Select ongoing clinical trials evaluating anti-programmed death 1/programmed death ligand 1 therapies in patients with primary advanced or recurrent endometrial cancer
| Study | Phase | Therapy | Disease | Previous therapy | Biomarkers | N | Location |
| ENGOT-en6/NSGO-RUBY18 NCT03981796 | 3 | Dostarlimab (anti-PD-1) + carboplatin + paclitaxel followed by dostarlimab with or without niraparib vs placebo + carboplatin + paclitaxel followed by placebo | First recurrent or primary stage III–IV endometrial cancer | Patients had received no previous systemic chemotherapy; previous neoadjuvant/adjuvant chemotherapy permitted if recurrence ≥6 months | MSI-H or MSS | ~470 | Europe, North America |
| ENGOT-en7/AtTEnd19 NCT03603184 | 3 | Paclitaxel + carboplatin + atezolizumab (anti-PD-L1) followed by atezolizumab vs paclitaxel + carboplatin + placebo followed by placebo | Newly diagnosed, advanced stage III–IV or recurrent endometrial cancer | Patients had received one previous line of chemotherapy if upfront/adjuvant and platinum-free interval ≥6 months | None | ~550 | Australia, Europe, Japan, New Zealand |
| ENGOT-en9/LEAP-001 (current study) NCT03884101 | 3 | Pembrolizumab + lenvatinib (anti-PD-1 + tyrosine kinase inhibitor) vs paclitaxel + carboplatin | Stage III, IV, or recurrent endometrial cancer | Patients may have received previous chemotherapy (as neoadjuvant/adjuvant therapy and/or concurrently with radiation) radiation, or hormonal therapy (completed ≥1 week prior) | dMMR or pMMR | ~875 | Asia, Australia, Europe, North America, South America |
| NRG-GY018 NCT03914612 | 3 | Pembrolizumab (anti-PD-1) + paclitaxel + carboplatin followed by pembrolizumab vs placebo + paclitaxel + carboplatin followed by placebo | Stage III–IVB or recurrent endometrial cancer | Patients may have received prior adjuvant chemotherapy (completed ≥12 months prior), radiation therapy (completed ≥4 weeks prior), or hormonal therapy (completed ≥3 weeks prior) | PD-L1-positive or negative; dMMR or pMMR | ~810 | North America |
dMMR, mismatch repair-deficient; MSI-H, microsatellite instability high; MSS, microsatellite stable; PD-1, programmed death 1; PD-L1, programmed death ligand 1; pMMR, mismatch repair-proficient.