A Phase 2 interventional study of Cabiralizumab and Nab-paclitaxel in Advanced Pancreatic Cancer, sponsored by Bristol-Myers Squibb. Completed at 41 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-23.
Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment
The purpose of this study is to determine whether an investigational immuno-therapy, cabiralizumab in combination with nivolumab, with or without chemotherapy, is effective for the treatment of advanced pancreatic cancer.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.
This study's enrollment of 205 is above the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Bristol-Myers Squibb is the lead sponsor of 1,561 studies on the registry; 117 are open to participants now.
Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigator choice of chemotherapy: Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE)
Drug: Nab-paclitaxel · Drug: Onivyde · Drug: Fluorouracil · Drug: Gemcitabine · Drug: Leucovorin · Drug: Irinotecan Hydrochloride
Cabiralizumab Q2W + Nivolumab Q4W
Biological: Cabiralizumab · Biological: Nivolumab
Cabiralizumab Q2W + Nivolumab Q4W and Gemcitabine + Nab-Paclitaxel (Abraxane®) D1, 8 and 15 Q4W
Biological: Cabiralizumab · Drug: Nab-paclitaxel · Biological: Nivolumab · Drug: Gemcitabine
Cabiralizumab Q2W + Nivolumab Q4W and Oxaliplatin/5-Flurouracil/Leucovorin (FOLFOX) Q2W
Biological: Cabiralizumab · Biological: Nivolumab · Drug: Fluorouracil · Drug: Oxaliplatin · Drug: Leucovorin
specified dose on specified days
Also known as: BMS-986227, FPA008
specified does on specified days
Also known as: Abraxane
specified dose on specified days
Also known as: irinotecan liposome
specified dose on specified days
Also known as: Opdivo, BMS-936558
specified dose on specified days
Also known as: 5-Fluorouracil
specified dose on specified days
specified dose on specified day
Specified dose on specified days
Specified dose on specified days
Progression Free Survival (PFS) by BICR
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.
Time frame: From randomization date to the date of first objectively documented disease progression or death (up to approximately 65 months)
Progression Free Survival (PFS) by Investigator
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.
Time frame: From randomization date to the date of first objectively documented disease progression or death (up to approximately 65 months)
Progression Free Survival Rate (PFSR) by BICR
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.
Time frame: At 6, 9, and 12 months
Progression Free Survival Rate (PFSR) by Investigator
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.
Time frame: At 6, 9, and 12 months
Objective Response Rate (ORR) by BICR
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.
Time frame: 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)
Objective Response Rate (ORR) by Investigator
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.
Time frame: 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)
Duration of Response (DOR) by BICR
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.
Time frame: From randomization the date of the first objectively documented tumor progression or death, whichever occurs first (up to approximately 65 months)
Duration of Response (DOR) by Investigator
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.
Time frame: From randomization the date of the first objectively documented tumor progression or death, whichever occurs first (up to approximately 65 months)
Overall Survival (OS)
OS is defined as the time from randomization to the date of death due to any cause. Based on Kaplan-Meier Estimates.
Time frame: From randomization to the date of death to any cause (up to approximately 65 months)
Overall Survival Rates (OSR)
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.
Time frame: At 6 months, 1 year, and 2 years
The Number of Participants With Adverse Events (AEs)
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Time frame: From first dose to 100 days after last dose of study therapy (up to approximately 51 months)
The Number of Participants With Serious Adverse Events (SAEs)
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Time frame: From first dose to 100 days after last dose of study therapy (up to approximately 51 months)
The Number of Participants With Adverse Events (AEs) Leading to Discontinuation
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Time frame: From first dose to 100 days after last dose of study therapy (up to approximately 51 months)
The Number of Participants Who Died
The number of participants that died during the study.
Time frame: From first dose to 150 days after last dose of study therapy (up to approximately 53 months)
The Number of Participants Who Experienced Abnormal Hepatic Tests
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)
Time frame: From first dose and 100 days after last dose of study therapy (up to approximately 51 months)
The Number of Participants With On-Treatment Laboratory Abnormalities in Specific Thyroid Tests
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) Lower Limit of Normal (LLN) Upper Limit of Normal (ULN)
Time frame: From first dose and 100 days after last dose of study therapy (up to approximately 51 months)
| Milestone | Arm A: Investigator Choice | Arm B: Cabiralizumab + Nivolumab | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy |
|---|---|---|---|---|
| Started | 54 | 54 | 54 | 43 |
| Completed | 40 | 49 | 48 | 42 |
| Not completed | 14 | 5 | 6 | 1 |
| Withdrew: Not reported | 2 | 0 | 1 | 0 |
| Withdrew: Other reasons | 1 | 1 | 1 | 0 |
| Withdrew: Participant no longer meets study criteria | 0 | 2 | 4 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 | 0 |
| Withdrew: Participant withdrew consent | 9 | 1 | 0 | 0 |
| Withdrew: Adverse event | 1 | 1 | 0 | 0 |
| Milestone | Arm A: Investigator Choice | Arm B: Cabiralizumab + Nivolumab | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy |
|---|---|---|---|---|
| Started | 40 | 49 | 48 | 42 |
| Completed | 0 | 1 | 0 | 1 |
| Not completed | 40 | 48 | 48 | 41 |
| Withdrew: Adverse event | 2 | 3 | 4 | 4 |
| Withdrew: Participant request to discontinue treatment | 2 | 1 | 2 | 2 |
| Withdrew: Participant withdrew consent | 7 | 2 | 3 | 2 |
| Withdrew: Death | 2 | 3 | 3 | 4 |
| Withdrew: Participant no longer meets study criteria | 0 | 1 | 0 | 0 |
| Withdrew: Other reasons | 2 | 0 | 0 | 3 |
| Withdrew: Disease progression | 23 | 34 | 33 | 26 |
| Withdrew: Study drug toxicity | 0 | 3 | 2 | 0 |
| Withdrew: Adverse event unrelated to study drug | 1 | 1 | 1 | 0 |
| Withdrew: Disease recurrence | 1 | 0 | 0 | 0 |
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.
| Months | Arm A: Investigator Choice | Arm B: Cabiralizumab + Nivolumab | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy |
|---|---|---|---|---|
| Progression Free Survival (PFS) by BICR | 3.52 (2.53 to 4.21) | 1.92 (1.77 to 2.14) | 3.68 (1.94 to 4.83) | 3.22 (2.04 to 3.94) |
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.
| Months | Arm A: Investigator Choice | Arm B: Cabiralizumab + Nivolumab | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy |
|---|---|---|---|---|
| Progression Free Survival (PFS) by Investigator | 3.38 (1.97 to 3.98) | 1.81 (1.74 to 1.97) | 3.68 (2.00 to 4.17) | 2.92 (1.81 to 3.94) |
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.
| Percentage of participants | Arm A: Investigator Choice | Arm B: Cabiralizumab + Nivolumab | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy |
|---|---|---|---|---|
| 6-MONTH | 15.5 (4.8 to 31.8) | 13.1 (5.3 to 24.4) | 21.7 (10.5 to 35.4) | 17.7 (7.8 to 30.8) |
| 9-MONTH | 5.2 (0.4 to 20.3) | 6.5 (1.7 to 16.1) | 9.5 (2.6 to 21.8) | 10.1 (3.2 to 21.7) |
| 12-MONTH | NA (NA to NA) | 2.2 (0.2 to 10.0) | 3.2 (0.3 to 13.6) | 5.1 (0.9 to 15.0) |
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.
| Percentage of participants | Arm A: Investigator Choice | Arm B: Cabiralizumab + Nivolumab | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy |
|---|---|---|---|---|
| 6-MONTH | 14.9 (4.9 to 30.0) | 16.3 (7.6 to 27.9) | 17.6 (8.2 to 29.8) | 14.7 (6.0 to 27.1) |
| 9-MONTH | 11.2 (3.0 to 25.6) | 8.2 (2.6 to 17.9) | 5.0 (0.9 to 14.7) | 7.3 (1.9 to 17.9) |
| 12-MONTH | 3.7 (0.3 to 15.9) | NA (NA to NA) | 2.5 (0.2 to 11.2) | 4.9 (0.9 to 14.5) |
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.
| Percentage of participants | Arm A: Investigator Choice | Arm B: Cabiralizumab + Nivolumab | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy |
|---|---|---|---|---|
| Objective Response Rate (ORR) by BICR | 2.5 (0.1 to 13.2) | 4.1 (0.5 to 14.0) | 12.5 (4.7 to 25.2) | 9.5 (2.7 to 22.6) |
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.
| Percentage of participants | Arm A: Investigator Choice | Arm B: Cabiralizumab + Nivolumab | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy |
|---|---|---|---|---|
| Objective Response Rate (ORR) by Investigator | 5.0 (0.6 to 16.9) | 4.1 (0.5 to 14.0) | 6.3 (1.3 to 17.2) | 4.8 (0.6 to 16.2) |
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.
| Months | Arm A: Investigator Choice | Arm B: Cabiralizumab + Nivolumab | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy |
|---|---|---|---|---|
| Duration of Response (DOR) by BICR | NA (NA to NA) | 4.2 (3.9 to NA) | 4.6 (3.0 to NA) | NA (5.6 to NA) |
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.
| Months | Arm A: Investigator Choice | Arm B: Cabiralizumab + Nivolumab | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy |
|---|---|---|---|---|
| Duration of Response (DOR) by Investigator | 10.2 (2.7 to NA) | 7.3 (4.5 to NA) | NA (3.7 to NA) | NA (NA to NA) |
OS is defined as the time from randomization to the date of death due to any cause. Based on Kaplan-Meier Estimates.
| Months | Arm A: Investigator Choice | Arm B: Cabiralizumab + Nivolumab | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy |
|---|---|---|---|---|
| Overall Survival (OS) | 6.28 (4.53 to 8.11) | 4.44 (3.19 to 7.26) | 6.72 (4.96 to 8.54) | 5.68 (4.57 to 7.33) |
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.
| Percentage of participants | Arm A: Investigator Choice | Arm B: Cabiralizumab + Nivolumab | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy |
|---|---|---|---|---|
| 6-MONTH | 55.8 (38.8 to 69.8) | 40.1 (26.1 to 53.8) | 54.2 (39.2 to 67.0) | 44.8 (29.4 to 59.0) |
| 12-MONTH | 14.7 (5.4 to 28.3) | 20.1 (10.0 to 32.7) | 20.6 (10.6 to 33.0) | 17.4 (7.7 to 30.4) |
| 24-MONTH | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) | NA (NA to NA) |
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
| Participants | Arm A: Investigator Choice | Arm B: Cabiralizumab + Nivolumab | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy |
|---|---|---|---|---|
| The Number of Participants With Adverse Events (AEs) | 40 | 49 | 48 | 42 |
A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
| Participants | Arm A: Investigator Choice | Arm B: Cabiralizumab + Nivolumab | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy |
|---|---|---|---|---|
| The Number of Participants With Serious Adverse Events (SAEs) | 23 | 41 | 39 | 33 |
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
| Participants | Arm A: Investigator Choice | Arm B: Cabiralizumab + Nivolumab | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy |
|---|---|---|---|---|
| The Number of Participants With Adverse Events (AEs) Leading to Discontinuation | 6 | 11 | 11 | 8 |
The number of participants that died during the study.
| Participants | Arm A: Investigator Choice | Arm B: Cabiralizumab + Nivolumab | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy |
|---|---|---|---|---|
| The Number of Participants Who Died | 25 | 33 | 30 | 28 |
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)
| Participants | Arm A: Investigator Choice | Arm B: Cabiralizumab + Nivolumab | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy |
|---|---|---|---|---|
| ALT or AST > 3xULN | 2 | 21 | 37 | 34 |
| ALT or AST > 5xULN | 0 | 10 | 19 | 18 |
| ALT or AST > 10xULN | 0 | 2 | 6 | 2 |
| ALT or AST > 12xULN | 0 | 2 | 4 | 2 |
| ALT or AST > 20xULN | 0 | 1 | 1 | 1 |
| TOTAL BILIRUBIN > 2xULN | 3 | 3 | 2 | 5 |
| ALP > 1.5xULN | 27 | 31 | 35 | 30 |
| ALT/AST > 3xULN; TOTAL BILIRUBIN > 2xULN and ALP <=2ULN IN 3 DAYS | 0 | 1 | 1 | 1 |
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) Lower Limit of Normal (LLN) Upper Limit of Normal (ULN)
| Participants | Arm A: Investigator Choice | Arm B: Cabiralizumab + Nivolumab | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy |
|---|---|---|---|---|
| TSH > ULN | 3 | 4 | 10 | 6 |
| TSH > ULN WITH TSH <= ULN AT BASELINE | 0 | 2 | 4 | 2 |
| TSH > ULN WITH AT LEAST ONE T3/T4 TEST VALUE < LLN | 0 | 1 | 1 | 0 |
| TSH > ULN WITH ALL T3/T4 TEST VALUES >= LLN | 0 | 0 | 0 | 0 |
| TSH > ULN WITH T3/T4 TEST MISSING | 0 | 1 | 0 | 0 |
| TSH < LLN | 0 | 0 | 1 | 1 |
| TSH < LLN WITH TSH >= LLN AT BASELINE | 0 | 0 | 0 | 1 |
| TSH < LLN WITH AT LEAST ONE T3/T4 TEST VALUE > ULN | 0 | 0 | 0 | 0 |
| TSH < LLN WITH ALL OTHER T3/T4 TEST VALUES <= ULN | 0 | 0 | 0 | 0 |
| TSH < LLN WITH T3/T4 TEST MISSING | 0 | 0 | 0 | 0 |
Collected over All-cause mortality was assessed from a participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 51 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A1: Investigator Choice - Gem/Nab-Based Chemotherapy | 19/26 (73.1%) | 11/21 (52.4%) | 19/21 (90.5%) |
| Arm A2: Investigator Choice - 5 FU-Based Chemotherapy | 17/28 (60.7%) | 12/19 (63.2%) | 17/19 (89.5%) |
| Arm B: Cabiralizumab + Nivolumab | 49/54 (90.7%) | 41/49 (83.7%) | 46/49 (93.9%) |
| Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | 49/54 (90.7%) | 39/48 (81.3%) | 47/48 (97.9%) |
| Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | 40/43 (93%) | 33/42 (78.6%) | 41/42 (97.6%) |
| Event | Arm A1: Investigator Choice - Gem/Nab-Based Chemotherapy | Arm A2: Investigator Choice - 5 FU-Based Chemotherapy | Arm B: Cabiralizumab + Nivolumab | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy |
|---|---|---|---|---|---|
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 8/21 | 6/19 | 22/49 | 19/48 | 15/42 |
| SepsisInfections and infestations | 1/21 | 0/19 | 3/49 | 4/48 | 6/42 |
| PyrexiaGeneral disorders | 1/21 | 2/19 | 0/49 | 3/48 | 5/42 |
| DiarrhoeaGastrointestinal disorders | 0/21 | 2/19 | 0/49 | 2/48 | 1/42 |
| VomitingGastrointestinal disorders | 0/21 | 2/19 | 3/49 | 1/48 | 1/42 |
| Septic shockInfections and infestations | 0/21 | 2/19 | 1/49 | 0/48 | 0/42 |
| Abdominal painGastrointestinal disorders | 2/21 | 1/19 | 1/49 | 3/48 | 0/42 |
| BacteraemiaInfections and infestations | 2/21 | 0/19 | 1/49 | 2/48 | 1/42 |
| Acute kidney injuryRenal and urinary disorders | 0/21 | 0/19 | 1/49 | 4/48 | 0/42 |
| PneumonitisRespiratory, thoracic and mediastinal disorders | 0/21 | 1/19 | 0/49 | 4/48 | 1/42 |
| Event | Arm A1: Investigator Choice - Gem/Nab-Based Chemotherapy | Arm A2: Investigator Choice - 5 FU-Based Chemotherapy | Arm B: Cabiralizumab + Nivolumab | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy |
|---|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 9/21 | 5/19 | 13/49 | 34/48 | 17/42 |
| FatigueGeneral disorders | 10/21 | 10/19 | 25/49 | 29/48 | 23/42 |
| DiarrhoeaGastrointestinal disorders | 5/21 | 9/19 | 11/49 | 16/48 | 24/42 |
| Aspartate aminotransferase increasedInvestigations | 3/21 | 1/19 | 14/49 | 27/48 | 24/42 |
| NauseaGastrointestinal disorders | 7/21 | 9/19 | 19/49 | 16/48 | 23/42 |
| Blood creatine phosphokinase increasedInvestigations | 1/21 | 0/19 | 15/49 | 18/48 | 23/42 |
| Decreased appetiteMetabolism and nutrition disorders | 7/21 | 6/19 | 11/49 | 17/48 | 23/42 |
| Periorbital oedemaEye disorders | 0/21 | 0/19 | 13/49 | 21/48 | 16/42 |
| VomitingGastrointestinal disorders | 9/21 | 7/19 | 11/49 | 15/48 | 13/42 |
| AlopeciaSkin and subcutaneous tissue disorders | 9/21 | 2/19 | 5/49 | 13/48 | 0/42 |
| Age, Continuous(Years) | Arm A: Investigator Choice | Arm B: Cabiralizumab + Nivolumab | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | Total |
|---|---|---|---|---|---|
| Mean | 62.7 ± 8.6 | 64.2 ± 9.1 | 59.1 ± 9.7 | 64.2 ± 9.6 | 62.4 ± 9.4 |
| Sex: Female, Male(Participants) | Arm A: Investigator Choice | Arm B: Cabiralizumab + Nivolumab | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | Total |
|---|---|---|---|---|---|
| Female | 26 | 28 | 26 | 26 | 106 |
| Male | 28 | 26 | 28 | 17 | 99 |
| Ethnicity (NIH/OMB)(Participants) | Arm A: Investigator Choice | Arm B: Cabiralizumab + Nivolumab | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 5 | 0 | 1 | 0 | 6 |
| Not Hispanic or Latino | 46 | 48 | 45 | 41 | 180 |
| Unknown or Not Reported | 3 | 6 | 8 | 2 | 19 |
| Race (NIH/OMB)(Participants) | Arm A: Investigator Choice | Arm B: Cabiralizumab + Nivolumab | Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy | Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 6 | 8 | 8 | 12 | 34 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 5 | 3 | 1 | 3 | 12 |
| White | 40 | 43 | 45 | 27 | 155 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 0 | 0 | 1 | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2017 to primary completion in Jun 2023, 65 months.
Results were first posted in Jul 2024, 1 year 1 month after primary completion.
Of 69 industry-sponsored phase 2 interventional studies under Pancreatic Neoplasms, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 68. This study's 65 months is above that.
Counting every sponsor, half of 393 studies reached it within 57 months; a quarter within 35 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Cabiralizumab · Albumin-Bound Paclitaxel · Fluorouracil · Gemcitabine · Leucovorin