ALPINE: Comparing Maintenance Treatments for Endometrial Cancer - Letrozole/Abemaciclib vs Pembrolizumab
Sponsor: Dana-Farber Cancer Institute
ClinicalTrials ID:NCT06366347
This study is exploring whether a combination of letrozole and abemaciclib is more effective than pembrolizumab alone as a maintenance treatment for endometrial cancer after initial chemotherapy and pembrolizumab treatment.
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Program Overview
This clinical trial is investigating two different maintenance treatments for endometrial cancer. After receiving chemotherapy and pembrolizumab, participants will either continue with pembrolizumab alone or switch to a combination of letrozole and abemaciclib. The study aims to determine which approach is more effective in delaying cancer progression. The drugs involved are abemaciclib, letrozole, and pembrolizumab, which are not yet approved for endometrial cancer but are used for other conditions.
Description
In this phase 2 study, participants with advanced or recurrent estrogen receptor-positive endometrial cancer will be randomly assigned to one of two groups: one receiving abemaciclib and letrozole, and the other receiving pembrolizumab. Random assignment means participants are placed into groups by chance, like flipping a coin.
The study involves several procedures, including eligibility screening, treatment visits, and various scans and tests to monitor health and cancer progression. Participants will receive the study drugs for up to two years and will be followed for three years after completing treatment.
Approximately 76 people are expected to participate in this study, which is supported by Eli Lilly, the provider of the study drug abemaciclib.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of specific types of endometrial cancer.
- Cancer must be estrogen receptor-positive, meaning a certain percentage of cancer cells react to estrogen.
- Tumor must be TP53 wild-type and mismatch repair proficient, as determined by specific lab tests.
- Must have completed 4 to 10 cycles of chemotherapy with carboplatin, paclitaxel, and pembrolizumab.
- Must be suitable for maintenance treatment with pembrolizumab.
- Must have had certain stages of endometrial cancer or recurrent cancer.
- May have received prior chemotherapy, radiation, or hormonal therapy for endometrial cancer.
- Must start study treatment 3 to 8 weeks after finishing chemotherapy and pembrolizumab.
- Must be in good health with a performance status of 0-2.
- Must be 18 years or older.
- Must have normal organ and bone marrow function based on specific lab tests.
- Must be able to understand and sign a consent form.
- Must be able to swallow and retain oral medication.
- Must have available tissue samples for analysis.
Exclusion Criteria
- Previous treatment with CDK4/6 inhibitors like abemaciclib.
- Gastrointestinal issues that affect drug absorption.
- Must have recovered from chemotherapy side effects, except for hair loss or mild nerve damage.
- Active infections requiring IV antibiotics or known viral infections like HIV or hepatitis.
- Recent major injuries or surgeries, or planned major surgery during the study.
- Other cancers within the last 3 years, except for certain low-risk cancers.
- Active brain metastases that are not stable or untreated.
- Pregnant or breastfeeding women, or those not using effective contraception.
- Serious medical conditions that could interfere with the study.
- Need for medications that interact with the study drugs.
- History of certain heart conditions or other malignancies, unless disease-free for 3 years or deemed low risk by the investigator.
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