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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

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

Study 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.Check my eligibility

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.See study design

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

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I do not have any other types of cancer.

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

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

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

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

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

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

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

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

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

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

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I have not taken specific medications before.

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My recent tests show no signs of cancer.

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I am not currently on IV antibiotics for an infection.

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I am not pregnant or breastfeeding.

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

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I am fully active or can carry out light work.

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My cancer is at stage IIIB.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 2017 Phase 3 trial • 1289 Patients • NCT01285609

38%

Alopecia

36%

Anaemia

32%

Nausea

31%

Decreased appetite

31%

Diarrhoea

30%

Fatigue

25%

Constipation

23%

Neutropenia

20%

Dyspnoea

19%

Vomiting

19%

Pyrexia

18%

Rash

17%

Asthenia

17%

Cough

16%

Pruritus

16%

Thrombocytopenia

16%

Arthralgia

15%

Peripheral sensory neuropathy

14%

Myalgia

13%

Insomnia

13%

Neuropathy peripheral

11%

Hypokalaemia

10%

Platelet count decreased

Pain in extremity

Weight decreased

Leukopenia

Alanine aminotransferase increased

Hyponatraemia

Pneumonia

Haemoglobin decreased

Neutrophil count decreased

Dizziness

Malignant neoplasm progression

Aspartate aminotransferase increased

Bone pain

Haemoptysis

Back pain

Headache

Hypomagnesaemia

Stomatitis

Abdominal pain upper

Oedema peripheral

White blood cell count decreased

Chest pain

Dehydration

Abdominal pain

Febrile neutropenia

Paraesthesia

Musculoskeletal pain

Colitis

Death

Lung infection

Pulmonary embolism

Mucosal inflammation

Multi-organ failure

Cerebrovascular accident

Lung neoplasm malignant

Lung abscess

General physical health deterioration

Interstitial lung disease

Liver function test abnormal

Sudden death

Chronic obstructive pulmonary disease

Metastases to central nervous system

Blood creatinine increased

Atrial fibrillation

Cardio-respiratory arrest

Confusional state

Intestinal perforation

Pulmonary haemorrhage

Drug hypersensitivity

Infection

Pneumothorax

Renal failure

Lower respiratory tract infection

Pain

Respiratory failure

Syncope

Hyperglycaemia

Sepsis

Acute kidney injury

Hypersensitivity

Urinary tract infection

Disease progression

Pneumonitis

100%

80%

60%

40%

20%

Study treatment Arm

10 MG/KG Ipilimumab + Paclitaxel/ Carbop

Placebo + Paclitaxel/ Carboplatin

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

0 / 18Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,687 Previous Clinical Trials

40,928,698 Total Patients Enrolled

557 Trials studying Melanoma

191,517 Patients Enrolled for Melanoma

Ahmad TarhiniPrincipal InvestigatorECOG-ACRIN Cancer Research Group

4 Previous Clinical Trials

273 Total Patients Enrolled

4 Trials studying Melanoma

273 Patients Enrolled for Melanoma

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01274338 — Phase 3

Melanoma Research Study Groups: Arm F (ages 12-17, low-dose ipilimumab), Arm A (age >= 18, high-dose ipilimumab), Arm B (age >= 18, recombinant interferon alfa-2b), Arm C (age >= 18, low-dose ipilimumab), Arm D (age 12-17, high-dose ipilimumab), Arm E (ages 12-17, recombinant interferon alfa-2b)

Melanoma Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT01274338 — Phase 3

Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01274338 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many hospitals are running this experiment?

"Patients can enroll at Rocky Mountain Oncology in Casper, Wyoming, Lancaster Radiation Oncology in Lancaster, Ohio, Forbes Hospital in Monroeville, Pennsylvania, and 100 other locations."

Answered by AI

When was Ipilimumab cleared by the FDA?

"The data supporting Ipilimumab's efficacy and safety, coming from multiple Phase 3 trials, is convincing enough for our team to rate it a 3."

Answered by AI

Does Ipilimumab have a track record of success?

"The first study observing the effects of ipilimumab was conducted in 1998 at the Allan Blair Cancer Centre. To date, there have been 383 completed studies with 357 ongoing trials. Many of these active studies are based in Casper, Wyoming."

Answered by AI

Does this study still need more participants?

"According to the latest information available on clinicaltrials.gov, this trial is no longer recruiting patients. Although the last edit to the trial was on May 7th, 2021, the trial is not presently looking for participants. However, there are many other trials (1200+) that are currently seeking patients."

Answered by AI

To what extent has Ipilimumab been shown to be effective?

"Ipilimumab is not only useful in treating patients that have undergone anthracycline-based chemotherapy, but also in combating acquired immunodeficiency syndrome, cutaneous melanoma, and other malignancies of the blood."

Answered by AI

What is the subject pool for this experiment?

"Presently, this clinical trial is not enrolling patients. This specific study was posted on 5/25/2011 and was last updated on 5/7/2021. There are 843 other trials relating to melanoma and 357 trials for Ipilimumab that are currently looking for participants."

Answered by AI