Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775])



Status:Recruiting
Conditions:Cervical Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:June 11, 2018
End Date:January 25, 2023
Contact:Eisai Medical Info
Email:esi_oncmedinfo@eisai.com
Phone:1-888-274-2378

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A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer

This is a study of pembrolizumab (MK-3475, KEYTRUDA®) in combination with lenvatinib (E7080)
versus treatment of physician's choice (doxorubicin or paclitaxel) for the treatment of
advanced endometrial cancer. Participants will be randomly assigned to receive either
pembrolizumab and lenvatinib or treatment of physician's choice. The primary study hypothesis
is that pembrolizumab in combination with lenvatinib prolongs progression free survival (PFS)
and overall survival (OS) when compared to treatment of physician's choice.


Inclusion Criteria:

1. Has a histologically confirmed diagnosis of endometrial carcinoma (EC)

2. Documented evidence of advanced, recurrent or metastatic EC.

3. Has radiographic evidence of disease progression after 1 prior systemic,
platinum-based chemotherapy regimen for EC. Participants may have received up to 1
additional line of platinum-based chemotherapy if given in the neoadjuvant or adjuvant
treatment setting.

Note: There is no restriction regarding prior hormonal therapy.

4. Has historical or fresh tumor biopsy specimen for determination of mismatch repair
(MMR) status.

5. Has at least 1 measurable target lesion according to Response Evaluation Criteria In
Solid Tumors (RECIST) 1.1 and confirmed by Blinded Independent Central Review BICR.

6. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7
days of starting study treatment.

7. Is not pregnant, breastfeeding, and agrees to use a highly effective method of
contraception during the treatment period and for at least 120 days (for participants
treated with lenvatinib plus pembrolizumab) or at least 180 days (for participants
treated with treatment of physician's choice [TPC]) after the last dose of study
treatment.

Exclusion Criteria:

1. Has carcinosarcoma (malignant mixed mullerian tumor), endometrial leiomyosarcoma and
endometrial stromal sarcomas.

2. Has unstable central nervous system (CNS) metastases.

3. Has active malignancy (except for endometrial cancer, definitively treated in-situ
carcinomas [e.g. breast, cervix, bladder], or basal or squamous cell carcinoma of the
skin) within 24 months of study start.

4. Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other
condition that might affect the absorption of lenvatinib.

5. Has a pre-existing greater than or equal (>=) Grade 3 gastrointestinal or
non-gastrointestinal fistula.

6. Has radiographic evidence of major blood vessel invasion/infiltration.

7. Has clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the
first dose of study treatment.

8. Has a history of congestive heart failure greater than New York Heart Association
(NYHA) Class II, unstable angina, myocardial infarction, cerebrovascular accident
(CVA) stroke, or cardiac arrhythmia associated with hemodynamic instability within 12
months of the first dose of study treatment.

9. Has an active infection requiring systemic treatment.

10. Has not recovered adequately from any toxicity and/or complications from major surgery
prior to starting therapy.

11. Is positive for Human Immunodeficiency Virus (HIV).

12. Has active Hepatitis B or C.

13. Has a history of (non-infectious) pneumonitis that required treatment with steroids,
or has current pneumonitis.

14. Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the study.

15. 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 study start -Has an active autoimmune
disease (with the exception of psoriasis) that has required systemic treatment in the
past 2 years.

16. Is pregnant or breastfeeding.

17. Has had an allogenic tissue/solid organ transplant.

18. Has received >1 prior systemic chemotherapy regimen (other than adjuvant or
neoadjuvant) for Endometrial Cancer. Participants may receive up to 2 regimens of
platinum-based chemotherapy in total, as long as one is given in the neoadjuvant or
adjuvant treatment setting.

19. Has received prior anticancer treatment within 28 days of study start. All acute
toxicities related to prior treatments must be resolved to Grade ≤1, except for
alopecia and Grade ≤2 peripheral neuropathy.

20. Has received prior treatment with any treatment targeting VEGF-directed angiogenesis,
any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.

21. Has received prior treatment with an agent directed to a stimulatory or co-inhibitory
T-cell receptor other than an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, and who has
discontinued from that treatment due to a Grade 3 or higher immune-related adverse
event.

22. Has received prior radiation therapy within 21 days of study start with the exception
of palliative radiotherapy to bone lesions, which is allowed if completed 2 weeks of
study start. Participants must have recovered from all radiation-related toxicities
and/or complications prior to randomization.

23. Has received a live vaccine within 30 days of study start.

24. Has a known intolerance to study treatment (or any of the excipients).

25. Prior enrollment on a clinical study evaluating pembrolizumab and lenvatinib for
endometrial carcinoma, regardless of treatment received.

26. Is currently participating in or has participated in a study of an investigational
agent or has used an investigational device within 4 weeks of study start.

27. Participants with urine protein ≥1 gram (g)/24 hour.

28. Prolongation of corrected QT (QTc) interval to >480 milliseconds (ms).

29. Left ventricular ejection fraction (LVEF) below the institutional normal range as
determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).
We found this trial at
27
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Wheaton, Maryland 20902
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Austin, Texas 78745
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6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Evanston, Illinois 60201
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Germantown, Tennessee 38138
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92 2nd St
Hackensack, New Jersey 07601
(201) 996-5900
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Miami, Florida 33136
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New Haven, Connecticut 06520
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New Orleans, Louisiana 70112
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Oklahoma City, Oklahoma 73104
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Orlando, Florida 32804
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Phoenix, Arizona 85016
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San Francisco, California 94143
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405 Hilgard Avenue
Santa Monica, California 90404
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Sioux Falls, South Dakota 57104
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Teaneck, New Jersey 07666
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Zion, Illinois 60099
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