Salivary Gland CancerPhase 2NCT05074940
Amivantamab in Adenoid Cystic Carcinoma
A Phase 2 study testing Amivantamab in people with Salivary Gland Cancer, run by Trisha Wise-Draper at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Salivary Gland Cancer
- What is being tested?
- Amivantamab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 5 sitesUnited States
- Study dates
- 5 Aug 2022to 5 Aug 2028
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- Participant must be willing and able to adhere to the lifestyle restrictions specified in this protocol.
Who cannot join
- History of allergy or intolerance to study drug components.
- Prior use of amivantamab.
- 3 .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.
- 4. 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.
- 5. 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.
- 6.Participant is positive for human immunodeficiency virus (HIV), with 1 or more of the following:
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- 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).
- 7.Other clinically active infectious liver disease.
- 8. 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 enrollment or any of the following within 6 months prior to enrollment: myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary/peripheral artery bypass graft, or any acute coronary syndrome. Clinically non-significant thrombosis, such as non-obstructive catheter-associated thrombus(clots), or incidental or asymptomatic pulmonary embolism are not exclusionary.
- 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.
- Congestive heart failure (CHF), defined as New York Heart Association (NYHA)class III-IV or hospitalization for CHF (any NYHA class; refer to Appendix 3:New York Heart Association Criteria) within 6 months of starting drug.
- 9. Subject has uncontrolled illness, including but not limited to:
- Uncontrolled diabetes
- Ongoing or active infection (includes infection requiring treatment with antimicrobial therapy [participants will be required to complete antibiotics 1 week prior to starting study treatment] or diagnosed or suspected viral infection).
- Active bleeding diathesis
- Impaired oxygenation requiring continuous oxygen supplementation (e.g., due to medical condition requiring chronic continuous oxygen therapy).
- Psychiatric illness/social situation that would limit compliance with study requirements.
- Any ophthalmologic condition that is clinically unstable
- 10. Active or past medical history of Interstitial lung disease (ILD)/pneumonitis, including drug-induced or radiation ILD/ pneumonitis.
- 11. Participant had major surgery excluding placement of vascular access or tumor biopsy or had significant traumatic injury within 4 weeks before enrollment, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study. Note: Participants with planned surgical procedures to be conducted under local anesthesia may participate.
- 12. Immune-mediated rash from checkpoint inhibitors that has not resolved prior to enrollment.
- 13. 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.
- 14. 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.
- 15. Pregnant women are excluded from this study. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with breastfeeding should be discontinued if the mother is treated with amivantamab.
- 16. Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Rogel Cancer Center - University of Michigan Health
Ann Arbor, Michigan, 48109
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
UC San Diego Moores Cancer Center
La Jolla, California, 92093
Washington University - School of Medicine in St. Louis
St Louis, Missouri, 63130
About this study
Official title: Phase II Study to Evaluate Amivantamab in Recurrent and Metastatic Adenoid Cystic Carcinoma
The purpose of the study is to determine if treatment with amivantamab will be efficacious in patients with recurrent and metastatic adenoid cystic carcinoma.
Read the 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).
- Conditions
- Salivary Gland Cancer
- Being tested
- Amivantamab
- Keywords
- Salivary Gland Cancer, Amivantamab, Adenoid cystic carcinoma
- Medical subject headings
- Salivary Gland Neoplasms, Carcinoma, Adenoid Cystic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmivantamabDrug
Patients will receive amivantamab at 1050mg weekly for the first cycle and biweekly thereafter (1400mg for patients ≥80kg).
| Study group | Role | What they receive |
|---|---|---|
| Amivantamab | Experimental | Amivantamab weekly for the first cycle and biweekly thereafter. Receives: Drug: Amivantamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."
Measured: 2 years
Secondary outcomes (2)
Progression Free Survival -Measured as Time of Treatment Allocation to Confirmed Progressive Disease or Death.
To determine the progression free survival with recurrent and metastatic adenoid cystic carcinoma treated with amivantamab.
Measured: Up to 27 months
Number of Participants With Adverse Events
To determine safety of amivantamab in patients with recurrent and metastatic adenoid cystic carcinoma as measured by CTCAE v5. Any subject that had at least one adverse event will be counted.
Measured: Up to 16 months regardless of attribution should be collected continuously during the treatment period and for a minimum of 30 days following the last dose of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start5 Aug 2022
- Primary completion2 Mar 2026
- Study completion5 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Salivary Gland CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label phase II single arm trial
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trisha Wise-Draper
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Trisha Wise-Draper, University of Cincinnati
- Investigators
- Trisha Wise-Draper, MD, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074940
- Sponsor's protocol ID
- UCCC-HN-21-02
- Status last verified
- May 2026
- First submitted
- 15 Sep 2021
- Last updated
- 8 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hanna GJ, Zamulko OY, Grover P, Adkins DR, Oppelt PJ, Romano AE, Lehn MA, Bachmann LM, Wikenheiser-Brokamp KA, Lemmon CA, Forsythe AJ, Allen CL, Pan J, Rai SN, El-Gamal D, Wise-Draper TM. Amivantamab for Recurrent or Metastatic Adenoid Cystic Carcinoma: A Phase 2 Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2026 Apr 1;152(4):376-383. doi: 10.1001/jamaoto.2025.5404.
PubMed 41746627
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Evaluate Amivantamab in Recurrent and Metastatic Adenoid Cystic Carcinoma
- ClinicalTrials.gov ID
- NCT05074940
- Acronym / sponsor ID
- UCCC-HN-21-02
- Conditions
- Salivary Gland Cancer
- Keywords
- Salivary Gland Cancer, Amivantamab, Adenoid cystic carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Trisha Wise-DraperUniversity, hospital or other
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 5 Aug 2028 (estimated)
- First posted
- 12 Oct 2021 (actual)
- Results
- Posted 8 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label phase II single arm trial
| Arm | Type | Receives |
|---|---|---|
| Amivantamab | Experimental | Drug: AmivantamabAmivantamab weekly for the first cycle and biweekly thereafter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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).
Key exclusion criteria (31 listed)
- History of allergy or intolerance to study drug components.
- Prior use of amivantamab.
- 3 .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.
- 4. 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.
- 5. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmivantamabPatients will receive amivantamab at 1050mg weekly for the first cycle and biweekly thereafter (1400mg for patients ≥80kg). | Drug | Amivantamab |
Primary outcome
Overall Response Rate Measured by RECIST Criteria
Time frame: 2 years
To determine the overall response rate in patients with recurrent and metastatic adenoid cystic carcinoma treated with amivantamab. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."
2 secondary outcomes
Progression Free Survival -Measured as Time of Treatment Allocation to Confirmed Progressive Disease or Death.
Time frame: Up to 27 months
Number of Participants With Adverse Events
Time frame: Up to 16 months regardless of attribution should be collected continuously during the treatment period and for a minimum of 30 days following the last dose of study treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41746627Hanna GJ, Zamulko OY, Grover P, Adkins DR, Oppelt PJ, Romano AE, Lehn MA, Bachmann LM, Wikenheiser-Brokamp KA, Lemmon CA, Forsythe AJ, Allen CL, Pan J, Rai SN, El-Gamal D, Wise-Draper TM. Amivantamab for Recurrent or Metastatic Adenoid Cystic Carcinoma: A Phase 2 Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2026 Apr 1;152(4):376-383. doi: 10.1001/jamaoto.2025.5404.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trisha Wise-Draper, MD, PhD principal investigator
University of Cincinnati
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amivantamab in people with Salivary Gland Cancer, run by Trisha Wise-Draper at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate Measured by RECIST Criteria (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05074940, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.