Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001)
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|ClinicalTrials.gov Identifier: NCT03884101|
Recruitment Status : Not yet recruiting
First Posted : March 21, 2019
Last Update Posted : March 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Neoplasms||Drug: Lenvatinib Biological: Pembrolizumab Drug: Paclitaxel Drug: Carboplatin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||720 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Estimated Study Start Date :||March 27, 2019|
|Estimated Primary Completion Date :||April 10, 2023|
|Estimated Study Completion Date :||April 10, 2023|
|Experimental: Lenvatinib + Pembrolizumab||
Lenvatinib 4 mg or 10 mg capsules at a total daily dose of 20 mg taken by mouth once per day.
Other Name: E7080, MK-7902, LENVIMA®
Pembrolizumab 200 mg intravenous (IV) infusion given on Day 1 of each cycle.
Other Name: MK-3475, KEYTRUDA®
|Active Comparator: Paclitaxel + Carboplatin||
Paclitaxel 175 mg/m^2 IV infusion given on Day 1 of each cycle.
Other Name: TAXOL®, ONXAL®
Carboplatin 10 mg/mL IV infusion at a total dose of are-under-the-curve (AUC) 6 (per Calvert's formula) given on Day 1 of each cycle.
Other Name: PARAPLATIN®
- 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) [ Time Frame: Up to approximately 31 months ]Progression-free survival based on RECIST 1.1 as assessed by BICR. Progression-free survival is measured from the time of randomization to the first documented disease progression or death due to any cause, whichever occurs first.
- Overall Survival (OS) [ Time Frame: Up to approximately 45 months ]Overall survival is measured from the time of randomization up to death due to any cause.
- Objective response rate (ORR ) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent review (BICR) [ Time Frame: Up to approximately 31 months ]The ORR (either confirmed complete response [CR] or partial response [PR]) based on RECIST 1.1 and assessed by BICR will be determined in mismatch repair proficient (pMMR) participants and in all-comer participants who have measurable disease at study entry.
- Change from baseline in the 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 [ Time Frame: Baseline and designated time points up to 27 months ]The EORTC QLQ-C30 was developed to assess the quality of life of patients with cancer. It contains 30 questions (items), 24 of which aggregate into nine multi-item scales representing various aspects, or dimensions, of quality of life (QoL): one global scale, five functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea, pain), and six additional single-symptom items assessing additional symptoms commonly reported by cancer patients (dyspnoea, loss of appetite, insomnia, constipation and diarrhoea) and perceived financial impact of the disease. Individual items are scored on a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Raw scores for each scale are standardized into a range of 0 to 100 by linear transformation; a higher score on the global and functional scales represents a higher ("better") level of functioning, and a higher score on the symptom scale represents a higher ("worse") level of symptoms.
- Percentage of participants experiencing an adverse event (AE) [ Time Frame: Up to approximately 27 months (through 90 days after the last dose of study treatment) ]An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
- Percentage of participants experiencing a serious adverse event (SAE) [ Time Frame: Up to approximately 28 months (through 120 days after the last dose of study treatment) ]An SAE is an AE that results in death, is life-threatening, requires or prolongs hospitalization, results in persistent or significant disability, is a congenital birth defect, or is another important medical event.
- Percentage of participants experiencing an immune-related AE (irAE) [ Time Frame: Up to approximately 27 months (through 90 days after the last dose of study treatment) ]Immune-related AEs will be monitored in both arms.
- Percentage of participants discontinuing from study treatment due to an AE(s) [ Time Frame: Up to approximately 24 months (through the last dose of study treatment) ]Discontinuations related to AEs will be monitored in both arms.
- Plasma clearance of lenvatinib versus time [ Time Frame: At designated timepoints through Cycle 2 Day 1 (each cycle is 21 days) ]The clearance of lenvatinib over time will be determined.
- Area under the plasma concentration-time curve (AUC) of lenvatinib [ Time Frame: At designated timepoints through Cycle 2 Day 1 (each cycle is 21 days) ]The AUC of lenvatinib will be determined in all participants.
- Plasma concentration of lenvatinib [ Time Frame: At designated timepoints through Cycle 2 Day 1 (each cycle is 21 days) ]The plasma concentration of lenvatinib versus time will be determined.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884101
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|