Your session is about to expire
← Back to Search
Monoclonal Antibodies
Vudalimab for Thyroid Cancer
Phase 2
Recruiting
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
EXPLORATORY COHORT (HCC): Subject's HCC must be incurable and metastatic
MAIN COHORT (ANAPLASTIC THYROID CANCER [ATC]): Subjects must have a histologically confirmed diagnosis of anaplastic thyroid cancer (ATC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
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 belowSelect...
My liver cancer cannot be cured and has spread to other parts.
Select...
I have been diagnosed with anaplastic thyroid cancer.
Select...
I have a BRAF V600E mutation and cannot tolerate or did not respond to BRAF/MEK inhibitors.
Select...
I have been diagnosed with Hurthle cell thyroid cancer.
Select...
I have liver cancer and previous treatments, especially those targeting blood vessel growth, didn’t work for me.
Select...
I can understand and am willing to sign the consent form for the study.
Select...
My cancer is either spreading or cannot be cured with surgery.
Select...
I have available tissue samples from previous biopsies or surgeries for study.
Select...
My cancer has worsened despite all standard treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 moreTrial 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
13,664 Previous Clinical Trials
40,925,951 Total Patients Enrolled
Northwestern UniversityLead Sponsor
1,586 Previous Clinical Trials
917,197 Total Patients Enrolled
Jochen H Lorch, M.D.Principal InvestigatorNorthwestern University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver cancer cannot be cured and has spread to other parts.You need to have a negative test for hepatitis B surface antigen (HBsAg) and total hepatitis B core antibody (HBcAb), or a positive total HBcAb followed by a negative HBV DNA test.I have previously received treatments targeting my immune system.I have been diagnosed with anaplastic thyroid cancer.I have recovered from side effects of my previous cancer treatments.I have active brain metastases or carcinomatous meningitis.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 has worsened in the last 14 months.I have another cancer, but it won't affect this treatment's safety or results.I do not have an active autoimmune disease, organ transplant, or serious infections in the last 30 days.You should not have antibodies for hepatitis C virus (HCV) in your blood, or if the test shows positive, a follow-up test for HCV RNA should be negative.I have liver cancer and previous treatments, especially those targeting blood vessel growth, didn’t work for me.I can understand and am willing to sign the consent form for the study.I am not currently on cancer treatments, steroids, immunosuppressants, or recent live vaccines.I am 18 or older, can care for myself, and my cancer can be measured.I am not pregnant, planning to become pregnant, or breastfeeding.My cancer is either spreading or cannot be cured with surgery.I have available tissue samples from previous biopsies or surgeries for study.You are allergic to drugs similar to XmAb20717 or any of its ingredients.You need to have a negative HIV test result or meet specific criteria if your result is positive.My cancer has worsened despite all standard treatments.Your blood levels of hemoglobin, white blood cells, and platelets are within a certain range. Your kidney function and liver enzymes are also within specific limits.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (vudalimab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger