mortality | Part 2: Exp Cervical + (IDO 100) | 16 | 18 |
| Total, all-cause mortality | Part 2: Exp Cervical + (IDO 200) | 12 | 17 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT02658890
GET https://conductscience.org/api/trials/v1/NCT02658890/registered?page=2