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Monoclonal Antibodies
Amivantamab for Salivary Gland Cancer
Phase 2
Recruiting
Led By Trisha Wise-Draper, MD, PhD
Research Sponsored by Trisha Wise-Draper
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years.
ECOG performance status
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial will test if amivantamab can shrink tumors in people with adenoid cystic carcinoma that has returned or spread.
Who is the study for?
This trial is for adults (18+) with adenoid cystic carcinoma, which can include non-salivary gland origins. Participants must have measurable disease and be in a stable condition, including those with HIV on effective therapy or treated brain metastases without recent progression. Prior cancers are okay if they don't affect this study's safety or results. People can't join if they've had certain treatments recently, have active hepatitis B/C, serious heart conditions, uncontrolled illnesses, unresolved severe side effects from previous cancer therapies, known allergies to amivantamab components or a history of specific lung diseases.Check my eligibility
What is being tested?
The trial is testing the effectiveness of amivantamab in patients with recurrent and metastatic adenoid cystic carcinoma that cannot be cured by other treatments. Amivantamab is an investigational drug given to see if it can control the growth of cancer cells.See study design
What are the potential side effects?
Potential side effects of amivantamab may include allergic reactions at the infusion site, fatigue, nausea and vomiting. There could also be changes in blood tests that monitor liver function and risks for developing infections due to immune system effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My daily activity is not severely restricted by my health.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate measured by RECIST criteria
Secondary outcome measures
Progression free survival -measured as time of treatment allocation to confirmed progressive disease or death.
Safety- measured by CTCAE v5 criteria and toxicity evaluation
Other outcome measures
Molecular signatures of response and resistance- measured by comprehensive analysis of Transcriptome Sequencing
Percent immune cell infiltration in responders versus non-responders, determined by IHC and/or IF
Quality of life - measured via FACT-HN
Trial Design
1Treatment groups
Experimental Treatment
Group I: AmivantamabExperimental Treatment1 Intervention
Amivantamab weekly for the first cycle and biweekly thereafter.
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Who is running the clinical trial?
Trisha Wise-DraperLead Sponsor
5 Previous Clinical Trials
214 Total Patients Enrolled
Trisha Wise-Draper, MD, PhDPrincipal InvestigatorUniversity of Cincinnati
4 Previous Clinical Trials
178 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My eye condition is stable.I am 18 years old or older.I have an ongoing heart condition.I do not have any active liver infections.I am not currently on any experimental drugs, or it has been 30 days since my last dose.I am not pregnant and will not breastfeed if treated.My cancer is confirmed as adenoid cystic carcinoma, not limited to salivary glands.My daily activity is not severely restricted by my health.My organs and bone marrow are working well.My brain scans show no cancer growth after treatment for brain metastases in the last month.I have previously used amivantamab.My cancer has returned or spread and cannot be cured with surgery or other treatments. It has also gotten worse in the last 6 months.I haven't had chemotherapy or immunotherapy in the last 4-6 weeks.I have recovered from previous cancer treatment side effects, except for hair loss or mild nerve pain.I can take care of myself but might not be able to do active work.My doctor agrees that my brain metastases don't need immediate treatment.I have been vaccinated for hepatitis B or have a low hepatitis B viral load.I have had hepatitis C but am now virus-free after treatment.I have severe heart failure or was hospitalized for it within the last 6 months.I have a rash from cancer immunotherapy that hasn't healed.I have or had lung inflammation not caused by an infection.I have another cancer type, but it won't affect this trial's treatment.I will use a condom during the study and for 6 months after, and if my partner can get pregnant, they will also use birth control.I haven't had major surgery or significant injury in the last 4 weeks, or if I did, I'm fully recovered.My cancer has returned or spread and cannot be cured with surgery or other treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Amivantamab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this a new type of clinical trial?
"Since 2016, Amivantamab has been the focus of 9 different clinical studies. The first study was sponsored by Janssen Research & Development, LLC in 2016 and 780 people were recruited. Amivantamab received Phase 1 drug approval after this initial study. Currently, these 9 active studies are being conducted across 105 cities and 33 countries."
Answered by AI
What are Amivantamab's primary therapeutic applications?
"Amivantamab can be used to treat patients that have received platinum based therapy, exons, and malignant neoplasms in the past."
Answered by AI
What is the FDA's current stance on Amivantamab?
"Amivantamab's safety is based on preliminary data and falls in the 2 range."
Answered by AI
Are new participants being recruited for this clinical trial at this time?
"This study, which is currently seeking patients, was originally posted on August 5th, 2022. The last edit to the listing was also made on that date."
Answered by AI
Could you share how many people are taking part in this research?
"The clinical trial is recruiting patients, with 18 participants needed from 1 site. The original posting was on 8/5/2022, and there have been no updates since."
Answered by AI
Who else is applying?
What state do they live in?
Connecticut
What site did they apply to?
University of Cincinnati Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I was just diagnosed with Adenoid Cystic Carcinoma through fine needle biopsy last week. As soon as I get my MRI results I will be searching for a hospital to have my 0.7 cm tumor removed. I live in Puerto Rico and finding comprehensive medical treatment can be a challenge. I have been searching for sites that specialize in this cancer and realize I need to try the latest research in hopes of improving my chances of survival. I have family in Cincinnati that I can stay with for the duration of the treatment.
PatientReceived no prior treatments
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