Amivantamab in Adenoid Cystic Carcinoma
Primary Purpose
Salivary Gland Cancer
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Amivantamab
Sponsored by
About this trial
This is an interventional treatment trial for Salivary Gland Cancer focused on measuring Salivary Gland Cancer, Amivantamab, Adenoid cystic carcinoma
Eligibility Criteria
Inclusion Criteria:
- Pathologically or cytologically confirmed adenoid cystic carcinoma. Non-salivary gland primary sites are allowed.
- Recurrent and/or metastatic disease not amenable to other curative intent therapy.
- Presence of measurable disease as defined by RECIST v1.1
- Age ≥18 years.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
- Patients must have adequate organ and marrow function
- Known human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression in the last 4 weeks.
- Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Exclusion Criteria
- History of allergy or intolerance to study drug components.
- Prior use of amivantamab
- Patients who have had chemotherapy or immunotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. Palliative radiotherapy is allowed and does not require washout as long as it does not include a target lesion.
- Positive hepatitis B (hepatitis B virus [HBV]) surface antigen (HBsAg) Note: Subjects with a prior history of HBV demonstrated by positive hepatitis B core antibody are eligible if they have at Screening 1) a negative HBsAg and 2) a HBV DNA (viral load) below the lower limit of quantification, per local testing. Subjects with a positive HBsAg due to recent vaccination are eligible if HBV DNA (viral load) is below the lower limit of quantification, per local testing.
- Positive hepatitis C antibody (anti-HCV). Note: Subjects with a prior history of HCV, who have completed antiviral treatment and have subsequently documented HCV RNA below the lower limit of quantification per local testing are eligible.
- Other clinically active or chronic liver disease.
Participant has active cardiovascular disease including, but not limited to:
- A medical history of deep vein thrombosis or pulmonary embolism within 1 month prior to first dose of study drug or any of the following within 6 months prior to the first dose of study drug: myocardial infarction, unstable angina, stroke, transient ischemic attack, uncontrolled hypertension, or clinically significant cardiac arrythmia. Clinically non-significant thrombosis, such as non-obstructive catheter-associated clots, are not exclusionary.
- Prolonged corrected QTcF >470 msec),
- Congestive heart failure (CHF), defined as New York Heart Association (NYHA) class III-IV or hospitalization for CHF (any NYHA class; refer to Appendix: New York Heart Association Criteria) within 6 months of randomization.
- Subject has uncontrolled inter-current illness, including but not limited to poorly controlled diabetes, ongoing or active infection (i.e., has discontinued all antibiotics for at least one week prior to first dose of study drug), or psychiatric illness/social situation that would limit compliance with study requirements. Subjects with medical conditions requiring chronic continuous oxygen therapy are excluded.
- Active or past medical history of Interstitial lung disease (ILD)/pneumonitis, including drug-induced ILD/pneumonitis or radiation pneumonitis requiring treatment with prolonged steroids or other immune suppressive agents that is unresolved or resolved within the last 3 months.
- Immune-mediated rash from checkpoint inhibitors that has not resolved prior to enrollment.
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia or Grade 2 neuropathy.
- Patients who are receiving any other investigational agents. Patients who have received other investigational agents previously who are no longer receiving these investigational agents may be eligible at the discretion of the PI. A 30 day washout from last dose of previous anticancer drug is required.
Sites / Locations
- UC San Diego Moores Cancer Center
- Dana Farber Cancer InstituteRecruiting
- Rogel Cancer Center - University of Michigan Health
- Washington University - School of Medicine in St. LouisRecruiting
- University of Cincinnati Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Amivantamab
Arm Description
Amivantamab weekly for the first cycle and biweekly thereafter.
Outcomes
Primary Outcome Measures
Overall response rate measured by RECIST criteria
To determine the overall response rate in patients with recurrent and metastatic adenoid cystic carcinoma treated with amivantamab.
Secondary Outcome Measures
Progression free survival -measured as time of treatment allocation to confirmed progressive disease or death.
To determine the progression free survival and overall survival in patients with recurrent and metastatic adenoid cystic carcinoma treated with amivantamab.
Safety- measured by CTCAE v5 criteria and toxicity evaluation
To determine safety of amivantamab in patients with recurrent and metastatic adenoid cystic carcinoma.
Full Information
NCT ID
NCT05074940
First Posted
September 15, 2021
Last Updated
October 24, 2023
Sponsor
Trisha Wise-Draper
1. Study Identification
Unique Protocol Identification Number
NCT05074940
Brief Title
Amivantamab in Adenoid Cystic Carcinoma
Official Title
Phase II Study to Evaluate Amivantamab in Recurrent and Metastatic Adenoid Cystic Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 5, 2022 (Actual)
Primary Completion Date
August 5, 2024 (Anticipated)
Study Completion Date
August 5, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Trisha Wise-Draper
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to determine if treatment with amivantamab will be efficacious in patients with recurrent and metastatic adenoid cystic carcinoma.
Detailed Description
ACC is a rare cancer of salivary glands and other glandular tissue. It is slow growing and is usually treated with surgery and radiation. However, this type of cancer tends to have a high rate of recurrence and metastatic spread, which develops over several years. We hypothesize that amivantamab, a bispecific EGFR and MET inhibitor will be efficacious in ACC. Patients will receive amivantamab at 1050mg weekly for the first cycle and biweekly thereafter (1400mg for patients ≥80kg).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Salivary Gland Cancer
Keywords
Salivary Gland Cancer, Amivantamab, Adenoid cystic carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Open-label phase II single arm trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Amivantamab
Arm Type
Experimental
Arm Description
Amivantamab weekly for the first cycle and biweekly thereafter.
Intervention Type
Drug
Intervention Name(s)
Amivantamab
Intervention Description
Patients will receive amivantamab at 1050mg weekly for the first cycle and biweekly thereafter (1400mg for patients ≥80kg).
Primary Outcome Measure Information:
Title
Overall response rate measured by RECIST criteria
Description
To determine the overall response rate in patients with recurrent and metastatic adenoid cystic carcinoma treated with amivantamab.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Progression free survival -measured as time of treatment allocation to confirmed progressive disease or death.
Description
To determine the progression free survival and overall survival in patients with recurrent and metastatic adenoid cystic carcinoma treated with amivantamab.
Time Frame
5 years
Title
Safety- measured by CTCAE v5 criteria and toxicity evaluation
Description
To determine safety of amivantamab in patients with recurrent and metastatic adenoid cystic carcinoma.
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Molecular signatures of response and resistance- measured by comprehensive analysis of Transcriptome Sequencing
Description
To determine the molecular signatures of response and resistance to amivantamab
Time Frame
2 years
Title
Percent immune cell infiltration in responders versus non-responders, determined by IHC and/or IF
Description
To determine immune cell infiltration in biopsy samples and correlation with response.
Time Frame
2 years
Title
Quality of life - measured via FACT-HN
Description
To evaluate the effect of amivantamab on patient quality of life using standardized patient reported outcome surveys.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pathologically or cytologically confirmed adenoid cystic carcinoma. Non-salivary gland primary sites are allowed.
Recurrent and/or metastatic disease not amenable to other curative intent therapy.
Presence of measurable disease as defined by RECIST v1.1
Age ≥18 years.
ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
Patients must have adequate organ and marrow function
Known human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression in the last 4 weeks.
Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Exclusion Criteria
History of allergy or intolerance to study drug components.
Prior use of amivantamab
Patients who have had chemotherapy or immunotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study. Palliative radiotherapy is allowed and does not require washout as long as it does not include a target lesion.
Positive hepatitis B (hepatitis B virus [HBV]) surface antigen (HBsAg) Note: Subjects with a prior history of HBV demonstrated by positive hepatitis B core antibody are eligible if they have at Screening 1) a negative HBsAg and 2) a HBV DNA (viral load) below the lower limit of quantification, per local testing. Subjects with a positive HBsAg due to recent vaccination are eligible if HBV DNA (viral load) is below the lower limit of quantification, per local testing.
Positive hepatitis C antibody (anti-HCV). Note: Subjects with a prior history of HCV, who have completed antiviral treatment and have subsequently documented HCV RNA below the lower limit of quantification per local testing are eligible.
Other clinically active or chronic liver disease.
Participant has active cardiovascular disease including, but not limited to:
A medical history of deep vein thrombosis or pulmonary embolism within 1 month prior to first dose of study drug or any of the following within 6 months prior to the first dose of study drug: myocardial infarction, unstable angina, stroke, transient ischemic attack, uncontrolled hypertension, or clinically significant cardiac arrythmia. Clinically non-significant thrombosis, such as non-obstructive catheter-associated clots, are not exclusionary.
Prolonged corrected QTcF >470 msec),
Congestive heart failure (CHF), defined as New York Heart Association (NYHA) class III-IV or hospitalization for CHF (any NYHA class; refer to Appendix: New York Heart Association Criteria) within 6 months of randomization.
Subject has uncontrolled inter-current illness, including but not limited to poorly controlled diabetes, ongoing or active infection (i.e., has discontinued all antibiotics for at least one week prior to first dose of study drug), or psychiatric illness/social situation that would limit compliance with study requirements. Subjects with medical conditions requiring chronic continuous oxygen therapy are excluded.
Active or past medical history of Interstitial lung disease (ILD)/pneumonitis, including drug-induced ILD/pneumonitis or radiation pneumonitis requiring treatment with prolonged steroids or other immune suppressive agents that is unresolved or resolved within the last 3 months.
Immune-mediated rash from checkpoint inhibitors that has not resolved prior to enrollment.
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia or Grade 2 neuropathy.
Patients who are receiving any other investigational agents. Patients who have received other investigational agents previously who are no longer receiving these investigational agents may be eligible at the discretion of the PI. A 30 day washout from last dose of previous anticancer drug is required.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
UCCC Clinical Trials Office
Phone
513-584-7698
Email
cancer@uchealth.com
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Vollmer
Phone
513-213-3203
Email
mccordce@ucmail.uc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trisha Wise-Draper, MD, PhD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC San Diego Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jasmine Cate
Email
jcate@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Ezra Cohen, MD
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liam Oakley
Email
liamb_oakley@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Glenn Hanna, MD
Facility Name
Rogel Cancer Center - University of Michigan Health
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elaine Granch
Email
granche@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Paul Swiecicki
Facility Name
Washington University - School of Medicine in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brianne Thomeczek
Email
bthomecz@wustl.edu
First Name & Middle Initial & Last Name & Degree
Douglas Adkins, MD
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UCCC CTO
Phone
513-584-7698
Email
cancer@uchealth.com
First Name & Middle Initial & Last Name & Degree
Trisha Wise-Draper, MD,PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Amivantamab in Adenoid Cystic Carcinoma
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