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Checkpoint Inhibitor

Nivolumab for Cancer

Phase 1

Recruiting

Led By Hussein A Tawbi

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Creatinine ULN OR glomerular filtration rate (GFR) >= 30 mL/min (if using the Cockcroft-Gault formula)

Patients with a malignancy for which a PD-1/PD-L1 inhibitor has been approved in the adjuvant setting

Must not have

Patients with prior therapy with an anti-PD-1 or anti-PD-L1

Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 100 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing nivolumab as a treatment for cancer and autoimmune disorders. It will study the side effects of the drug and how well it works.

Who is the study for?

Adults with advanced or inoperable cancer and an autoimmune disorder (like lupus, rheumatoid arthritis, or multiple sclerosis) can join this trial. They should have a life expectancy over 12 weeks, be relatively active (ECOG 0-2), and have not had certain treatments recently. Those with controlled hepatitis B/C are eligible; however, pregnant women must use contraception.

What is being tested?

The trial is testing Nivolumab's effectiveness and safety for patients who have both cancer and autoimmune diseases. It's a phase Ib study to see how well the immune system responds to this monoclonal antibody treatment in attacking cancer cells that spread or cannot be surgically removed.

What are the potential side effects?

Nivolumab may cause immune-related side effects such as inflammation of organs, potential worsening of autoimmune conditions, fatigue, infusion reactions like fever or chills, skin rash, digestive issues like diarrhea or liver enzyme changes.

Eligibility Criteria

Inclusion Criteria

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

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My kidney function, measured by creatinine level or GFR, is within the normal range.

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I have a cancer type that can be treated with PD-1/PD-L1 inhibitors.

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I have received treatments like high-dose IL-2, IFN, or CTLA-4.

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My hepatitis B is under control with undetectable viral load on treatment.

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I am 18 years old or older.

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My cancer is confirmed, cannot be surgically removed, and has spread.

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I can take care of myself but might not be able to do heavy physical work.

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My cancer responds to specific immune therapy drugs.

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I had hepatitis C but have been treated and now have no detectable virus.

Exclusion Criteria

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

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I have been treated with drugs targeting PD-1 or PD-L1 before.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 100 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 100 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 100 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in disease assessments

Changes in serum chemokines and circulating immune cells over time

Clinical measures of interest

+3 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

1Treatment groups

Experimental Treatment

Group I: Treatment (nivolumab)Experimental Treatment2 Interventions

Patients receive nivolumab IV over 30 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood, CSF, tissue, stool, and urine samples throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Nivolumab

2014

Completed Phase 3

~5220