Enfortumab Vedotin for the Treatment of Unresectable or Metastatic Radioiodine Refractory Differentiated Thyroid Cancer, Anaplastic Thyroid Cancer, Medullary Thyroid Cancer, or NUT Carcinoma

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT07863765
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Metastatic Differentiated Thyroid Gland Carcinoma
  • Metastatic NUT Carcinoma
  • Metastatic Thyroid Gland Anaplastic Carcinoma
  • Metastatic Thyroid Gland Medullary Carcinoma
  • Refractory Differentiated Thyroid Gland Carcinoma
  • Stage III Differentiated Thyroid Gland Carcinoma AJCC v8
  • Stage III Thyroid Gland Medullary Carcinoma AJCC v8
  • Stage IV Differentiated Thyroid Gland Carcinoma AJCC v8
  • Stage IV Thyroid Gland Medullary Carcinoma AJCC v8
  • Unresectable Differentiated Thyroid Gland Carcinoma
  • Unresectable NUT Carcinoma
  • Unresectable Thyroid Gland Anaplastic Carcinoma
  • Unresectable Thyroid Gland Medullary Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo biopsy procedure
  • Biospecimen Collection — PROCEDURE
    Undergo blood and urine sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Enfortumab Vedotin — DRUG
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Survey Administration — OTHER
    Ancillary studies
  • X-Ray Imaging — PROCEDURE
    Undergo x-ray imaging

Study Details

This trial tests how well giving enfortumab vedotin works for the treatment of differentiated thyroid cancer that does not respond to treatment with radioiodine (refractory), anaplastic thyroid cancer, medullary thyroid cancer or NUT carcinoma that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic). Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of cancer cells. Enfortumab attaches to a protein called nectin-4 on cancer cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate.

Key Dates

First listed
Oct 7, 2026
Start date
May 5, 2027
Status verified
Oct 2026
Primary completion
May 5, 2030
Completion
May 5, 2031

Study Design

Enrollment
56 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (enfortumab vedotin)
    Patients receive enfortumab vedotin intravenously (IV) on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, x-ray imaging or MRI and blood and urine sample collection throughout the study and optionally undergo biopsy at progression.

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: At 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Jochen H. Lorch, MD
[email protected]
312-694-6959
Jochen H. Lorch, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Northwestern University· Chicago, IL

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