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Kinase Inhibitor

Triple Drug Therapy for Melanoma

Phase 2
Waitlist Available
Led By Matthew Taylor, MD
Research Sponsored by Providence Health & Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who develop unresectable/metastatic disease while receiving or following completion of adjuvant systemic anti-PD-1/PD-L1 therapy are eligible.
Must have been treated previously with an immune checkpoint inhibitor targeting PD-1 or PD-L1.
Must not have
Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation.
History of solid organ or allogenic stem cell transplant.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Summary

This trial is testing a new combination of drugs to treat metastatic melanoma that has stopped responding to other treatments.

Who is the study for?
Adults with metastatic cutaneous melanoma that didn't respond to PD-1/PD-L1 inhibitors can join. They must have measurable disease, good organ function, and an ECOG status ≤ 1. Participants need a negative pregnancy test and agree to contraception. Exclusions include prior VEGF(R) inhibitor treatment, other cancers within 3 years (with exceptions), autoimmune diseases, recent steroids or immunosuppressants use, certain cardiovascular issues, CNS metastases unless meeting criteria, significant bleeding history or major surgery recently.Check my eligibility
What is being tested?
The trial tests the combination of Ipilimumab + Nivolumab + Cabozantinib in patients whose melanoma has not improved after anti-PD-1/PD-L1 therapy. It aims to see if this triplet improves clinical outcomes and delays cancer progression compared to previous treatments.See study design
What are the potential side effects?
Possible side effects include immune-related reactions like inflammation in organs; skin rash; liver enzyme elevation; endocrine issues such as thyroid dysfunction; gastrointestinal problems like diarrhea; fatigue; increased risk of infections 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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My cancer spread while on or after anti-PD-1/PD-L1 therapy.
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I have been treated with drugs targeting PD-1 or PD-L1.
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I am fully active and can carry on all my pre-disease activities without restriction.
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My skin cancer has been confirmed to have spread.
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My heart is healthy according to specific tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have lung lesions or disease in my airways.
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I have had a solid organ or stem cell transplant.
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I have a muscle disorder that could increase my CK levels.
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I have a serious wound, ulcer, or bone fracture that is not healing.
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I have a tumor affecting my digestive system or have had recent serious digestive issues.
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I don't have brain metastases or leptomeningeal carcinomatosis, or if I do, they meet certain conditions.
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My melanoma has spread to the lining of my brain and spinal cord.
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I have not had significant bleeding in the last 3 months.
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My liver is not working well.
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I have been treated with a VEGF(R) inhibitor, with or without immune checkpoint inhibitors.
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I haven't had any cancer treatment in the last 2 weeks.
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I have been treated with an anti-CTLA-4 antibody before.
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I have heart problems or diseases.
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I require dialysis.
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I have a history of specific lung conditions or signs of lung inflammation on a CT scan.
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I have not had major surgery in the last 3 weeks or minor surgery in the last 10 days.
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I am currently taking blood thinners.
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I haven't had radiation for bone metastases in 2 weeks, other radiation in 4 weeks, or radionuclide treatment in 6 weeks.
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My cancer is affecting major blood vessels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To evaluate the clinical efficacy and progression free survival of the triplet combination of ipilimumab + nivolumab + cabozantinib in patients with anti-PD-1/PD-L1 refractory metastatic cutaneous melanoma.
Secondary outcome measures
Overall Survival
Safety/Tolerability (CTCAE v5.0)

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%
Multi-organ failure
1%
Lung abscess
1%
Cerebrovascular accident
1%
Lung neoplasm malignant
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: Cabozantinib + Ipilimumab + NivolumabExperimental Treatment3 Interventions
Ipilimumab 1 mg/kg + Nivolumab 3 mg/kg IV every 3 weeks + Cabozantinib 40 mg PO daily for 4 cycles followed by Nivolumab 480 mg IV every 4 weeks + Cabozantinib 40 mg PO daily for up to 24 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4740
Ipilimumab
2014
Completed Phase 3
~2610
Cabozantinib
2020
Completed Phase 2
~1760

Find a Location

Who is running the clinical trial?

Providence Health & ServicesLead Sponsor
119 Previous Clinical Trials
822,583 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,652 Previous Clinical Trials
4,130,745 Total Patients Enrolled
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,530 Total Patients Enrolled

Media Library

Cabozantinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05200143 — Phase 2
Cutaneous Melanoma Research Study Groups: Cabozantinib + Ipilimumab + Nivolumab
Cutaneous Melanoma Clinical Trial 2023: Cabozantinib Highlights & Side Effects. Trial Name: NCT05200143 — Phase 2
Cabozantinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05200143 — Phase 2
~2 spots leftby Jun 2027
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