Actively Recruiting
Stereotactic Body Radiotherapy Plus FAK and RAF/MEK Inhibition in Advanced Pancreatic Adenocarcinoma
Led by Washington University School of Medicine · Updated on 2026-04-15
36
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
V
Verastem, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Advanced pancreatic cancer patients receiving treatment of adaptive stereotactic body radiotherapy (SBRT) with concurrent and adjuvant defactinib plus avutometinib will have increased progression-free survival (PFS) compared to historical PFS rates for patients receiving adaptive SBRT alone.
CONDITIONS
Official Title
Stereotactic Body Radiotherapy Plus FAK and RAF/MEK Inhibition in Advanced Pancreatic Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced pancreatic adenocarcinoma that is borderline resectable or locally advanced per institutional criteria
- Patients with locoregional adenopathy adjacent to the primary tumor
- Completed at least 2 months of systemic chemotherapy for this disease without progression
- At least 18 years old
- ECOG performance status of 0 or 1
- Life expectancy greater than 3 months
- Adequate bone marrow and organ function as defined by specific blood counts and chemistry levels
- Adequate cardiac function with left ventricular ejection fraction of 55% or higher
- Corrected QT interval less than 480 ms
- Agree to use highly effective contraception if of childbearing potential
- Ability to understand and sign informed consent
You will not qualify if you...
- History of other malignancy interfering with study safety or efficacy
- Clinically evident ascites or pleural effusion requiring therapeutic drainage
- Prior treatment with FAK or RAF/MEK inhibitors or certain immune checkpoint inhibitors
- Prior anti-human antibody response
- Current or recent use of other investigational agents
- Allergic reactions to study drugs or their ingredients
- Diagnosis of immunodeficiency or use of immunosuppressive therapy outside chemotherapy
- Inability to stop warfarin or safely switch anticoagulants
- Active autoimmune disease requiring systemic treatment within 2 years
- Received live vaccines within 30 days prior to randomization
- Known active hepatitis B or C infection
- History or current pneumonitis requiring steroids
- Known active tuberculosis
- Major surgery within 28 days prior to randomization
- Pregnant or breastfeeding; women must have negative pregnancy test within 14 days
- HIV patients with low CD4 counts or recent opportunistic infection
- Recent COVID-19 infection within 10 days
- Use of medications or substances that interact with study drugs within 14 days
- Inability to swallow oral medications or impaired gastrointestinal absorption
- Active skin disorders requiring systemic therapy within past year
- History of significant rhabdomyolysis
- Certain ocular disorders including glaucoma, retinal vein occlusion risk, or significant corneal disease
- Congestive heart failure or recent severe cardiac or pulmonary conditions
- Other medical conditions posing high toxicity risk
- Active uncontrolled infection requiring systemic therapy
- Unwillingness to follow study lifestyle guidance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
P
Patrick Grierson, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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