Trial Summary
What is the purpose of this trial?
This trial is testing two drugs, nivolumab and ipilimumab, to see if they can help treat thyroid cancer by boosting the immune system to fight cancer cells. These drugs have shown promising results in treating various cancers by enhancing the immune system's response to tumors.
Research Team
Kartik Sehgal
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
This trial is for adults with thyroid cancer, including those who've had prior treatments. It's open to patients with medullary thyroid cancer after TKI failure and anaplastic thyroid cancer, as well as metastatic RAI refractory differentiated thyroid cancer. Participants must be in good health otherwise, able to consent, and use effective contraception if of childbearing potential.Inclusion Criteria
Your blood test results need to be within certain limits.
Ability to understand and the willingness to sign a written informed consent document
I have thyroid cancer that didn't respond to previous treatment and got worse in the last 13 months.
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Exclusion Criteria
I am at risk for liver damage from some medications.
I haven't had chemotherapy or radiotherapy in the last 4 weeks and have recovered from any side effects.
I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
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Treatment Details
Interventions
- Ipilimumab (Checkpoint Inhibitor)
- Nivolumab (Checkpoint Inhibitor)
Trial OverviewThe study tests a combination of two investigational drugs: Nivolumab (Opdivo™) and Ipilimumab (Yervoy™), for treating different types of advanced or aggressive thyroid cancers that have not responded well to previous treatments.
Participant Groups
10Treatment groups
Experimental Treatment
Group I: Medullary Thyroid Cancer (Exploratory Cohort)Experimental Treatment2 Interventions
Medullary Thyroid Cancer (MTC) participants received Ipilimumab (Ipi) 1mg/kg q6 weeks and Nivolumab (Nivo) 3mg/kg q6 weeks sequentially either Ipi or Nivo first with 2 weeks apart prior to start of either Ipi or Nivo second, or started Ipi or Nivo together.
Per protocol order in sequential design was not expected to impact efficacy rather was for exploratory correlative analyses. Participants were treated indefinitely until disease progression or withdrawal for other reasons.
Group II: MTC - Nivolumab alone for two weekExperimental Treatment2 Interventions
Medullary Thyroid Cancer (MTC)participants received Ipilimumab 1mg/kg q6 weeks via IV infusion, starting two weeks after Nivolumab 3mg/kg q6 weeks.
Group III: MTC - Ipilimumab alone for two weeksExperimental Treatment2 Interventions
Medullary Thyroid Cancer (MTC) participants received Nivolumab 3mg/kg q6 weeks via IV infusion, starting two weeks after Ipilimumab 1mg/kg q6 weeks.
Group IV: Differentiated Thyroid Cancer (Primary cohort)Experimental Treatment2 Interventions
Differentiated Thyroid Cancer (DTC) participants received Ipilimumab (Ipi) 1mg/kg q6 weeks and Nivolumab (Nivo) 3mg/kg q6 weeks sequentially either Ipi or Nivo first with 2 weeks apart prior to start of either Ipi or Nivo second.
Per protocol order in sequential design was not expected to impact efficacy rather was for exploratory correlative analyses. Participants were treated indefinitely until disease progression or withdrawal for other reasons.
Group V: DTC - Nivolumab alone for two weeksExperimental Treatment2 Interventions
Differentiated Thyroid Cancer (DTC) participants received Ipilimumab 1mg/kg q6 weeks via IV infusion, starting two weeks after Nivolumab 3mg/kg q6 weeks.
Group VI: DTC - Ipilimumab alone for two weeksExperimental Treatment2 Interventions
Differentiated Thyroid Cancer (DTC) participants received Nivolumab 3mg/kg q6 weeks via IV infusion, starting two weeks after Ipilimumab 1mg/kg q6 weeks.
Group VII: Anaplastic Thyroid Cancer (Exploratory Cohort)Experimental Treatment2 Interventions
Anaplastic Thyroid Cancer (ATC) participants received Ipilimumab (Ipi) 1mg/kg q6 weeks and Nivolumab (Nivo) 3mg/kg q6 weeks sequentially either Ipi or Nivo first with 2 weeks apart prior to start of either Ipi or Nivo second prior to study amendment or in combination from the start after study amendment due to aggressive nature of the disease in this cohort.
Per protocol order in sequential design was not expected to impact efficacy rather was for exploratory correlative analyses. Participants were treated indefinitely until disease progression or withdrawal for other reasons.
Group VIII: ATC - Nivolumab alone for two weekExperimental Treatment2 Interventions
Anaplastic Thyroid Cancer (ATC) received Ipilimumab 1mg/kg q6 weeks via IV infusion, starting two weeks after Nivolumab 3mg/kg q6 weeks.
Group IX: ATC - Ipilimumab alone for two weekExperimental Treatment2 Interventions
Anaplastic Thyroid Cancer (ATC) received Nivolumab 3mg/kg q6 weeks via IV infusion, starting two weeks after Ipilimumab 1mg/kg q6 weeks.
Group X: ATC - Ipilimumab + NivolumabExperimental Treatment2 Interventions
Anaplastic Thyroid Cancer (ATC) received Nivolumab 3mg/kg q6 weeks and Ipilimumab 1mg/kg q6 weeks via IV infusion.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Trials
1,128
Recruited
382,000+
Dr. Benjamin L. Ebert
Dana-Farber Cancer Institute
Chief Executive Officer
MD from Harvard Medical School, PhD from Oxford University
Dr. Craig A. Bunnell
Dana-Farber Cancer Institute
Chief Medical Officer since 2012
MD from Harvard Medical School, MPH from Harvard School of Public Health, MBA from MIT Sloan School of Management
Bristol-Myers Squibb
Industry Sponsor
Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania