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Checkpoint Inhibitor

Nivolumab +/- Ipilimumab for Anal Cancer

Phase 2

Waitlist Available

Led By Cathy Eng

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

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Karnofsky >= 80%)

At least one prior systemic treatment for incurable advanced or metastatic SCCA of the anal canal

Must not have

Condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration

Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing nivolumab with or without ipilimumab to see if it can treat anal canal cancer that has not responded to other treatments and has spread to other parts of the body.

Who is the study for?

This trial is for adults with metastatic anal canal cancer that hasn't improved after treatment. Participants must have adequate organ function, agree to contraception, and be willing to undergo HIV/hepatitis testing. Exclusions include recent chemotherapy, other investigational drugs, allergies to similar compounds, uncontrolled illnesses, certain prior cancers unless in remission for three years or more.

What is being tested?

The study examines the effectiveness of nivolumab alone or combined with ipilimumab in treating refractory metastatic anal canal cancer. These are immunotherapy drugs designed to help the immune system fight cancer by blocking tumor growth and spread.

What are the potential side effects?

Potential side effects may include immune-related reactions affecting organs like the liver or lungs, infusion reactions from the drug entering the body, fatigue, skin issues such as rash or itching, digestive problems like diarrhea or colitis (inflammation of colon), hormonal gland problems leading to changes in mood or behavior.

Eligibility Criteria

Inclusion Criteria

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

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

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I have had at least one treatment for advanced anal cancer that cannot be cured.

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My cancer is a type of anal cancer that has spread and was previously treated.

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I am 18 years old or older.

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I am fully active or able to carry out light work.

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I am HIV positive with a good immune status, undetectable virus, and on HAART.

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I am 18 years old or older.

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I have had treatment for metastatic anal canal cancer before.

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My kidney function, measured by creatinine levels or clearance, is within the required range.

Exclusion Criteria

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

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I haven't taken high-dose steroids or immunosuppressants in the last 14 days.

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I have previously been treated with specific immunotherapy drugs.

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I have an autoimmune disease that could come back or affects my organs.

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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 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Overall response rate: number of participants with response (Part A)

Secondary study objectives

Incidence of grade 3/4/5 adverse events (Part B)

Number of participants with toxicities (Part A)

Overall response rates (Part B)

+2 more

Other study objectives

Expression of biomarkers using immunohistochemistry and blood samples (Part A)

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

3Treatment groups

Experimental Treatment

Group I: Part B Arm II (nivolumab, ipilimumab)Experimental Treatment5 Interventions

Patients receive nivolumab as in Arm I. Patients also receive ipilimumab IV over 30 minutes once every 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.

Group II: Part B Arm I (nivolumab)Experimental Treatment4 Interventions

Patients receive nivolumab IV over 30 minutes once every 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.

Group III: Part A (nivolumab)Experimental Treatment4 Interventions

Patients receive nivolumab IV over 60 minutes once every two weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, MRI and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2030

Computed Tomography

2017

Completed Phase 2

~2790