A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer

July 21, 2024 updated by: Bristol-Myers Squibb

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
205

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Local Institution - 0037
      • Toronto, Ontario, Canada, M5G 2M9
        • Local Institution - 0035
  • Denmark
      • Herlev, Denmark, 2730
        • Local Institution - 0041
  • Germany
      • Heidelberg, Germany, 69120
        • Local Institution - 0032
      • Mannheim, Germany, 68167
        • Local Institution - 0029
      • Ulm, Germany, 89081
        • Universitaetsklinikum Ulm
      • Wuerzburg, Germany, 97080
        • Local Institution - 0030
  • Italy
      • Padova, Italy, Padova
        • Local Institution - 0025
      • Roma, Italy, 00168
        • Local Institution - 0026
  • Japan
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 2778577
        • Local Institution - 0023
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 1040045
        • Local Institution - 0022
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Local Institution - 0018
      • Seoul, Korea, Republic of, 06351
        • Local Institution - 0017
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution - 0021
      • Madrid, Spain, 28007
        • Local Institution - 0019
      • Madrid, Spain, 28041
        • Local Institution - 0020
  • Switzerland
      • Chur, Switzerland, 7000
        • Local Institution - 0033
      • Lausanne, Switzerland, 1011
        • Local Institution - 0034
  • Taiwan
      • Taipei, Taiwan, 112
        • Local Institution - 0031
      • Taipei City, Taiwan, 100
        • Local Institution - 0024
  • United Kingdom
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G12 0YN
        • Local Institution - 0016
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic in Rochester, Minnesota
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth Research Institute
    • California
      • Los Angeles, California, United States, 90095
        • Local Institution - 0007
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists - South
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists - North
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Local Institution - 0001
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02114
        • Dana Farber Cancer Institute.
      • Boston, Massachusetts, United States, 02114
        • Local Institution - 0010
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • New York
      • New York, New York, United States, 10065
        • Local Institution - 0005
      • New York, New York, United States, 10016
        • Local Institution - 0012
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Local Institution - 0006
      • Pittsburgh, Pennsylvania, United States, 15232
        • Local Institution - 0009
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology Chattanooga
    • Texas
      • Dallas, Texas, United States, 75390
        • Local Institution - 0013
      • Houston, Texas, United States, 77030
        • Local Institution - 0011
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Arm A

Investigator choice of chemotherapy:

Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE)
Drug: Leucovorin
Specified dose on specified days
Drug: Nab-paclitaxel
specified does on specified days
Other Names:
  • Abraxane
Drug: Onivyde
specified dose on specified days
Other Names:
  • irinotecan liposome
Drug: Fluorouracil
specified dose on specified days
Other Names:
  • 5-Fluorouracil
Drug: Gemcitabine
specified dose on specified days
Drug: Irinotecan Hydrochloride
Specified dose on specified days
Experimental: Arm B
Cabiralizumab Q2W + Nivolumab Q4W
Biological: Nivolumab
specified dose on specified days
Other Names:
  • Opdivo, BMS-936558
Biological: Cabiralizumab
specified dose on specified days
Other Names:
  • BMS-986227, FPA008
Experimental: Arm C
Cabiralizumab Q2W + Nivolumab Q4W and Gemcitabine + Nab-Paclitaxel (Abraxane®) D1, 8 and 15 Q4W
Biological: Nivolumab
specified dose on specified days
Other Names:
  • Opdivo, BMS-936558
Drug: Nab-paclitaxel
specified does on specified days
Other Names:
  • Abraxane
Drug: Gemcitabine
specified dose on specified days
Biological: Cabiralizumab
specified dose on specified days
Other Names:
  • BMS-986227, FPA008
Experimental: Arm D
Cabiralizumab Q2W + Nivolumab Q4W and Oxaliplatin/5-Flurouracil/Leucovorin (FOLFOX) Q2W
Biological: Nivolumab
specified dose on specified days
Other Names:
  • Opdivo, BMS-936558
Drug: Leucovorin
Specified dose on specified days
Drug: Fluorouracil
specified dose on specified days
Other Names:
  • 5-Fluorouracil
Biological: Cabiralizumab
specified dose on specified days
Other Names:
  • BMS-986227, FPA008
Drug: Oxaliplatin
specified dose on specified day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From randomization date to the date of first objectively documented disease progression or death (up to approximately 65 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)

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.
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 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.
At 6, 9, and 12 months
Progression Free Survival Rate (PFSR) by Investigator
Time Frame: 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.
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)

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.
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)

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.
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)

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.
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)

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.
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)
OS is defined as the time from randomization to the date of death due to any cause. Based on Kaplan-Meier Estimates.
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
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.
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)
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.
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)
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.
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)
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.
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 that died during the study.
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 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)
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)

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)
From first dose and 100 days after last dose of study therapy (up to approximately 51 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA025-006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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