BO-112 With Pembrolizumab in Unresectable Malignant Melanoma (NCT04570332) | Clinical Trial Compass
CompletedPhase 2
BO-112 With Pembrolizumab in Unresectable Malignant Melanoma
France42 participantsStarted 2020-12-30
Plain-language summary
This is a phase 2, single arm, open label, adaptive design study to determine the preliminary anti-tumor activity and confirm the safety of IT BO-112 in combination with intravenous (IV) pembrolizumab. The study will enroll patients with advanced and/or metastatic melanoma that have progressed on anti-PD-1-containing treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Be willing and able to give written informed consent for the study.
✓. Be ≥ 18 years of age on day of informed consent.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Histologically or cytologically confirmed diagnosis of cutaneous or mucosal melanoma.
✓. Known BRAF status.
✓. Have unresectable stage III or stage IV melanoma. Patients must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (mAb) administered as monotherapy, or in combination with other checkpoint inhibitors or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria:
✓. Received at least 6 weeks of standard dosing of an approved anti-PD-1/L1 mAb.
✓. Demonstrated disease progression (PD) on or after PD-1/L1 as defined by RECIST v1.1. The initial evidence of PD is to be confirmed by a second assessment no less than four weeks from the date of the first documented PD, in the absence of rapid clinical progression.
Exclusion criteria
✕. Uveal melanoma.
✕. Prior grade 3-4 irAE due to immune checkpoint inhibitors requiring systemic steroids for more than 2 weeks.
✕. Prior intra-tumoral treatments.
✕
What they're measuring
1
Overall Response Rate
Timeframe: From the first dose of study treatment to the date of CR or PR assessed up to 2 years