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Checkpoint Inhibitor

Nivolumab + Ipilimumab for Breast Cancer

Phase 2
Waitlist Available
Led By Sara Tolaney, MD, MPH
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
ECOG performance status ≤1(Karnofsky ≥70%, see Appendix A).
Patients with hormone receptor positive breast cancer must have progressed on at least one prior line of endocrine therapy in the metastatic setting or have disease recurrence while on adjuvant endocrine therapy.
Must not have
The participant has received a live vaccine within 28 days prior to the first dose of trial treatment and while participating in the trial. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, and typhoid vaccine. The use of the inactivated seasonal influenza vaccine (Fluzone®) is allowed.
Concurrent administration of other anti-cancer therapy within 14 days of starting protocol therapy and during the course of this study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

This trial is testing whether the two drugs work better together than either drug alone in treating breast cancer.

Who is the study for?
This trial is for adults with metastatic HER2-negative breast cancer that's hypermutated (TMB ≥9 mutations/megabase). They can have had up to three prior chemo treatments and must be off chemo for at least 14 days. Participants need functioning major organs, no severe illnesses, not pregnant or breastfeeding, and agree to use effective contraception.
What is being tested?
The study tests a combination of two drugs: Nivolumab (Opdivo) and Ipilimumab (Yervoy), as potential treatment for this type of breast cancer. It includes patients who've tried other treatments without success and measures the effectiveness of these drugs in controlling the disease.
What are the potential side effects?
Possible side effects include immune-related reactions like inflammation in various organs, skin rash, hormone gland problems (like thyroid dysfunction), fatigue, diarrhea, nausea, liver issues such as hepatitis, and potentially serious infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am mostly able to care for myself and carry out daily activities.
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My breast cancer is hormone receptor positive and has worsened despite previous hormone therapy.
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My blood and organ functions are within normal ranges required for the trial.
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I am 18 years old or older.
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My breast cancer has spread, confirmed by tests or clear signs.
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I've had up to 3 chemotherapy treatments for breast cancer and have been off chemo for at least 14 days.
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My tumor has a high mutation rate, confirmed by a specific gene test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not received a live vaccine in the last 28 days.
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I have not taken any other cancer treatments in the last 14 days.
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I do not have any other cancer needing treatment at the same time.
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I have not had major surgery in the last 2 weeks.
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I am not on steroids or immunosuppressants, except for hormone replacements.
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I have been treated with specific immune therapy drugs before.
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I am HIV positive and not on antiretroviral therapy.
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I am currently on IV antibiotics for an infection.
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I have lung inflammation or need extra oxygen.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ipilimumab
Secondary study objectives
Clinical Benefit Rate
Overall Response Rate of the Combination According to Immune-related Response Criteria
Overall Survival
+1 more

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Cushingoid
10%
Tinnitus
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

Trial Design

1Treatment groups
Experimental Treatment
Group I: Nivolumab+IpilimumabExperimental Treatment2 Interventions
* Ipilimumab is administered intravenously every 6 weeks * Nivolumab is administered intravenously every 2 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~5220
Ipilimumab
2014
Completed Phase 3
~3140

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,100 Previous Clinical Trials
353,063 Total Patients Enrolled
144 Trials studying Breast Cancer
21,978 Patients Enrolled for Breast Cancer
Bristol-Myers SquibbIndustry Sponsor
2,678 Previous Clinical Trials
4,125,615 Total Patients Enrolled
50 Trials studying Breast Cancer
8,217 Patients Enrolled for Breast Cancer
Sara Tolaney, MD, MPHPrincipal InvestigatorDana-Farber Cancer Institute
7 Previous Clinical Trials
1,068 Total Patients Enrolled
6 Trials studying Breast Cancer
1,034 Patients Enrolled for Breast Cancer

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03789110 — Phase 2
Breast Cancer Research Study Groups: Nivolumab+Ipilimumab
Breast Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT03789110 — Phase 2
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03789110 — Phase 2
~5 spots leftby Sep 2025
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