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Pembrolizumab + lenvatinib versus chemotherapy in advanced endometrial carcinoma
NCT03884101Phase 3
Key facts
- Status
- Completed
- Start
- Apr 2019
- Primary completion
- Oct 2023
- Countries
- 22
- Sponsor
- Merck & Co.
- Modality
- Immune Checkpoint Inhibitors, Recombinant Proteins and Enzymes
- Drugs
- pembrolizumab
- Conditions
- endometrial carcinoma
01
Overview
Phase 3, randomised, open-label trial of pembrolizumab in endometrial carcinoma (2 arms), sponsored by Merck & Co. Primary endpoints: Progression-Free Survival at 44 months and Overall Survival at 51 months. Started Apr 2019; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Lenvatinib + Pembrolizumab
Experimental arm receiving pembrolizumab 200 mg IV Q3W + lenvatinib 20 mg PO daily
Paclitaxel + Carboplatin
Active comparator arm receiving paclitaxel 175 mg/m² IV + carboplatin AUC 6 IV Q3W
03
Who it enrols
Female patients with Stage III, IV, or recurrent endometrial carcinoma (excluding carcinosarcoma and sarcomas), ECOG 0-1, no prior systemic chemotherapy (except concurrent with radiation), no prior immunotherapy or VEGF-directed therapy, adequate organ function, controlled blood pressure, no active infections, HIV/HBV/HCV negative
04
Endpoints
Primary
Progression-Free Survival
Overall Survival
Secondary
Objective Response Rate
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 Global Health Status/Quality of Life
Adverse Event
Serious Adverse Event
Immune-Related Adverse Event
Discontinuation due to Adverse Event
05
Results
Not all primary endpoints met
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