Study on Adding Pembrolizumab to Usual Chemotherapy for Advanced or Recurrent Endometrial Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03914612
This clinical trial is testing whether adding the immunotherapy drug pembrolizumab to the usual chemotherapy treatment of paclitaxel and carboplatin can improve outcomes for patients with advanced or recurrent endometrial cancer.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study aims to find out if combining the immunotherapy drug pembrolizumab with the standard chemotherapy drugs paclitaxel and carboplatin is more effective than chemotherapy alone in treating patients with advanced or recurrent endometrial cancer. Pembrolizumab may help the immune system attack cancer cells and prevent them from growing and spreading. The trial will compare the effectiveness and safety of the combination treatment against the standard chemotherapy approach.
Description
The main goal of this study is to evaluate how well pembrolizumab works when combined with paclitaxel and carboplatin in patients with advanced or recurrent endometrial cancer. Researchers will also look at the side effects of each treatment option and how they affect patients' quality of life.
Participants will be randomly assigned to one of two groups:
- Group 1: Receives a placebo (inactive substance) along with paclitaxel and carboplatin for up to 6 cycles, followed by placebo maintenance treatment every 6 weeks for up to 14 cycles.
- Group 2: Receives pembrolizumab along with paclitaxel and carboplatin for up to 6 cycles, followed by pembrolizumab maintenance treatment every 6 weeks for up to 14 cycles.
Throughout the study, participants will undergo regular CT scans to monitor the cancer's response to treatment. After completing the study treatment, participants will have follow-up visits every 3 months for 2 years, then every 6 months for 3 years.
Eligibility Criteria
Inclusion Criteria
- Have advanced or recurrent endometrial cancer that can be measured by scans.
- Have a pathology report confirming the type of endometrial cancer.
- Have not received prior chemotherapy for endometrial cancer, or completed prior chemotherapy at least 12 months ago.
- May have received prior radiation or hormonal therapy, but must have stopped at least 4 weeks before joining the study.
- Be 18 years or older.
- Have a performance status score of 0, 1, or 2, indicating full activity or some restriction in strenuous activities.
- Have adequate blood cell counts and organ function as determined by specific blood tests.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 120 days after the last dose.
- Provide informed consent to participate in the study.
Exclusion Criteria
- Have received prior treatment with pembrolizumab or similar immunotherapy drugs.
- Have a history of severe allergic reactions to the study drugs.
- Are currently participating in another cancer treatment study.
- Have an active autoimmune disease or require immunosuppressive therapy.
- Have untreated or unstable brain metastases.
- Have uncontrolled illnesses such as active infections, heart failure, or psychiatric conditions.
- Have significant liver disease or active hepatitis.
- Are pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| CTCA at Western Regional Medical Center | 85338 | Goodyear | Arizona |
| NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro | 72401 | Jonesboro | Arkansas |
| University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
| Kaiser Permanente-Baldwin Park | 91706 | Baldwin Park | California |
| Kaiser Permanente-Bellflower | 90706 | Bellflower | California |
| Alta Bates Summit Medical Center-Herrick Campus | 94704 | Berkeley | California |
| Community Cancer Institute | 93611 | Clovis | California |
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.