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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
If BRAFV600-mutant melanoma, patients may have had prior BRAF/MEK inhibitor therapy, or intolerance to these drugs
Prior treatment-related toxicity resolved to ≤ Grade 2 or baseline
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 below
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I have melanoma with a BRAF mutation and may have been treated with or intolerant to BRAF/MEK inhibitors.
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My side effects from previous treatments are mild or gone.
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My blood tests and organ functions are within normal ranges.
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My brain metastases have been treated and are stable without needing steroids.
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I have had treatments before, but never ipilimumab.
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My cancer did not respond or couldn't tolerate treatment with anti-PD-1/PD-L1 inhibitors.
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I have HIV with undetectable viral load or cured hepatitis C.
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I have another cancer, but it won't affect this trial's treatment.
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I am not on strong medication for an autoimmune disease, but I may be taking basic replacement therapy.
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I had my last major surgery more than 2 weeks ago.
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My blood pressure is below 150/100.
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I have advanced melanoma that cannot be surgically removed, but it's not uveal melanoma.
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I can take care of myself and am up and about more than half of my waking hours.
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I can have a biopsy before and during treatment.

Timeline

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

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 more

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
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
~2670
Axitinib
2020
Completed Phase 2
~3050

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,467 Total Patients Enrolled
43 Trials studying Melanoma
3,193 Patients Enrolled for Melanoma
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,848 Total Patients Enrolled
51 Trials studying Melanoma
49,428 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

Axitinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04996823 — Phase 2
Melanoma Research Study Groups: Ipilimumab + Axtinib
Melanoma Clinical Trial 2023: Axitinib Highlights & Side Effects. Trial Name: NCT04996823 — Phase 2
Axitinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04996823 — Phase 2

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
~2 spots leftby Aug 2024