← Back to Search

Checkpoint Inhibitor

Ipilimumab vs Interferon Alfa-2b for Skin Cancer

Phase 3

Waitlist Available

Led By Ahmad Tarhini

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

Patients who have other current malignancies are not eligible

T1-4b N1b M0

Must not have

Patients with autoimmune hypothyroid disease or type I diabetes on replacement treatment are eligible

Patients with stage IV melanoma must have specific conditions to be eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed every 3 months for 2 years, then every 6 months for years 3-5

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares ipilimumab to interferon alfa-2b to see which is more effective in treating patients with high-risk stage III-IV melanoma.

Who is the study for?

This trial is for patients with high-risk stage III-IV melanoma that's been surgically removed. Eligible participants must have certain blood test results, no history of specific medical conditions, and not be on treatments that could affect the trial. They can't have other cancers, active infections like HIV or hepatitis B/C, autoimmune disorders needing steroids, or vaccinations within 4 weeks prior to joining. Women who can become pregnant and men must use contraception.

What is being tested?

The study compares ipilimumab (an immunotherapy drug) with high-dose interferon alfa-2b (a treatment slowing cancer growth) in melanoma patients post-surgery. It aims to determine which is more effective at preventing cancer recurrence by either boosting the immune system or inhibiting tumor cell growth.

What are the potential side effects?

Ipilimumab may cause immune-related side effects such as inflammation in organs, skin rash, diarrhea, and fatigue. Interferon alfa-2b might lead to flu-like symptoms including fever and chills, fatigue, thinning hair, nausea and depression.

Eligibility Criteria

Inclusion Criteria

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

Select...

I do not have any other types of cancer.

Select...

My breast cancer has spread to nearby lymph nodes but not to distant parts of my body.

Select...

I do not have a history of the specified medical conditions.

Select...

I haven't received any vaccines in the last 4 weeks.

Select...

I do not have HIV, hepatitis B, or hepatitis C.

Select...

I am not on steroids or other drugs for autoimmune diseases.

Select...

My skin cancer is at a specific stage according to the AJCC.

Select...

My cancer is in the breast and nearby lymph nodes but hasn't spread to distant parts.

Select...

My breast cancer is in an early to advanced stage but hasn't spread to distant organs.

Select...

My cancer is in the breast and nearby lymph nodes but not spread to distant organs.

Select...

My cancer is in an early stage but has spread to nearby lymph nodes.

Select...

I have not taken specific medications before.

Select...

My recent tests show no signs of cancer.

Select...

I am not currently on IV antibiotics for an infection.

Select...

I am not pregnant or breastfeeding.

Select...

I haven't had any treatment after surgery that qualifies me for this trial.

Select...

I am fully active or can carry out light work.

Select...

My cancer is at stage IIIB.

Exclusion Criteria

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

Select...

I have autoimmune thyroid disease or type 1 diabetes and am on replacement therapy.

Select...

I have stage IV melanoma with specific eligibility conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed every 3 months for 2 years, then every 6 months for years 3-5 and then annually up to 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed every 3 months for 2 years, then every 6 months for years 3-5 and then annually up to 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 3 months for 2 years, then every 6 months for years 3-5 and then annually up to 8 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

5-year Overall Survival (OS) Rate (Arm A [HIP] vs. Arm B [HDI])

5-year Overall Survival (OS) Rate (Arm B [HDI] vs. Arm C [LIP])

Recurrence-free Survival (RFS; Arm A [HIP] vs. Arm B [HDI])

+1 more

Secondary study objectives

Change in FACIT-D (Functional Assessment of Cancer Therapy - Diarrhea) Diarrhea Subscale Score From Baseline to 3 Months

Change in FACT-BRM (Functional Assessment of Cancer Therapy - Biologic Response Modifiers) Total Score From Baseline to 3 Months

Change in FACT-G (Functional Assessment of Cancer Therapy - General) Total Score From Baseline to 3 Months

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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Arm F (ages 12-17, low-dose ipilimumab)Experimental Treatment1 Intervention

Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 90 days for a maximum of 4 cycles in the absence of disease progression or unacceptable toxicity. (ages 12-17)

Group II: Arm E (ages 12-17, recombinant interferon alfa-2b)Experimental Treatment1 Intervention

Patients receive high-dose recombinant interferon alpha-2b IV on days 1-5, 8-12, 15-19, and 22-26 in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance high-dose recombinant interferon alpha-2b SC on days 1, 3, and 5. Treatment repeats every week for 48 weeks in the absence of disease progression or unacceptable toxicity. (ages 12-17)

Group III: Arm D (age 12-17, high-dose ipilimumab)Experimental Treatment1 Intervention

Patients receive induction high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance high-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 90 days for a maximum of 4 cycles in the absence of disease progression or unacceptable toxicity.

Group IV: Arm C (age >= 18, low-dose ipilimumab)Experimental Treatment2 Interventions

Patients receive induction low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for a total of 4 cyclees in the absence of disease progression or unacceptable toxicity. Beginning on week 24, patients receive maintenance low-dose ipilimumab IV over 90 minutes on day 1. Treatment repeats every 90 days for a maximum of 4 cycles in the absence of disease progression or unacceptable toxicity. (adult accrual has completed to Arms A, B, and C as of 8/15/2014)

Group V: Arm B (age >= 18, recombinant interferon alfa-2b)Experimental Treatment2 Interventions

Group VI: Arm A (age >= 18, high-dose ipilimumab)Experimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

FDA approved

Recombinant Interferon Alfa-2b

2019

Completed Phase 2

~150