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Checkpoint Inhibitor
Axitinib and Avelumab in Treating Patients With Recurrent or Metastatic 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
- Cancer
- Progressive Disease
- Adenoid Cystic Carcinoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 40 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 40 months
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 moreSide effects data
From 2019 Phase 2 trial • 13 Patients • NCT0212964730%
Mucositis
10%
Fatigue
10%
Rash
10%
nausea
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,551 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,540 Total Patients Enrolled
Renata FerrarottoPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
133 Total Patients Enrolled