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Alkylating agents

Nivolumab + Chemotherapy for Mesothelioma

Phase 1

Waitlist Available

Led By Michael Offin, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years

Karnofsky performance status > 70%

Must not have

Prior treatment with chemotherapy or immunotherapy for mesothelioma

Active pneumonitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days of the initially planned date

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new combo therapy for mesothelioma that could make surgery safer and more effective.

Who is the study for?

This trial is for adults with resectable malignant pleural mesothelioma. Participants must have a performance status indicating they are relatively active, agree to contraception if of childbearing potential, and not be pregnant or breastfeeding. They should not have had prior chemo or immunotherapy for mesothelioma, no serious illnesses or other cancers requiring treatment, and no active hepatitis B/C or HIV.

What is being tested?

The study tests the combination of Nivolumab (an immunotherapy drug) with chemotherapy drugs Pemetrexed and either Cisplatin or Carboplatin before surgery in patients with mesothelioma. It aims to determine if this approach is safe and effective without delaying surgical intervention.

What are the potential side effects?

Nivolumab can cause immune-related side effects like inflammation in various organs, skin reactions, hormonal gland problems leading to hormone deficiencies. Chemotherapies such as Cisplatin/Carboplatin and Pemetrexed may cause nausea, kidney damage, low blood cell counts increasing infection risk.

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 mostly independent and can care for myself.

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I have been diagnosed with cancer in the lining of my lungs.

Exclusion Criteria

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

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I have received chemotherapy or immunotherapy for mesothelioma.

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I currently have lung inflammation.

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I do not have any serious illnesses or other cancers needing treatment.

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I am currently taking 10 mg or more of prednisone daily.

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I have been treated for an autoimmune disease with immune-modifying drugs in the last 2 years.

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I have active hepatitis B or C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days of the initially planned date

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days of the initially planned date

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days of the initially planned date for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

number of patients going to operating room for surgical resection

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

1Treatment groups

Experimental Treatment

Group I: nivolumab with pemetrexed and cisplatin or carboplatinExperimental Treatment3 Interventions

Eligible patients will receive two cycles of neoadjuvant therapy with nivolumab 360 mg, pemetrexed 500 mg/m2, and cisplatin 75 mg/m2 or carboplatin AUC=5. Subsequently, they will undergo pleurectomy/decortication.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin or Carboplatin

2015

Completed Phase 2

~140

Nivolumab

2015

Completed Phase 3

~4010