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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
No Placebo-Only Group

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
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My organs are functioning well.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am a woman who can have children and have a negative pregnancy test.
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I am 18 years old or older.

Exclusion Criteria

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
3,063 Previous Clinical Trials
1,800,731 Total Patients Enrolled
Ecaterina Dumbrava, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
30 Total Patients Enrolled
~33 spots leftby Aug 2027
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