Actively Recruiting
Neoadjuvant Pembrolizumab and Lenvatinib for Renal Cell Carcinoma
Led by Abramson Cancer Center at Penn Medicine · Updated on 2026-03-24
30
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
Sponsors
A
Abramson Cancer Center at Penn Medicine
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will evaluate the effect of investigational drugs, pembrolizumab alone or pembrolizumab with lenvatinib, on the immune systems response to kidney cancer when given before and after surgery to remove kidney cancer.
CONDITIONS
Official Title
Neoadjuvant Pembrolizumab and Lenvatinib for Renal Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with confirmed renal cell carcinoma
- Male participants must agree to abstain from heterosexual intercourse or use effective contraception during treatment and for at least 7 days after last lenvatinib dose
- Female participants must not be pregnant or breastfeeding and either not be of childbearing potential or use highly effective contraception or abstain from heterosexual intercourse during treatment and for at least 120 days post pembrolizumab or 30 days post lenvatinib
- Provide written informed consent
- Diagnosis confirmed by renal mass core biopsy during screening
- Clinical stage cT2 to cT4 renal cell carcinoma eligible for surgical removal; patients with regional lymph node involvement may be included if disease is resectable
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 evaluated within 7 days before first dose
- Adequately controlled blood pressure (≤150/90 mm Hg) with no recent medication changes
- Adequate organ function
You will not qualify if you...
- Women of childbearing potential with positive pregnancy test before first dose
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell receptor agents
- Prior systemic anti-cancer therapy, including investigational agents, within 4 weeks before randomization
- Major surgery within 3 weeks before first dose
- Presence of distant metastatic disease (regional nodal or ipsilateral adrenal metastases allowed if resectable)
- Urgent need for surgical removal
- Preexisting Grade 3 or higher gastrointestinal or non-gastrointestinal fistula
- Left ventricular ejection fraction ≤40%
- Proteinuria >1+ on urine dipstick unless 24-hour urine protein <1 g
- QTcF interval >480 ms
- Recent significant cardiovascular disease within 12 months
- Gastrointestinal conditions affecting lenvatinib absorption
- Active hemoptysis within 3 weeks prior to first dose
- Live vaccine within 30 days before first dose
- Participation in other investigational studies within 4 weeks before first dose
- Immunodeficiency or recent immunosuppressive therapy
- Active or recent malignancies requiring treatment (exceptions apply)
- Severe hypersensitivity to pembrolizumab, lenvatinib, or excipients
- Active autoimmune disease requiring recent systemic treatment
- History or current pneumonitis/interstitial lung disease requiring steroids
- Active infection needing systemic therapy
- Known HIV, active Hepatitis B or C infection
- Conditions or therapies interfering with study participation or results
- Psychiatric or substance abuse disorders interfering with study compliance
- Pregnancy, breastfeeding, or plans to conceive/father children during study and 120 days after last treatment
- Prior allogenic tissue or solid organ transplant
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Abramson Cancer Center at University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
M
Matt Doyle
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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