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Alkylating agents

Carboplatin +/− Nivolumab for Breast Cancer

Phase 2

Waitlist Available

Led By Sara Tolaney, 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

Participants must agree to undergo a research biopsy, if tumor is safely accessible, at baseline

Prior biologic therapy: Prior poly-ADP ribose polymerase (PARP) inhibitors are not allowed in the metastatic setting

Must not have

Major surgery within 2 weeks prior to registration

Prior hypersensitivity to platinum chemotherapy or to any of the excipients of platinum or nivolumab therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed from the time measurement criteria are met for cr or pr by recist 1.1 (whichever is first recorded) to the time of first progression, up to 2.75 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the effectiveness of Carboplatin with or without Nivolumab as a treatment for triple-negative breast cancer that has metastasized.

Who is the study for?

This trial is for women over 18 with metastatic triple-negative breast cancer who haven't had chemotherapy for it yet. They must not be pregnant, have normal organ function, and no history of certain cancers or immune conditions. Participants need to agree to use contraception and can undergo a biopsy if needed.

What is being tested?

The study tests Carboplatin alone versus Carboplatin combined with Nivolumab in treating advanced breast cancer. It aims to see if adding Nivolumab improves outcomes. Patients will be assigned randomly to receive either the single drug or the combination therapy.

What are the potential side effects?

Carboplatin may cause nausea, low blood counts leading to infection risk, kidney issues, and allergic reactions. Nivolumab could lead to immune-related side effects like inflammation in organs such as lungs (pneumonitis), liver problems, skin rash, and endocrine disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to a research biopsy if my tumor can be safely accessed.

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I have not taken PARP inhibitors for metastatic cancer.

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My breast cancer is advanced and cannot be removed by surgery.

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My cancer is negative for estrogen, progesterone receptors, and HER2.

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My PD-L1 status is known.

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My organ and bone marrow functions are normal.

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I understand the study requirements and agree to participate.

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I am mostly able to care for myself and carry out daily activities.

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I am 18 years old or older.

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I agree to use birth control during and for 7 months after my treatment.

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I have not received chemotherapy for metastatic breast cancer before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had major surgery in the last 2 weeks.

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I am allergic to platinum-based chemotherapy or nivolumab.

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I have brain metastases that are either untreated, causing symptoms, or need treatment for symptoms.

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I do not have any severe illnesses that are not under control.

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I have been treated with specific immune therapy before.

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I have a history of lung inflammation not caused by an infection.

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I am currently on steroids or immunosuppressants for an autoimmune disease.

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I am on long-term steroids or other drugs that weaken my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed from the time measurement criteria are met for cr or pr by recist 1.1 (whichever is first recorded) to the time of first progression, up to 2.75 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed from the time measurement criteria are met for cr or pr by recist 1.1 (whichever is first recorded) to the time of first progression, up to 2.75 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed from the time measurement criteria are met for cr or pr by recist 1.1 (whichever is first recorded) to the time of first progression, up to 2.75 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

Progression-free Survival

Secondary study objectives

Clinical Benefit Rate

Clinical Benefit Rate Among BRCA-mutant Patients

Clinical Benefit Rate Among PD-L1-positive Patients

+24 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%

Tinnitus

10%

Cushingoid

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%

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Carboplatin + NivolumabExperimental Treatment2 Interventions

* Nivolumab is administered every three weeks intravenously * Nivolumab dosage is 360mg * Carboplatin is administered every three weeks intravenously * Carboplatin dosage is pre-determined by the PI

Group II: CarboplatinActive Control1 Intervention

* Carboplatin is administered every three weeks intravenously * Carboplatin dosage is pre-determined by the PI

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

Carboplatin

2014