Study on Lenvatinib and Pembrolizumab Maintenance Therapy for Advanced Pancreatic Cancer
Sponsor: City of Hope Medical Center
ClinicalTrials ID:NCT04887805
This clinical trial is exploring the effects of using lenvatinib and pembrolizumab as ongoing treatment for patients with advanced pancreatic cancer that cannot be removed by surgery. The study aims to see if this combination can help control the cancer and improve patient outcomes.
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Program Overview
This phase II study is testing whether the combination of lenvatinib and pembrolizumab can be an effective maintenance therapy for patients with advanced pancreatic cancer that has spread and cannot be surgically removed. Lenvatinib may help stop tumor growth by blocking certain enzymes, while pembrolizumab, an immunotherapy, may help the immune system attack cancer cells. The study will assess if this combination can help maintain control over the cancer.
Description
The main goal of this study is to see if lenvatinib and pembrolizumab can help keep pancreatic cancer from getting worse in patients who have already responded to initial treatments. Researchers will also look at how safe and tolerable this combination is for patients. They will evaluate how well the cancer responds to the treatment and if it helps patients live longer.
The study will also explore if the treatment causes any changes in the immune system and in the genes related to the tumor.
Participants will receive pembrolizumab through an IV on the first day and take lenvatinib pills daily for 21 days. This cycle repeats every 21 days as long as the cancer does not progress and side effects are manageable. After finishing the treatment, patients will have follow-up visits for up to a year.
Eligibility Criteria
Inclusion Criteria
- Must provide informed consent and be willing to give tissue and blood samples.
- Age 18 or older.
- Must have a good performance status, meaning they are fully active or have some restrictions but can still do light work.
- Must have advanced pancreatic cancer that cannot be removed by surgery.
- Must have received at least 16 weeks of prior treatment and shown stable disease or partial response.
- Last chemotherapy must have been within 30 days before starting the study treatment.
- No previous treatment with certain immune therapies.
- Must have measurable disease according to specific criteria.
- Must have recovered from previous treatment side effects to a certain level.
- Men must agree to use contraception during and after the study.
- Women must not be pregnant or breastfeeding and must use effective contraception if of childbearing potential.
- Must meet specific blood and organ function criteria.
Exclusion Criteria
- Cannot have an immune deficiency or be on high-dose steroids or other immune-suppressing treatments.
- Cannot be taking certain supplements or medications that interfere with the study drugs.
- Cannot have uncontrolled high blood pressure.
- Cannot have allergies to the study drugs.
- Cannot have had another cancer within the last two years, except for certain skin or cervical cancers.
- Cannot have had recent radiation therapy or have active brain metastases.
- Cannot have certain medical conditions that increase risk or interfere with the study.
- Cannot have received a live vaccine recently.
- Cannot have active autoimmune diseases requiring treatment.
- Cannot have a history of lung inflammation requiring steroids.
- Cannot have active infections or certain viral infections.
- Cannot have a history of tuberculosis.
- Cannot have conditions that might affect study results or participation.
- Cannot have psychiatric or substance abuse issues that interfere with the study.
- Cannot be pregnant or planning to become pregnant during the study.
- Cannot have had a recent organ transplant.
- Cannot have certain heart conditions or bleeding disorders.
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