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OpenTrials
Completed

NCT Number: NCT03336216

A Study of Cabiralizumab Given With Nivolumab 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.

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Key information

Conditions

Advanced Pancreatic Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cross Cancer Institute, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cabiralizumab

Biological

specified dose on specified days

Other names: BMS-986227, FPA008

Nab-paclitaxel

Drug

specified does on specified days

Other names: Abraxane

ONIVYDE

Drug

specified dose on specified days

Other names: irinotecan liposome

Nivolumab

Biological

specified dose on specified days

Other names: Opdivo, BMS-936558

Fluorouracil

Drug

specified dose on specified days

Other names: 5-Fluorouracil

Gemcitabine

Drug

specified dose on specified days

Oxaliplatin

Drug

specified dose on specified day

Leucovorin

Drug

Specified dose on specified days

irinotecan hydrochloride

Drug

Specified dose on specified days

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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)

  15. 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)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Nov 8, 2017
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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