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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 from start of intervention until 30 days following discontinuation of intervention
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a combination of two drugs, BXCL701 and pembrolizumab, in patients with advanced pancreatic cancer. These patients have already tried other treatments without success. The drugs work together to help the immune system better identify and attack cancer cells. Pembrolizumab has shown effectiveness in patients with various cancers, including pancreatic cancer.

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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of intervention until 30 days following discontinuation of intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of intervention until 30 days following discontinuation of intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change in tumor marker (CA19-9)
Incidence of Adverse events
Objective response rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 3
~2810

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
BXCL701, a dipeptidyl peptidase inhibitor, works by inhibiting enzymes that contribute to tumor growth and immune evasion, while Pembrolizumab, a PD-1 inhibitor, enhances the immune system's ability to detect and destroy cancer cells by blocking the PD-1 pathway. These mechanisms are significant for pancreatic cancer patients as they offer a targeted approach to treatment, potentially improving outcomes and reducing side effects compared to traditional chemotherapy.

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor
347 Previous Clinical Trials
137,073 Total Patients Enrolled
BioXcel Therapeutics IncIndustry Sponsor
19 Previous Clinical Trials
2,312 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,996 Previous Clinical Trials
5,181,199 Total Patients Enrolled

Media Library

BXCL701 (Immune Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05558982 — Phase 2
Pancreatic Cancer Research Study Groups: BXCL701 plus Pembrolizumab
Pancreatic Cancer Clinical Trial 2023: BXCL701 Highlights & Side Effects. Trial Name: NCT05558982 — Phase 2
BXCL701 (Immune Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05558982 — Phase 2
~27 spots leftby Nov 2026