Checkpoint Inhibitor

Nivolumab +/- Ipilimumab for Anal Cancer

Hershey, PA

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.

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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.Check my eligibility

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.See study design

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.

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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.

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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

70%

Fatigue

50%

Headache

45%

Confusional state

45%

Cough

40%

Malignant neoplasm progression

35%

Hemiparesis

35%

Diarrhoea

30%

Gait disturbance

30%

Nausea

30%

Pruritus

25%

Urinary tract infection

25%

Fall

25%

Hyperglycaemia

25%

Muscular weakness

25%

Rash

20%

Constipation

20%

Vomiting

20%

Lethargy

20%

Memory impairment

20%

Urinary incontinence

20%

Dizziness

20%

Nasal congestion

15%

Abdominal pain

15%

Alanine aminotransferase increased

15%

Lymphocyte count decreased

15%

Platelet count decreased

15%

Decreased appetite

15%

Arthralgia

15%

Cognitive disorder

10%

Aspartate aminotransferase increased

10%

Oedema peripheral

10%

Facial paresis

10%

Pyrexia

10%

Candida infection

10%

Depressed level of consciousness

10%

Syncope

10%

Pulmonary embolism

10%

Anaemia

10%

Sinus tachycardia

10%

Anal incontinence

10%

Asthenia

10%

Tooth infection

10%

Upper respiratory tract infection

10%

Lipase increased

10%

Paraesthesia

10%

Psychomotor skills impaired

10%

Seizure

10%

Agitation

10%

Anxiety

10%

Disorientation

10%

Dehydration

10%

Hypoalbuminaemia

10%

Hypokalaemia

10%

Hyponatraemia

10%

Aphasia

10%

Dysarthria

10%

Dyspnoea

10%

Rash maculo-papular

Dermatitis acneiform

Dysphagia

Oedema

Pain

Cardio-respiratory arrest

Autoimmune thyroiditis

Pneumonia

Hip fracture

White blood cell count decreased

Enterocolitis infectious

Tumour flare

Brain oedema

Cerebrovascular accident

Ischaemic stroke

Mental status changes

Aspiration

Herpes zoster

Haemorrhage intracranial

Hypoxia

Pneumonitis

Respiratory distress

Atrial fibrillation

Cushingoid

Hyperthyroidism

Hypothyroidism

Dry eye

Eyelid ptosis

Visual field defect

Visual impairment

Dyspepsia

Oral candidiasis

Stomatitis

Chills

Amylase increased

Blood alkaline phosphatase increased

Blood bilirubin increased

Weight decreased

Weight increased

Tremor

Vasogenic cerebral oedema

Depression

Insomnia

Pollakiuria

Hypocalcaemia

Proteinuria

Back pain

Myalgia

Amnesia

Ataxia

Balance disorder

Dysphonia

Dry skin

Deep vein thrombosis

Hypertension

Hypotension

Colitis

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1b: Arm N3+I1

Cohort 1: Arm N3

Cohort 1: Arm N1+I3

Cohort 2: Arm N3

Part A Cohort 1c: Arm N3+RT+TMZ

Cohort 2: Arm B

Part B Cohort 1c: Arm N3+RT+TMZ

Part B Cohort 1d: Arm N3+RT

Part A Cohort 1d: Arm N3+RT

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

~1810

Computed Tomography

2017

Completed Phase 2

~2440