RecruitingPhase 2NCT04887805

Lenvatinib and Pembrolizumab Maintenance Therapy for the Treatment of Patients of Advanced Unresectable Pancreatic Cancer

Phase II Trial of Lenvatinib-Pembrolizumab Maintenance Therapy in Patients With Advanced Unresectable Pancreatic Cancer


Sponsor

City of Hope Medical Center

Enrollment

28 participants

Start Date

Jul 21, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies the effects of lenvatinib and pembrolizumab maintenance therapy in treating patients with pancreatic cancer that has spread to other places in the body (advanced) and cannot be removed by surgery (unresectable). Lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Giving lenvatinib and pembrolizumab may be effective as a maintenance therapy in patients with pancreatic cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether combining two cancer drugs — lenvatinib (a targeted therapy) and pembrolizumab (an immunotherapy) — can work as a maintenance treatment for patients with advanced pancreatic cancer whose disease has not progressed during first or second-line chemotherapy. **You may be eligible if...** - You are 18 or older with a good performance status (able to carry out normal activities) - You have advanced pancreatic cancer that cannot be surgically removed - You have received at least 16 weeks of chemotherapy and your disease is stable or responding - Your last chemotherapy was within the past 30 days - You have not previously received immunotherapy drugs (like anti-PD-1 or anti-PD-L1 agents) - You have adequate blood counts and organ function - You are not pregnant or breastfeeding and agree to use contraception **You may NOT be eligible if...** - You have uncontrolled high blood pressure - You have active autoimmune disease requiring systemic treatment in the past 2 years - You have active brain metastases or a history of certain serious heart conditions - You have a known HIV, active hepatitis B or C infection - You cannot swallow oral medications - You have active serious infections or recent live vaccine 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 Mesylate

Given PO

BIOLOGICALPembrolizumab

Given IV


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT04887805


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