Nivolumab + Ipilimumab for Thyroid Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Autoimmune disease, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 6

Duration: Indefinite until progression

53 Participants Needed

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Nivolumab and Ipilimumab sequentially or in combination, with treatment continuing until disease progression or withdrawal

Indefinite until progression

Every 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

• Ipilimumab
• Nivolumab

Trial Overview The 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

Group I: Medullary Thyroid Cancer (Exploratory Cohort) Experimental Treatment 2 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 week Experimental Treatment 2 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 weeks Experimental Treatment 2 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 Treatment 2 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 weeks Experimental Treatment 2 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 weeks Experimental Treatment 2 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 Treatment 2 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 week Experimental Treatment 2 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 week Experimental Treatment 2 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 + Nivolumab Experimental Treatment 2 Interventions

Anaplastic Thyroid Cancer (ATC) received Nivolumab 3mg/kg q6 weeks and Ipilimumab 1mg/kg q6 weeks via IV infusion.

Ipilimumab is already approved in United States, European Union for the following indications:

Approved in United States as Yervoy for:

• Advanced melanoma
• Stage III unresectable melanoma
• Stage IV metastatic melanoma

Approved in European Union as Yervoy for:

• Advanced melanoma
• Stage III unresectable melanoma
• Stage IV metastatic melanoma

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

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