Study on Avelumab Alone and in Combination with Talazoparib or Axitinib for Recurrent or Persistent Endometrial Cancer
Sponsor: Dana-Farber Cancer Institute
ClinicalTrials ID:NCT02912572
This clinical trial is exploring the use of Avelumab, alone or combined with Talazoparib or Axitinib, to treat endometrial cancer that has returned or spread. The study aims to determine if these treatments are effective in managing the disease.
Patient Parameters
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Program Overview
This study is testing Avelumab, a drug that may help the immune system fight cancer, alone and in combination with Talazoparib or Axitinib, for treating endometrial cancer that has come back or spread. Researchers want to see if these treatments can effectively manage the cancer, especially in patients with specific genetic markers.
Description
This Phase II clinical trial is investigating the effectiveness of Avelumab, a drug that may help the immune system attack cancer cells, in treating recurrent or metastatic endometrial cancer. The study also examines Avelumab in combination with Talazoparib, which blocks a protein involved in DNA repair, and Axitinib, which may prevent cancer cells from forming new blood vessels. These drugs are still being studied, and the FDA has not yet approved them for this specific use.
The trial aims to find out if these treatments can help manage endometrial cancer, particularly in patients with certain genetic profiles. Researchers are looking at how well the drugs work, the safest doses, and any side effects they may cause. Participants will be grouped based on their cancer's genetic makeup to see if certain groups respond better to the treatments.
Eligibility Criteria
Inclusion Criteria
- Have recurrent or persistent endometrial cancer, classified into specific genetic groups.
- Cancer must be measurable by scans or exams.
- Have had at least one prior chemotherapy treatment for endometrial cancer.
- Must not have received drugs targeting PD-1/PD-L1 pathways, PARP inhibitors, or Axitinib before.
- Be 18 years or older.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Provide a sample of cancer tissue from a previous surgery or biopsy.
- Have normal organ and blood function based on specific tests.
- Not be pregnant or breastfeeding and agree to use effective contraception during the study.
- Understand and agree to sign an informed consent document.
- For the Avelumab/Axitinib group, have controlled blood pressure and normal heart function.
Exclusion Criteria
- Have had recent chemotherapy or radiation therapy within the last 4-6 weeks.
- Be taking other investigational drugs.
- Have known brain metastases.
- Have severe allergic reactions to Avelumab or similar drugs.
- Have a history of treatment with certain immune checkpoint inhibitors.
- Have active infections or require systemic therapy for infections.
- Have autoimmune diseases that could worsen with treatment.
- Have had organ transplants.
- Have severe gastrointestinal conditions or uncontrolled illnesses.
- Have significant heart disease or recent heart events.
- Have a history of other cancers unless disease-free for at least 5 years.
- Have received a live vaccine recently.
- Use herbal products or remedies during the study.
- For the Avelumab/Axitinib group, have significant protein in urine, bowel involvement, or active gastrointestinal bleeding.
- Be on certain medications that interact with the study drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Chicago | 60637 | Chicago | Illinois |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| Beth Israel Deaconess Medical Center | 02115 | Boston | Massachusetts |
| Dana Farber Cancer Institute | 02115 | Boston | Massachusetts |
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