Actively Recruiting
Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab in the Treatment of Metastatic BRAF-mutated Colorectal Cancer Refractory
Led by Northwestern University · Updated on 2025-10-20
43
Participants Needed
1
Research Sites
298 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a Phase II, open label, single-arm trial study of adding hydroxychloroquine to encorafenib and cetuximab in patients with metastatic BRAF V600E colon cancer with progression on at least 1 prior line of therapy. We hypothesize that autophagy is a major mechanism of resistance to BRAF inhibition in stage IV BRAF V600E colorectal cancer, and that the addition of hydroxychloroquine to standard encorafenib and cetuximab therapy will help overcome this resistance.
CONDITIONS
Official Title
Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab in the Treatment of Metastatic BRAF-mutated Colorectal Cancer Refractory
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed stage IV colorectal cancer positive for BRAF V600E mutation
- At least 18 years of age
- On at least 1 prior line of systemic therapy and no previous BRAF inhibitor therapy
- Measurable disease as defined by RECIST 1.1
- Discontinued prior chemotherapy or targeted therapy at least 14 days before starting study treatment
- ECOG performance status of 0 or 1
- Adequate organ and bone marrow function as defined by specific laboratory thresholds (WBC 600/mcL, ANC 500/mcL, Hemoglobin 9 g/dL with limited transfusions, Platelets 100,000/mcL with limited transfusions, bilirubin and liver enzymes within defined limits, creatinine or GFR above specified levels)
- Undetectable viral loads if HIV or HBV positive, and treated or undetectable for HCV
- Patients with treated brain metastases without progression
- Patients with prior or concurrent malignancies not interfering with study
- Cardiac function class 2B or better by New York Heart Association Functional Classification
- Negative pregnancy test for females of child-bearing potential prior to dosing
- Agreement to use effective contraception for both females of child-bearing potential and men during and after study
- Ability to swallow and retain oral medication without significant gastrointestinal abnormalities
- Ability and willingness to sign informed consent
You will not qualify if you...
- Chemotherapy or radiotherapy within 14 days prior to planned treatment start (except up to 14 days standard care with Encorafenib and Cetuximab)
- Use of other investigational agents within 28 days before starting study treatment
- Cyclical chemotherapy with cycles shorter than usual prior to treatment
- Biologic therapy except bevacizumab or aflibercept within 5 half-lives or 28 days prior
- Bevacizumab or aflibercept therapy within 21 days prior
- Radiation therapy involving more than 30% bone marrow (palliative allowed)
- Symptomatic or unstable leptomeningeal disease or spinal cord compression
- Recent corticosteroid use above defined limits without appropriate approval
- History of allergic reactions to study drugs or related compounds
- Use of strong CYP3A4/5 inhibitors or inducers within 7 days prior
- History of acute or chronic pancreatitis
- Severe eye diseases or risk factors for retinal vein occlusion
- Thromboembolic or cerebrovascular events within 90 days prior
- Neuromuscular disorders with elevated creatine kinase potential
- Known Gilbert's syndrome or specific UGT1A1 genotypes
- Known psoriasis or porphyria
- Uncontrolled intercurrent illnesses including recent serious cardiac events, infections, symptomatic heart failure, or uncontrolled hypertension
- Pregnant or nursing females
- Psychiatric or social conditions limiting compliance with study requirements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
S
Study Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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