Advanced Pancreatic CancerPhase 2NCT03336216
A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer
A Phase 2 study testing Cabiralizumab, Nab-paclitaxel and Onivyde in people with Advanced Pancreatic Cancer, run by Bristol-Myers Squibb at 41 sites in 11 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Pancreatic Cancer
- What is being tested?
- Cabiralizumab, Nab-paclitaxel and Onivyde
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 41 sitesin 11 countries
- Study dates
- 18 Dec 2017to 1 Jun 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have histological or cytological confirmed diagnosis of locally advanced or metastatic adenocarcinoma of the pancreas, which has progressed on or after one line of chemotherapy
- ECOG Performance status 0-1
- Adequate organ functions
- Measurable disease
Who cannot join
- Suspected or known CNS metastasis
- Participants with active, known, or suspected autoimmune disease
- Uncontrolled or significant cardiovascular disease
- Prior exposure to selected immune cell-modulating antibody regimens
Trial locations and contacts
41 sites in 11 countries.
41 sites in 11 countries
United States19 sites
University Of Colorado
Aurora, Colorado, 80045
Local Institution - 0001
Baltimore, Maryland, 21287
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02114
Dana Farber Cancer Institute.
Boston, Massachusetts, 02114
Local Institution - 0010
Boston, Massachusetts, 02114
Local Institution - 0013
Dallas, Texas, 75390
Florida Cancer Specialists - South
Fort Myers, Florida, 33901
Local Institution - 0011
Houston, Texas, 77030
Local Institution - 0007
Los Angeles, California, 90095
Tennessee Oncology Chattanooga
Nashville, Tennessee, 37203
Local Institution - 0012
New York, New York, 10016
Local Institution - 0005
New York, New York, 10065
Local Institution - 0006
Philadelphia, Pennsylvania, 19104
Mayo Clinic in Rochester, Minnesota
Phoenix, Arizona, 85054
Local Institution - 0009
Pittsburgh, Pennsylvania, 15232
HonorHealth Research Institute
Scottsdale, Arizona, 85258
University Of Washington
Seattle, Washington, 98109
Washington University
St Louis, Missouri, 63110
Florida Cancer Specialists - North
St. Petersburg, Florida, 33705
Germany4 sites
Local Institution - 0032
Heidelberg, 69120
Local Institution - 0029
Mannheim, 68167
Universitaetsklinikum Ulm
Ulm, 89081
Local Institution - 0030
Würzburg, 97080
Canada3 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Local Institution - 0037
Kingston, Ontario, K7L 2V7
Local Institution - 0035
Toronto, Ontario, M5G 2M9
Spain3 sites
Local Institution - 0021
Barcelona, 08035
Local Institution - 0019
Madrid, 28007
Local Institution - 0020
Madrid, 28041
Italy2 sites
Local Institution - 0025
Padova, Padova
Local Institution - 0026
Roma, 00168
Japan2 sites
Local Institution - 0022
Chuo-ku, Tokyo, 1040045
Local Institution - 0023
Kashiwa-shi, Chiba, 2778577
South Korea2 sites
Local Institution - 0018
Seoul, 03080
Local Institution - 0017
Seoul, 06351
Switzerland2 sites
Local Institution - 0033
Chur, 7000
Local Institution - 0034
Lausanne, 1011
Taiwan2 sites
Local Institution - 0024
Taipei, 100
Local Institution - 0031
Taipei, 112
United Kingdom1 site
Local Institution - 0016
Glasgow, Lanarkshire, G12 0YN
About this study
Official title: A Phase 2 Study of Cabiralizumab (BMS-986227, FPA008) Administered in Combination With Nivolumab (BMS-936558) With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer
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.
- Conditions
- Advanced Pancreatic Cancer
- Being tested
- Cabiralizumab, Nab-paclitaxel, Onivyde, Nivolumab, Fluorouracil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabiralizumabBiological
Also called BMS-986227, FPA008
specified dose on specified days
Nab-paclitaxelDrug
Also called Abraxane
specified does on specified days
OnivydeDrug
Also called irinotecan liposome
specified dose on specified days
NivolumabBiological
Also called Opdivo, BMS-936558
specified dose on specified days
FluorouracilDrug
Also called 5-Fluorouracil
specified dose on specified days
GemcitabineDrug
specified dose on specified days
OxaliplatinDrug
specified dose on specified day
LeucovorinDrug
Specified dose on specified days
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Investigator choice of chemotherapy:
Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE) Receives: Drug: Nab-paclitaxel; Drug: Onivyde; Drug: Fluorouracil; Drug: Gemcitabine; Drug: Leucovorin; Drug: Irinotecan Hydrochloride |
| Arm B | Experimental | Cabiralizumab Q2W + Nivolumab Q4W Receives: Biological: Cabiralizumab; Biological: Nivolumab |
| Arm C | Experimental | Cabiralizumab Q2W + Nivolumab Q4W and Gemcitabine + Nab-Paclitaxel (Abraxane®) D1, 8 and 15 Q4W Receives: Biological: Cabiralizumab; Drug: Nab-paclitaxel; Biological: Nivolumab; Drug: Gemcitabine |
| Arm D | Experimental | Cabiralizumab Q2W + Nivolumab Q4W and Oxaliplatin/5-Flurouracil/Leucovorin (FOLFOX) Q2W Receives: Biological: Cabiralizumab; Biological: Nivolumab; Drug: Fluorouracil; Drug: Oxaliplatin; Drug: Leucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization date to the date of first objectively documented disease progression or death (up to approximately 65 months)
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: From first dose and 100 days after last dose of study therapy (up to approximately 51 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start18 Dec 2017
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03336216
- Sponsor's protocol ID
- CA025-006
- Status last verified
- Jul 2024
- First submitted
- 6 Nov 2017
- Last updated
- 23 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Cabiralizumab (BMS-986227, FPA008) Administered in Combination With Nivolumab (BMS-936558) With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03336216
- Acronym / sponsor ID
- CA025-006
- Conditions
- Advanced Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 8 Nov 2017 (actual)
- Results
- Posted 23 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Nab-paclitaxel, Drug: Onivyde, Drug: Fluorouracil, Drug: Gemcitabine, Drug: Leucovorin, Drug: Irinotecan HydrochlorideInvestigator choice of chemotherapy: Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE) |
| Arm B | Experimental | Biological: Cabiralizumab, Biological: NivolumabCabiralizumab Q2W + Nivolumab Q4W |
| Arm C | Experimental | Biological: Cabiralizumab, Drug: Nab-paclitaxel, Biological: Nivolumab, Drug: GemcitabineCabiralizumab Q2W + Nivolumab Q4W and Gemcitabine + Nab-Paclitaxel (Abraxane®) D1, 8 and 15 Q4W |
| Arm D | Experimental | Biological: Cabiralizumab, Biological: Nivolumab, Drug: Fluorouracil, Drug: Oxaliplatin, Drug: LeucovorinCabiralizumab Q2W + Nivolumab Q4W and Oxaliplatin/5-Flurouracil/Leucovorin (FOLFOX) Q2W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must have histological or cytological confirmed diagnosis of locally advanced or metastatic adenocarcinoma of the pancreas, which has progressed on or after one line of chemotherapy
- ECOG Performance status 0-1
- Adequate organ functions
- Measurable disease
Key exclusion criteria (4 listed)
- Suspected or known CNS metastasis
- Participants with active, known, or suspected autoimmune disease
- Uncontrolled or significant cardiovascular disease
- Prior exposure to selected immune cell-modulating antibody regimens
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CabiralizumabAlso: BMS-986227, FPA008specified dose on specified days | Biological | Arm B, Arm C, Arm D |
| Nab-paclitaxelAlso: Abraxanespecified does on specified days | Drug | Arm A, Arm C |
| OnivydeAlso: irinotecan liposomespecified dose on specified days | Drug | Arm A |
| NivolumabAlso: Opdivo, BMS-936558specified dose on specified days | Biological | Arm B, Arm C, Arm D |
| FluorouracilAlso: 5-Fluorouracilspecified dose on specified days | Drug | Arm A, Arm D |
| Gemcitabinespecified dose on specified days | Drug | Arm A, Arm C |
| Oxaliplatinspecified dose on specified day | Drug | Arm D |
| LeucovorinSpecified dose on specified days | Drug | Arm A, Arm D |
| Irinotecan HydrochlorideSpecified dose on specified days | Drug | Arm A |
Primary outcome
Progression Free Survival (PFS) by BICR
Time frame: 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.
15 secondary outcomes
Progression Free Survival (PFS) by Investigator
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
Time frame: At 6, 9, and 12 months
Progression Free Survival Rate (PFSR) by Investigator
Time frame: At 6, 9, and 12 months
Objective Response Rate (ORR) by BICR
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
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
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
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)
Time frame: From randomization to the date of death to any cause (up to approximately 65 months)
Overall Survival Rates (OSR)
Time frame: At 6 months, 1 year, and 2 years
The Number of Participants With Adverse Events (AEs)
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)
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
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
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
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
Time frame: From first dose and 100 days after last dose of study therapy (up to approximately 51 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
41 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cabiralizumab, Nab-paclitaxel and Onivyde in people with Advanced Pancreatic Cancer, run by Bristol-Myers Squibb at 41 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Germany, Canada, Spain, Italy and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) by BICR (time frame: From randomization date to the date of first objectively documented disease progression or death (up to approximately 65 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.