Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 56 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Select...
I am using two birth control methods or am not having sex to avoid pregnancy during and up to 120 days after the study.
Select...
I can provide a tumor sample from a metastatic site for testing.
Select...
I am fully active or can carry out light work.
Select...
My melanoma cannot be removed by surgery and is either stage III or has spread.
Select...
I do not have HIV, Hepatitis B, or Hepatitis C.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 56 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate as assessed by RECIST 1.1 and immune-related Response Criteria
Secondary outcome measures
Melanoma-associated serological markers by multiplexed array will be generated
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Overall Survival
+1 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
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:- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Pembrolizumab received formal recognition from the FDA?
"Pembrolizumab's safety is estimated to be a 2. This score comes from the fact that, while there is data supporting its safety, there is no evidence yet of the medication's efficacy."
Answered by AI
How many study participants are being given this medication?
"This study is not enrolling patients at the moment. The trial was initially posted on 5/19/2016 and was most recently edited on 2/17/2021. For people looking for other studies, there are 783 clinical trials actively searching for patients with melanoma and 2076 studies for Pembrolizumab that need participants."
Answered by AI
Are there any open positions for participants in this experiment?
"Unfortunately, this study has already wrapped up recruitment for participants. However, there are presently 783 other studies actively searching for patients with melanoma and 2076 trials involving Pembrolizumab that are still admitting patients."
Answered by AI
What are some of the most common indications for Pembrolizumab?
"Pembrolizumab is commonly used to treat malignant neoplasms, and can also be effective in treating other conditions such as unresectable melanoma, microsatellite instability high, and high risk of recurrence."
Answered by AI
What other research has been conducted that is similar to this Pembrolizumab clinical trial?
"Pembrolizumab is presently being trialled in 2076 separate studies, with 424 of those investigations being in Phase 3. Many of these trials take place in Shanghai, but there are 92200 locations running Pembrolizumab trials globally."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger