Study on Adding Bevacizumab to Chemotherapy and Immunotherapy for Advanced or Recurrent Endometrial Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT07198074
This clinical trial is testing whether adding the drug bevacizumab to a combination of chemotherapy and immunotherapy can improve treatment outcomes for patients with advanced or recurrent endometrial cancer that has specific genetic characteristics.
Patient Parameters
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Program Overview
This study is exploring if adding bevacizumab, a drug that stops blood vessels from feeding tumors, to the usual chemotherapy drugs carboplatin and paclitaxel, along with the immunotherapy drug pembrolizumab, can better treat advanced or recurrent endometrial cancer. The trial compares this new combination to the standard treatments to see if it helps slow down the cancer's growth and spread.
Description
The main goal of this study is to see if adding bevacizumab to the combination of carboplatin, paclitaxel, and pembrolizumab can help patients with advanced or recurrent endometrial cancer live longer without the disease getting worse. Researchers also want to see if this combination helps patients live longer overall compared to the usual treatments.
Patients in the study will be randomly assigned to one of three groups:
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Group 1 (Reference Group): Patients receive paclitaxel, carboplatin, and pembrolizumab every three weeks for up to 6-10 cycles. After that, they may continue with pembrolizumab every six weeks for up to 14 more cycles.
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Group 2 (Experimental Triplet Group): Patients receive paclitaxel, carboplatin, and bevacizumab every three weeks for up to 6-10 cycles. After that, they may continue with bevacizumab every three weeks for up to 28 more doses.
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Group 3 (Experimental Quadruplet Group): Patients receive paclitaxel, carboplatin, pembrolizumab, and bevacizumab every three weeks for up to 6-10 cycles. After that, they may continue with pembrolizumab every six weeks for up to 14 more cycles and bevacizumab every three weeks for up to 28 more doses.
Throughout the study, patients will have regular urine and blood tests, as well as CT or MRI scans to monitor their health and the cancer's response to treatment. After completing the study treatment, patients will have follow-up visits every three months for two years, then every six months for up to three years.
Eligibility Criteria
Inclusion Criteria
- Have stage III, IVA, or IVB endometrial cancer, or recurrent endometrial cancer.
- Cancer must be confirmed by lab tests and have specific genetic markers (pMMR and TP53 mutation).
- May have had prior chemotherapy or radiation therapy, but not within the last 12 months for chemotherapy.
- No prior treatment with pembrolizumab or bevacizumab.
- Age 18 or older.
- Good overall health with an ECOG performance status of 0 to 2.
- Not pregnant or nursing.
- Meet specific blood count and organ function requirements.
- No active infections or recent major surgeries.
- No history of severe autoimmune diseases or organ transplants.
- No history of severe allergic reactions to similar drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Cancer Center at Saint Joseph's | 85004 | Phoenix | Arizona |
| Highlands Oncology Group - Fayetteville | 72703 | Fayetteville | Arkansas |
| Highlands Oncology Group - Rogers | 72758 | Rogers | Arkansas |
| Highlands Oncology Group | 72762 | Springdale | Arkansas |
| Mercy Cancer Center - Carmichael | 95608 | Carmichael | California |
| Mercy San Juan Medical Center | 95608 | Carmichael | California |
| Mercy Cancer Center - Elk Grove | 95758 | Elk Grove | California |
| Eisenhower Medical Center | 92270 | Rancho Mirage | California |
| Mercy Cancer Center - Rocklin | 95765 | Rocklin | California |
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