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PI3K-Beta Inhibitor
GSK2636771 + Pembrolizumab for Metastatic Melanoma
Phase 1 & 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
Be >/= 18 years of age on day of signing informed consent
Within 10 days of treatment initiation, the subject must demonstrate adequate organ function defined as follows: Absolute neutrophil count must be >/= 1500 per microliter (uL). Platelets must be >/=100,000 per uL. Hemoglobin must be >/= 9 grams per deciliter or >/= 5.6 millimoles per liter without transfusion or EPO dependency within 7 days of assessment. Serum creatinine must be </= 1.0 times the upper limit of normal (ULN) OR measured or calculated creatinine clearance per institutional standard (Glomerular Filtration Rate (GFR) can also be used in place of creatinine or CrCl) must be >/= 60 milliliters per minute OR proteinuria by urine dipstick must be </= 1+. Aspartate aminotransferase (AST) AND alanine aminotransferase (ALT) must be </= 2.5 times the ULN OR each must be </= 5 times the ULN for subjects with liver metastases. Alkaline phosphatase (ALP) must be </= 2 times the ULN. Serum total bilirubin must be </= 2.0 milligrams per deciliter except in patients with Gilbert's disease. Direct bilirubin must be </= the upper limit of normal for subjects with total bilirubin levels > 1.5 times the upper limit of normal. Albumin must be >/= 2.5 grams per deciliter. Left ventricular ejection fraction (LVEF) must be >/= 50% by echocardiogram (ECHO) or Multigated Acquisition (MUGA) scan. International Normalized Ratio (INR) must be </= 1.5 times the upper limit of normal unless the subject is receiving anticoagulant therapy as long as prothrombin time(PT) or partial thromboplastin time(PTT) is within therapeutic range of intended use of anticoagulants. Activated partial thromboplastin time(aPTT) must be </= 1.5 times the upper limit of normal unless the subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants. Serum phosphate must be within normal limit. Serum calcium must be within normal limit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is studying a combination of drugs as a possible treatment for melanoma that has spread to other parts of the body and has not responded to other treatments.
Who is the study for?
This trial is for adults with metastatic melanoma that hasn't improved after treatment, including PD-1 or PD-L1 therapy. Participants must have PTEN loss in their tumors, measurable disease, and a life expectancy of at least 12 weeks. They should be able to take oral medication and have good organ function. Women of childbearing potential and men with partners of childbearing potential must agree to use contraception.Check my eligibility
What is being tested?
The study tests GSK2636771 combined with pembrolizumab on patients whose metastatic melanoma has not responded to previous treatments. Pembrolizumab is FDA-approved; GSK2636771 isn't and is used only for research now. The aim is to see if this drug combo can control the disease better than current options.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with cancer therapies like pembrolizumab include fatigue, skin reactions, diarrhea, musculoskeletal pain, fever, coughing and shortness of breath among others. Side effects from GSK2636771 are unknown due to its experimental nature.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My blood counts, kidney, liver, and heart functions are within safe ranges for treatment.
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My tumor shows PTEN loss.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I can take pills by mouth and keep them down.
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I haven't had any cancer treatment or used new medical devices in the last 28 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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 (MTD) of GSK2636771 in Combination with Pembrolizumab in Participants with Metastatic Melanoma and PTEN Loss
Objective Response Rate (ORR) of GSK2636771 in Combination with Pembrolizumab in Participants with Metastatic Melanoma and PTEN Loss
Secondary outcome measures
Overall survival (OS)
Side effects data
From 2019 Phase 1 trial • 37 Patients • NCT0221509655%
Diarrhoea
36%
Nausea
27%
Fatigue
27%
Anaemia
18%
Hypophosphataemia
18%
Hypocalcaemia
18%
Cough
18%
Blood creatinine increased
18%
Dizziness
18%
Decreased appetite
18%
Blood alkaline phosphatase increased
18%
Neutropenia
18%
Dysgeusia
18%
Haematuria
18%
Constipation
18%
Pain in extremity
18%
Hyperkalaemia
18%
Oropharyngeal pain
9%
Sinus bradycardia
9%
Insomnia
9%
Palpitations
9%
Hyperglycaemia
9%
Skin laceration
9%
Inguinal hernia
9%
Back pain
9%
Epistaxis
9%
Blood phosphorus increased
9%
Agitation
9%
Hypotension
9%
Face oedema
9%
Hydronephrosis
9%
Abdominal pain
9%
Abdominal tenderness
9%
Hypertension
9%
Hot flush
9%
Dyspepsia
9%
Urinary tract infection
9%
Proteinuria
9%
Hypernatraemia
9%
Malaise
9%
Fall
9%
Hypoalbuminaemia
9%
Chills
9%
Cellulitis
9%
Mouth ulceration
9%
Nasopharyngitis
9%
Rash
9%
Hypersensitivity
9%
Paraesthesia
9%
Myalgia intercostal
9%
Arthralgia
9%
Lymphocyte count decreased
9%
Dry skin
9%
Pelvic pain
9%
Arthritis
9%
Aspartate aminotransferase increased
9%
Confusional state
9%
Abdominal distension
9%
Hyponatraemia
9%
Pyrexia
9%
Alopecia
9%
Conjunctivitis
9%
Gout
9%
Peripheral swelling
9%
Pollakiuria
100%
80%
60%
40%
20%
0%
Study treatment Arm
GSK2636771 200mg/Enzalutamide 160mg Escalation
Enzalutamide Only (run-in Period)
GSK2636771 200mg/Enzalutamide 160mg Expansion
GSK2636771 300mg/Enzalutamide 160mg Escalation
GSK2636771 400mg/Enzalutamide 160mg Escalation
Trial Design
1Treatment groups
Experimental Treatment
Group I: GSK2636771 + PembrolizumabExperimental Treatment2 Interventions
Phase I: Participants receive the lowest dose level of GSK2636771. Each new group receives a higher dose of GSK2636771 than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of GSK2636771 is found. Participants receive the same dose level of Pembrolizumab.
Phase II: Participants receive GSK2636771 at the highest dose that was tolerated in Phase 1. Participants receive the same dose level of Pembrolizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GSK-2636771
Not yet FDA approved
Pembrolizumab
FDA approved
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineIndustry Sponsor
4,750 Previous Clinical Trials
8,067,425 Total Patients Enrolled
38 Trials studying Melanoma
19,802 Patients Enrolled for Melanoma
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,754 Total Patients Enrolled
102 Trials studying Melanoma
25,308 Patients Enrolled for Melanoma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,126 Total Patients Enrolled
557 Trials studying Melanoma
193,206 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of serious heart issues or my heart doesn’t pump well.I have had pneumonitis treated with steroids or have it now.You have a history of testing positive for HIV. Testing for HIV at the time of screening is not needed.I am not using, nor will I need, any medication not allowed in the study. I understand the flu shot is okay, but nasal spray vaccines are not.I am 18 years old or older.I do not have an active or history of certain autoimmune diseases.I don't have severe side effects from past cancer treatments, except for hair loss or mild anemia.I haven't had ulcers, fistulas, GI perforations, or abscesses in the last 28 days.I have not had major surgery in the last 28 days.Your heart's QT interval is longer than 450 milliseconds, or longer than 480 milliseconds if you have a specific heart condition.I have an active tuberculosis infection.My blood counts, kidney, liver, and heart functions are within safe ranges for treatment.I do not have any serious infections or conditions like heart attack, stroke, or severe breathing problems.I have a significant stomach or intestine issue that affects food absorption.I do not have severe or uncontrolled health issues like heart, liver, kidney, or lung diseases.My blood pressure is well-controlled and not above 150/100 mmHg.I am not on high-dose steroids or immunosuppressants, except for low-dose prednisone.I am allergic to Pembrolizumab, GSK2636771, or their ingredients.My tumor shows PTEN loss.I am fully active or restricted in physically strenuous activity but can do light work.I can take pills by mouth and keep them down.I agree to provide tumor tissue samples before and during the treatment.I agree to use birth control during and for 4 months after the study ends.I have another cancer besides skin or in situ cervical cancer that is getting worse or needs treatment.I have stable brain metastases and haven't used steroids in the last 7 days.I have a genetic condition affecting my platelets.My advanced cancer hasn't improved after 6 months of treatment or has worsened on specific immunotherapies.I have had 3 or fewer treatments for my advanced cancer if entering Phase II of the trial.I have not received a live vaccine in the last 30 days.I will use birth control during and for 3 months after the study if my partner can have children.You have a disease that can be measured using a specific set of guidelines.I haven't had any cancer treatment or used new medical devices in the last 28 days.You are expected to live for at least 12 more weeks.Women who could become pregnant need to have a negative pregnancy test before starting the study. If the urine test is positive or uncertain, a blood test will be needed.You have a current or past history of hepatitis B or C.
Research Study Groups:
This trial has the following groups:- Group 1: GSK2636771 + 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.
Why is GSK2636771 often prescribed?
"GSK2636771 is a medication used to fight cancerous growths, unresectable melanoma, and microsatellite instability high."
Answered by AI
How many test subjects are included in this experiment?
"Unfortunately, this particular trial is no longer recruiting patients. The study was originally posted on July 17th, 2017 and last updated September 22nd, 2022; however, there are currently 3215 trials searching for participants with skin cancer and 1003 trials for GSK2636771 actively recruiting patients."
Answered by AI
Are participants currently being recruited for this research project?
"Unfortunately, this specific trial is not looking for new patients at the moment. It was initially posted on July 17th, 2017 and updated September 22nd of 2022. Although, there are over 4000 other trials that are actively recruiting participants."
Answered by AI
Are there any other similar medical studies that have used GSK2636771?
"As of now, 1003 clinical trials are underway to study GSK2636771. 122 of those trials have reached Phase 3 and are currently enrolling patients. 37489 different locations across the globe are running these tests, with a high concentration in Houston, Texas."
Answered by AI
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