Trials / Not Yet Recruiting
Not Yet RecruitingNCT05077215
Efficacy and Safety of a Repurposed Drug Added to the Combination of Len Plus Pem in Advanced Endometrial Cancer
A Phase 3, Randomized, Open-Label, Active-Controlled, Superiority Trial of EG007, Added to the Combination of Lenvatinib Plus Pembrolizumab vs. Lenvatinib Plus Pembrolizumab in Patients With Advanced Endometrial Cancer
- Status
- Not Yet Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 450 (estimated)
- Sponsor
- Evergreen Therapeutics, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 3, multicenter, randomized, open-label trial to evaluate whether EG-007 plus Len+Pem is superior to Len+Pem alone in patients with advanced endometrial cancer (Stage III or IV). This trial will be preceded by a safety lead-in study with up to 28 patients (the safety lead-in is a separate, free-standing protocol). Approximately 450 patients will be randomized equally (1:1) to receive EG-007 plus Len+Pem or Len+Pem alone. The randomization will be stratified by the following stratification factors: * Diagnosis Classification (advanced Stage III/IV vs. recurrent endometrial cancer) * ECOG score at baseline (0 vs 1) * Geographic region (Asia vs ROW)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | EG-007 | A Repurposed Drug |
| DRUG | Pembrolizumab 100 mg/ 4 ml (25 mg/ml) Injection | Pembrolizumab will be provided as a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution that requires dilution for intravenous infusion. Each vial contains 100 mg of pembrolizumab in 4 mL of solution. |
| DRUG | Lenvatinib Capsules | Lenvatinib will be provided as 4-mg and 10-mg capsules. Lenvatinib is formulated with calcium carbonate, mannitol, microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, and talc. |
Timeline
- Start date
- 2026-12-01
- Primary completion
- 2027-12-01
- Completion
- 2027-12-01
- First posted
- 2021-10-14
- Last updated
- 2025-12-08
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05077215. Inclusion in this directory is not an endorsement.