Neoplasms

All Conditions

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Rare Diseases

Carcinoma

Thyroid Neoplasms

Thyroid Diseases

Aggression

Thyroid Carcinoma, Anaplastic

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Anaplastic Thyroid Cancer

Hurthle Cell Thyroid Cancer

All Drugs and Chemicals

Antibodies

Antibodies, Bispecific

Immunoglobulins

Immunoglobulins, Intravenous

Immunologic Factors

Patients receive vudalimab IV over 1 hour on days 1 and 15 of each cycle. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Vudalimab

Study Coordinator

Jochen H. Lorch, M.D.

Maria E. Cabanillas, M.D.

Jochen H Lorch, M.D.

This phase II trial tests whether vudalimab works to shrink tumors in patients with anaplastic thyroid cancer or hurthle cell thyroid cancer that has spread to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as vudalimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

PRIMARY OBJECTIVE:

I. To evaluate the antineoplastic efficacy of vudalimab (XmAb2071) in anaplastic thyroid cancer, as measured by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

SECONDARY OBJECTIVES:

I. To estimate progression-free survival (PFS) in patients with anaplastic thyroid cancer who have received XmAb20717 therapy.

II. To estimate 16-week progression-free survival (PFS-16) in patients with anaplastic thyroid cancer who have received XmAb20717 therapy.

III. To estimate overall survival (OS) in patients with anaplastic thyroid cancer who have received XmAb20717 therapy.

IV. To determine the clinical benefit rate (CBR) in patients with anaplastic thyroid cancer who have received XmAb20717 therapy.

V. To calculate the duration of response (DOR) in patients with anaplastic thyroid cancer who have responded to XmAb20717 therapy.

VI. To calculate the duration of clinical benefit (DoCB) in patients with anaplastic thyroid cancer who have received XmAb20717 therapy.

VII. To assess the toxicity profile of XmAb20717 in patients with anaplastic thyroid cancer, according to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.

EXPLORATORY OBJECTIVES:

I. To conduct correlative, translational research to identify markers associated with response to XmAb20717 (i.e., neo-epitopes) and to explore the immune microenvironment in patients with anaplastic thyroid cancer and Hurtle cell cancer.

II. To administer XmAb20717 to a small, exploratory cohort of patients with Hurtle cell thyroid cancer (HCC) to obtain pilot efficacy, safety, and correlative data for this population.

OUTLINE:

Patients receive vudalimab intravenously (IV) over 1 hour on days 1 and 15 of each cycle. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 4 years.

Vudalimab for the Treatment of Locally Advanced or Metastatic Anaplastic Thyroid Cancer or Hurthle Cell Thyroid Cancer

A Phase II, Multicenter Study of XmAb20717 in Patients With Metastatic Anaplastic Thyroid Cancer With an Exploratory Cohort in Aggressive Hurthle Cell Thyroid Cancer

Defined as the proportion of treated subjects in the Main Cohort (ATC) who experience an objective response. Objective response is defined as achieving a confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Confirmation of response should be conducted via imaging \>= 28 days after the response was first documented. The date of first response for either CR or PR will be used for the calculation of ORR.

Median PFS will be calculated based on the Kaplan-Meier estimates of PFS.

Will be calculated based on the Kaplan- Meier estimates of PFS as the proportion of evaluable subjects who are alive and progression-free at 16 weeks after registration.

Participants will be followed for overall survival for up to 5 years, or until withdrawal of consent, or death; whichever occurs first.

Defined as a RECIST 1.1 'best response' of confirmed 'complete response (CR),' or confirmed 'partial response (PR),' or 'stable disease (SD) for \>= 16 weeks' (calculated from the time of registration). For CR and PR, confirmation of response should be conducted via imaging \>= 28 days after the response was first documented.

Confirmation of response for CR or PR should be conducted via imaging \>= 28 days after the response was first documented. The date of first response for either CR or PR will be used as the starting point for the calculation of DOR. Disease progression is defined as 'progressive disease (PD)' per RECIST 1.1 (taking as reference for progressive disease the smallest tumor measurements recorded on study).

Confirmation of response (CR or PR) should be conducted via imaging \>= 28 days after the response was first documented. Disease progression is defined as 'progressive disease (PD)' per RECIST 1.1 (taking as reference for progressive disease the smallest tumor measurements recorded on study). If disease progression is not observed prior to initiating subsequent anti-cancer therapy, or prior to the end of the study follow-up period, or completion of study participation (whichever is sooner), the DoCB will be censored at the last date when the patient was known to be alive and progression-free.

Frequency of adverse events by type, severity (grade), timing, and attribution to vudalimab (XmAb2071), according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Vudalimab for the Treatment of Locally Advanced or Metastatic Anaplastic Thyroid Cancer or Hurthle Cell Thyroid Cancer	NCT05453799	Locally Advance... Metastatic Thyr... Metastatic Thyr...	Vudalimab	18 Years -	Northwestern University
Vudalimab for the Treatment of Locally Advanced or Metastatic Anaplastic Thyroid Cancer or Hurthle Cell Thyroid Cancer	NCT05453799	Locally Advance... Metastatic Thyr... Metastatic Thyr...	Vudalimab	18 Years -	Northwestern University

Spots Global Cancer Trial Database for locally advanced thyroid gland anaplastic carcinoma