Trial · NCT02750514
An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer
NCT02750514, Phase 2, Terminated, Bristol-Myers Squibb; results first posted 2021-03-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer. Trials, record NCT02750514. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02750514
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer
- NCT number
- NCT02750514
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 295 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Advanced Cancer
- Interventions
- Nivolumab, Dasatinib, Relatlimab, Ipilimumab, BMS-986205
- First posted
- 2016-04-25
- Last updated
- 2021-03-22
- Results first posted
- 2021-03-22
- Limitations and caveats
- This study was terminated early by sponsor for reasons unrelated to safety.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | From first dose to 2 years following last dose (up to 30 months) | ORR is defined as the percentage of participants whose confirmed best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR was assessed by investigator per RECIST1.1. Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3). Results for each study track are presented only for treatment groups who received a treatment in that specific track. |
| Primary | Duration of Response (DOR) | From first dose to 2 years following last dose (up to 30 months) | DOR, computed for all treated participants with a confirmed BOR of CR or PR, is defined as the time between the date of first response and the date of first documented disease progression (as determined by RECIST 1.1) or death due to any cause. Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3). Results for each study track are presented only for treatment groups who received a treatment in that specific track. |
| Primary | Progression Free Survival Rate (PFSR) at 24 Weeks | From first dose to 24 weeks after first dose | The PFSR at 24 weeks is defined as the proportion of treated participants remaining progression free and surviving at 24 weeks since the first dosing date. Results are presented by study track. Track 1 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 positive (\>=1%) Track 2 = participants naive for prior immuno-oncology (IO) therapy and PD-L1 negative (\<1%) Track 3 = participants with prior anti-PD-1/PD-L1 therapy Track 4 = participants naive for prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3) Track 5 = participants with prior anti-PD-1/PD-L1 therapy (established upon enrollment closure of tracks 1,2 and 3). Results for each study track are presented only for treatment groups who received a treatment in that specific track. |
| Secondary | Percentage of Participants Experiencing Adverse Events (AEs) | From first dose to 100 days following last dose | This outcome measure describes the percentage of participants who experienced any grade, all causality AEs during the specified time frame |
| Secondary | Percentage of Participants Experiencing Serious Adverse Events (SAEs) | From first dose to 100 days following last dose | This outcome measure describes the percentage of participants who experienced any grade, all causality SAEs during the specified time frame |
| Secondary | Percentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | From first dose to 100 days following last dose | This outcome measure describes the percentage of participants who experienced all causality AEs leading to discontinuation of study therapy during the specified time frame |
| Secondary | Percentage of Participants Experiencing Death | From first dose to up to 45 months following first dose | This outcome measure describes the percentage of participants who died (due to any cause) during the specified time frame |
| Secondary | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | From first dose to 100 days following last dose (approximately 9 months) | The following measurements will be considered laboratory abnormalities for hepatic tests: * ALT or AST \> 3 x ULN, \> 5 x ULN, \> 10 x ULN and \> 20 x ULN * Total bilirubin \> 2 x ULN * Concurrent (within 1 day) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN * Concurrent (within 30 days) ALT or AST \> 3 x ULN and total bilirubin \> 2 x ULN ALT=Alanine aminotransferase AST=Aspartate aminotransferase ULN=Upper Limit of Normal |
| Secondary | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | From first dose to 100 days following last dose (approximately 9 months) | The following measurements will be considered laboratory abnormalities for thyroid tests: * TSH value \> ULN and * With baseline TSH value ≤ ULN * At least one T3/T4 test value \< LLN * Low TSH \< LLN and * With baseline TSH value ≥ LLN * At least one T3/T4 test value \> ULN TSH = thyroid stimulating hormone ULN=Upper Limit of Normal LLN=Lower Limit of Normal T3=Triiodothyronine T4=Thyroxine |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) | From first dose to 2 years following last dose (up to 30 months) | All treated participants. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. They were analyzed under both groups they received treatment for. | Percent of Participants | NUMBER |
| PRIMARY | Duration of Response (DOR) | From first dose to 2 years following last dose (up to 30 months) | All participants with a confirmed best overall response (BOR) of Complete Response (CR) or Partial Response (PR). | Months | MEDIAN |
| PRIMARY | Progression Free Survival Rate (PFSR) at 24 Weeks | From first dose to 24 weeks after first dose | All treated participants. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. They were analyzed under both groups they received treatment for. | Proportion of Participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing Adverse Events (AEs) | From first dose to 100 days following last dose | All treated participants. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. They were analyzed under both groups they received treatment for. | Percent of Participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing Serious Adverse Events (SAEs) | From first dose to 100 days following last dose | All treated participants. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. They were analyzed under both groups they received treatment for. | Percent of Participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | From first dose to 100 days following last dose | All treated participants. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. They were analyzed under both groups they received treatment for. | Percent of Participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing Death | From first dose to up to 45 months following first dose | All treated participants. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. They were analyzed under both groups they received treatment for. | Percent of Participants | NUMBER |
| SECONDARY | Number of Participants Experiencing Laboratory Abnormalities in Hepatic Tests | From first dose to 100 days following last dose (approximately 9 months) | All treated participants with available measurements. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. When measurements were available, these participants were analyzed under both groups they received treatment for. | Participants | NUMBER |
| SECONDARY | Number of Participants Experiencing Laboratory Abnormalities in Thyroid Tests | From first dose to 100 days following last dose (approximately 9 months) | All treated participants with available measurements. 14 participants, after receiving initial treatment, were re-randomized to a second, different treatment. When measurements were available, these participants were analyzed under both groups they received treatment for. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group119
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | Nivolumab | Study Track 1 | 17.5 | 95% Confidence Interval 7.3 to 32.8 | Percent of Participants |
| Objective Response Rate (ORR) | Nivolumab + Dasatinib | Study Track 1 | 25.0 | 95% Confidence Interval 0.6 to 80.6 | Percent of Participants |
| Objective Response Rate (ORR) | Nivolumab + Ipilimumab | Study Track 1 | 0 | 95% Confidence Interval 0.0 to 70.8 | Percent of Participants |
| Objective Response Rate (ORR) | Nivolumab | Study Track 2 | 0 | 95% Confidence Interval 0.0 to 33.6 | Percent of Participants |
| Objective Response Rate (ORR) | Nivolumab + Dasatinib | Study Track 2 | 0 | 95% Confidence Interval 0.0 to 33.6 | Percent of Participants |
| Objective Response Rate (ORR) | Nivolumab + BMS986016 | Study Track 2 | 0 | 95% Confidence Interval 0.0 to 84.2 | Percent of Participants |
| Objective Response Rate (ORR) | Nivolumab + Ipilimumab | Study Track 2 | 25.0 | 95% Confidence Interval 5.5 to 57.2 | Percent of Participants |
| Objective Response Rate (ORR) | Nivolumab + Dasatinib | Study Track 3 | 2.4 | 95% Confidence Interval 0.1 to 12.9 | Percent of Participants |
| Objective Response Rate (ORR) | Nivolumab + BMS986016 | Study Track 3 | 0 | 95% Confidence Interval 0.0 to 20.6 | Percent of Participants |
| Objective Response Rate (ORR) | Nivolumab + Ipilimumab | Study Track 3 | 5.6 | 95% Confidence Interval 0.1 to 27.3 | Percent of Participants |
1 to 10 of 119Source ClinicalTrials.gov
See all 119 results by groupParticipant flow75
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Track 1 | STARTED | Nivolumab | 40 | |
| Track 1 | STARTED | Nivolumab + Dasatinib | 4 | |
| Track 1 | STARTED | Nivolumab + BMS986016 | 0 | |
| Track 1 | STARTED | Nivolumab + Ipilimumab | 3 | |
| Track 1 | STARTED | Nivolumab + BMS986205 | 0 | |
| Track 1 | COMPLETED | Nivolumab | 13 | |
| Track 1 | COMPLETED | Nivolumab + Dasatinib | 2 | |
| Track 1 | COMPLETED | Nivolumab + BMS986016 | 0 | |
| Track 1 | COMPLETED | Nivolumab + Ipilimumab | 1 | |
| Track 1 | COMPLETED | Nivolumab + BMS986205 | 0 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 participant flowAdverse events4,407
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 | Track 1 - Nivolumab | 7 | 40 | |
| other | Anaemia | Blood and lymphatic system disorders | Track 1 - Nivolumab + Dasatinib | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Track 1 - Nivolumab + Ipilimumab | 0 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Track 2 - Nivolumab | 1 | 9 | |
| other | Anaemia | Blood and lymphatic system disorders | Track 2 - Nivolumab + Dasatinib | 3 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Track 2 - Nivolumab + BMS986016 | 0 | 2 | |
| other | Anaemia | Blood and lymphatic system disorders | Track 2 - Nivolumab + Ipilimumab | 3 | 12 | |
| other | Anaemia | Blood and lymphatic system disorders | Track 3 - Nivolumab + Dasatinib | 6 | 41 | |
| other | Anaemia | Blood and lymphatic system disorders | Track 3 - Nivolumab + BMS986016 | 2 | 16 | |
| other | Anaemia | Blood and lymphatic system disorders | Track 3 - Nivolumab + Ipilimumab | 1 | 18 |
1 to 10 of 4,407Source ClinicalTrials.gov
See all 4,407 adverse eventsAdverse event totals39
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Track 1 - Nivolumab | 22 | 40 |
| Total, all-cause mortality | Track 1 - Nivolumab + Dasatinib | 2 | 4 |
| Total, all-cause mortality | Track 1 - Nivolumab + Ipilimumab | 1 | 3 |
| Total, all-cause mortality | Track 2 - Nivolumab | 6 | 9 |
| Total, all-cause mortality | Track 2 - Nivolumab + Dasatinib | 4 | 8 |
| Total, all-cause mortality | Track 2 - Nivolumab + BMS986016 | 2 | 2 |
| Total, all-cause mortality | Track 2 - Nivolumab + Ipilimumab | 6 | 12 |
| Total, all-cause mortality | Track 3 - Nivolumab + Dasatinib | 20 | 41 |
| Total, all-cause mortality | Track 3 - Nivolumab + BMS986016 | 10 | 16 |
| Total, all-cause mortality | Track 3 - Nivolumab + Ipilimumab | 9 | 18 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 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/NCT02750514
GET https://conductscience.org/api/trials/v1/NCT02750514/results?page=2