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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
Must not have
Has a known history of active TB (Bacillus Tuberculosis)
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of active tuberculosis.
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I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.
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I do not have eye melanoma.
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I have a history of lung inflammation not caused by an infection.
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I am currently being treated for an infection.
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I haven't been part of a clinical trial for any treatment, except for anti-PD1/L1 antibody, in the last 4 weeks.
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I have not received a live vaccine in the last 30 days.
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I have been treated with a medication that targets CTLA4.
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I have cancer that has spread to my brain or spinal cord.
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I have been treated for an autoimmune disease in the last 2 years.
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I have been diagnosed with HIV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Response Rate (OR) Per irRECIST
Secondary study objectives
Number of Participants With Adverse Events
Progression Free Survival Using the Kaplan Meier Method
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
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: 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 3
~3150
Ipilimumab
2015
Completed Phase 3
~3070
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,055 Previous Clinical Trials
760,639 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.
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