A Phase 3 Randomized, Open-Label, Study of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for First-line Treatment of Advanced or Recurrent Endometrial Carcinoma (LEAP-001)

Conditions

Participants with advanced or recurrent endometrial carcinoma

Brief summary

Progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, Overall Survival

Detailed description

Objective response rate (ORR; either confirmed complete response [CR] or partial response [PR]) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent review (BICR) in mismatch repair proficient (pMMR) participants and in all-comer participants who have measurable disease at study entry, Change from baseline in Health-Related Quality-of-Life (HRQoL) global score of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ C30) in pMMR and in all-comer participants, Percentage of participants experiencing an adverse event (AE), Percentage of participants experiencing a serious AE (SAE), Percentage of participants experiencing an immune-related AE (irAE), Percentage of participants discontinuing from study treatment due to an AE(s)

Related papers

No related papers found yet.

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGLenvatinib

DRUGCARBOPLATIN

DRUGPACLITAXEL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR), modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, Overall Survival	—

Secondary

Measure	Time frame
Objective response rate (ORR; either confirmed complete response [CR] or partial response [PR]) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent review (BICR) in mismatch repair proficient (pMMR) participants and in all-comer participants who have measurable disease at study entry, Change from baseline in Health-Related Quality-of-Life (HRQoL) global score of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ C30) in pMMR and in all-comer participants, Percentage of participants experiencing an adverse event (AE), Percentage of participants experiencing a serious AE (SAE), Percentage of participants experiencing an immune-related AE (irAE), Percentage of participants discontinuing from study treatment due to an AE(s)	—

Measure

Time frame

Objective response rate (ORR; either confirmed complete response [CR] or partial response [PR]) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent review (BICR) in mismatch repair proficient (pMMR) participants and in all-comer participants who have measurable disease at study entry, Change from baseline in Health-Related Quality-of-Life (HRQoL) global score of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core-30 (QLQ C30) in pMMR and in all-comer participants, Percentage of participants experiencing an adverse event (AE), Percentage of participants experiencing a serious AE (SAE), Percentage of participants experiencing an immune-related AE (irAE), Percentage of participants discontinuing from study treatment due to an AE(s)

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Countries

Austria, Belgium, Germany, Ireland, Italy, Poland, Spain

Outcome results

None listed