What side effects are associated with this type of intervention?

Common treatments for Salivary Gland Cancer, particularly those targeting EGFR and MET pathways like Amivantamab, often result in side effects such as acneiform rash, diarrhea, hepatotoxicity, peripheral edema, fatigue, and gastrointestinal disturbances. These side effects are generally manageable with appropriate supportive care.

What prior FDA approvals exist?

FDA-approved treatments for salivary gland cancer are limited, with no specific approvals for drugs targeting EGFR and MET pathways like amivantamab. However, HER2 overexpression is noted in a significant proportion of salivary gland ductal carcinoma cases, making HER2-targeted therapies relevant. Treatments such as trastuzumab, which targets HER2, may be considered for these patients. Broader treatment options include surgery, radiation, and chemotherapy, often tailored to the specific type and genetic profile of the tumor.

What other types of research exist?

Promising novel alternatives to Amivantamab for Salivary Gland Cancer patients include Afatinib combined with Pembrolizumab, as studied in the ALPHA study for recurrent or metastatic HNSCC. Additionally, CDK4/6 inhibitors like Palbociclib, especially in combination with other agents such as Cetuximab, are being investigated for their potential efficacy in similar cancer types.

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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

Must not have

Any ophthalmologic condition that is clinically unstable

Other clinically active infectious liver disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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 below

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I am 18 years old or older.

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My daily activity is not severely restricted by my health.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My eye condition is stable.

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I do not have any active liver infections.

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I am not pregnant and will not breastfeed if treated.

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I have previously used amivantamab.

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I have a rash from cancer immunotherapy that hasn't healed.

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I have or had lung inflammation not caused by an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall response rate measured by RECIST criteria

Secondary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: AmivantamabExperimental Treatment1 Intervention

Amivantamab weekly for the first cycle and biweekly thereafter.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Salivary Gland Cancer include surgery, radiation therapy, and targeted therapies. Targeted therapies, such as Amivantamab, work by specifically inhibiting pathways that are crucial for cancer cell growth and survival. Amivantamab is a bispecific antibody that targets both EGFR and MET pathways, which are often overactive in cancer cells, leading to uncontrolled growth and metastasis. By blocking these pathways, Amivantamab can effectively reduce tumor growth and spread. This is particularly important for Salivary Gland Cancer patients as it offers a more precise treatment option with potentially fewer side effects compared to traditional chemotherapy, thereby improving the quality of life and treatment outcomes.

Afatinib and Pembrolizumab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (ALPHA Study): A Phase II Study with Biomarker Analysis.Current Landscape of Targeted Therapy in Hormone Receptor-Positive and HER2-Negative Breast Cancer.Efficacy of treatment for acneiform eruptions related to epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) for non-small cell lung cancer (NSCLC): A protocol of systematic review and network meta-analysis.