RecruitingEarly Phase 1NCT05041153

Pembrolizumab and Lenvatinib for the Treatment of Advanced, Unresectable, or Metastatic Gastroesophageal Adenocarcinoma

A Pilot Study of Pembrolizumab and Lenvatinib Combination Therapy in Patients With Previously Treated Advanced Gastroesophageal Adenocarcinoma


Sponsor

M.D. Anderson Cancer Center

Enrollment

15 participants

Start Date

Feb 14, 2022

Study Type

INTERVENTIONAL

Conditions

Clinical Stage III Gastric Cancer AJCC v8Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IV Gastric Cancer AJCC v8Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IVA Gastric Cancer AJCC v8Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IVB Gastric Cancer AJCC v8Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8Metastatic Gastric AdenocarcinomaMetastatic Gastroesophageal Junction AdenocarcinomaUnresectable Gastric AdenocarcinomaUnresectable Gastroesophageal Junction AdenocarcinomaPostneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8Advanced Gastroesophageal Junction AdenocarcinomaPostneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IV Gastric Cancer AJCC v8Pathologic Stage III Gastric Cancer AJCC v8Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IIIA Gastric Cancer AJCC v8Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IIIB Gastric Cancer AJCC v8Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8Pathologic Stage IIIC Gastric Cancer AJCC v8Postneoadjuvant Therapy Stage III Gastric Cancer AJCC v8Advanced Gastric Adenocarcinoma

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of pembrolizumab (an immunotherapy drug) and lenvatinib (a targeted therapy) in patients with advanced stomach or gastroesophageal junction cancer that has grown despite at least one prior treatment. **You may be eligible if...** - You are 18 or older with confirmed advanced gastric or gastroesophageal adenocarcinoma - Your cancer has progressed after at least one prior standard treatment - You are in generally good health (ECOG 0–1) - Your organ function and blood counts are adequate - You have measurable disease on imaging **You may NOT be eligible if...** - Your cancer is resectable (can be surgically removed) - You have poorly controlled high blood pressure or recent cardiovascular events (heart attack, stroke) - You have active autoimmune disease - You have received prior pembrolizumab or lenvatinib treatment - You are pregnant or breastfeeding - You have significant heart or liver problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLenvatinib

Given by PO

BIOLOGICALPembrolizumab

Given by IV


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT05041153


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