Your session is about to expire
← Back to Search
Checkpoint Inhibitor
Ipilimumab + Pembrolizumab for Brain Metastasis from Melanoma
Phase 2
Waitlist Available
Led By Isabella C Glitza
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks are preferred) OR at least 4 unstained slides with an associated pathology report for testing of tumor PD-L1 expression
At least one measurable intracranial target lesion, which previously was not treated with local therapy (no prior stereotactic radiosurgery [SRS] to this lesion). Largest diameter of >= 0.5 cm, but =< 3 cm as determined by contrast-enhanced MRI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is testing ipilimumab and pembrolizumab to treat melanoma that has spread to the brain. These drugs may help the body's immune system attack the cancer.
Who is the study for?
This trial is for melanoma patients with brain metastases who can follow the study plan, have a measurable brain lesion not previously treated locally, normal blood clotting levels unless on anticoagulants, good organ function, and no severe medical conditions. Pregnant or breastfeeding women and those with certain autoimmune diseases or recent corticosteroid use are excluded.Check my eligibility
What is being tested?
The trial tests low dose ipilimumab combined with pembrolizumab in melanoma that has spread to the brain. It aims to see how well these immunotherapy drugs work together by enabling the immune system to target cancer cells more effectively.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs like the liver or intestines, skin rash, hormone gland problems (like thyroid dysfunction), fatigue, infusion reactions related to drug administration, and potential worsening of pre-existing autoimmune diseases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can provide tumor samples in blocks or slides for PD-L1 testing.
Select...
I have a brain lesion between 0.5 and 3 cm that hasn't been treated with targeted radiation.
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
My melanoma has spread to my brain with tumors larger than 0.5 cm.
Select...
I have no brain-related symptoms from cancer and haven't taken steroids in the last 10 days.
Select...
My kidney function, measured by creatinine levels, is within the normal range or slightly above.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical benefit rate (CBR)
Secondary outcome measures
Change in relative apparent diffusion coefficient and circulating cell-free deoxyribonucleic acid (cfDNA) by CBR (yes versus no)
Changes in the T-cell population in the cerebrospinal fluid (CSF) and blood
Cytokine levels
+3 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: Treatment (ipilimumab, pembrolizumab)Experimental Treatment2 Interventions
Patients receive ipilimumab IV over 90 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 4 cycles for ipilimumab and up to 35 cycles for pembrolizumab in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2670
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,755 Total Patients Enrolled
102 Trials studying Melanoma
25,309 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,127 Total Patients Enrolled
557 Trials studying Melanoma
193,207 Patients Enrolled for Melanoma
Isabella C GlitzaPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
85 Total Patients Enrolled
2 Trials studying Melanoma
85 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken high-dose steroids or other immune-weakening drugs in the last 2 weeks.I have previously received checkpoint inhibitor therapy.My blood clotting tests are within normal limits, or if I'm on blood thinners, they're in the therapeutic range.I haven't had major surgery or significant injury in the last 14 days, and I don't expect to need major surgery during the study.I am not breastfeeding and have a recent negative pregnancy test.Any side effects from my past cancer treatments have mostly gone away.You have been diagnosed with HIV.I can provide tumor samples in blocks or slides for PD-L1 testing.I am not pregnant or breastfeeding.I have a heart condition that is not severe.I have or have had hepatitis B or C.I have a wound, ulcer, or bone fracture that hasn’t healed.Your AST and ALT levels in the blood are not more than 2.5 times the normal limit, or 5 times the normal limit if you have cancer that has spread to the liver.I have not had precise radiotherapy within the last 2 weeks.I have a history of cancer spreading to the lining of my brain and spinal cord.I have a brain lesion larger than 3 cm.I haven't taken corticosteroids for 10 days, except as a replacement therapy.You have a currently active autoimmune disease or are suspected to have one.I do not have any severe illnesses that would stop me from joining the study.I have had stereotactic radiosurgery on more than 5 brain lesions.I have a brain lesion between 0.5 and 3 cm that hasn't been treated with targeted radiation.I am fully active and can carry on all pre-disease activities without restriction.You are expected to live for at least 12 more weeks.I have had lung inflammation treated with steroids or have it now.I am taking steroids only as a replacement therapy.I had severe side effects from ipilimumab except those treatable with standard care.I had another cancer but was treated successfully and have been cancer-free for 2 years.Your blood must have a certain amount of a type of white blood cell called neutrophils.My melanoma has spread to my brain with tumors larger than 0.5 cm.Your platelet count is at least 100,000 per microliter.Your hemoglobin level is at least 9.0 g/dL or 5.6 mmol/L.I've had targeted brain radiation or surgery for up to 5 brain metastases and fully recovered.I haven't taken any experimental drugs recently.Your bilirubin levels must be within a certain range to participate in the study.I have had radiation therapy outside of my brain and spinal cord.I have no brain-related symptoms from cancer and haven't taken steroids in the last 10 days.My kidney function, measured by creatinine levels, is within the normal range or slightly above.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ipilimumab, pembrolizumab)
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.
Could you please elucidate the other investigations that have been completed regarding Pembrolizumab?
"According to the available data, 1254 clinical trials related to Pembrolizumab are currently underway. Of those experiments, 156 have progressed into Phase 3 and there is a total of 54663 sites employing this medication across the US. Houston, Texas holds majority of these studies."
Answered by AI
Is recruitment currently open for this experimental trial?
"Data provided by clinicaltrials.gov demonstrates that this medical trial is currently recruiting; it was originally posted on February 21st 2019 and the most recent update took place on September 22nd 2022."
Answered by AI
What medical condition is Pembrolizumab commonly prescribed to treat?
"Pembrolizumab is primarily used to address the inoperability of melanoma, but it can also treat cases where patients have high recurrence risk and show signs of microsatellite instability."
Answered by AI
Has the Federal Drug Administration greenlit Pembrolizumab?
"The safety of pembrolizumab is tentatively rated at a 2, as Phase 2 trials have not provided efficacy data but do suggest some assurances regarding the drug's security."
Answered by AI
How many participants are actively engaged in this research endeavor?
"Indeed, the information available on clinicaltrials.gov reveals that recruitment for this trial is currently open. This experiment was initially advertised on February 21st 2019 and its details have been revised as recently as September 22nd 2022. As of now, 30 volunteers are needed from 1 medical facility."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger