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Monoclonal Antibodies

Cabiralizumab for Pancreatic Cancer

Phase 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing an immunotherapy drug combo to treat advanced pancreatic cancer.

Eligible Conditions
  • Pancreatic Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression free survival (PFS) by Blinded Independent Central Review (BICR)
Secondary outcome measures
Duration of response (DOR)
Incidence of Adverse Events (AE)
Incidence of Adverse Events (AE) leading to discontinuation
+10 more

Side effects data

From 2019 Phase 1 trial • 19 Patients • NCT03158272
67%
Aspartate aminotransferase increased
67%
Pyrexia
67%
Blood creatine phosphokinase increased
33%
Alanine aminotransferase increased
33%
Cough
33%
Rash maculo-papular
33%
Tumour pain
33%
Fatigue
33%
Rash
33%
Upper limb fracture
33%
Bladder disorder
33%
Anaemia
33%
Periorbital oedema
33%
Abdominal pain
33%
Blood alkaline phosphatase increased
33%
Blood creatinine increased
33%
Lipase increased
33%
Arthralgia
33%
Neuropathy peripheral
33%
Dyspnoea
33%
Constipation
33%
Herpes zoster
33%
Amylase increased
33%
Nausea
33%
Anorectal disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
M1 Cohort
M2 Cohort
C1 Cohort
C2 Cohort

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Arm DExperimental Treatment5 Interventions
Cabiralizumab Q2W + Nivolumab Q4W and Oxaliplatin/5-Flurouracil/Leucovorin (FOLFOX) Q2W
Group II: Arm CExperimental Treatment4 Interventions
Cabiralizumab Q2W + Nivolumab Q4W and Gemcitabine + Nab-Paclitaxel (Abraxane®) D1, 8 and 15 Q4W
Group III: Arm BExperimental Treatment2 Interventions
Cabiralizumab Q2W + Nivolumab Q4W
Group IV: Arm AActive Control6 Interventions
Investigator choice of chemotherapy: Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Fluorouracil
2014
Completed Phase 3
~11540
Gemcitabine
2017
Completed Phase 3
~2070
Cabiralizumab
2018
Completed Phase 2
~620
Nab-paclitaxel
2014
Completed Phase 3
~2030
Oxaliplatin
2011
Completed Phase 4
~2560
Leucovorin
2005
Completed Phase 4
~5730

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,634 Previous Clinical Trials
4,126,649 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Cabiralizumab been tested in other research studies?

"Cabiralizumab was first investigated in 1997 by City of Hope Comprehensive Cancer Center. In the intervening years, there have been 3190 completed trials and an additional 2259 studies are currently recruiting patients; numerous sites can be found across New york State."

Answered by AI

How many sites are involved in this trial's execution?

"This trial is taking place at 33 distinct medical sites, such as Local Institution - 0005 in New york City, Local Institution -0007 located in Los Angeles and another one based in Pittsburgh. The rest of the locations are scattered around the United States."

Answered by AI

What is the current status of Cabiralizumab's regulatory approval?

"Cabiralizumab has been evaluated for safety in Phase 2 trials, thus warranting a score of two. As yet, there is no evidence to suggest its efficacy."

Answered by AI

What clinical applications is Cabiralizumab typically employed for?

"Cabiralizumab proves to be the most effective treatment for unresectable melanoma. Furthermore, this medication has been found to reduce recurrence risk and manage certain other diseases such as squamous cell carcinoma."

Answered by AI

What is the extent of participation in this experiment?

"This clinical trial is no longer searching for participants. It was first posted on December 19th 2017 and its last edit occurred on October 31st 2022. For those looking to join another medical study, there are 579 trials with openings related to pancreatic carcinoma and 2,259 studies enrolling patients who will be receiving cabiralizumab."

Answered by AI

Are there any available slots for participants in this research?

"This trial has ceased its recruitment of participants. It was initially made available on December 19th, 2017 and the last update occurred October 31st 2022. If you are seeking alternative trials, 579 clinical studies related to pancreatic carcinoma and 2259 involving Cabiralizumab are actively recruiting patients at this time."

Answered by AI
~28 spots leftby Apr 2025