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

ConditionsMetastatic Differentiated Thyroid Gland CarcinomaMetastatic NUT CarcinomaMetastatic Thyroid Gland Anaplastic CarcinomaMetastatic Thyroid Gland Medullary CarcinomaRefractory Differentiated Thyroid Gland CarcinomaStage III Differentiated Thyroid Gland Carcinoma AJCC v8Stage III Thyroid Gland Medullary Carcinoma AJCC v8Stage IV Differentiated Thyroid Gland Carcinoma AJCC v8Stage IV Thyroid Gland Medullary Carcinoma AJCC v8Unresectable Differentiated Thyroid Gland CarcinomaUnresectable NUT CarcinomaUnresectable Thyroid Gland Anaplastic CarcinomaUnresectable Thyroid Gland Medullary Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

radioiodine refractory (RAIR) differentiated thyroid cancer (DTC)^A (including RAIR poorly differentiated thyroid cancer [PDTC])^A

radioiodine refractory (RAIR) differentiated thyroid cancer (DTC^1), (including RAIR poorly differentiated thyroid cancer ([PDTC²]), that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective

≥ 1 line of systemic therapy allowed including radioactive iodine (RAI) therapy, tyrosine kinase inhibitors (TKIs), targeted therapies, radiation therapy, chemotherapy and immunotherapy. NOTE: prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE) based antibody-drug conjugates (anti-drug congigates [ADCs] is not allowed.)

Washout of 2 weeks from prior anti-cancer treatments before start of study treatment (C1D1) required OR

Disqualifiers

Patients who have had prior treatment with chemotherapy, radiotherapy, biologics, investigational agents or devices, and/or anti-cancer treatment with immunotherapy ≤ 14 days prior to planned treatment start date

Patients who have had prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE) based antibody-drug conjugates (ADCs)

Patients who have had major surgery within 4 weeks of the planned date of the start of study treatment (C1D1)

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, neuropathy and other non-significant adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 6.0

Trial design

Design model

Single group

Treatments tested in this trial

  • Biopsy Procedure

    Procedure/Surgery

    Undergo biopsy procedure

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood and urine sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan

  • Enfortumab Vedotin

    Drug

    Given IV

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Survey Administration

    Other intervention

    Ancillary studies

  • X-Ray Imaging

    Procedure/Surgery

    Undergo x-ray imaging

Treatment groups

56 Participants
are divided into 1 treatment group
Group A: Treatment (enfortumab vedotin)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Progression free survival (PFS)

Calculated from the first dose of study treatment to the earliest occurrence of disease progression or death from any cause, whichever occurs first. Disease progression defined as progressive disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1, other documented clinical or radiographical progression per physician judgement, or death due to disease. Will be calculated as the Kaplan-Meier estimate of the survival function at 6 months, along with the 95% confidence interval.

Time frame
At 6 months

Secondary outcomes

1

Objective response rate

Defined as the proportion of patients who achieve a complete response or partial response as per RECIST v 1.1. The proportion of evaluable patients experiencing an objective response will be estimated with a 95% exact binomial confidence interval. The confidence interval will be adjusted for the sequential nature of the two-stage procedure.

Time frame
From the time of baseline imaging until the radiographic response has been confirmed, the patient experiences disease progression, or initiates subsequent anti-cancer therapy, up to 1 year
2

PFS

Will calculate the proportion of patients alive and without progression as described: Disease progression defined as progressive disease per RECIST v 1.1, other documented clinical or radiographical progression per physician judgement, or death due to disease. PFS will be analyzed using the Kaplan-Meier method. The overall (median) PFS estimate will be reported along with the confidence interval.

Time frame
From the first dose of study treatment to the earliest occurrence of disease progression or death from any cause, whichever occurs first, up to 1 year
3

Overall survival (OS)

Calculated from the start of trial therapy until the patient completes study follow up participation or experiences death from any cause. Will be analyzed using the Kaplan-Meier method. The median OS estimate at 6 months will be reported along with the confidence interval.

Time frame
At 6 months
4

OS

Overall survival will be analyzed using the Kaplan-Meier method. The median OS estimate will be reported along with the confidence interval.

Time frame
From the start of trial therapy until the patient completes study follow up participation or experiences death from any cause, up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: