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Pembrolizumab +/− Defactinib for Pancreatic Cancer

Phase 2
Recruiting
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has resectable disease at the time of diagnosis
Has pancreatic ductal adenocarcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study Summary

This trial will test a new combination of drugs to treat pancreatic cancer. The drugs will be given before and after surgery, and the trial will compare the effectiveness of the combination with and without a third drug.

Who is the study for?
Adults over 18 with resectable pancreatic cancer, not previously treated for it, and in good physical condition can join. They must have a specific tumor marker level (CA 19-9 >200) and be able to conceive children only using approved birth control methods. Exclusions include pregnancy, recent other treatments or studies, immune system suppressants within the last week, known allergies to study drugs, active infections or autoimmune diseases.Check my eligibility
What is being tested?
The trial is testing pembrolizumab (a PD-1 antibody) with or without defactinib (a FAK inhibitor), alongside standard chemotherapy before and after surgery for high-risk pancreatic cancer patients. It aims to see if targeting FAK can enhance the body's immune response against cancer when combined with PD-1 inhibition.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as inflammation of organs, infusion-related reactions like fever or chills; fatigue; digestive issues; changes in blood counts leading to increased risk of infections; and possible allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition can be treated with surgery.
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I have pancreatic cancer.
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I am fully active or can carry out light work.
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I have not had any drug treatments for pancreatic cancer.
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My cancer was stage IIb or lower when diagnosed.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 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
Pathologic complete response (pCR) rate
Secondary outcome measures
Disease free survival (DFS)
Number of participants experiencing study drug-related toxicities
Overall survival (OS)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B - PembrolizumabExperimental Treatment1 Intervention
Group II: Arm A - Pembrolizumab and DefactinibExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Defactinib
2013
Completed Phase 1
~60
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
556 Previous Clinical Trials
32,844 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,868 Previous Clinical Trials
5,051,963 Total Patients Enrolled
Verastem, Inc.Industry Sponsor
38 Previous Clinical Trials
2,562 Total Patients Enrolled

Media Library

Defactinib Clinical Trial Eligibility Overview. Trial Name: NCT03727880 — Phase 2
Pancreatic Cancer Research Study Groups: Arm A - Pembrolizumab and Defactinib, Arm B - Pembrolizumab
Pancreatic Cancer Clinical Trial 2023: Defactinib Highlights & Side Effects. Trial Name: NCT03727880 — Phase 2
Defactinib 2023 Treatment Timeline for Medical Study. Trial Name: NCT03727880 — Phase 2

Frequently Asked Questions

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

What have been the observed risks associated with Pembrolizumab use?

"With prior safety data, Pembrolizumab was given a score of 2 since this is only Phase 2 trial. As such, there has yet to be evidence proving its efficacy."

Answered by AI

In what ways has Pembrolizumab been used therapeutically?

"Medical experts often use Pembrolizumab to treat malignant neoplasms, as well as unresectable melanoma, cases of microsatellite instability high and disease progression after chemotherapy."

Answered by AI

Could you provide an overview of all the trials that have featured Pembrolizumab?

"At the current moment, 969 clinical trials concerning Pembrolizumab are ongoing, with 122 in Phase 3. Whilst Houston Texas hosts a majority of these studies, 37286 other locations have been assigned to conduct research into this drug."

Answered by AI

Does the trial extend to those who are more than three decades old?

"According to the requirements, those wishing to participate must be between 18 and 100. For minors there are 36 clinical trials available, while senior citizens may choose from a selection of 1763 studies."

Answered by AI

Am I eligible to partake in this medical study?

"Those wishing to join this clinical trial must possess adenocarcinoma and be within the age range of 18-100. The recruitment process is targeting a total of 36 individuals."

Answered by AI

What is the maximum number of participants being admitted to this clinical research?

"Affirmative. On clinicaltrials.gov, one can find that this trial commenced on June 4th 2019 and was recently updated on March 22nd 2022. The study requires 36 recruits to be gathered from two medical sites."

Answered by AI

Is there still a possibility for individuals to become involved in this experiment?

"As indicated by the information hosted on clinicaltrials.gov, this investigation is presently seeking participants. It was first advertised in June 2019 and has been revised as recently as March 2022."

Answered by AI
~4 spots leftby Dec 2024