A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF … (NCT05503797) | Clinical Trial Compass
RecruitingPhase 2
A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations
United States254 participantsStarted 2023-02-21
Plain-language summary
The objective of this Master Protocol is to evaluate the efficacy and safety of plixorafenib in participants with locally advanced or metastatic solid tumors, or recurrent or progressive primary central nervous system (CNS) tumors harboring BRAF fusions, or in participants with rare BRAF V600-mutated solid tumors, melanoma, thyroid, or recurrent primary CNS tumors.
Who can participate
Age range10 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male and female, ≥10 years of age, and weighing ≥30 kg.
✓. Histologic diagnosis of a solid tumor or primary CNS tumor.
✓. Documentation of BRAF gene fusion in tumor and/or blood detected by an analytically validated test by DNA sequencing or RNA (transcriptome) sequencing.
✓. Have an archival tissue sample available meeting protocol requirements.
✓. Consent to provide scan(s) prior to baseline to assess change in tumor trajectory.
✓. Received all available standard therapy, is intolerant to available therapies, or the investigator has determined that treatment with standard therapy is not appropriate.
✓. All adverse events related to prior therapies (chemotherapy; radiotherapy; surgery) must have resolved to Grade 1 or baseline.
✓. Male and female, ≥10 years of age, and weighing ≥30 kg.
Exclusion criteria
✕. Prior treatment with RAF/BRAF inhibitors active for Class 2 BRAF alterations for advanced unresectable or metastatic disease.
✕. Prior treatment with a MEK inhibitor.
✕. Tyrosine kinase inhibitor(s) and/or targeted therapies are allowed (other than BRAF/MAPK pathway inhibitors per Exclusion Criteria 3 and 4) and will be restricted to no more than the number of lines of therapy that are consistent with standard treatment guidelines.
What they're measuring
1
Objective Response Rate (ORR) (Subprotocols A, B and C)
✕. Malignancy with co-occurring activating RAS mutation(s) at any time.
✕. Uncontrolled intercurrent illness that would limit compliance with study requirements.
✕. HIV infection with exceptions; discuss with treating physician.
✕. Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral plixorafenib or cobicistat (such as ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, and small bowel resection).
✕. Grade ≥2 changes in AST, ALT, GGT, or bilirubin attributed to prior immune checkpoint inhibitor treatment are exclusionary, even if resolved.