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

Recruiting in Palo Alto (17 mi)

Overseen byRenata Ferrarotto

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial studies how well axitinib and avelumab work together in treating patients with adenoid cystic carcinoma that has returned or spread. Axitinib blocks enzymes needed for cancer growth, while avelumab helps the immune system attack the cancer. The goal is to see if this combination can better control the disease.

Research Team

Renata Ferrarotto

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Inclusion Criteria

Total bilirubin level =< 1.5 x ULN range

You have enough white blood cells called neutrophils in your body (at least 1.5 x 10^9/L).

Your platelet count should be at least 100 billion per liter (a measure of the amount of blood in your body).

See 19 more

Exclusion Criteria

Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 grade >= 3)

You cannot have any live vaccines within 4 weeks before starting the trial or during the trial. You may be allowed to have inactive vaccines.

Your high blood pressure is not well managed.

See 20 more

Treatment Details

Interventions

Avelumab (Checkpoint Inhibitor)
Axitinib (Tyrosine Kinase Inhibitor)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (axitinib, avelumab)Experimental Treatment2 Interventions

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

Avelumab is already approved in Japan for the following indications: