Amivantamab in Adenoid Cystic Carcinoma

NCT05074940 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: UCCC-HN-21-02
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 5

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.

Conditions

Salivary Gland Cancer

Keywords

Salivary Gland Cancer; Amivantamab; Adenoid cystic carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (2)

• Progression free survival -measured as time of treatment allocation to confirmed progressive disease or death.

  5 years

• Safety- measured by CTCAE v5 criteria and toxicity evaluation

  5 years

Other Outcomes (3)

• Molecular signatures of response and resistance- measured by comprehensive analysis of Transcriptome Sequencing

  2 years

• Percent immune cell infiltration in responders versus non-responders, determined by IHC and/or IF

  2 years

• Quality of life - measured via FACT-HN

  2 years

Study Arms (1)

Amivantamab

EXPERIMENTAL

Amivantamab weekly for the first cycle and biweekly thereafter.

Drug: Amivantamab

Interventions

Amivantamab DRUG

Patients will receive amivantamab at 1050mg weekly for the first cycle and biweekly thereafter (1400mg for patients ≥80kg).

Amivantamab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. Patients must have had evidence of progressive disease by RECIST v1.1 within 6 months of study enrollment.
• Presence of measurable disease as defined by RECIST v1.1
• Age ≥18 years.
• ECOG performance status, see Appendix A).
• Patients must have adequate organ and marrow function
• 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 4weeks.
• 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.
• Before enrollment, a participant must be (as defined in Appendix 2: Contraceptive Guidance and Collection of Pregnancy Information)
• A participant of childbearing potential must have a negative serum (b-human chorionic gonadotropin \[b-hCG\]) at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study.
• A participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study drug.
• A participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for 6 months after receiving the last dose of study treatment. A participant who is sexually active with a partner of childbearing potential must agree to use a condom with spermicidal foam/gel/film/cream/suppository and his partner must also be practicing a highly effective method of contraception (i.e., established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device \[IUD\] or intrauterine system \[IUS\]). If the subject is vasectomized, they must still use a condom (with or without spermicide) for prevention of passage of exposure through ejaculation, but their partner is not required to use contraception.
• The subject must also not donate sperm during the study and for 6 months after receiving the last dose of study drug.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• 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.
• Participant is positive for human immunodeficiency virus (HIV), with 1 or more of the following:
• Receiving ART that may interfere with study treatment (consult sponsor for review of medication prior to enrollment)
• CD4 count \<350 at screening
• AIDS-defining opportunistic infection within 6 months of start of screening
• Not agreeing to start ART and be on ART\>4 weeks plus having HIV viral load\<400 copies/mL at end of 4-week period (to ensure ART is tolerated and HIV controlled).
• Other clinically active infectious liver disease.
• \. Participant has active cardiovascular disease including, but not limited to:
• Participant has a significant genetic predisposition to venous thromboembolic(VTE) events such as Factor V Leiden.
• Participant has a prior history of VTE and is not on appropriate therapeutic anticoagulation as per NCCN or local guidelines.
• Uncontrolled (persistent) hypertension: systolic blood pressure \>160 mm Hg;diastolic blood pressure \>100 mm Hg.

Sponsors & Collaborators

• Trisha Wise-Draper: lead

Study Sites (5)

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Rogel Cancer Center - University of Michigan Health

Ann Arbor, Michigan, 48109, United States

Location

Washington University - School of Medicine in St. Louis

St Louis, Missouri, 63130, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Salivary Gland Neoplasms; Carcinoma, Adenoid Cystic

Interventions

amivantamab

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Trisha Wise-Draper, MD, PhD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open-label phase II single arm trial

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 12, 2021
• Study Start: August 5, 2022
• Primary Completion: August 5, 2025
• Study Completion (Estimated): August 5, 2028
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)