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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety: Incidence of adverse events
Secondary outcome measures
Putative Early Cellular and/or Molecular Biomarker levels
To determine ORR and clinical benefit rate (ORR + SD ≥ 24 weeks), by immune related response criteria (irRC) and modified WHO criteria (mWHO) of ipilimumab when given with carboplatin and paclitaxel at two different dosing regimens.
To determine progression free survival (PFS) per irRC and mWHO of patients receiving ipilimumab with carboplatin and paclitaxel.
+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
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
Carboplatin
FDA approved
Ipilimumab
FDA approved
Find a Location
Who is running the clinical trial?
Jewish General HospitalLead Sponsor
138 Previous Clinical Trials
272,364 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:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
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.
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