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Anti-metabolites
Azacitidine + Pembrolizumab for Melanoma
Phase 2
Waitlist Available
Led By Hussein Tawbi, MD, PHD
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
Age >/= 18 years at the time of signing informed consent
Patients who have not received prior PD-1 directed therapy (Arm A) or have progressed despite prior PD-1 directed therapy (Arm B)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is for people with advanced melanoma who have been treated with ipilimumab and, if their disease progressed, a BRAF or MEK inhibitor.
Who is the study for?
This study is for adults with advanced melanoma who haven't had PD-1 therapy (Arm A) or have worsened despite it (Arm B). Participants need functioning organs, measurable disease, and must not be pregnant or breastfeeding. They should agree to use birth control and provide a tissue sample from the tumor. Those with active infections, recent other cancer treatments, certain heart diseases, CNS metastases, or immunodeficiency can't join.Check my eligibility
What is being tested?
The trial investigates if combining oral azacitidine (CC-486) with pembrolizumab (MK-3475) can control advanced melanoma and studies the safety of this mix. Both drugs are FDA approved separately; their combination for treating melanoma is experimental. Up to 71 participants at MD Anderson will receive these drugs to see how well they work together.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions like fever or chills, fatigue, possible blood disorders including changes in white cell counts leading to increased 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 have never had PD-1 therapy (Arm A) or my cancer got worse despite it (Arm B).
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My melanoma cannot be removed by surgery and is in stage III or IV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate in Participants with Metastatic Melanoma That Are PD-1 Naïve (Arm A) or That Have Progressed on PD-1 Directed Therapy (Arm B)
Secondary outcome measures
Overall Survival in Participants with Metastatic Melanoma That Are PD-1 Naïve (Arm A) or That Have Progressed on PD-1 Directed Therapy (Arm B)
Progression Free Survival in Participants with Metastatic Melanoma That Are PD-1 Naïve (Arm A) or That Have Progressed on PD-1 Directed Therapy (Arm B)
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
2Treatment groups
Experimental Treatment
Group I: Arm B: Metastatic Melanoma - Post PD-1 ProgressionExperimental Treatment2 Interventions
Thirty-five participants with metastatic melanoma that have progressed on PD-1 directed therapy enrolled in treatment Arm B.
Treatment consists of 3-week cycles and continues until disease progression. Oral Azacitidine administered by mouth daily for 15 days (Days 1-15) of every cycle. Pembrolizumab administered by vein every 3 weeks and after the oral dose of Azacitidine on concurrent treatment days.
Group II: Arm A: Metastatic Melanoma - PD-1 NaiveExperimental Treatment2 Interventions
Thirty-six participants with metastatic melanoma that are PD-1 naïve enrolled in treatment Arm A.
Treatment consists of 3-week cycles and continues until disease progression. Oral Azacitidine administered by mouth daily for 15 days (Days 1-15) of every cycle. Pembrolizumab administered by vein every 3 weeks and after the oral dose of Azacitidine on concurrent treatment days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1440
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,297 Total Patients Enrolled
102 Trials studying Melanoma
25,290 Patients Enrolled for Melanoma
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,055,059 Total Patients Enrolled
120 Trials studying Melanoma
21,659 Patients Enrolled for Melanoma
CelgeneIndustry Sponsor
636 Previous Clinical Trials
128,931 Total Patients Enrolled
10 Trials studying Melanoma
1,146 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had to take medicine for an autoimmune disease in the last 2 years.You are allergic to certain medications or their ingredients.You have a disease that can be measured or evaluated using specific guidelines.I am 18 years old or older.My blood, kidney, liver, and clotting tests are within normal ranges.I don't have any health issues that could affect the trial's results or my participation.I have been treated with a drug targeting PD-1, PD-L1, or PD-L2 before [for Arm A only].I have not received a live vaccine in the last 30 days.I have never had PD-1 therapy (Arm A) or my cancer got worse despite it (Arm B).I am willing to provide a tissue sample from my tumor for the study.I am fully active or restricted in physically strenuous activity but can do light work.I am not pregnant, using two forms of birth control, sterile, or not having sex.I agree to use effective birth control.I haven't had chemotherapy, targeted therapy, or radiation in the last 2 weeks.I do not have another cancer that is getting worse or needs treatment.I am currently being treated for an infection.I am not in a clinical study or haven't received study therapy in the last 4 weeks.I do not have active brain metastases or carcinomatous meningitis, except for certain exceptions.I haven't taken steroids or immunosuppressants in the last 7 days.I haven't taken any cancer antibody treatments in the last 4 weeks or still have side effects from them.I have been diagnosed with HIV.I have not had serious heart problems in the last 6 months.I have an active tuberculosis infection.I have a history of or currently have non-infectious lung inflammation.My melanoma cannot be removed by surgery and is in stage III or IV.I have an active Hepatitis B or C infection.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Metastatic Melanoma - PD-1 Naive
- Group 2: Arm B: Metastatic Melanoma - Post PD-1 Progression
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.
What health conditions does Pembrolizumab commonly address?
"Pembrolizumab is a medication used to treat patients that have relapsed or are unresponsive to other treatments for mediastinal large b-cell lymphoma. Additionally, this drug can be administered as part of chemotherapy treatment for malignant neoplasms."
Answered by AI
How many people are being asked to participate in this research project?
"This study is no longer recruiting patients. It was posted on February 14th, 2017 and last updated on October 31st, 2022. However, there are 3,215 other trials for metastatic melanoma and 1,174 trials for Pembrolizumab that are still enrolling patients."
Answered by AI
Are new patients being accepted into the study at this time?
"This study is no longer recruiting patients. The original posting date was February 14th, 2017 and the last edit was on October 31st, 2022. There are currently 3215 clinical trials actively enrolling participants with metastatic melanoma and 1174 studies for Pembrolizumab actively enrolling patients."
Answered by AI
What are some potential negative side effects of Pembrolizumab?
"Pembrolizumab is still being tested for efficacy in Phase 2 clinical trials, so it received a score of 2 for safety."
Answered by AI
What are the most recent outcomes of Pembrolizumab clinical trials?
"1174 different clinical trials are currently underway to research pembrolizumab. 155 of these ongoing trials are in Phase 3. Though many of the trials originated in Houston, Texas, there are 41668 locations worldwide where researchers are looking into this treatment option."
Answered by AI
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