Actively Recruiting
Pembrolizumab and Lenvatinib for the Treatment of Advanced, Unresectable, or Metastatic Gastroesophageal Adenocarcinoma
Led by M.D. Anderson Cancer Center · Updated on 2026-01-12
15
Participants Needed
1
Research Sites
254 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This early phase I trial studies the effect of pembrolizumab and lenvatinib in treating patients with gastroesophageal adenocarcinoma that has spread to other places in the body (advanced/metastatic) or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and lenvatinib may kill more tumor cells.
CONDITIONS
Official Title
Pembrolizumab and Lenvatinib for the Treatment of Advanced, Unresectable, or Metastatic Gastroesophageal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically or cytologically confirmed gastric or gastroesophageal adenocarcinoma
- Previously treated advanced (unresectable and/or metastatic) gastroesophageal adenocarcinoma with failed prior standard treatments
- Submission of a newly obtained tumor tissue sample for biomarker analysis within 6 weeks before treatment
- Measurable disease per RECIST 1.1 criteria
- ECOG performance status of 0 or 1 within 5 days before treatment
- Life expectancy greater than 3 months
- Adequately controlled blood pressure (<=150/90 mm Hg) with or without medication
- Absolute neutrophil count >= 1,500/uL within 5 days before treatment
- Platelet count >= 100,000/uL within 5 days before treatment
- Hemoglobin >= 9 g/dL without transfusion dependency within 5 days before treatment
- Serum creatinine <= 1.5 x ULN or creatinine clearance >= 60 mL/min within 5 days before treatment
- Total bilirubin < 1.5 x ULN or direct bilirubin <= ULN within 5 days before treatment
- AST and ALT <= 2.5 x ULN or <= 5 x ULN for patients with liver metastases within 5 days before treatment
- Albumin >= 2.5 mg/dL within 5 days before treatment
- INR or PT/aPTT <= 1.5 x ULN unless on anticoagulants with therapeutic levels within 5 days before treatment
- Male participants must agree to abstain or use contraception during treatment and for 30 days after lenvatinib
- Female participants must not be pregnant or breastfeeding and must use effective contraception or be abstinent during treatment and post-treatment periods
- Negative pregnancy test within 24 hours before starting treatment for women of childbearing potential
You will not qualify if you...
- Participation in another investigational trial or use of investigational agents within 4 weeks before treatment
- Diagnosis of immunodeficiency or systemic immunosuppressive therapy within 7 days before treatment
- Major surgery within 3 weeks before treatment without adequate wound healing
- Preexisting grade 3 or higher gastrointestinal or non-gastrointestinal fistula
- Urine protein >= 1 g/24 hours
- Significant gastrointestinal malabsorption or conditions affecting lenvatinib absorption
- Radiographic evidence of major blood vessel encasement or intratumoral cavitation
- Clinically significant hemoptysis or tumor bleeding within 2 weeks before treatment
- Significant cardiovascular issues within 12 months before treatment
- Prolonged QTc interval over 480 ms
- Reduced left ventricular ejection fraction below normal range
- Known severe hypersensitivity to pembrolizumab, lenvatinib, or their ingredients
- Prior treatment with lenvatinib, anti-PD-1/PD-L1/L2 agents, VEGFR2 agents, or certain T-cell receptor agents
- Recent systemic anti-cancer therapy or investigational agents within 4 weeks or 5 half-lives of previous treatment
- Radiotherapy within 2 weeks prior to treatment without recovery
- Active malignancy requiring treatment, except certain skin or in situ cancers
- Active central nervous system metastases or carcinomatous meningitis
- Active autoimmune disease requiring systemic treatment in past 2 years
- Symptomatic ascites or pleural effusion without clinical stability
- History or current pneumonitis requiring steroids
- Active infection requiring systemic therapy
- Conditions or therapies interfering with trial participation or safety
- Psychiatric or substance abuse disorders interfering with trial requirements
- Pregnancy, breastfeeding, or planning pregnancy/fathering children during trial and 120 days after last treatment
- Known HIV infection
- History of allogenic tissue/solid organ or hematologic transplant
- Known active hepatitis B or C infection
- Receipt of live or live-attenuated vaccine within 30 days before treatment; killed vaccines allowed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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