Trial · NCT03336216
A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer
NCT03336216, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2024-07-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer. Trials, record NCT03336216. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03336216
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer
- NCT number
- NCT03336216
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 205 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Advanced Pancreatic Cancer
- Interventions
- Cabiralizumab, Nab-paclitaxel, Onivyde, Nivolumab, Fluorouracil, Gemcitabine, Oxaliplatin, Leucovorin, Irinotecan Hydrochloride
- First posted
- 2017-11-08
- Last updated
- 2024-07-23
- Results first posted
- 2024-07-23
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) by BICR | From randomization date to the date of first objectively documented disease progression or death (up to approximately 65 months) | PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Progression Free Survival (PFS) by Investigator | From randomization date to the date of first objectively documented disease progression or death (up to approximately 65 months) | PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Progression Free Survival Rate (PFSR) by BICR | At 6, 9, and 12 months | Progression Free Survival Rates at 6, 9, and 12 months is defined as the percentage of participants who achieve PFS at 6, 9, and 12 months. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Progression Free Survival Rate (PFSR) by Investigator | At 6, 9, and 12 months | Progression Free Survival Rates at 6, 9, and 12 months is defined as the percentage of participants who achieve PFS at 6, 9, and 12 months. PFS for a participant is defined as the time from randomization date to the date of first objectively documented disease progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause, whichever occurs first. Based on Kaplan-Meier Estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Objective Response Rate (ORR) by BICR | From randomization to the date of objectively documented progression per RECIST v1.1 or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 65 months) | ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) 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 during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Objective Response Rate (ORR) by Investigator | From randomization to the date of objectively documented progression per RECIST v1.1 or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 65 months) | ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) 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 during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Duration of Response (DOR) by BICR | From randomization the date of the first objectively documented tumor progression or death, whichever occurs first (up to approximately 65 months) | DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by blinded independent central review (BICR) per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first. Median computed using Kaplan-Meier method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) 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 during the study (this includes the baseline sum). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Duration of Response (DOR) by Investigator | From randomization the date of the first objectively documented tumor progression or death, whichever occurs first (up to approximately 65 months) | DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first. Median computed using Kaplan-Meier method. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) 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 during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. |
| Secondary | Overall Survival (OS) | From randomization to the date of death to any cause (up to approximately 65 months) | OS is defined as the time from randomization to the date of death due to any cause. Based on Kaplan-Meier Estimates. |
| Secondary | Overall Survival Rates (OSR) | At 6 months, 1 year, and 2 years | Overall survival at 6 months, 1 year, and 2 years is defined as the percentage of participants who are alive at 6 months, 1 year, and 2 years. Based on Kaplan-Meier Estimates. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) by BICR | From randomization date to the date of first objectively documented disease progression or death (up to approximately 65 months) | All Efficacy Participants: Randomized population with at least one dose of study drug. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) by Investigator | From randomization date to the date of first objectively documented disease progression or death (up to approximately 65 months) | All Efficacy Participants: Randomized population with at least one dose of study drug. | Months | MEDIAN |
| SECONDARY | Progression Free Survival Rate (PFSR) by BICR | At 6, 9, and 12 months | All Efficacy Participants: Randomized population with at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival Rate (PFSR) by Investigator | At 6, 9, and 12 months | All Efficacy Participants: Randomized population with at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) by BICR | From randomization to the date of objectively documented progression per RECIST v1.1 or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 65 months) | All Efficacy Participants: Randomized population with at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) by Investigator | From randomization to the date of objectively documented progression per RECIST v1.1 or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 65 months) | All Efficacy Participants: Randomized population with at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) by BICR | From randomization the date of the first objectively documented tumor progression or death, whichever occurs first (up to approximately 65 months) | All Confirmed Responders: All efficacy evaluable participants (randomized population with at least one dose of study drug) with CR or PR | Months | MEDIAN |
| SECONDARY | Duration of Response (DOR) by Investigator | From randomization the date of the first objectively documented tumor progression or death, whichever occurs first (up to approximately 65 months) | All Confirmed Responders: All efficacy evaluable participants (randomized population with at least one dose of study drug) with CR or PR | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization to the date of death to any cause (up to approximately 65 months) | All Efficacy Participants: Randomized population with at least one dose of study drug. | Months | MEDIAN |
| SECONDARY | Overall Survival Rates (OSR) | At 6 months, 1 year, and 2 years | All Efficacy Participants: Randomized population with at least one dose of study drug. | Percentage of participants | NUMBER |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group152
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) by BICR | Arm A: Investigator Choice | 3.52 | 95% Confidence Interval 2.53 to 4.21 | Months | |
| Progression Free Survival (PFS) by BICR | Arm B: Cabiralizumab + Nivolumab | 1.92 | 95% Confidence Interval 1.77 to 2.14 | Months | |
| Progression Free Survival (PFS) by BICR | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | 3.68 | 95% Confidence Interval 1.94 to 4.83 | Months | |
| Progression Free Survival (PFS) by BICR | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | 3.22 | 95% Confidence Interval 2.04 to 3.94 | Months | |
| Progression Free Survival (PFS) by Investigator | Arm A: Investigator Choice | 3.38 | 95% Confidence Interval 1.97 to 3.98 | Months | |
| Progression Free Survival (PFS) by Investigator | Arm B: Cabiralizumab + Nivolumab | 1.81 | 95% Confidence Interval 1.74 to 1.97 | Months | |
| Progression Free Survival (PFS) by Investigator | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | 3.68 | 95% Confidence Interval 2.00 to 4.17 | Months | |
| Progression Free Survival (PFS) by Investigator | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | 2.92 | 95% Confidence Interval 1.81 to 3.94 | Months | |
| Progression Free Survival Rate (PFSR) by BICR | Arm A: Investigator Choice | 6-MONTH | 15.5 | 95% Confidence Interval 4.8 to 31.8 | Percentage of participants |
| Progression Free Survival Rate (PFSR) by BICR | Arm B: Cabiralizumab + Nivolumab | 6-MONTH | 13.1 | 95% Confidence Interval 5.3 to 24.4 | Percentage of participants |
1 to 10 of 152Source ClinicalTrials.gov
See all 152 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomization | STARTED | Arm A: Investigator Choice | 54 | |
| Randomization | STARTED | Arm B: Cabiralizumab + Nivolumab | 54 | |
| Randomization | STARTED | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | 54 | |
| Randomization | STARTED | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | 43 | |
| Randomization | COMPLETED | Arm A: Investigator Choice | 40 | |
| Randomization | COMPLETED | Arm B: Cabiralizumab + Nivolumab | 49 | |
| Randomization | COMPLETED | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | 48 | |
| Randomization | COMPLETED | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | 42 | |
| Randomization | NOT COMPLETED | Arm A: Investigator Choice | 14 | |
| Randomization | NOT COMPLETED | Arm B: Cabiralizumab + Nivolumab | 5 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events1,395
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 | Arm A1: Investigator Choice - Gem/Nab-Based Chemotherapy | 9 | 21 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm A2: Investigator Choice - 5 FU-Based Chemotherapy | 5 | 19 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm B: Cabiralizumab + Nivolumab | 13 | 49 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | 34 | 48 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | 17 | 42 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm A1: Investigator Choice - Gem/Nab-Based Chemotherapy | 0 | 21 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm A2: Investigator Choice - 5 FU-Based Chemotherapy | 0 | 19 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm B: Cabiralizumab + Nivolumab | 0 | 49 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | 3 | 48 | |
| other | Leukopenia | Blood and lymphatic system disorders | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | 1 | 42 |
1 to 10 of 1,395Source ClinicalTrials.gov
See all 1,395 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A1: Investigator Choice - Gem/Nab-Based Chemotherapy | 19 | 26 |
| Total, all-cause mortality | Arm A2: Investigator Choice - 5 FU-Based Chemotherapy | 17 | 28 |
| Total, all-cause mortality | Arm B: Cabiralizumab + Nivolumab | 49 | 54 |
| Total, all-cause mortality | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | 49 | 54 |
| Total, all-cause mortality | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | 40 | 43 |
| Total, other adverse events | Arm A1: Investigator Choice - Gem/Nab-Based Chemotherapy | 19 | 21 |
| Total, other adverse events | Arm A2: Investigator Choice - 5 FU-Based Chemotherapy | 17 | 19 |
| Total, other adverse events | Arm B: Cabiralizumab + Nivolumab | 46 | 49 |
| Total, other adverse events | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | 47 | 48 |
| Total, other adverse events | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | 41 | 42 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 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/NCT03336216
GET https://conductscience.org/api/trials/v1/NCT03336216/results?page=2