Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06610682 | A Trial to Evaluate CSF ctDNA and Safety of Plixorafenib Alone or With Retifanlimab in Patients With BRAF-altered Glioma | EARLY_PHASE1 | RECRUITING | 24 | — | — | Apr 7, 2025 | Jun 30, 2028 | Apr 16, 2026 | 1 | United States |
Proportion of patients with detectable ctDNA in CSF and/or plasma detected at surgery, baseline (C1D1), and pre-Cycle 2 (week 4).
| Arm | Type | Description |
|---|---|---|
| Plixorafenib alone (Arm A) | EXPERIMENTAL | Patients will start the study drug (plixorafenib 900mg daily 30 minutes after a full meal or meal supplement) 7-28 days post-operatively, when clinically stable. Patients will take the drug daily by mouth continuously for 28-day cycles until progressive disease or up to 24 cycles. MRI will be performed post-operatively (between surgery and start of study drug) for evaluation of measurable disease, at the beginning of Cycle 2, then at the beginning of every odd cycle. Blood and CSF samples will be obtained on day of surgery, C1D1 (baseline), pre-C2 (week 4) and with every odd cycle up to and including C7 and EOT |
| Plixorafenib in combination with retifanlimab (Arm B) | EXPERIMENTAL | Participants will receive one dose of retifanlimab prior to surgery. Following surgery, the participants will start plixorafenib 7-28 days post-operatively, when clinically stable. Retifanlimab (administered by IV every 28 days) will be restarted after one cycle of plixorafenib or after the 2nd cycle of plixorafenib per physician discretion. Patients will take the drugs in 28-day cycles until progressive disease or up to 24 cycles. MRI, blood, CSF and other study assessments will be performed as for Arm A. |
| Name | Type | Description |
|---|---|---|
| Plixorafenib | DRUG | Patients will start the study drug (plixorafenib 900mg daily 30 minutes after a full meal or meal supplement) 7-28 days post-operatively, when clinically stable. Patients will take the drug daily by mouth continuously for 28-day cycles until progressive disease or up to 24 cycles. MRI will be performed post-operatively (between surgery and start of study drug) for evaluation of measurable disease, at the beginning of Cycle 2, then at the beginning of every odd cycle. Blood and CSF samples will be obtained on day of surgery, C1D1 (baseline), pre-C2 (week 4) and with every odd cycle up to and including C7 and EOT. |
| Retifanlimab | DRUG | Investigators will evaluate the sensitivity of ctDNA from plasma and CSF at baseline and over time in response to treatment with plixorafenib alone or in combination with retifanlimab in patients with BRAF-V600E mutant glioma refractory to prior therapies. |
Inclusion Arm A Only: * Patient must have received prior BRAF and/or MEK inhibitor therapy. 1. Prior RAF dimer disruptor or pan-RAF inhibitor not allowed 2. Prior immunotherapy allowed * The following intervals from previous treatments should have elapsed prior to enrollment: a. BRAFi/MEKi ...