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Clinical Trials/2023-504944-32-00
2023-504944-32-00
Active, not recruiting
Phase 2

A Phase 2, Single-arm, Open-label Clinical Trial of Pembrolizumab Plus Lenvatinib in Participants with First-line Advanced/Metastatic Non-clear Cell Renal Cell Carcinoma (nccRCC) (KEYNOTE-B61)

Merck Sharp & Dohme LLC16 sites in 5 countries59 target enrollmentStarted: August 9, 2023Last updated:
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Overview

Phase
Phase 2
Status
Active, not recruiting
Enrollment
59
Locations
16
Primary Endpoint
Objective Response Rate (ORR) is defined as the percentage of participants with a complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors 1.1 (RECIST 1.1) by blinded independent central review (BICR).
OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

To evaluate the objective response rate (ORR) of pembrolizumab + lenvatinib per response evaluation criteria in solid tumors 1.1 (RECIST 1.1) by blinded independent central review (BICR)

Eligibility Criteria

Ages
18 years to 65+ years (18-64 Years, 65+ Years)
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Must have a histologically confirmed diagnosis of nccRCC.
  • •Have adequate organ function.
  • •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 7 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.

Exclusion Criteria

  • •Has collecting duct histology.
  • •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.

Outcomes

Primary Outcomes

Objective Response Rate (ORR) is defined as the percentage of participants with a complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors 1.1 (RECIST 1.1) by blinded independent central review (BICR).

Objective Response Rate (ORR) is defined as the percentage of participants with a complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors 1.1 (RECIST 1.1) by blinded independent central review (BICR).

Secondary Outcomes

  • Duration of Response (DOR) is defined for participants who demonstrate confirmed CR or PR as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
  • Progression-free Survival (PFS) is defined as the time from the date of first dose to the first documented progressive disease (PD) per RECIST 1.1 by BICR or death from any cause, whichever occurs first.
  • Overall Survival (OS) is defined as the time from date of first dose until death from any cause.
  • Clinical Benefit Ratio (CBR) is defined as the percentage of participants who achieved CR, PR, or stable disease (SD) for at least 6 months per RECIST 1.1 by BICR.
  • Disease Control Rate (DCR) is defined as the percentage of participants who achieved CR, PR, or SD per RECIST 1.1 by BICR.
  • Number of Participants Who Experienced One or More Adverse Events (AEs).
  • Number of Participants Who Discontinued Study Medication Due to an AE.

Investigators

Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

Manish Sharma

Scientific

Merck Sharp & Dohme LLC

Study Sites (16)

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