← Back to Search

PI3K Inhibitor

Alpelisib + Pembrolizumab for Metastatic Breast Cancer

Phase 1 & 2
Waitlist Available
Led By Ecaterina Dumbrava, MD
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
Has adequate organ function as defined
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Must not have
Evidence of severe or uncontrolled systemic disease
Established diagnosis of diabetes mellitus type I or uncontrolled type II
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights

Summary

"This trial aims to determine the right amount of alpelisib and pembrolizumab to give to patients with metastatic breast cancer or melanoma."

Who is the study for?
This trial is for patients with advanced breast cancer or melanoma. Participants must have a certain type of tumor and be able to take oral medication. They should not have had previous treatments that conflict with the trial drugs.
What is being tested?
The study is testing the combination of two drugs, Alpelisib and Pembrolizumab, to determine a safe dosage level for patients with metastatic breast cancer or melanoma.
What are the potential side effects?
Possible side effects include high blood sugar levels, skin rash, diarrhea, fatigue, immune-related issues such as thyroid problems or lung inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My organs are functioning well.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I am a woman who can have children and have a negative pregnancy test.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a serious illness that is not under control.
Select...
I have been diagnosed with type 1 diabetes or my type 2 diabetes is not under control.
Select...
My heart's electrical activity is within normal range and I don't have congenital long QT syndrome.
Select...
I have a history of heart problems.
Select...
I have not had a serious illness or infection in the last 6 months.
Select...
I am allergic to medications similar to alpelisib or pembrolizumab.
Select...
I don't have lasting side effects from cancer treatment worse than mild.
Select...
I have had acute pancreatitis within the last year or have chronic pancreatitis.
Select...
I have had pneumonitis treated with steroids or have it now.
Select...
I have a history of hepatitis B or C, or I am HIV positive.
Select...
I have not received a live vaccine in the last 30 days.
Select...
I am not using, nor will I need, any forbidden medications during the study.
Select...
I have a stomach or intestine problem that affects how my body absorbs medicine.
Select...
My blood pressure is not well controlled.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events

Side effects data

From 2022 Phase 1 & 2 trial • 35 Patients • NCT03003468
40%
FATIGUE
37%
INFUSION RELATED REACTION
37%
NAUSEA
23%
DIARRHEA
23%
BACK PAIN
23%
ABDOMINAL PAIN
23%
ANOREXIA
20%
ARTHRALGIA
20%
COUGH
20%
NON-CARDIAC CHEST PAIN
17%
DYSPNEA
17%
CONSTIPATION
17%
CHILLS
17%
MYALGIA
13%
DIZZINESS
13%
HEADACHE
13%
PRURITUS
13%
RASH MACULO-PAPULAR
10%
ANEMIA
10%
URTICARIA
10%
SINUS TACHYCARDIA
10%
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
10%
EDEMA LIMBS
10%
ALLERGIC REACTION
10%
ANXIETY
10%
LUNG INFECTION
10%
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
7%
TUMOR PAIN
7%
EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY
7%
HYPERGLYCEMIA
7%
PAIN
7%
PELVIC PAIN
7%
PRODUCTIVE COUGH
7%
PLEURAL EFFUSION
7%
VOICE ALTERATION
7%
VOMITING
7%
FEVER
7%
FLATULENCE
7%
CREATININE INCREASED
7%
HYPERTHYROIDISM
7%
NECK PAIN
7%
DEPRESSION
7%
FLU LIKE SYMPTOMS
7%
LYMPHOCYTE COUNT DECREASED
7%
DYSPEPSIA
7%
FLUSHING
7%
HYPONATREMIA
7%
HYPOTHYROIDISM
7%
URINARY TRACT INFECTION
3%
MUSCLE WEAKNESS LOWER LIMB
3%
ALKALINE PHOSPHATASE INCREASED
3%
DYSPHAGIA
3%
ESOPHAGITIS
3%
GASTROESOPHAGEAL REFLUX DISEASE
3%
OSTEONECROSIS OF JAW
3%
BRONCHOSPASM
3%
PNEUMONITIS
3%
BLURRED VISION
3%
GAIT DISTURBANCE
3%
HEMORRHOIDS
3%
POSTNASAL DRIP
3%
PRESYNCOPE
3%
SORE THROAT
3%
ACUTE KIDNEY INJURY
3%
PERIPHERAL MOTOR NEUROPATHY
3%
DRY SKIN
3%
FLASHING LIGHTS
3%
HYPOMAGNESEMIA
3%
HYPERTENSION
3%
HYPOTENSION
3%
SINUSITIS
3%
SYNCOPE
3%
HEARING IMPAIRED
3%
RASH ACNEIFORM
3%
SOMNOLENCE
3%
COLITIS
3%
HOT FLASHES
3%
RESPIRATORY FAILURE
3%
CONJUNCTIVITIS
3%
MOVEMENTS INVOLUNTARY
3%
NASAL CONGESTION
3%
PARESTHESIA
3%
VAGINAL INFECTION
3%
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
3%
NEUTROPHIL COUNT DECREASED
3%
ALLERGIC RHINITIS
3%
PAIN IN EXTREMITY
3%
SEPSIS
3%
BLOATING
3%
DEHYDRATION
3%
DRY MOUTH
3%
INSOMNIA
3%
MALAISE
3%
PAIN OF SKIN
3%
THROMBOEMBOLIC EVENT
3%
TREMOR
3%
WEIGHT GAIN
100%
80%
60%
40%
20%
0%
Study treatment Arm
Imprime PGG 4 mg/kg
Imprime PGG 2 mg/kg

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose ExpansionExperimental Treatment1 Intervention
Study treatment will be administered on an outpatient basis.
Group II: Dose EscalationExperimental Treatment1 Intervention
Study treatment will be administered on an outpatient basis.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,651 Total Patients Enrolled
Ecaterina Dumbrava, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
30 Total Patients Enrolled
~33 spots leftby Aug 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top