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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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

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 • NCT03040999
64%
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
~2810
Ipilimumab
2014
Completed Phase 3
~3140

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,052 Previous Clinical Trials
758,969 Total Patients Enrolled
Thomas Gajewski, M.D.Principal InvestigatorUniversity of Chicago

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02743819 — Phase 2
Skin Cancer Research Study Groups: Treatment
Skin Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT02743819 — Phase 2
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02743819 — Phase 2
~7 spots leftby Nov 2025
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