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Checkpoint Inhibitor

Axitinib for Adenoid Cystic Carcinoma

Phase 2

Waitlist Available

Led By Renata Ferrarotto

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 40 months

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

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.

Eligible Conditions

Adenoid Cystic Carcinoma
Progressive Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 40 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 40 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 40 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assess the Objective Response Rate (ORR) to Axitinib and Avelumab Combination According to RECIST 1.1 Criteria.

Secondary study objectives

Estimate Duration of Response

Estimate Median Progression-free Survival, Median Overall Survival

Estimate Progression Free Survival Rate at 6 Months After Start of Treatment, Overall Survival Rate 6 Months After Start of Treatment

+1 more

Side effects data

From 2019 Phase 2 trial • 13 Patients • NCT02129647

30%

Mucositis

10%

Fatigue

10%

Rash

10%

nausea

100%

80%

60%

40%

20%

Study treatment Arm

Axitinib

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Axitinib

FDA approved

Avelumab

FDA approved

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