What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as BXCL701 (a Dipeptidyl Peptidase Inhibitor) and Pembrolizumab (a PD-1 Inhibitor), have known side effects. BXCL701 can cause fatigue, anemia, and other general adverse reactions. Pembrolizumab is associated with immune-related side effects, including fatigue, pruritus, pyrexia, decreased appetite, and pneumonitis. These treatments aim to manage the disease but can lead to significant side effects that need to be monitored closely.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, primarily focusing on chemotherapy and targeted therapies. Notably, pembrolizumab, a PD-1 inhibitor, has been approved for use in various cancers, including microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, which can include pancreatic cancer. However, there are no specific FDA approvals for Dipeptidyl Peptidase Inhibitors like BXCL701 in pancreatic cancer. Other approved treatments include gemcitabine, nab-paclitaxel, and FOLFIRINOX, which are standard chemotherapy regimens.

What other types of research exist?

A promising novel alternative to BXCL701 and Pembrolizumab for pancreatic cancer patients is the combination of durvalumab (anti-PD-L1 antibody) and tremelimumab (anti-CTLA-4 antibody).

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of intervention until 30 days following discontinuation of intervention

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

~3130

Do I qualify?Apply below to find out

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.