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Checkpoint Inhibitor
Ipilimumab +/- Bevacizumab for Melanoma
Phase 2
Waitlist Available
Led By Frank S Hodi
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
No concomitant therapy with any of the following: interleukin (IL) 2, interferon, or other non-study immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids; must have been discontinued >= 4 weeks prior to randomization
Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1
Must not have
Patients are excluded if they have had a surgical procedure or a significant traumatic injury within 28 days prior to randomization
Patients are ineligible if they have any history of central nervous system (CNS) metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial is studying ipilimumab with or without bevacizumab to treat patients with stage III-IV melanoma.
Who is the study for?
This trial is for patients with stage III-IV melanoma that can't be surgically removed. Participants must have known BRAF mutation status, normal organ function tests, and no recent history of certain heart conditions or infections like HIV or hepatitis. They should not be pregnant, breastfeeding, or on immunosuppressants and must agree to use contraception.
What is being tested?
The study is testing the effectiveness of ipilimumab alone versus combined with bevacizumab in treating advanced melanoma. These drugs are types of immunotherapy that may help the immune system fight cancer by stopping tumor growth and spread.
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs, infusion reactions similar to allergic responses, fatigue, digestive issues such as diarrhea or liver problems, increased risk of infection due to immune system suppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not currently on treatments like IL2, interferon, chemotherapy, or steroids.
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I am fully active or can carry out light work.
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I do not have an active or chronic hepatitis C infection.
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I know my cancer's BRAF mutation status.
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I do not have an active hepatitis B infection.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had surgery or a major injury in the last 28 days.
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I have never had cancer spread to my brain or spinal cord.
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I do not have any current infections.
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My blood pressure is controlled and within normal limits on medication.
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I have never had a hypertensive crisis or brain issues due to high blood pressure.
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I have not had a heart attack or unstable chest pain in the last 6 months.
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I have not had a stroke or mini-stroke in the last 6 months.
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I do not have symptoms from poor blood flow in my limbs.
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I have not coughed up a significant amount of blood in the last 3 months.
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I do not have major blood vessel problems like an aortic aneurysm.
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I do not have any non-healing wounds or ulcers.
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I do not have severe heart failure.
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I have had a condition where my lymphocytes grow abnormally.
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I do not have any bleeding disorders or conditions that affect blood clotting.
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My melanoma has not spread to my gastrointestinal tract.
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My urine test shows less than 1g of protein in 24 hours after a high initial result.
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I haven't had any major abdominal issues like a fistula, perforation, or abscess in the last 6 months.
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I have a history of cancer.
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I am not taking any systemic steroids for another health condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Survival (OS)
Secondary study objectives
Clinical Response Rate
Immune-related (ir) Responses Rate (Ir-CR+Ir-PR)
Incidence of Adverse Events (AE)
+1 moreSide effects data
From 2024 Phase 3 trial • 529 Patients • NCT0201771780%
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%
Cushingoid
10%
Tinnitus
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%
0%
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
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B (ipilimumab and bevacizumab)Experimental Treatment2 Interventions
INDUCTION THERAPY: Patients receive ipilimumab IV over 90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Patients receive bevacizumab as in Induction Therapy. Beginning cycle 8, patients also receive ipilimumab IV over 90 minutes on day 1. Cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (ipilimumab)Active Control1 Intervention
INDUCTION THERAPY: Patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY: Beginning cycle 8, patients receive ipilimumab IV over 90 minutes on day 1. Cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5540
Ipilimumab
2014
Completed Phase 3
~3140
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,842 Previous Clinical Trials
41,002,831 Total Patients Enrolled
561 Trials studying Melanoma
195,598 Patients Enrolled for Melanoma
Frank S HodiPrincipal InvestigatorECOG-ACRIN Cancer Research Group
3 Previous Clinical Trials
923 Total Patients Enrolled
3 Trials studying Melanoma
923 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had surgery or a major injury in the last 28 days.I am not pregnant or breastfeeding and have confirmed this with a test.Your hemoglobin level is 9 grams per deciliter or higher within the last 4 weeks before the study starts.Your blood bilirubin level should not be higher than 2 times the upper limit of normal, unless you have Gilbert's syndrome, in which case it should be less than 3.0 mg/dL.I have never had cancer spread to my brain or spinal cord.I do not have any current infections.My blood pressure is controlled and within normal limits on medication.I have never had a hypertensive crisis or brain issues due to high blood pressure.I have not had a heart attack or unstable chest pain in the last 6 months.I have advanced melanoma and have had limited or no previous treatments.I do not have an autoimmune disease like inflammatory bowel disease, rheumatoid arthritis, or lupus.I have not been treated with ipilimumab, bevacizumab, or specific immune therapy drugs before.I have not had a stroke or mini-stroke in the last 6 months.I do not have symptoms from poor blood flow in my limbs.I have not had any minor surgeries, except for a vascular access device placement, in the last 7 days.My urine protein level is high but less than 1000 mg in 24 hours.I have not coughed up a significant amount of blood in the last 3 months.I haven't taken any medication that affects blood clotting for at least 2 weeks.I haven't had vaccines for infectious diseases 1 month before or after receiving ipilimumab.I do not have major blood vessel problems like an aortic aneurysm.I do not have any non-healing wounds or ulcers.I am not currently on treatments like IL2, interferon, chemotherapy, or steroids.I am fully active or can carry out light work.I have recovered from side effects of my previous cancer treatment.I do not have an active or chronic hepatitis C infection.I do not have severe heart failure.You cannot participate if you have protein in your urine when tested at the beginning of the study.I finished my last cancer treatment more than 4 weeks ago, or more than 6 weeks ago for certain drugs.I have had a condition where my lymphocytes grow abnormally.I haven't taken high-dose aspirin or NSAIDs regularly in the last 10 days.I do not have HIV.I have not taken warfarin or similar blood thinners in full dose for at least 2 weeks.Your kidney function test results should show that the level of creatinine in your blood is not more than twice the upper limit of normal.Your platelet count is at least 75,000 per microliter of blood, measured within the last 4 weeks.I agree to use effective birth control or practice abstinence.You are allergic to Chinese hamster ovary cell products or other similar human antibodies.I had a heart test showing normal function after anthracycline treatment.I do not have any bleeding disorders or conditions that affect blood clotting.Your white blood cell count is at least 2000 cells per microliter.My melanoma has not spread to my gastrointestinal tract.Your liver enzyme levels are not too high, depending on whether you have cancer that has spread to your liver or not.My urine test shows less than 1g of protein in 24 hours after a high initial result.I know my cancer's BRAF mutation status.I haven't had any major abdominal issues like a fistula, perforation, or abscess in the last 6 months.Your blood test within the last 4 weeks shows a healthy level of a specific type of white blood cell called neutrophils.I have been cancer-free for over 2 years, except for certain skin, bladder, or cervical cancers.I have a history of cancer.I am not taking any systemic steroids for another health condition.I do not have an active hepatitis B infection.My cancer was checked within the last month and can be measured.I haven't had cancer in the last 5 years, except for skin cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (ipilimumab and bevacizumab)
- Group 2: Arm A (ipilimumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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