Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001)

  • STATUS
    Recruiting
  • End date
    Apr 10, 2023
  • participants needed
    720
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 23 November 2020
Investigator
Toll Free Number
Primary Contact
Royal North Shore Hospital ( Site 1600) (4.8 mi away) Contact
+211 other location
paclitaxel
carcinoma
carboplatin
hormone therapy
pembrolizumab
solid tumour
mk-3475
endometrial carcinoma
recurrent endometrial cancer

Summary

The purpose of this study is to compare the efficacy of pembrolizumab + lenvatinib to chemotherapy in female participants with Stage III, IV, or recurrent endometrial carcinoma. It is hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for progression-free survival (PFS) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR). It is also hypothesized that the combination of pembrolizumab + lenvatinib will be superior to chemotherapy for overall survival (OS).

Details
Treatment carboplatin, Paclitaxel, Pembrolizumab, Lenvatinib
Clinical Study IdentifierNCT03884101
SponsorMerck Sharp & Dohme Corp.
Last Modified on23 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have any of these conditions: Endometrial Cancer or Endometrial Carcinoma or Uterine Cancer?
Do you have any of these conditions: Uterine Cancer or Endometrial Cancer or Endometrial Carcinoma?
Has Stage III, Stage IV, or recurrent, histologically-confirmed endometrial carcinoma with disease that is either measurable or non-measurable but radiographically apparent, per RECIST 1.1 as assessed by BICR (note: may have received prior chemotherapy only if administered concurrently with radiation; may have received prior radiation without concurrent chemotherapy; may have received prior hormonal therapy for treatment of endometrial carcinoma, provided that it was discontinued 1 week prior to randomization; and may have received 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy)
Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion that was not previously irradiated, for determination of mismatch repair (MMR) status
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to the first dose of study intervention
Is not pregnant or breastfeeding, and is either not a woman of childbearing potential (WOCBP) or is a WOCBP who agrees to use contraception during the study and for 120 days after pembrolizumab, 30 days after lenvatinib, or 196 days after (chemotherapy) [if a WOCBP, a pregnancy test will be required within 24 hours of first dose of study drug]
Has adequately controlled blood pressure within 7 days prior to randomization
Has adequate organ function based on assessment within 7 days prior to the first dose of study intervention

Exclusion Criteria

Has carcinosarcoma (malignant mixed Mllerian tumor), endometrial leiomyosarcoma or other high grade sarcomas, or endometrial stromal sarcomas
Has a central nervous system (CNS) metastasis, unless local therapy (e.g., whole brain radiation therapy, surgery, or radiosurgery) has been completed and have discontinued use of corticosteroids for this indication for 4 weeks prior to starting study medication (major surgery within 3 weeks of the first dose of study drug will be exclusionary)
Has a known additional malignancy (other than endometrial carcinoma) that is progressing or has required active treatment in the last 3 years
Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib
Has a pre-existing Grade 3 gastrointestinal or non-gastrointestinal fistula
Has radiographic evidence of major blood vessel invasion/infiltration
Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to randomization
Has significant cardiovascular impairment within 12 months of the first dose of study intervention such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident (CVA) stroke, or cardiac arrhythmia associated with hemodynamic instability
Has any infection requiring systemic treatment
Has not recovered adequately from any toxicity and/or complications from major surgery prior to randomization
Has a known history of human immunodeficiency virus (HIV) infection (HIV test is required at screening)
Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (Hepatitis B and C testing is required at screening)
Has a history of (non-infectious) pneumonitis that required treatment with steroids, or has current pneumonitis
Has a known history of active tuberculosis (tuberculosis test is required at screening)
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization
Has an active autoimmune disease (with the exception of psoriasis) that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
Has received prior systemic chemotherapy in any setting for the treatment of endometrial carcinoma (note: prior chemotherapy administered concurrently with radiation is permitted)
Has received prior radiotherapy within 4 weeks prior to randomization (participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis - a 2-week washout is permitted for palliative radiation to non-CNS disease and vaginal brachytherapy)
Has received prior hormonal therapy for the treatment of endometrial carcinoma within 1 week of randomization
Has received prior therapy with any treatment targeting vascular endothelial growth factor (VEGF)-directed angiogenesis, an anti-programmed cell death (PD)-1, anti-PD ligand (L)1, or anti-PD L2 agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137)
Has received a live vaccine within 30 days prior to the first dose of study intervention
Has known intolerance to study intervention (or any of the excipients)
Has had an allogenic tissue/solid organ transplant
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization
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