NCT03108131

Cobimetinib and Atezolizumab in Treating Participants With Advanced or Refractory Rare Tumors

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the efficacy of cobimetinib plus atezolizumab (COTEZO) in cohorts of advanced rare tumors using objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. SECONDARY OBJECTIVES: I. To determine progression-free survival (PFS) on COTEZO in cohorts of advanced rare tumors per RECIST v1.1 and immune-related (ir)RECIST. II. To determine overall survival (OS) on COTEZO in cohorts of advanced rare tumors. III. To determine disease control rate (DCR) and duration of response (DOR) on COTEZO in cohorts of advanced rare tumors per RECIST v1.1 and irRECIST. IV. To determine objective response rate (ORR) per immune-related RECIST criteria. V. To determine safety profile and adverse events encountered by patients with advanced rare tumors treated with COTEZO. VI. To collect and bank tumor tissue and peripheral blood for future correlative analyses from patients with advanced rare tumors treated with COTEZO. OUTLINE: Participants receive cobimetinib orally (PO) once daily (QD) on days 1-21 and atezolizumab intravenously (IV) over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants followed up every 3 months thereafter.

Conditions

• Skin Squamous Cell Carcinoma
• Appendix Adenocarcinoma
• Rare Lesion
• Locally Advanced Malignant Neoplasm
• Locally Advanced Skin Squamous Cell Carcinoma
• Metastatic Malignant Neoplasm
• Metastatic Skin Squamous Cell Carcinoma
• Metastatic Small Intestinal Adenocarcinoma
• Rare Neoplastic Syndrome
• Refractory Malignant Neoplasm
• Stage IV Small Intestinal Adenocarcinoma AJCC v8
• Unresectable Malignant Neoplasm

Interventions

Type	Name	Description
DRUG	Atezolizumab	Given IV
DRUG	Cobimetinib	Given PO

Timeline

• Start date: 2017-04-07
• Primary completion: 2024-04-02
• Completion: 2024-04-02
• First posted: 2017-04-11
• Last updated: 2025-05-28
• Results posted: 2025-05-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study