Actively Recruiting
Pembrolizumab and Lenvatinib Combination Therapy for Previously Treated Advanced Gastroesophageal Adenocarcinoma
Led by M.D. Anderson Cancer Center · Updated on 2026-01-12
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of pembrolizumab combined with lenvatinib in adults with advanced or metastatic gastroesophageal adenocarcinoma that cannot be removed by surgery or has spread to other parts of the body. This early phase I trial aims to estimate how well this combination works to shrink tumors and control disease, while also assessing its safety and exploring biomarkers related to treatment response. Participants receive pembrolizumab through an intravenous infusion on the first day of each 42-day cycle and take lenvatinib orally once daily. Treatment continues for up to 17 cycles unless the disease progresses or side effects become unacceptable. After the treatment phase, patients are followed up 30 days later and then every 12 weeks to monitor outcomes. Throughout the study, patients undergo evaluations including tumor imaging based on RECIST 1.1 criteria to measure tumor response and progression. Blood and tissue samples are collected for biomarker analysis. Researchers also track overall survival and treatment safety. The total participation duration varies depending on the number of treatment cycles and follow-up visits over about one year or more.
CONDITIONS
Brief Title
Pembrolizumab and Lenvatinib for the Treatment of Advanced, Unresectable, or Metastatic Gastroesophageal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent for the trial
- Male or female aged 18 years or older
- Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal adenocarcinoma
- Previously treated advanced (unresectable and/or metastatic) gastroesophageal adenocarcinoma that is incurable and failed prior standard treatments
- Submit a newly obtained tumor tissue sample suitable for biomarker analysis
- Have measurable disease based on RECIST 1.1 criteria
- Performance status of 0 or 1 on the ECOG scale
- Life expectancy greater than 3 months
- Adequately controlled blood pressure (≤ 150/90 mm Hg)
- Adequate blood counts and organ function as specified
- Male participants agree to abstain or use contraception during treatment and for 30 days after lenvatinib
- Female participants are not pregnant or breastfeeding and meet contraception requirements
- Negative pregnancy test prior to treatment if female of childbearing potential
You will not qualify if you...
- Participation in another investigational study or use of investigational devices within 4 weeks prior to treatment
- Diagnosis of immunodeficiency or use of immunosuppressive therapy within 7 days prior to treatment
- Major surgery within 3 weeks prior to treatment
- Preexisting grade 3 or higher fistula
- Proteinuria ≥ 1 g/24 hours
- Significant gastrointestinal malabsorption or conditions affecting lenvatinib absorption
- Radiographic evidence of major blood vessel involvement or tumor cavitation
- Clinically significant bleeding within 2 weeks prior to treatment
- Significant cardiovascular impairment within 12 months prior to treatment
- Prolonged QTc interval > 480 ms
- Low left ventricular ejection fraction
- Known severe allergy to pembrolizumab, lenvatinib, or their components
- Prior treatment with lenvatinib, PD-1/PD-L1 agents, or related immunotherapies
- Recent systemic anti-cancer therapy or radiotherapy as specified
- Active malignancy requiring treatment
- Active central nervous system metastases or carcinomatous meningitis
- Active autoimmune disease requiring systemic treatment in past 2 years
- Symptomatic ascites or pleural effusion without stability
- History or current pneumonitis requiring steroids
- Active infection requiring systemic therapy
- Psychiatric or substance abuse disorders interfering with trial participation
- Pregnancy, breastfeeding, or planning conception during trial
- Known HIV, hepatitis B or C infection
- Prior organ or hematologic transplant
- Use of live vaccines within 30 days before treatment start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 17 cycles of 42 days each
Participants receive pembrolizumab intravenously over 30 minutes on day 1 and take lenvatinib orally once daily. This treatment cycle repeats every 42 days for up to 17 cycles unless disease progression or unacceptable toxicity occurs.
Visits every 42 days for treatment administration and monitoring
Duration - 30 days after treatment completion, then every 12 weeks
After completing treatment, participants are followed up to monitor their health and disease status.
1 visit at 30 days post-treatment and then visits every 12 weeks
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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