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Checkpoint Inhibitor
Nivolumab 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ipilimumab
Secondary outcome measures
Clinical Benefit Rate
Overall Response Rate of the Combination According to Immune-related Response Criteria
Overall Survival
+1 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
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%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
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%
Bronchitis
7%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Chills
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Small intestinal haemorrhage
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Confusional state
1%
Cancer pain
1%
Hypercalcaemia
1%
Femur fracture
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
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
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
~4750
Ipilimumab
2014
Completed Phase 3
~2620
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,956 Total Patients Enrolled
141 Trials studying Breast Cancer
22,587 Patients Enrolled for Breast Cancer
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,129,002 Total Patients Enrolled
50 Trials studying Breast Cancer
8,235 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recovered from previous cancer treatment side effects, except for hair loss and numbness.I have not received a live vaccine in the last 28 days.I have not taken any other cancer treatments in the last 14 days.I do not have any other cancer needing treatment at the same time.I am mostly able to care for myself and carry out daily activities.I have not had major surgery in the last 2 weeks.I am not on steroids or immunosuppressants, except for hormone replacements.My breast cancer is HER2-negative and may be hormone receptor positive or negative.I have been treated with specific immune therapy drugs before.My breast cancer is hormone receptor positive and has worsened despite previous hormone therapy.I agree to have a research biopsy if my tumor can be safely accessed.I understand the study requirements and have signed the consent form.I am HIV positive and not on antiretroviral therapy.I can continue or start bisphosphonate therapy while in the study.My brain metastases are treated and stable without steroids, or I'm on a low, stable dose.I am not pregnant, can use effective birth control, and agree to do so during the study.My blood and organ functions are within normal ranges required for the trial.I am 18 years old or older.I am currently on IV antibiotics for an infection.My breast cancer has spread, confirmed by tests or clear signs.I do not have any severe illnesses and have been cancer-free for 3 years, except for my current condition.I've had up to 3 chemotherapy treatments for breast cancer and have been off chemo for at least 14 days.My tumor has a high mutation rate, confirmed by a specific gene test.I have lung inflammation or need extra oxygen.I stopped all biologic therapy at least 14 days before starting the study treatment.I completed any radiation therapy at least 14 days ago and have no ongoing side effects.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab+Ipilimumab
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.
Is the utilization of Nivolumab accompanied by any potential risks?
"Our company has tentatively assigned Nivolumab a safety rating of 2 on the 1-3 scale, as Phase 2 trials have produced some evidence of its protective effects but no proof of efficacy."
Answered by AI
What are the typical applications of Nivolumab?
"Nivolumab is typically used as a follow-up to anti-angiogenic treatments. Additionally, this medication has proven effective in combating malignant neoplasms and serious cases of melanoma or squamous cell carcinoma."
Answered by AI
Has Nivolumab been previously investigated in other research?
"Since its initial clinical investigation at Texas Children's Hospital in 2009, Nivolumab has been the focus of 365 completed trials. As of present day, there are 765 active studies related to this drug with many located in Boston, Massachusetts."
Answered by AI
Is this trial open to new participants at present?
"This specific trial is no longer accepting participants, as indicated by the clinicaltrials.gov record which was last edited on October 21st 2022, despite having initially been created on March 8th 2019. Nevertheless, over 3 thousand other trials remain open to recruitment at this current moment in time."
Answered by AI
What is the current enrolment capacity of this trial?
"At the present time, this research trial is not recruiting new patients. The project was initially posted on March 8th 2019 and has been most recently updated October 21st 2022. For those exploring alternate trials, 2596 studies for breast cancer are actively enrolling participants while 765 Nivolumab trials are open to recruitment."
Answered by AI
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