Enfortumab Vedotin for Adenoid Cystic Carcinoma

Recruiting at 6 trial locations

Overseen By David Pfister, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Brain metastasis, Prior malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 months

34 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial requires that at least 4 weeks have passed since your last systemic treatment before starting the study drug. This suggests you may need to stop certain medications, but the protocol does not specify all details about other medications you might be taking.

What data supports the effectiveness of the drug Enfortumab Vedotin for treating Adenoid Cystic Carcinoma?

Enfortumab Vedotin has shown effectiveness in treating advanced urothelial carcinoma, with a 44% response rate in patients who had previously received other treatments. This suggests potential for effectiveness in other cancers, although specific data for Adenoid Cystic Carcinoma is not available. ^{1 2 3 4 5}

How is the drug Enfortumab Vedotin different from other treatments for adenoid cystic carcinoma?

Enfortumab Vedotin is unique because it is an antibody-drug conjugate that targets a protein called Nectin-4, which is not a common target in adenoid cystic carcinoma treatments. This drug is designed to deliver a toxic agent directly to cancer cells, potentially offering a new approach for patients with this condition. ^{1 3 4 6 7}

What is the purpose of this trial?

The purpose of this study is to find out whether enfortumab vedotin is an effective and safe treatment for people with adenoid cystic carcinoma (ACC).

Research Team

Alan Ho, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This clinical trial is for individuals with adenoid cystic carcinoma, a type of cancer that can occur in various parts of the body. Participants should have this specific diagnosis to be eligible.

Inclusion Criteria

I have or can provide tumor tissue samples for study.

Participants must be willing to sign the written informed consent form

Screening laboratory values must meet specific criteria including Neutrophils, Platelets, Hemoglobin, AST, ALT, Total Bilirubin, Serum creatinine, and Creatinine clearance

Exclusion Criteria

I have brain metastasis that has not been treated.

I haven't had cancer treatment in the last 4 weeks.

I haven't had serious heart issues like heart failure, unstable angina, heart attack, or dangerous arrhythmias in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are treated with enfortumab vedotin intravenously on Days 1, 8, and 15 of a 28-day cycle

12 months

3 visits per 28-day cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Enfortumab Vedotin

Trial Overview The study is testing enfortumab vedotin's effectiveness and safety as a treatment option for those suffering from adenoid cystic carcinoma.

Participant Groups

Group I: Enfortumab Vedotin Experimental Treatment 1 Intervention

Participants are treated with enfortumab vedotin at the FDA-approved dose and schedule of intravenously on Days 1, 8 and 15 of a 28-day cycle.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Astellas Pharma US, Inc.

Industry Sponsor

Trials

90

Recruited

12,900+

Naoki Okamura

Astellas Pharma US, Inc.

Chief Executive Officer since 2023

Not available

Tadaaki Taniguchi

Astellas Pharma US, Inc.

Chief Medical Officer since 2023

MD, PhD

Findings from Research

Enfortumab vedotin, a treatment for advanced bladder cancer, can cause severe skin reactions, with a case report highlighting a patient who developed toxic epidermal necrolysis shortly after starting the drug.

The case emphasizes the need for careful monitoring of skin reactions and suggests that if such reactions occur, treatment may need to be reduced or stopped to prevent serious complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxic epidermal necrolysis after the administration of enfortumab vedotin for urinary bladder urothelial carcinoma. Mimura, Y., Kobayashi, A., Utazu, H., et al.[2023]

Enfortumab vedotin, an antibody drug conjugate for advanced urothelial carcinoma, can cause extravasation leading to serious skin reactions like bullae and cellulitis, as seen in two reported cases.

Both patients successfully managed their cellulitis conservatively and resumed treatment without further complications, suggesting that with proper management, the risks associated with extravasation can be mitigated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug extravasation with Enfortumab vedotin. Grant, CR., de Kouchkovsky, D., Kalebasty, AR., et al.[2023]

Enfortumab vedotin showed a 44% overall response rate in a phase II trial involving 125 patients with locally advanced or metastatic urothelial carcinoma who had previously undergone platinum-based chemotherapy and PD-1 or PD-L1 checkpoint inhibitor treatment.

While nearly all patients experienced treatment-related adverse events, most of these side effects were mild to moderate, indicating a manageable safety profile for this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enfortumab Vedotin Checks Urothelial Cancer. [2020]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Toxic epidermal necrolysis after the administration of enfortumab vedotin for urinary bladder urothelial carcinoma. [2023]

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

EV-301 long-term outcomes: 24-month findings from the phase III trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Drug extravasation with Enfortumab vedotin. [2023]

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

Pivotal Trial of Enfortumab Vedotin in Urothelial Carcinoma After Platinum and Anti-Programmed Death 1/Programmed Death Ligand 1 Therapy. [2020]

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

Enfortumab Vedotin Checks Urothelial Cancer. [2020]

6. Spain pubmed.ncbi.nlm.nih.gov

Enfortumab vedotin to treat urothelial carcinoma. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Use of enfortumab vedotin in an HIV-positive patient with urothelial carcinoma. [2023]