NCT02721459

XL888 + Vemurafenib + Cobimetinib for Unresectable BRAF Mutated Stage III/IV Melanoma

Phase I Study of Escalating Doses of XL888 With Vemurafenib Plus Cobimetinib for Patients With Unresectable BRAF Mutated Stage III/IV Melanoma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of XL888 when administered orally with vemurafenib plus cobimetinib in participants with BRAF V600 mutated melanoma and to evaluate the safety and tolerability of this combination.

Conditions

• Melanoma
• Skin Cancer

Interventions

Type	Name	Description
DRUG	XL888	Level 1: XL888 30 mg by mouth (PO) twice weekly (BIW). Level 2: XL888 45 mg PO BIW. Level 3: XL888 60 mg PO BIW. Level 4: XL888 90 mg PO BIW.
DRUG	Vemurafenib	Vemurafenib 720 mg by mouth twice a day (BID)
DRUG	Cobimetinib	Cobimetinib 40 mg by mouth once daily (QD). Administered 3 weeks on, 1 week off.

Timeline

• Start date: 2016-09-07
• Primary completion: 2019-10-31
• Completion: 2026-11-04
• First posted: 2016-03-29
• Last updated: 2026-03-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study