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MDM2 Inhibitor
APG-115 + Pembrolizumab for Skin Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Ascentage Pharma Group Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Tumor tissue must be provided for all subjects for biomarker analysis before treatment with investigational product
Left ventricular ejection fraction (LVEF) ≥ lower limit of institutional normal (LLN) as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial is testing a new drug, APG-115, in combination with pembrolizumab, to see if it is effective in treating cancer.
Who is the study for?
This trial is for adults with metastatic melanomas or advanced solid tumors who have specific heart health measures, can provide tumor tissue samples, and are willing to use effective contraception. It's not for those with active brain metastases, certain recent treatments, uncontrolled illnesses, autoimmune diseases requiring steroids, live vaccines recently taken, or women who are pregnant.Check my eligibility
What is being tested?
The study tests APG-115 combined with pembrolizumab. Part 1 finds the safe dose level; Part 2 uses this dose in a larger group to see how well it works against different types of cancer like melanoma and nerve sheath tumors.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as inflammation in various organs (like lungs), fatigue, skin reactions, hormonal changes affecting normal body functions and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can provide a sample of my tumor for testing before starting the trial treatment.
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My heart's pumping ability is within the normal range.
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My side effects from previous cancer treatments are mild.
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My blood tests show my organs and bone marrow are working well.
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My tumor is a type of sarcoma that cannot be removed surgically.
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I can take care of myself and am up and about more than half of the day.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose
Overall Response Rate
Recommended Phase II Dose
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: APG-115+Pembrolizumab open label, two-part phase Ib/IIExperimental Treatment1 Intervention
single arm dose escalation and dose expansion
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,054,871 Total Patients Enrolled
Ascentage Pharma Group Inc.Lead Sponsor
46 Previous Clinical Trials
4,110 Total Patients Enrolled
Yifan Zhai, MD, PhDStudy ChairAscentage Pharma Group Inc.
18 Previous Clinical Trials
1,082 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can provide a sample of my tumor for testing before starting the trial treatment.My melanoma cannot be surgically removed, has returned or didn't respond to PD-1 treatment, and I can't receive other standard treatments.I have never been treated with MDM2-p53 inhibitors.I haven't used any experimental drugs or devices recently.I haven't had a heart attack or heart surgery recently.I have a condition like RA or IBD that causes long-term inflammation.I have not received a live vaccine recently.I have received chemotherapy within the required timeframe before starting this treatment.I had a local treatment for melanoma that cannot be surgically removed within the last 6 weeks.I received lung radiation of more than 30Gy less than 6 months ago.I have taken cancer treatments like hormone therapy or targeted therapy recently.I have not had recent surgery or thoracic radiation.I do not have an active infection needing antibiotics or have hepatitis, HIV, or COVID-19.I have an autoimmune disease that needs steroids or immunosuppressants.You had a really bad allergic reaction to another type of monoclonal antibody treatment before.My heart's pumping ability is within the normal range.I am an adult or a teenager over 12 and weigh at least 40 kg, not pregnant or breastfeeding.My side effects from previous cancer treatments are mild.I have had a transplant of tissue, organ, stem cells, or bone marrow.I have had an organ transplant and take medication to suppress my immune system.I need corticosteroids for my condition, with some exceptions.The time it takes for your heart to beat is within a certain range.I have had pneumonitis treated with steroids or have it now.My blood tests show my organs and bone marrow are working well.My tumor is a type of sarcoma that cannot be removed surgically.You are expected to live for at least 3 more months.My cancer has a known FGFR gene mutation.I do not have any severe illnesses like heart failure or mental health issues that would stop me from following the study's requirements.My cancer has spread to my brain or spinal cord.My cancer can be measured by scans and is not in an area treated by radiation.I can take care of myself and am up and about more than half of the day.I haven't fully recovered from my last surgery as expected.
Research Study Groups:
This trial has the following groups:- Group 1: APG-115+Pembrolizumab open label, two-part phase Ib/II
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 therapeutic purpose does APG-115+Pembrolizumab serve?
"APG-115+Pembrolizumab is most often used to treat malignant neoplasms, but it can also be effective in patients with unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."
Answered by AI
How many people are currently signed up for this experiment?
"This clinical trial needs 224 patients that meet the pre-determined inclusion criteria in order to commence. Patients can travel to locations such as UCLA Hematology & Oncology Clinic in Los Angeles, Arkansas and Highlands Oncology in Rogers, Florida in order to participate."
Answered by AI
Does the combination of APG-115 and Pembrolizumab have a history of being studied?
"City of Hope first studied APG-115+Pembrolizumab in 2010 and, to date, there have been 247 completed studies. Currently, there are 1000 trials recruiting patients with a large number being based in Los Angeles and Arkansas."
Answered by AI
Are new patients being accepted for this research program at this time?
"As indicated by data found on clinicaltrials.gov, this particular trial is currently looking for participants. 8/29/2018 marks the date when the study was first posted online, with the 7/8/2022 update being the most recent change."
Answered by AI
Are there several hospitals running this trial in Canada?
"Currently, there are 16 operational sites for this study. A few examples include UCLA Hematology & Oncology Clinic in Los Angeles, Highlands Oncology in Rogers, and Sarah Cannon/FCSRI in Fort Myers."
Answered by AI
Who else is applying?
What site did they apply to?
University of Texas MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Most responsive sites:
- University of Texas MD Anderson Cancer Center: < 24 hours
Typically responds via
Email
Average response time
- < 1 Day
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