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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival (OS)
Secondary outcome measures
Immune response
Incidence of adverse events (AE)
Progression-free survival (PFS)
+1 moreSide effects data
From 2017 Phase 3 trial • 1289 Patients • NCT0128560938%
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
9%
Pain in extremity
9%
Weight decreased
9%
Leukopenia
8%
Alanine aminotransferase increased
8%
Hyponatraemia
8%
Pneumonia
8%
Haemoglobin decreased
7%
Neutrophil count decreased
7%
Dizziness
7%
Malignant neoplasm progression
7%
Aspartate aminotransferase increased
7%
Bone pain
7%
Haemoptysis
7%
Back pain
6%
Headache
6%
Hypomagnesaemia
6%
Stomatitis
5%
Abdominal pain upper
5%
Oedema peripheral
5%
White blood cell count decreased
5%
Chest pain
5%
Dehydration
5%
Abdominal pain
4%
Febrile neutropenia
4%
Paraesthesia
4%
Musculoskeletal pain
3%
Colitis
2%
Death
2%
Lung infection
2%
Pulmonary embolism
2%
Mucosal inflammation
1%
Lung neoplasm malignant
1%
Multi-organ failure
1%
Cerebrovascular accident
1%
Lung abscess
1%
General physical health deterioration
1%
Interstitial lung disease
1%
Liver function test abnormal
1%
Sudden death
1%
Chronic obstructive pulmonary disease
1%
Metastases to central nervous system
1%
Blood creatinine increased
1%
Atrial fibrillation
1%
Cardio-respiratory arrest
1%
Confusional state
1%
Intestinal perforation
1%
Pulmonary haemorrhage
1%
Drug hypersensitivity
1%
Infection
1%
Pneumothorax
1%
Renal failure
1%
Lower respiratory tract infection
1%
Pain
1%
Respiratory failure
1%
Syncope
1%
Hyperglycaemia
1%
Sepsis
1%
Acute kidney injury
1%
Hypersensitivity
1%
Urinary tract infection
1%
Disease progression
1%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 MG/KG Ipilimumab + Paclitaxel/ Carbop
Placebo + Paclitaxel/ Carboplatin
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
~5280
Ipilimumab
2014
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,984 Total Patients Enrolled
557 Trials studying Melanoma
193,064 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current openings for individuals who want to participate in this clinical trial?
"This study has completed recruitment. It was originally posted on December 13th, 2013 and last updated on September 23rd, 2022. If you are interested in other studies, 848 clinical trials for patients with melanoma and 694 for Ipilimumab are currently underway."
Answered by AI
What are the most common maladies that Ipilimumab is prescribed for?
"Ipilimumab is a medication that can be taken to manage recurrent platinum-resistant epithelial ovarian cancer as well as other conditions like malignant neoplasms, recurrent platinum sensitive primary peritoneal cancer, and unresectable melanoma."
Answered by AI
How many facilities are administering this research project?
"Currently, patients are being accepted at 4 locations: Wayne Hospital in Greenville, Michigan, University of Toledo in Toledo, North carolina, Mercy Health Mercy Campus in Muskegon, South carolina. There are also 100 other sites enrolling for this study."
Answered by AI
How many people are allowed to participate in this experiment at one time?
"This clinical trial is no longer recruiting participants. The study was originally posted on December 13th, 2013 and ended recruitment on September 23rd, 2022. However, there are currently 848 other trials actively recruiting patients with melanoma and 694 studies for Ipilimumab that need participants."
Answered by AI
Can Ipilimumab help patients with my particular condition?
"While Phase 2 trials don't have evidence supporting efficacy, there is some data suggesting that Ipilimumab is safe."
Answered by AI
Can you provide a list of other research studies that have used Ipilimumab?
"Ipilimumab was first trialled in 2004 at Memoral Sloan Kettering Basking Ridge (Follow Up Only). So far, there have been 1191 completed clinical trials. Right now, 694 are ongoing with a large number of these taking place in Greenville, Michigan."
Answered by AI
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