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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study 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 belowSelect...
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.
Select...
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.
Select...
My heart is healthy according to specific tests.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
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 • 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: 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
~4750
Ipilimumab
2014
Completed Phase 3
~2670
Cabozantinib
2020
Completed Phase 2
~1080
Find a Location
Who is running the clinical trial?
Providence Health & ServicesLead Sponsor
117 Previous Clinical Trials
822,531 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,510 Total Patients Enrolled
ExelixisIndustry Sponsor
117 Previous Clinical Trials
19,547 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.If you can have children, you need to have a negative pregnancy test before starting the study medication and every 4 weeks while on treatment.I have lung lesions or disease in my airways.I have had a solid organ or stem cell transplant.I have a muscle disorder that could increase my CK levels.My cancer spread while on or after anti-PD-1/PD-L1 therapy.I haven't had any major abdominal issues like fistulas or obstructions in the last 6 months.I have been treated with drugs targeting PD-1 or PD-L1.I have a serious wound, ulcer, or bone fracture that is not healing.I have a tumor affecting my digestive system or have had recent serious digestive issues.I don't have brain metastases or leptomeningeal carcinomatosis, or if I do, they meet certain conditions.My cancer progressed after anti-PD-1/PD-L1 therapy, confirmed 4 weeks post first signs.I am fully active and can carry on all my pre-disease activities without restriction.My melanoma has spread to the lining of my brain and spinal cord.I have recovered from previous treatment side effects, or they are minor and stable.My recent tests show my organs and bone marrow are functioning well.I have not had significant bleeding in the last 3 months.You have a current or suspected autoimmune disease.I haven't taken steroids or immunosuppressants in the last 14 days.My liver is not working well.You have HIV, hepatitis B, or hepatitis C infection.I have not received a live vaccine in the last 30 days.I have been treated with a VEGF(R) inhibitor, with or without immune checkpoint inhibitors.I haven't had any cancer treatment in the last 2 weeks.I haven't had cancer within the last 3 years, except for certain types.I have not had a stroke or blood clot in the last 6 months.My skin cancer has been confirmed to have spread.Your heart's electrical system shows a specific abnormality on a recent test.I have been treated with an anti-CTLA-4 antibody before.I have heart problems or diseases.I require dialysis.I have a history of specific lung conditions or signs of lung inflammation on a CT scan.You have a disease that can be measured according to specific criteria.I have not had major surgery in the last 3 weeks or minor surgery in the last 10 days.My heart is healthy according to specific tests.I am currently taking blood thinners.I do not have stomach or bowel problems that affect how I absorb medication.I haven't had radiation for bone metastases in 2 weeks, other radiation in 4 weeks, or radionuclide treatment in 6 weeks.I may or may not have been treated with BRAF/MEK inhibitors before.My cancer is affecting major blood vessels.
Research Study Groups:
This trial has the following groups:- Group 1: Cabozantinib + Ipilimumab + Nivolumab
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.
Is this experiment currently enrolling participants?
"Affirmative. Per the information stored on clinicaltrials.gov, this research endeavour is actively recruiting participants. Beginning June 8th 2022, it has been in search of 41 volunteers from a single site."
Answered by AI
How many participants can join this trial at its fullest capacity?
"Affirmative, clinicaltrials.gov supports the active recruitment for this trial which was published on June 8th 2022 and most recently updated on that same day. Across a solitary medical centre, 41 patients are sought to participate in this study."
Answered by AI
Has the FDA certified Ipilimumab for therapeutic use?
"Due to the lack of clinical data confirming its efficacy, Ipilimumab was assigned a safety score 2 on Power's scale. It has been tested in Phase 2 trials, which have provided some evidence for its security."
Answered by AI
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