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Alkylating agents
Pembrolizumab + Chemotherapy for Metastatic Melanoma
Phase 2
Waitlist Available
Led By Wilson Miller, MD, PhD
Research Sponsored by Wilson Miller
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be ≥ 18 years of age on day of signing informed consent
Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication
Must not have
Has had prior treatment for advanced unresectable or metastatic melanoma. Prior treatment with BRAF and MEK inhibitors is permitted in this setting. A washout of at least 5-half-lives (median terminal half-life) prior to the first dose of trial treatment must have elapsed
Has ≥ Grade 2 peripheral neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial is testing a new combination drug therapy for melanoma that has spread or can't be removed by surgery.
Who is the study for?
This trial is for adults over 18 with unresectable Stage III or metastatic melanoma who haven't had prior treatments for advanced melanoma (except BRAF/MEK inhibitors). Participants must have good organ function, not be pregnant, agree to contraception, and have no active infections like HIV or Hepatitis. Those with certain autoimmune diseases, symptomatic CNS lesions, severe neuropathy, or on immunosuppressants can't join.
What is being tested?
The study tests pembrolizumab combined with carboplatin/paclitaxel in patients with advanced melanoma. It's an open-label Phase II trial where all participants receive the treatment to see how effective it is and what side effects occur.
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs, infusion-related symptoms like chills or fever, fatigue from chemotherapy drugs carboplatin/paclitaxel which may also cause nerve damage (neuropathy), blood cell count changes increasing infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am using two birth control methods or am not having sex to avoid pregnancy during and up to 120 days after the study.
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I can provide a tumor sample from a metastatic site for testing.
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I am fully active or can carry out light work.
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My melanoma cannot be removed by surgery and is either stage III or has spread.
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I do not have HIV, Hepatitis B, or Hepatitis C.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I've been treated for advanced melanoma before, including BRAF and MEK inhibitors, with a sufficient washout period.
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I have moderate to severe numbness, tingling, or pain in my hands or feet.
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I have an active tuberculosis infection.
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I am currently being treated for an infection.
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I have another cancer that is getting worse or needs treatment.
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I have been treated with specific immune therapy drugs before.
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 • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab
Awards & Highlights
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab, Carboplatin, PaclitaxelExperimental Treatment3 Interventions
Carboplatin will be administered at AUC = 6, IV over 60 minutes every 3 weeks for up to 4 doses. Paclitaxel will be administered at 175mg/m2, IV over 3 hours every 3 weeks for up to 4 doses. Pembrolizumab will be administered at 200 mg, IV over 30 minutes every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Carboplatin
FDA approved
Paclitaxel
FDA approved
Find a Location
Who is running the clinical trial?
Wilson MillerLead Sponsor
Wilson Miller, MD, PhDPrincipal InvestigatorJewish General Hospital
2 Previous Clinical Trials
34 Total Patients Enrolled
Rahima Jamal, MD, PhDPrincipal InvestigatorCHUM, Hopital Notre-Dame
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have an autoimmune disease but it's controlled without strong medication, except for vitiligo, stable hypothyroidism, or mild asthma.I am not on high-dose steroids or other drugs that weaken my immune system.I have brain lesions that cause symptoms, or I had treatment for brain lesions that no longer cause symptoms.I've been treated for advanced melanoma before, including BRAF and MEK inhibitors, with a sufficient washout period.My organs are functioning well.I am using two birth control methods or am not having sex to avoid pregnancy during and up to 120 days after the study.I have not received a live vaccine within the last 30 days.I can provide a tumor sample from a metastatic site for testing.I am fully active or can carry out light work.I have moderate to severe numbness, tingling, or pain in my hands or feet.I have an active tuberculosis infection.My melanoma cannot be removed by surgery and is either stage III or has spread.I am currently being treated for an infection.I agree to use birth control during and for 4 months after the study treatment.You have a disease that can be measured using a specific medical guideline.I do not have HIV, Hepatitis B, or Hepatitis C.I have taken a pregnancy test within the last 72 hours and it was negative.I have another cancer that is getting worse or needs treatment.I have been treated with specific immune therapy drugs before.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab, Carboplatin, Paclitaxel
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
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