Pembrolizumab Plus Lenvatinib for First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (1L nccRCC) (MK-3475-B61)

  • STATUS
    Recruiting
  • End date
    Oct 22, 2025
  • participants needed
    152
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 26 September 2021
Investigator
Toll Free Number
Primary Contact
Borsod-Aba j-Zempl n Megyei K zponti K rh z s Egyetemi Okta-Klinikai Onkol giai s Sug rter pi s C (1.4 mi away) Contact
+55 other location
cancer
systemic therapy
measurable disease
carcinoma
karnofsky performance status
progressive disease
pembrolizumab
lenvatinib
clear cell renal cell carcinoma

Summary

This study is being performed as a single-arm open-label study in order to rapidly provide information on the potential benefits of the combination of pembrolizumab and lenvatinib in participants with previously untreated advanced/metastatic non-clear cell renal cell carcinoma.

Details
Condition Adenocarcinoma, Malignant neoplasm of kidney, Renal Cell Carcinoma, Kidney Cancer, Malignant Adenoma, Renal Cell Cancer, Renal Cancer, clear cell renal cell carcinoma
Treatment Pembrolizumab, Lenvatinib
Clinical Study IdentifierNCT04704219
SponsorMerck Sharp & Dohme Corp.
Last Modified on26 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Must have a histologically-confirmed diagnosis of non-clear cell RCC
Has locally advanced/metastatic disease (ie, Stage IV per the American Joint Committee on Cancer )
Has received no prior systemic therapy for advanced nccRCC. Note: Prior neoadjuvant/adjuvant therapy for nccRCC is acceptable if completed >12 months prior to allocation
Male participants agree to use approved contraception during the treatment period for at least 5 days after the last dose of study medication, or refrain from heterosexual intercourse during this period
Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period and for at least 120 days post pembrolizumab, or 30 days post lenvatinib, whichever occurs last
Has measurable disease per RECIST 1.1 as assessed by BICR. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
Has submitted an archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue
Has Karnofsky Performance Status (KPS) 70% as assessed within 10 days prior to the start of study intervention
Has adequately controlled blood pressure with or without antihypertensive medications
Have adequate organ function

Exclusion Criteria

Has collecting duct histology
A WOCBP who has a positive urine pregnancy test within 24 hours before the first dose of study intervention
Has a left ventricular ejection fraction below the institutional (or local laboratory) normal range
Has radiographic encasement or invasion of a major blood vessel, or of intratumoral cavitation
Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib
Has active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug
Has had major surgery within 3 weeks prior to first dose of study intervention
Has received prior therapy with an anti-programmed cell-death 1 (PD-1), anti-programmed cell-death ligand 1 (PD-L1), or anti-programmed cell-death ligand 2 (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 prior systemic anticancer therapy including investigational agents within 4 weeks prior to allocation
Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (2 weeks of radiotherapy) to non-central nervous system (CNS) disease
Has received a live or attenuated vaccine within 30 days before the first dose of study intervention
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 the first dose of study intervention
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 the first dose of study intervention
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
Note: Participants with basal cell carcinoma of the skin, squamous cell
carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical
cancer in situ) that have undergone potentially curative therapy are not
excluded
\. Has known active CNS metastases and/or carcinomatous meningitis
\. Has severe hypersensitivity (Grade 3) to pembrolizumab, lenvatinib and/or
any of their excipients
\. Has an active autoimmune disease that has required systemic treatment in
past 2 years
\. Has a history of (non-infectious) pneumonitis that required steroids or
has current pneumonitis
\. Has an active infection requiring systemic therapy
\. Has a known history of human immunodeficiency virus (HIV) infection. No
HIV testing is required unless mandated by local health authority
\. Has a known history of Hepatitis B (defined as HBsAg reactive) or known
active Hepatitis C virus
\. Has a known history of active tuberculosis (TB; Bacillus tuberculosis)
\. Has had an allogenic tissue/solid organ transplant
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