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Monoclonal Antibodies

Combination Therapy for Pancreatic Cancer

Phase 1
Recruiting
Led By Paul Oberstein, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have not received previous anti-cancer therapy for the treatment of pancreatic ductal adenocarcinoma
Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) as determined by a local laboratory (adenosquamous is also allowed)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months post treatment
Awards & highlights

Study Summary

This trial tests a combination of chemo and drugs to evaluate safety/toxicity in patients with pancreatic cancer before surgery, and assess the clinical anti-tumor activity of the treatment.

Who is the study for?
This trial is for adults over 18 with confirmed pancreatic ductal adenocarcinoma who haven't had cancer treatment before. They should be in good health overall, able to follow the study schedule, and willing to use contraception. It's not for those with certain other cancers, advanced or metastatic disease, previous immunotherapy for pancreatic cancer, immune system issues, significant medical risks, known allergies to study drugs or their ingredients.Check my eligibility
What is being tested?
The trial tests a combination of Canakinumab and Tislelizumab with Nab-Paclitaxel and Gemcitabine as pre-surgery (neo-adjuvant) treatment for pancreatic cancer. The aim is to find safe doses of this four-drug regimen and see if it helps patients proceed to surgery while assessing its preliminary effects on tumors.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in different organs; blood disorders; liver and kidney function changes; fatigue; nausea; increased risk of infections due to weakened immunity; potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not had any cancer treatment for pancreatic cancer.
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My cancer is confirmed to be pancreatic ductal adenocarcinoma.
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I am using two birth control methods or am not having sex to avoid pregnancy during and 9 months after the study.
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I am fully active or can carry out light work.
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My pancreatic cancer is still within the pancreas and can possibly be removed surgically.
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I am older than 18 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of dose limiting toxicities (DLTs)
Number of patients who proceeded to surgical resection
Secondary outcome measures
Number of changes in outcome of surgery that is attributed to study drug
Number of delays outcome of surgery that is attributed to study drug
Overall Response Rate (ORR)
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Quadruplet regimen prior to resection for pancreatic cancerExperimental Treatment4 Interventions
Treatment of Canakinumab and Tislelizumab in Combination with Nab-Paclitaxel and Gemcitabine up to 4 cycles (4 months)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Canakinumab
2011
Completed Phase 3
~3090
Tislelizumab
2018
Completed Phase 3
~4260
Nab-Paclitaxel
2014
Completed Phase 3
~4410
Gemcitabine
2017
Completed Phase 3
~2070

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,588 Total Patients Enrolled
Paul Oberstein, MDPrincipal InvestigatorPerlmutter Cancer Center
2 Previous Clinical Trials
115 Total Patients Enrolled

Media Library

Canakinumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05984602 — Phase 1
Pancreatic Cancer Research Study Groups: Quadruplet regimen prior to resection for pancreatic cancer
Pancreatic Cancer Clinical Trial 2023: Canakinumab Highlights & Side Effects. Trial Name: NCT05984602 — Phase 1
Canakinumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05984602 — Phase 1

Frequently Asked Questions

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

Is there a possibility for me to take part in this experiment?

"Eligibility criteria for this pancreatic cancer trial mandates that participants be between 18 and 100 years of age. 10 brave individuals are being recruited in total."

Answered by AI

How hazardous is the Quadruplet regimen prior to surgical removal of pancreatic cancer for individuals?

"Our team has tentatively estimated the safety of this Quadruplet regimen prior to resection for pancreatic cancer to be a 1 due its Phase 1 trial status, signifying that there is limited data confirming both efficacy and safety."

Answered by AI

Are there openings in this clinical exploration for participants?

"Affirmative. According to the clinicaltrials.gov listing, this medical trial is recruiting patients as of August 2nd 2023 and was first posted on July 14th 2023. 10 participants are needed from 3 separate sites for enrollment in the study."

Answered by AI

How many participants are currently being accepted into this research project?

"Indeed, the information available on clinicaltrials.gov confirms that this research project is recruiting participants at present. It was initially announced July 14th 2023 and has since been updated August 2nd of the same year. 10 individuals need to be recruited from 3 locations for the completion of this trial."

Answered by AI

Does the research team have an age restriction for enrollees?

"The medical trial seeks individuals ranging from 18 to 100 years old. For those under the age of 18, there are 10 separate studies while 710 trials exist for applicants over 65."

Answered by AI

What results are investigators expecting to observe from this clinical trial?

"The primary evaluation metric of this 56-day clinical trial is the number of patients that successfully undergo surgical resection. Other metrics, such as Progression Free Survival (PFS), Overall Survival (OS) and R0 Resection Rate are also used to measure success; PFS being defined as time from first dose to initial progression or death, OS representing the span between first treatment dose and eventual passing due to any cause, while R0 Resection Rate designates a surgery completely removing visible tumors deemed negative on pathology report."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Phase IB Study to Determine the Safety and Tolerability of Canakinumab and Tislelizumab in Combination With Nab-Paclitaxel and Gemcitabine in the Neo-adjuvant Treatment of Patients With Pancreatic Cancer
2023. "A Phase IB Study to Determine the Safety and Tolerability of Canakinumab and Tislelizumab in Combination With Nab-Paclitaxel and Gemcitabine in the Neo-adjuvant Treatment of Patients With Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05984602.
~5 spots leftby Feb 2025
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