Study on PF-08634404 with Chemotherapy for Advanced or Returning Endometrial Cancer
Sponsor: Pfizer
ClinicalTrials ID:NCT07578649
This clinical trial is exploring a new treatment using the study medicine PF-08634404 combined with chemotherapy to see if it improves outcomes for women with advanced or recurrent endometrial cancer, compared to the existing treatment pembrolizumab plus chemotherapy.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to find out if the new medicine PF-08634404, when used with chemotherapy, can better treat advanced or recurrent endometrial cancer compared to the current treatment option, pembrolizumab plus chemotherapy. Endometrial cancer is a type of cancer that starts in the lining of the uterus. This study focuses on cancers where the body's natural DNA repair system, called mismatch repair (MMR), is working normally, known as MMR-proficient (pMMR) cancers. These cancers are harder for the immune system to detect and fight. The study involves adult women with advanced or recurrent pMMR endometrial cancer.
Description
In this study, about 600 adult women will participate. They will be randomly assigned to one of two groups: one group will receive the new study medicine PF-08634404 with chemotherapy, followed by PF-08634404 alone for up to two years. The other group will receive the approved medicine pembrolizumab with chemotherapy, followed by pembrolizumab alone for up to two years. Both treatments are given through intravenous infusions, meaning the medicine is delivered directly into a vein.
Participants will have regular visits to the study site for treatment, health checks, and tests. After stopping treatment, there will be a final visit within a month to check their health and review any reactions. Follow-up will continue every 12 weeks by phone, in person, or by reviewing health records to monitor health and any new treatments. Tests will be conducted every 9 weeks during the first 104 weeks to see how the cancer is responding, and then every 12 weeks after that.
Eligibility Criteria
Inclusion Criteria
- Women aged 18 or older who are not pregnant.
- Diagnosed with recurrent or advanced endometrial cancer, including carcinosarcomas but not pure sarcomas.
- Newly diagnosed Stage III or IV disease, or recurrent disease, where surgery or radiotherapy is unlikely to cure.
- For recurrent disease, previous chemotherapy is allowed if the cancer returned more than 6 months after the last treatment.
- Must provide a tumor sample for testing.
- Cancer must be MMR-proficient (pMMR) as confirmed by testing.
- Good overall health with an ECOG performance status of 0 to 1.
- Life expectancy of at least 12 weeks.
- Adequate organ function as specified in the study protocol.
Exclusion Criteria
- Previous systemic therapy for advanced or recurrent endometrial cancer.
- Previous immunotherapy or anti-angiogenic therapy.
- Cancer that is MMR-deficient (dMMR) as confirmed by testing.
- Active or untreated brain metastases, unless previously treated and stable without steroids.
- Significant risk of bleeding or fistula, or history of severe bleeding disorders.
- History of another cancer within 3 years, except for those with low risk of recurrence.
- History of organ or stem cell transplant, active autoimmune disease needing treatment in the past 2 years, or immunodeficiency.
- Lung diseases like interstitial lung disease or pneumonitis.
- Uncontrolled or significant heart, metabolic, kidney, liver, or vascular disease.
- Active or uncontrolled infection.
- Recent major surgery or severe trauma within specified timeframes.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Jupiter Medical Center/ Anderson Family Cancer Institute | 33458 | Jupiter | Florida |
| Orlando Health Ambulatory Care Center | 32806 | Orlando | Florida |
| Orlando Health Cancer Institute | 32806 | Orlando | Florida |
| Orlando Health Orlando Regional Medical Center | 32806 | Orlando | Florida |
| Orlando Health Winnie Palmer Hospital for Women & Babies | 32806 | Orlando | Florida |
| Minnesota Oncology Hematology, PA | 55433 | Coon Rapids | Minnesota |
| Minnesota Oncology Hematology, PA | 55435 | Edina | Minnesota |
| Minnesota Oncology Hematology, PA | 55369 | Maple Grove | Minnesota |
| Minnesota Oncology Hematology, PA | 55109 | Maplewood | Minnesota |
| Minnesota Oncology Hematology, PA | 55125 | Woodbury | Minnesota |
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