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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

No Placebo-Only Group

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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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 Survival (OS)

Secondary study objectives

Clinical Response Rate

Immune-related (ir) Responses Rate (Ir-CR+Ir-PR)

Incidence of Adverse Events (AE)

+1 more

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

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

2015

Completed Phase 3

~3070