RecruitingPancreatic AdenocarcinomaCancer of the PancreasPancreas Cancer
Stereotactic Body Radiotherapy Plus FAK and RAF/MEK Inhibition in Advanced Pancreatic Adenocarcinoma
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Washington University School of Medicine
You may qualify if…
- ✓ Histologically or cytologically confirmed advanced pancreatic adenocarcinoma that is considered borderline resectable or locally advanced per institutional standardized criteria of unresectability or medical inoperability (NCCN guidelines 2.2021 PANC-C 1 of 2).
- ✓ Patients with locoregional adenopathy are eligible as long as all suspicious lymph nodes are deemed to be adjacent to the primary tumor as per radiation oncologist assessment.
- ✓ Patients must have received at least 2 months of systemic chemotherapy, such as FOLFOX, FOLFIRINOX, gemcitabine, nab-paclitaxel, cisplatin, or other regimens, for this disease without progression of local or systemic disease. Newly diagnosed patients may be screened for enrollment in this study and can be enrolled once they have completed 2 months of systemic chemotherapy (and still meet all eligibility criteria) prior to randomization. The last dose of chemotherapy must be ≥ 2 weeks prior to randomization.
- ✓ At least 18 years of age.
- ✓ ECOG performance status ≤ 1.
- ✓ Life expectancy \> 3 months
- ✓ Adequate bone marrow and organ function as defined below:
- ✓ Absolute neutrophil count ≥ 1.5 K/cumm
You may not qualify if…
- ✕ A history of other malignancy with the exception of prior or concurrent malignancies whose natural history is unlikely to interfere with the safety or efficacy of the investigational regimen (in the opinion of the treating physician).
- ✕ Clinically evident ascites or pleural effusion that requires therapeutic paracentesis or thoracentesis.
- ✕ Prior treatment with a drug of the FAK inhibitor or RAF/MEK inhibitor class, or with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte associated antigen 4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
- ✕ Prior anti-human antibody response (AHA or ADA).
- ✕ Currently receiving any other investigational agents or has received any other investigational agents within 4 weeks or 5 half-lives, whichever is shorter, of randomization.
- ✕ A history of allergic reactions attributed to compounds of similar chemical or biologic composition to defactinib, avutometinib, or other agents used in the study, or a history of hypersensitivity to any of the inactive ingredients (hydroxypropylmethylcellulose, mannitol, magnesium stearate) of the investigational product.
- ✕ Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy not routinely associated with chemotherapeutic regimen.
- ✕ Requires continued use of warfarin for anticoagulation and cannot stop warfarin or be safely switched to another anticoagulant or direct oral anticoagulant.
Where it's recruiting
Missouri
St Louis
Source: ClinicalTrials.gov · NCT07126158 · last updated 2026-04-15