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Axitinib and Avelumab in Treating Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma

2019-06-25 03:58:33 | BioPortfolio

Summary

This phase II trial studies how well axitinib and avelumab work in treating patients with adenoid cystic carcinoma that has come back or spread to other places in the body. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving axitinib and avelumab together may help to control adenoid cystic carcinoma.

Description

PRIMARY OBJECTIVES:

I. Assess the objective response rate (ORR) to axitinib and avelumab combination according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria patients with recurrent or metastatic adenoid cystic carcinoma (ACC) who have evidence of disease progression within 6 months prior to study enrollment.

SECONDARY OBJECTIVES:

I. Assess ORR to axitinib and avelumab combination according to immune-related (ir)RECIST criteria patients with recurrent or metastatic adenoid cystic carcinoma (ACC).

II. Evaluate median progression free survival (PFS), PFS rate at 6 months after start of treatment.

III. Evaluate median overall survival (OS), OS rate at 6 months after start of treatment.

IV. Evaluate duration of response (DoR). V. Evaluate safety and toxicity.

EXPLORATORY OBJECTIVES:

I. Assess molecular markers associated with response and resistance to the study combination using tissue and/or plasma obtained from study participants.

OUTLINE:

Patients receive axitinib orally (PO) twice daily (BID) on days 1-28 and avelumab intravenously (IV) over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 and 90 days and then every 6 months thereafter.

Study Design

Conditions

Metastatic Adenoid Cystic Carcinoma

Intervention

Avelumab, Axitinib

Location

M D Anderson Cancer Center
Houston
Texas
United States
77030

Status

Not yet recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-06-25T03:58:33-0400

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PubMed Articles [5060 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

Carcinoma characterized by bands or cylinders of hyalinized or mucinous stroma separating or surrounded by nests or cords of small epithelial cells. When the cylinders occur within masses of epithelial cells, they give the tissue a perforated, sievelike, or cribriform appearance. Such tumors occur in the mammary glands, the mucous glands of the upper and lower respiratory tract, and the salivary glands. They are malignant but slow-growing, and tend to spread locally via the nerves. (Dorland, 27th ed)

Mucocellular carcinoma of the ovary, usually metastatic from the gastrointestinal tract, characterized by areas of mucoid degeneration and the presence of signet-ring-like cells. It accounts for 30%-40% of metastatic cancers to the ovaries and possibly 1%-2% of all malignant ovarian tumors. The lesions may not be discovered until the primary disease is advanced, and most patients die of their disease within a year. In some cases, a primary tumor is not found. (From Dorland, 27th ed; Holland et al., Cancer Medicine, 3d ed, p1685)

A cystic growth originating from lymphatic tissue. It is usually found in the neck, axilla, or groin.

A condition in which abnormal cells have not spread outside the duct, lobule, or nipple to other tissues of the breast. There are 3 types of breast carcinoma in situ: DUCTAL CARCINOMA IN SITU; LOBULAR CARCINOMA IN SITU; and PAGET DISEASE OF THE NIPPLE

A transplantable carcinoma of the rat that originally appeared spontaneously in the mammary gland of a pregnant albino rat, and which now resembles a carcinoma in young transplants and a sarcoma in older transplants. (Stedman, 25th ed)

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