Phase Ib Study of Alpelisib and Pembrolizumab for Patients with Metastatic Breast Cancer or Melanoma (SELENA)

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06545682

Provider View

This clinical trial is testing a combination of two drugs, alpelisib and pembrolizumab, to find the best dose for treating patients with advanced breast cancer or melanoma that has spread to other parts of the body.

Patient Parameters

Program Overview

The purpose of this study is to determine a safe and effective dose of the drug combination alpelisib and pembrolizumab for patients with metastatic breast cancer or melanoma. Researchers aim to find out if this combination can help control the cancer in patients whose disease has progressed despite previous treatments.

Description

The main goal of this study is to find a safe dose of alpelisib and pembrolizumab that can be used in future research for treating advanced breast cancer or melanoma. The study will also look at how well the treatment works in shrinking tumors and improving patients' health.

Participants will receive the drug combination and be monitored for side effects and how well the cancer responds to the treatment. The study will also explore how the treatment affects certain biological markers in the body and how the drugs are processed by the body.

Patients will need to meet specific health criteria to participate, including having a certain level of organ function and being able to swallow pills. Women who can become pregnant must use effective birth control during the study and for a period after the treatment ends. Men with partners who can become pregnant must also use birth control during and after the study.

The study will exclude patients with certain health conditions, such as active infections, uncontrolled diabetes, or a history of severe allergic reactions to similar drugs. Patients who have received certain treatments recently or have specific medical conditions that could interfere with the study will also be excluded.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must be able to provide informed consent.
  • Have advanced breast cancer or melanoma that has spread and not responded to previous treatments.
  • Have had a brain MRI scan recently to check for brain metastases.
  • Have measurable disease based on specific criteria.
  • Have adequate organ function and a good performance status.
  • Have a life expectancy of at least 12 weeks.
  • Be able to swallow pills.
  • Women of childbearing potential must have a negative pregnancy test and use effective birth control.
  • Men with partners of childbearing potential must use effective birth control.

Exclusion Criteria

  • Have a history of autoimmune diseases or active infections.
  • Have unresolved side effects from previous cancer treatments.
  • Have had recent chemotherapy or radiation therapy.
  • Have gastrointestinal conditions that affect drug absorption.
  • Have uncontrolled systemic diseases or diabetes.
  • Have a history of severe skin reactions or heart problems.
  • Have poorly controlled high blood pressure.
  • Have active brain metastases that require immediate treatment.
  • Have a history of lung inflammation or psychiatric disorders that could interfere with the study.
  • Have a history of hepatitis B or C, or HIV.
  • Have received a live vaccine recently.
  • Are pregnant or nursing.

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