Amivantamab for Salivary Gland Cancer

Recruiting at4 trial locations

Overseen by Trisha Wise-Draper, MD,PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Trisha Wise-Draper

Must not be taking: Chemotherapy, Immunotherapy

Disqualifiers: HIV, Cardiovascular disease, Hepatitis, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing amivantamab, a medication that targets specific proteins to stop cancer growth, in patients with a rare type of cancer called adenoid cystic carcinoma (ACC). ACC often comes back and spreads even after surgery and radiation. The medication aims to block proteins that help the cancer grow and spread.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy or immunotherapy within 4 weeks before starting the study, and a 30-day break from any previous investigational drugs is required.

What makes the drug Amivantamab unique for treating salivary gland cancer?

Amivantamab is unique because it targets specific molecular alterations in salivary gland cancers, such as HER2 upregulation, which are not effectively addressed by traditional chemotherapy or immunotherapy. This targeted approach can potentially improve treatment outcomes for patients with these rare and aggressive cancers. ^{1 2 3 4 5}

Research Team

Trisha Wise-Draper, MD,PhD

Principal Investigator

University of Cincinnati

Eligibility Criteria

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.

Inclusion Criteria

Presence of measurable disease as defined by RECIST v1.1

I am 18 years old or older.

Before enrollment, a participant must be (as defined in Appendix 2: Contraceptive Guidance and Collection of Pregnancy Information)

Exclusion Criteria

My eye condition is stable.

History of allergy or intolerance to study drug components.

I have an ongoing heart condition.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive amivantamab at 1050mg weekly for the first cycle and biweekly thereafter

2 years

Weekly visits for the first cycle, biweekly visits thereafter

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Treatment Details

Interventions

• Amivantamab (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: Amivantamab Experimental Treatment 1 Intervention

Amivantamab weekly for the first cycle and biweekly thereafter.

Who Is Running the Clinical Trial?

Trisha Wise-Draper

Lead Sponsor

Trials

6

Recruited

230+

Findings from Research

Surgery, guided by imaging techniques like MRI or CT scans, is the primary treatment for salivary gland tumors, with a focus on preserving the facial nerve and ensuring excision margins of at least 5 mm for malignant tumors.

Adjuvant therapies, including radiation and chemotherapy, are being explored for high-risk cases, with ongoing trials investigating the combination of cisplatin and radiation therapy, while targeted therapies are also under research to improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of salivary gland tumors. Andry, G., Hamoir, M., Locati, LD., et al.[2022]

In a study of six patients with metastatic salivary gland carcinoma treated with trastuzumab and a taxane, the therapy was well tolerated and resulted in five partial responses and a median progression-free survival of 10.8 months, indicating its efficacy.

One patient achieved a complete and durable remission, and trastuzumab showed greater activity than androgen deprivation therapy when both HER-2 and androgen receptors were co-expressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metastatic HER-2-positive salivary gland carcinoma treated with trastuzumab and a taxane: a series of six patients. De Block, K., Vander Poorten, V., Dormaar, T., et al.[2017]

In a phase 2 trial involving 64 patients with metastatic salivary gland cancers, the combination of nivolumab and ipilimumab showed limited efficacy, with only 6% of patients with adenoid cystic carcinoma responding, while 16% of patients with other salivary gland cancers had objective responses.

The treatment was associated with significant safety concerns, as 38% of patients experienced severe adverse events, and the median progression-free survival was only 4.4 months for adenoid cystic carcinoma and 2.2 months for other types, indicating a need for more effective therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nivolumab plus ipilimumab in advanced salivary gland cancer: a phase 2 trial. Vos, JL., Burman, B., Jain, S., et al.[2023]

Salivary gland carcinomas (SGC) have historically been difficult to treat with standard chemotherapy and immunotherapy, but recent discoveries of targetable molecular alterations have led to improved treatment outcomes.

Identified alterations such as HER2 upregulation and NTRK gene fusions are paving the way for precision therapies, with ongoing clinical trials exploring these new treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A molecular guide to systemic therapy in salivary gland carcinoma. Weaver, AN., Lakritz, S., Mandair, D., et al.[2023]

In a study of 287 patients with major salivary duct carcinoma, advanced age, larger tumor size (greater than 4 cm), and positive lymph nodes were identified as independent risk factors for poorer survival outcomes.

Postoperative radiotherapy significantly improved overall survival for patients with tumors larger than 4 cm, highlighting the potential benefit of adjuvant therapy in this subgroup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical value of adjuvant therapy on the prognosis of ductal carcinoma of the major salivary gland: a large-scale cohort study. Zhang, D., Li, L., Wen, T., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Management of salivary gland tumors. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Metastatic HER-2-positive salivary gland carcinoma treated with trastuzumab and a taxane: a series of six patients. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Nivolumab plus ipilimumab in advanced salivary gland cancer: a phase 2 trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A molecular guide to systemic therapy in salivary gland carcinoma. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Clinical value of adjuvant therapy on the prognosis of ductal carcinoma of the major salivary gland: a large-scale cohort study. [2023]