At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed rare tumor (metastatic or locally advanced unresectable); cutaneous SCC patients with resectable disease eligible if surgery would cause substantial functional impairment or disfigurement
- ✓Refractory or intolerant to standard lines of therapy
- ✓Prior chemotherapy, immunotherapy, or radiation completed ≥14 days before treatment with resolution of toxicity to CTCAE v4.0 grade 1 (grade 2 neuropathy allowed)
- ✓Radiographically evaluable disease
- ✕Brain metastases unless adequately treated, stable ≥30 days, neurologically asymptomatic, and off corticosteroids ≥7 days
- ✕Uncontrolled intercurrent illness: uncontrolled diabetes/hypertension, severe infection, severe malnutrition, unstable angina, NYHA class III-IV CHF, ventricular arrhythmias, active ischemic heart disease, or MI within 6 months
- ✕History of or evidence of retinal pathology on ophthalmologic exam that is a risk factor for neurosensory retinal detachment, central serous chorioretinopathy, RVO, or neovascular macular degeneration
- ✕Risk factors for RVO: glaucoma with IOP ≥21 mmHg, grade ≥2 serum cholesterol, grade ≥2 hypertriglyceridemia, grade ≥2 or symptomatic hyperglycemia (fasting), or grade ≥2 uncontrolled hypertension
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Open-Label, Single-Arm, Multi-Cohort, Proof-of-Principle Study to Investigate the Efficacy of Cobimetinib and Atezolizumab in Advanced Rare Tumors
In Brief
A Phase 2 clinical trial evaluating Atezolizumab and Cobimetinib for Skin Squamous Cell Carcinoma and 11 related conditions. Completed, enrolled 49 participants across 1 site.
Detailed Summary
This phase II trial studies how well cobimetinib and atezolizumab work in treating participants with rare tumors that have spread to other places in the body (advanced) or that does not respond to treatment (refractory). Cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cobimetinib and atezolizumab may work better in treating participants with advanced or refractory rare tumors.
Study Details
Timeline
Interventions
Given IV
Given PO