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Alkylating agents

Nivolumab + Chemotherapy for Triple-negative Breast Cancer

Phase 1 & 2

Waitlist Available

Led By Mateusz Opyrchal, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years of age

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Must not have

History of non-breast malignancy unless meeting specific criteria for cancer survivor

History of chronic hepatitis or positive test for latent tuberculosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through completion of follow-up (estimated to be 3 years and 12 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for early stage triple-negative breast cancer. The hypothesis is that the new treatment will decrease tumor associated macrophages and increase tumor infiltrating lymphocytes, compared to the current standard of care. If the hypothesis is correct, this could improve clinical outcomes for patients with early stage triple-negative breast cancer.

Who is the study for?

This trial is for adults with early stage triple-negative breast cancer who are fit (ECOG ≤ 1), have not had previous treatments, and whose organs function normally. They must be able to consent, follow the study plan, and agree to use contraception if of childbearing potential. Exclusions include certain autoimmune diseases, other cancers unless in remission under conditions, uncontrolled illnesses or infections, recent immunosuppressants use or major surgery.

What is being tested?

The trial tests if adding nivolumab to standard neoadjuvant chemotherapy before surgery can change immune cells in tumors (decrease TAMs and increase TILs) compared to just chemotherapy alone. This could potentially improve outcomes for patients with localized triple-negative breast cancer.

What are the potential side effects?

Nivolumab may cause immune-related side effects like inflammation in various organs including the lungs and intestines, skin reactions, hormone gland problems (like thyroid issues), infusion reactions; fatigue; blood disorders; increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am fully active or have some restrictions but can still care for myself.

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My blood tests for bone marrow and organ function are normal.

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I have not received any treatment for my current illness.

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My breast cancer is at stage II or III, and I am eligible for treatment before surgery to remove the cancer.

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My breast cancer is ER-/HER2- and confirmed by tests.

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My tumor is at least 2 cm big.

Exclusion Criteria

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

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I had cancer other than breast cancer but meet the survivor criteria.

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I have a history of chronic hepatitis or tested positive for latent tuberculosis.

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I currently have an infection that is not under control.

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I have previously received immunotherapy for my cancer.

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I do not have serious heart problems.

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I have a history of lung conditions.

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My cancer has spread to other parts of my body.

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I have cancer in both breasts.

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I have not had major surgery in the last 28 days.

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I have had a bone marrow or organ transplant in the past.

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I need treatment for fluid buildup in my abdomen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of follow-up (estimated to be 3 years and 12 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through completion of follow-up (estimated to be 3 years and 12 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of follow-up (estimated to be 3 years and 12 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent Change in Tumor Infiltrating Lymphocytes (TILs)

Safety of the Regimen as Measured by Incidence of Adverse Events (Safety lead-in Only)

Secondary study objectives

Adverse Events Measured by Number of Participants With Cabiralizumab Related Grade 3 or Higher Adverse Events

Adverse Events Measured by Number of Participants With Carboplain Related Grade 3 or Higher Adverse Events

Adverse Events Measured by Number of Participants With Nivolumab Related Grade 3 or Higher Adverse Events

+5 more

Side effects data

From 2023 Phase 2 trial • 205 Patients • NCT03336216

57%

Diarrhoea

57%

Aspartate aminotransferase increased

55%

Nausea

55%

Decreased appetite

55%

Fatigue

55%

Blood creatine phosphokinase increased

40%

Anaemia

38%

Alanine aminotransferase increased

38%

Periorbital oedema

36%

Pyrexia

36%

Malignant neoplasm progression

33%

Rash

31%

Stomatitis

31%

Vomiting

31%

Face oedema

29%

Constipation

26%

Hyponatraemia

26%

Hypophosphataemia

24%

Blood alkaline phosphatase increased

24%

Blood lactate dehydrogenase increased

21%

Peripheral sensory neuropathy

21%

Abdominal pain

21%

Neutrophil count decreased

19%

Hypocalcaemia

19%

Platelet count decreased

19%

Dry mouth

19%

Dysgeusia

17%

Epistaxis

17%

Dizziness

17%

Mucosal inflammation

17%

Lymphocyte count decreased

17%

Neuropathy peripheral

17%

Cough

17%

Dehydration

14%

Insomnia

14%

Sepsis

14%

Oedema peripheral

14%

Neutropenia

14%

Hypertension

14%

Chills

14%

Hypokalaemia

14%

Arthralgia

14%

Dyspnoea

14%

Pruritus

14%

Abdominal pain upper

14%

White blood cell count decreased

12%

Myalgia

12%

Hypoalbuminaemia

12%

Asthenia

12%

Rash maculo-papular

10%

Hyperglycaemia

10%

Weight decreased

10%

Fall

10%

Palmar-plantar erythrodysaesthesia syndrome

10%

Headache

Vision blurred

Generalised oedema

Infusion related reaction

Back pain

Temperature intolerance

Dry skin

Dyspepsia

Urinary tract infection

Depression

Blood bilirubin increased

Anxiety

Nasal congestion

Contusion

Abdominal distension

Colitis

Haemorrhoids

Gastrooesophageal reflux disease

Deep vein thrombosis

Hiccups

Cholangitis

Confusional state

Stevens-Johnson syndrome

Hypomagnesaemia

Musculoskeletal chest pain

Muscular weakness

Haematuria

Pneumonitis

Febrile neutropenia

Hepatic failure

Muscle spasms

Myocarditis

Cerebral ischaemia

Proteinuria

Hyperglycaemic hyperosmolar nonketotic syndrome

Hypothyroidism

Liver abscess

Blood creatinine increased

Ascites

Fungal infection

Bacterial infection

Spinal compression fracture

Enterocolitis

Pleural effusion

Wheezing

Flatulence

Skin hyperpigmentation

Embolism

Immune-mediated hepatitis

Pain in jaw

Ileus

Pancreatitis

General physical health deterioration

Bacteraemia

Biliary tract infection

Toxicity to various agents

Blood electrolytes abnormal

Failure to thrive

Myositis

Neurotoxicity

Mental status changes

Benign prostatic hyperplasia

Leukopenia

Lymphopenia

Tachycardia

Rectal haemorrhage

Influenza like illness

Peripheral swelling

Hepatic function abnormal

Vertigo

Candida infection

Amylase increased

International normalised ratio increased

Bone pain

Pain in extremity

Hypoxia

Haemorrhage intracranial

Mouth ulceration

Gastric haemorrhage

Metabolic encephalopathy

Pain

Neutrophil count increased

100%

80%

60%

40%

20%

Study treatment Arm

Arm D: Cabiralizumab + Nivolumab + 5-FU-Based Chemotherapy

Arm C: Cabiralizumab + Nivolumab + Gemcitabine-Based Chemotherapy

Arm A1: Investigator Choice - Gem/Nab-Based Chemotherapy

Arm A2: Investigator Choice - 5 FU-Based Chemotherapy

Arm B: Cabiralizumab + Nivolumab

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Unrandomized Arm: Neoadjuvant Chemo + NivolumabExperimental Treatment6 Interventions

* As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. Remaining patients will be enrolled in single arm study. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.

Group II: Arm B: Neoadjuvant chemo + nivolumab + cabiralizumabExperimental Treatment7 Interventions

As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. * Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel. * Cabiralizumab will be given IV at a dose of 4 mg/kg every 2 weeks for 12 weeks.

Group III: Arm A: Neoadjuvant chemo + nivolumabActive Control6 Interventions

-Neoadjuvant chemotherapy consists of paclitaxel and carboplatin. Paclitaxel will be given intravenously (IV) at a dose of 80 mg/m\^2 on a weekly basis for 12 weeks. Carboplatin will be given IV at a dose of AUC 5 every 3 weeks for 12 weeks. Nivolumab will be given IV at a dose of 240 mg every 2 weeks for 12 weeks. Nivolumab will be administered first, followed by carboplatin, followed by paclitaxel.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5370

Carboplatin

2014

Completed Phase 3

~6120