Figure 1.

ENGOT-en9/LEAP-001 study design. ^aTreat until disease progression or unacceptable toxicity. Pembrolizumab must be stopped after 35 cycles, but lenvatinib may continue after stopping pembrolizumab. ^bStudy will be fully enrolled when 612 patients with mismatch repair-proficient (pMMR) tumors and ~263 patients with mismatch repair-deficient (dMMR) tumors are recruited. ^cA lower starting dose of paclitaxel (135 mg/m²) and carboplatin (AUC 5 mg/mL/min) may be administered to patients at risk of developing toxicities due to previous pelvic/spine radiation. An AUC of 5 mg/mL/min dose of carboplatin may be administered in accordance with local practice. ^dPatients may receive up to seven cycles of paclitaxel/carboplatin; however, chemotherapy treatment beyond seven cycles may be permitted (with the sponsors’ approval) for patients who continue to derive clinical benefit. AUC, area under the curve (unit, mg/mL/min); ECOG, Eastern Cooperative Oncology Group; IV, intravenous; PS, performance status; QD, once daily; Q3W, every 3 weeks.