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Monoclonal Antibodies

Vudalimab for Thyroid Cancer

Phase 2
Led By Jochen H Lorch, M.D.
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
MAIN COHORT (ANAPLASTIC THYROID CANCER [ATC]): Subjects must have a histologically confirmed diagnosis of anaplastic thyroid cancer (ATC)
MAIN COHORT (ATC): Subject's ATC must be either metastatic or incurable, locally-advanced
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing an immunotherapy drug to see if it can shrink tumors in patients with certain types of thyroid cancer.

Who is the study for?
Adults with advanced or metastatic anaplastic thyroid cancer (ATC) or Hurthle cell thyroid cancer (HCC), who have tried all standard treatments without success. Participants must be in good enough health to perform daily activities, not pregnant, and willing to use contraception. They can't join if they've had certain previous therapies like CTLA4 or PD-1/PD-L1 inhibitors, are on immunosuppressants, have active brain metastases, serious infections recently, or known allergies to similar drugs.Check my eligibility
What is being tested?
The trial is testing Vudalimab's effectiveness in shrinking tumors for patients with ATC or HCC that has spread. It's a phase II study where Vudalimab—a type of immunotherapy—aims to boost the immune system's fight against cancer and prevent tumor growth.See study design
What are the potential side effects?
Potential side effects of Vudalimab may include reactions related to the immune system attacking normal cells leading to inflammation in various organs, infusion-related reactions due to the drug administration process, fatigue from treatment burden on the body, digestive issues as a common reaction to therapy affecting gut health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I have been diagnosed with anaplastic thyroid cancer.
My cancer is either spreading or cannot be cured with surgery.
I have a BRAF V600E mutation and cannot tolerate or did not respond to BRAF/MEK inhibitors.
I have been diagnosed with Hurthle cell thyroid cancer.
My liver cancer cannot be cured and has spread to other parts.
I have liver cancer and previous treatments, especially those targeting blood vessel growth, didn’t work for me.
My liver cancer has worsened in the last 14 months.
My cancer has worsened despite all standard treatments.
I am 18 or older, can care for myself, and my cancer can be measured.
I have available tissue samples from previous biopsies or surgeries for study.
I have another cancer, but it won't affect this treatment's safety or results.
I have recovered from side effects of my previous cancer treatments.
I can understand and am willing to sign the consent form for the study.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Clinical benefit rate
Duration of clinical benefit(DoCB)
Duration of response
+4 more

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: Treatment (vudalimab)Experimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,587 Previous Clinical Trials
41,242,448 Total Patients Enrolled
Northwestern UniversityLead Sponsor
1,573 Previous Clinical Trials
909,701 Total Patients Enrolled
Jochen H Lorch, M.D.Principal InvestigatorNorthwestern University

Media Library

Vudalimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05453799 — Phase 2
Thyroid Carcinoma Research Study Groups: Treatment (vudalimab)
Thyroid Carcinoma Clinical Trial 2023: Vudalimab Highlights & Side Effects. Trial Name: NCT05453799 — Phase 2
Vudalimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05453799 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been enlisted in this clinical experiment?

"Correct. According to clinicaltrials.gov, this medical study is still recruiting participants for its experiment as of August 23rd 2022; the trial was initially posted on July 21st 2022 and requires 54 patients from 2 locations."

Answered by AI

Is it possible to join this clinical experiment as a participant?

"According to clinicaltrials.gov, this research is still in search of participants and was initially posted on July 21st 2022 with the most recent update having been recorded as August 23rd 2022."

Answered by AI

What potential risks does Vudalimab pose for patients?

"Vudalimab's safety rating is a 2, as it has been subject to clinical trials and there are data points reassuring its safety yet none testifying to the drug’s efficacy."

Answered by AI
~9 spots leftby Jul 2024