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Checkpoint Inhibitor

Nivolumab + Ipilimumab for Thyroid Cancer

Phase 2
Waitlist Available
Led By Jochen Lorch, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Exploratory cohort: incurable medullary thyroid cancer with prior tyrosine kinase inhibitor (TKI) failure and progression within 13 months prior to enrollment (10 patients) and anaplastic thyroid cancer (7 patients)
Any line of prior treatment for patients under 65y, over 65y must have at least one prior line of TKI treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is researching whether or not the combination of these two drugs is effective in treating thyroid cancer.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation in various organs, skin rash, hormone gland problems (like the thyroid), digestive issues like diarrhea or colitis, liver inflammation, fatigue and can affect how other organs function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have thyroid cancer that didn't respond to previous treatment and got worse in the last 13 months.
Select...
I am under 65 with any prior treatment or over 65 and have had TKI treatment.
Select...
I can care for myself but may not be able to do active work.
Select...
My organ and bone marrow functions are normal.
Select...
I use a highly effective birth control method.
Select...
I have had multiple treatments for my condition.
Select...
I am 18 years old or older.
Select...
I am 18 years old or older.
Select...
My thyroid cancer has spread and didn't respond to RAI, worsening in the last 13 months.
Select...
I can take care of myself but might not be able to do active work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
Radiographic Response Rate
Secondary outcome measures
Overall Survival
Progression Free Survival
Tolerability

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Neutropenia
21%
Pyrexia
19%
Hypomagnesaemia
19%
Headache
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Insomnia
15%
Thrombocytopenia
14%
Rash
14%
Hyponatraemia
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Pruritus
12%
Hypokalaemia
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Muscular weakness
10%
Dry skin
10%
Alopecia
10%
Chest pain
10%
Hypoalbuminaemia
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Upper respiratory tract infection
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Hypertension
7%
Chills
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Dry mouth
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Hypotension
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Embolism
2%
Malignant pleural effusion
2%
Sepsis
2%
Cardiac failure
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Adrenal insufficiency
1%
Syncope
1%
Superior vena cava syndrome
1%
Neoplasm progression
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Lung cancer metastatic
1%
Bronchial obstruction
1%
Performance status decreased
1%
Ileus
1%
Pericardial effusion
1%
Colitis
1%
Atrial flutter
1%
Small intestinal obstruction
1%
Pancytopenia
1%
Gastrointestinal haemorrhage
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Hypercalcaemia
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

Trial Design

2Treatment groups
Experimental Treatment
Group I: Nivolumab alone for two weeksExperimental Treatment2 Interventions
Ipilimumab will be administered via IV infusion, starting two weeks after Nivolumab
Group II: Ipilimumab alone for two weeksExperimental Treatment2 Interventions
Nivolumab will be administered via IV infusion, starting two weeks after Ipilimumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2640
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,072 Previous Clinical Trials
340,353 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,629 Previous Clinical Trials
4,126,483 Total Patients Enrolled
Jochen Lorch, MDPrincipal InvestigatorDana-Farber Cancer Institute
7 Previous Clinical Trials
154 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03246958 — Phase 2
Thyroid Cancer Research Study Groups: Ipilimumab alone for two weeks, Nivolumab alone for two weeks
Thyroid Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT03246958 — Phase 2
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03246958 — 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 people total are involved in this experiment?

"This study is not recruiting patients at the moment. The listing for this clinical trial was created on September 20th, 2017 and last updated on February 18th, 2022. However, there are presently 240 other trials involving thyroid cancer patients and 796 studies utilising Nivolumab that are actively enrolling new participants."

Answered by AI

Is Nivolumab currently cleared by the FDA?

"Nivolumab's safety is supported by Phase 2 data, but since there are no studies demonstrating efficacy, it received a score of 2."

Answered by AI

What are the conditions that Nivolumab is known to be an effective treatment for?

"Nivolumab, which is sometimes used to counteract the effects of anti-angiogenic therapy, can also be an effective treatment for various other conditions such as malignant neoplasms and squamous cell carcinoma."

Answered by AI

Are we able to enroll patients at this time?

"No, this study is not recruiting new participants at the moment. However, that may change in the future as the study's administrators last updated it on February 18th, 2022. There are currently 1036 other trials that are actively looking for test subjects."

Answered by AI

Could you walk me through the other Nivolumab studies that have been conducted?

"Out of the 86 Phase 3 trials for Nivolumab, 796 are still active. In addition to the few locations running out of Pittsburgh, Pennsylvania, there are 43200 other centres researching this medication."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Dana Farber Cancer Institute
What portion of applicants met pre-screening criteria?
Met criteria
~7 spots leftby Mar 2025