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Immune Modulator
BXCL701 + Pembrolizumab for Pancreatic Cancer (EXPEL PANC Trial)
Phase 2
Recruiting
Research Sponsored by Georgetown University
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 24 months
Awards & highlights
EXPEL PANC Trial Summary
This trial will test a new combination of drugs to treat pancreatic cancer that has spread.
Who is the study for?
Adults with metastatic pancreatic ductal adenocarcinoma who've had one prior treatment can join. They must be able to swallow pills, consent to biopsies, and have measurable disease. Women of childbearing age need a negative pregnancy test and agree to contraception. Exclusions include pregnant/breastfeeding women, other recent cancers except certain skin/cervical cancers, uncontrolled medical conditions or heart disease, active infections like HIV/hepatitis, autoimmune diseases needing systemic treatment in the past 2 years (except for some exceptions), and those on steroids/immunosuppressants.Check my eligibility
What is being tested?
The trial is testing BXCL701 combined with Pembrolizumab in patients who have already undergone one line of therapy for their cancer. It's an open-label study where all participants receive the same treatment without a comparison group. The main goal is to see if this combination helps patients avoid cancer progression for at least 18 weeks.See study design
What are the potential side effects?
Possible side effects may include immune system reactions that could affect organs, infusion-related responses such as fever or chills during drug administration, fatigue from energy level reduction, digestive issues like nausea or diarrhea, blood disorders affecting cell counts which might increase infection risk.
EXPEL PANC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
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 at 18 weeks
Secondary outcome measures
Change in tumor marker (CA19-9)
Incidence of Adverse events
Median Duration of response (DOR)
+3 moreEXPEL PANC Trial Design
1Treatment groups
Experimental Treatment
Group I: BXCL701 plus PembrolizumabExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Georgetown UniversityLead Sponsor
343 Previous Clinical Trials
136,459 Total Patients Enrolled
BioXcel Therapeutics IncIndustry Sponsor
19 Previous Clinical Trials
2,389 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,061,103 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My pancreatic cancer has spread and is mainly adenocarcinoma.I can take care of myself and am up and about more than half of my waking hours.I haven't had cancer treatment in the last 2 weeks.My CNS cancer meets specific eligibility criteria.I have a serious lung condition that is not under control.I have had dizziness upon standing in the last 3 months.I am not pregnant or breastfeeding.I have a history of HIV or chronic hepatitis B or C.I haven't taken steroids or immunosuppressants in the last 14 days.My cancer has worsened or I couldn't tolerate at least one treatment for it.I am 18 years old or older.I have fully recovered from any surgery effects.My liver tests are within normal limits.I can swallow pills whole.I agree to have two biopsies and my tumor can be biopsied multiple times.My side effects from cancer treatment are mild, except for possible nerve pain or hair loss.I have a GI condition that affects how my body absorbs medication.I am not pregnant or have been without periods for at least 12 months.I have no active brain cancer, and if treated for it, it was over 4 weeks ago.I haven't had cancer in the past 2 years, except for certain types.I understand the study requirements and can follow them.I have an autoimmune disease that needed treatment in the last 2 years.I do not have uncontrolled heart problems.I do not have any severe health conditions that would make it unsafe for me to join the study.I have had lung inflammation treated with steroids or have a lung condition.I have not had a live-virus vaccine in the last 30 days.My kidney function is within the normal range.I agree to use barrier contraception and ensure my partner uses additional contraception during and 6 months after the study.I have been treated with FAP, DPP inhibitors, or certain immune-targeting drugs.
Research Study Groups:
This trial has the following groups:- Group 1: BXCL701 plus Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the combination of BXCL701 and Pembrolizumab safe for patients?
"Our team has assigned BXCL701 plus Pembrolizumab a safety score of 2, as there exists clinical evidence that the drug is secure but no data affirming its efficacy."
Answered by AI
Has recruitment for this research begun?
"According to the clinicaltrials.gov website, this trial is no longer actively recruiting participants; its last update was on September 26th 2022 and it initially opened for enrollment on December 1st. Nonetheless, there are still 772 other studies that are currently in need of patients."
Answered by AI
Who else is applying?
What state do they live in?
Virginia
Massachusetts
What site did they apply to?
Georgetown Lombardi Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
2
What questions have other patients asked about this trial?
How to proceed forward?
PatientReceived no prior treatments
Why did patients apply to this trial?
How responsive is this trial?
Most responsive sites:
- Georgetown Lombardi Comprehensive Cancer Center: < 48 hours
Average response time
- < 2 Days
Typically responds via
Phone Call
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