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Checkpoint Inhibitor
Pembrolizumab + Ipilimumab for Melanoma
Phase 2
Waitlist Available
Led By Thomas Gajewski, M.D.
Research Sponsored by University of Chicago
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
Have a performance status of 0 or 1 on the ECOG Performance Scale
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial looks at whether combining two drugs can improve treatment for advanced melanoma, with response rate and safety as key measures.
Who is the study for?
This trial is for adults with advanced melanoma who've seen their cancer progress or remain stable after at least 24 weeks on anti-PD1/L1 therapy, or within 6 months of adjuvant anti-PD1. They must be in good health otherwise, not pregnant, willing to use birth control, and have no history of severe allergies to the drugs being tested or certain other medical conditions.Check my eligibility
What is being tested?
The study tests a combination of two immunotherapy drugs: Pembrolizumab (anti-PD1) and Ipilimumab (anti-CTLA4), following prior treatment with an anti-PD1/L1 antibody. It aims to see how well this combo works against melanoma by measuring tumor response and tracking how long patients live without their disease getting worse.See study design
What are the potential side effects?
Possible side effects include immune-related reactions that can affect organs like the liver or lungs, skin rashes, hormone gland problems (like thyroid dysfunction), fatigue, nausea, and potentially serious infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 18 years old.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am using two birth control methods or am not having sex to join this study.
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
Overall Response Rate (OR) Per irRECIST
Secondary outcome measures
Number of Participants With Adverse Events
Progression Free Survival Using the Kaplan Meier Method
Side 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: TreatmentExperimental Treatment2 Interventions
Treatment with the combination of pembrolizumab and ipilimumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Ipilimumab
2014
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,001 Previous Clinical Trials
817,660 Total Patients Enrolled
10 Trials studying Melanoma
360 Patients Enrolled for Melanoma
Thomas Gajewski, M.D.Principal InvestigatorUniversity of Chicago
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of active tuberculosis.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I do not have eye melanoma.I have a history of lung inflammation not caused by an infection.I haven't had cancer treatment in the last 2 weeks or have recovered from side effects.I am at least 18 years old.I haven't been part of a clinical trial for any treatment, except for anti-PD1/L1 antibody, in the last 4 weeks.You have active Hepatitis B or Hepatitis C.I have not received a live vaccine in the last 30 days.I have taken a pregnancy test in the last 72 hours and it was negative.I am currently being treated for an infection.My cancer progressed or didn't worsen for 24 weeks on anti-PD1/L1 treatment, or it worsened within 6 months after adjuvant anti-PD1 therapy.I agree to use birth control during and for 4 months after the study.You have a disease that can be measured using a specific guideline called irRECIST 1.1.I am fully active or restricted in physically strenuous activity but can do light work.I have been treated with a medication that targets CTLA4.I have another cancer besides skin or in situ cervical cancer that is getting worse or needs treatment.I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks, except for anti-PD1 or anti-PD-L1.I have cancer that has spread to my brain or spinal cord.My organ functions are within normal ranges as required.I have been treated for an autoimmune disease in the last 2 years.I have been diagnosed with HIV.I am using two birth control methods or am not having sex to join this study.You are allergic to pembrolizumab or any of its ingredients.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
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.
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