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Chemotherapy
Ipilimumab + Chemotherapy for Melanoma
Phase 2
Waitlist Available
Led By Wilson Miller, MD, PhD
Research Sponsored by Jewish General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologic diagnosis of malignant melanoma
Be older than 18 years old
Must not have
Patients with ≥ Grade 2 peripheral neuropathy
A history of prior treatment with ipilimumab or prior CD137 agonist or CTLA 4 inhibitor or agonist
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group
Summary
This trial will study the safety of combining the drugs ipilimumab and carboplatin/paclitaxel to treat metastatic melanoma. It will also look at whether the combination can help patients and what features of the immune system may predict who will respond to the treatment.
Who is the study for?
This trial is for adults with advanced melanoma that can't be removed by surgery. Participants must have measurable disease, acceptable organ function, and no active infections like HIV or hepatitis. They should not have symptomatic brain lesions or autoimmune diseases, and must agree to use effective contraception.
What is being tested?
The trial tests the safety of combining ipilimumab (an immune therapy) with carboplatin/paclitaxel (chemotherapy) in two dosing schedules for metastatic melanoma. It aims to assess clinical benefits and identify immune system factors predicting response to treatment.
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, infusion-related symptoms, blood abnormalities, fatigue, liver enzyme changes, and increased risk of infection. The severity of side effects may vary among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with malignant melanoma.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have moderate to severe numbness, tingling, or pain in my hands or feet.
Select...
I have been treated with ipilimumab or drugs targeting CTLA-4 before.
Select...
I am not pregnant, breastfeeding, and can avoid pregnancy during and for 26 weeks after the study.
Select...
I do not have autoimmune diseases like Crohn's, lupus, or Guillain-Barre Syndrome.
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
Side effects data
From 2024 Phase 3 trial • 529 Patients • NCT0201771780%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: BExperimental Treatment3 Interventions
Carboplatin (week 1, week 4, week 7, week 10, and week 13) Paclitaxel (week 1, week 4, week 7, week 10, and week 13) Ipilimumab (week 5, week 8, week 11, and week 14)
Group II: AExperimental Treatment3 Interventions
Arm A: Carboplatin (week 1, week 4, week 7, week 10, and week 13) Paclitaxel (week 1, week 4, week 7, week 10, and week 13) Ipilimumab (week 4, week 7, week 10, and week 13)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Ipilimumab
FDA approved
Carboplatin
FDA approved
Find a Location
Who is running the clinical trial?
Jewish General HospitalLead Sponsor
142 Previous Clinical Trials
279,621 Total Patients Enrolled
Wilson Miller, MD, PhDPrincipal InvestigatorJewish General Hospital
2 Previous Clinical Trials
34 Total Patients Enrolled
1 Trials studying Melanoma
30 Patients Enrolled for Melanoma
Rahima Jamal, MDPrincipal InvestigatorNotre-Dame Hospital (CHUM)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been cancer-free for less than a year, except for certain skin, bladder, or cervical cancers.I have moderate to severe numbness, tingling, or pain in my hands or feet.I am not on treatments like IL 2, interferon, other immune therapies, immunosuppressants, experimental drugs, or long-term steroids.I haven't had vaccines for infectious diseases 1 month before or after ipilimumab.I have been treated with ipilimumab or drugs targeting CTLA-4 before.I am not pregnant, breastfeeding, and can avoid pregnancy during and for 26 weeks after the study.I have advanced melanoma that hasn't been treated with surgery, but I may have had adjuvant therapy or BRAF inhibitors.You have a disease that can be measured or evaluated.I have brain lesions but no symptoms, or they were treated.I do not have autoimmune diseases like Crohn's, lupus, or Guillain-Barre Syndrome.People who are in prison or are being held against their will for treatment cannot participate.I do not have any health or mental conditions that could make treatment risky.I have been diagnosed with malignant melanoma.
Research Study Groups:
This trial has the following groups:- Group 1: B
- Group 2: A
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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.