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Tyrosine Kinase Inhibitor
Axitinib + Ipilimumab for Advanced Melanoma
Phase 2
Recruiting
Led By Zeynep Eroglu, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prior treatment-related toxicity resolved to ≤ Grade 2 or baseline
No limit to prior lines of treatment but prior ipilimumab not permitted
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will test whether combining two drugs can better treat advanced melanoma than either drug alone.
Who is the study for?
This trial is for adults with advanced melanoma, excluding uveal melanoma. Participants can have had any number of prior treatments but not ipilimumab. They must be at least 2 weeks out from major surgery and recovered from previous treatment side effects to Grade 2 or baseline. Those with treated brain metastases are eligible unless they're unstable or need steroids. No active autoimmune diseases requiring therapy, except replacement therapy like corticosteroids, are allowed.Check my eligibility
What is being tested?
The study is testing the effectiveness of combining axitinib with ipilimumab in treating advanced melanoma. It's looking for people who haven't responded well to anti-PD-1/PD-L1 inhibitors or relapsed soon after treatment. Patients will receive both drugs and their response will be measured using specific criteria for tumor size changes over time.See study design
What are the potential side effects?
Possible side effects include high blood pressure (which needs to be controlled before joining), bleeding issues, heart problems like severe angina or congestive heart failure within the past six months, stroke risks, and interactions with certain other medications that affect liver enzymes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My side effects from previous treatments are mild or gone.
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I have had treatments before, but never ipilimumab.
Select...
I have HIV with undetectable viral load or cured hepatitis C.
Select...
I am not on strong medication for an autoimmune disease, but I may be taking basic replacement therapy.
Select...
My blood pressure is below 150/100.
Select...
I have advanced melanoma that cannot be surgically removed, but it's not uveal melanoma.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I can have a biopsy before and during treatment.
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 Response Rate
Secondary outcome measures
Clinical Benefit Rate
Duration of Response
Overall Survival
+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
1Treatment groups
Experimental Treatment
Group I: Ipilimumab + AxtinibExperimental Treatment2 Interventions
Participants will receive treatment with ipilimumab 3 mg/kg IV q3 weeks x 4 doses and axitinib at 5 mg by mouth twice daily. Each cycle is 3 weeks/21 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2620
Axitinib
2020
Completed Phase 2
~3050
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
543 Previous Clinical Trials
135,470 Total Patients Enrolled
43 Trials studying Melanoma
3,193 Patients Enrolled for Melanoma
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,915,961 Total Patients Enrolled
51 Trials studying Melanoma
49,429 Patients Enrolled for Melanoma
Zeynep Eroglu, MDPrincipal InvestigatorMoffitt Cancer Center
3 Previous Clinical Trials
109 Total Patients Enrolled
1 Trials studying Melanoma
50 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have melanoma with a BRAF mutation and may have been treated with or intolerant to BRAF/MEK inhibitors.My side effects from previous treatments are mild or gone.My blood tests and organ functions are within normal ranges.My brain metastases have been treated and are stable without needing steroids.I have had treatments before, but never ipilimumab.I have not had severe heart problems or heart failure in the last 6 months.You have at least one spot that can be measured according to specific criteria.My cancer did not respond or couldn't tolerate treatment with anti-PD-1/PD-L1 inhibitors.I have not had a stroke or mini-stroke in the last 6 months.I have HIV with undetectable viral load or cured hepatitis C.I have another cancer, but it won't affect this trial's treatment.I am not on strong medication for an autoimmune disease, but I may be taking basic replacement therapy.I am not using, nor do I plan to use, strong CYP3A4/5 inhibitors or inducers.I had my last major surgery more than 2 weeks ago.I do not have severe liver cirrhosis.I have not had severe bleeding in the last month.My blood pressure is below 150/100.I have advanced melanoma that cannot be surgically removed, but it's not uveal melanoma.I can take care of myself and am up and about more than half of my waking hours.I can have a biopsy before and during treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Ipilimumab + Axtinib
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.
What other research projects have been done concerning the effects of Ipilimumab?
"As of this date, the number of clinical trials researching Ipilimumab stands at 363 with 42 in Phase 3. Most are based in Pittsburgh, Pennsylvania; however, there are an array of other sites across 21354 locations conducting relevant research."
Answered by AI
What is the upper limit of participants for this clinical experiment?
"Affirmative. Clinicaltrials.gov data reveals that this experiment, which was initially advertised on August 4th 2021, is actively recruiting participants. Approximately 25 individuals need to be identified from 1 medical centre."
Answered by AI
Is there availability for participants to be part of this trial?
"Affirmative. According to the record on clinicaltrials.gov, enrollment for this medical trial is currently open and has been since August 4th 2021. The last update was made on November 11th 2022. 25 participants are needed from one location in total."
Answered by AI
To what medical conditions is ipilimumab mainly utilized?
"Ipilimumab is usually prescribed for metastatic melanoma; however, it can additionally be administered to treat cases of intermediate risk and advanced thyroid cancer as well as unresectable melanoma."
Answered by AI
Has Ipilimumab obtained sanction from the Federal Drug Administration?
"Due to lacking evidence supporting Ipilimumab's efficacy, its safety rating is a 2. However, there are some data points indicating that this medication can be safely administered."
Answered by AI
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