What side effects are associated with this type of intervention?

Treatments for pancreatic cancer, particularly those involving enzyme inhibition like lenvatinib and immune system activation like pembrolizumab, have specific side effects. Lenvatinib commonly causes hypertension, diarrhea, fatigue, proteinuria, and palmar-plantar erythrodysesthesia syndrome. Pembrolizumab often leads to immune-related adverse events such as colitis, hepatitis, pneumonitis, endocrinopathies, and skin reactions. Combining these therapies may increase the incidence of these side effects, necessitating careful monitoring and management.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer that involve enzyme inhibition and immune system activation. For enzyme inhibition, erlotinib, an EGFR inhibitor, is approved in combination with gemcitabine. For immune system activation, pembrolizumab, a PD-1 inhibitor, is approved for tumors with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). These treatments share mechanisms similar to lenvatinib (enzyme inhibition) and pembrolizumab (immune system activation) being studied in the trial.

What other types of research exist?

Promising novel alternatives for pancreatic cancer treatment in 2024 include nonagonistic CD28 antibodies, which are in preclinical development and aim to activate inhibitory pathways by allowing CTLA4 and PD-L1 binding of CD80/CD86. Additionally, combining immune checkpoint inhibitors (ICIs) with PARP inhibitors is being explored, particularly for patients with specific genetic alterations. These approaches aim to enhance the efficacy and safety of treatment regimens.

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Checkpoint Inhibitor

Lenvatinib + Pembrolizumab for Pancreatic Cancer

Phase 2

Recruiting

Led By Vincent Chung

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status =< 1

Age: >= 18 years

Must not have

Uncontrolled blood pressure (systolic blood pressure [BP] > 140 mmHg or diastolic BP > 90 mmHg) in spite of an optimized regimen of antihypertensive medication

Current or planned se of agents contraindicated for use with strong CYP3A4 inducers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 4 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial studies the effects of lenvatinib and pembrolizumab in patients with advanced pancreatic cancer that cannot be surgically removed. Lenvatinib blocks proteins needed for cancer growth, and pembrolizumab boosts the immune system to attack the cancer. The goal is to see if this combination can help control the disease.

Who is the study for?

Adults with advanced, inoperable pancreatic cancer who've had at least 16 weeks of prior therapy without disease progression. They must have proper liver and kidney function, controlled blood pressure, no recent immunosuppressive treatments or active infections, and not be pregnant or breastfeeding. Participants should agree to use contraception and provide samples for research.

What is being tested?

The trial is testing the combination of lenvatinib (an enzyme inhibitor) and pembrolizumab (an immunotherapy drug) as maintenance therapy for patients with advanced pancreatic cancer to see if it can stop tumor growth by blocking cell growth enzymes and boosting the immune system's attack on cancer cells.

What are the potential side effects?

Potential side effects include high blood pressure, fatigue, loss of appetite, thyroid issues from lenvatinib; pembrolizumab may cause immune-related reactions affecting organs like lungs or intestines, skin rash, infusion reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active and can carry on all pre-disease activities without restriction.

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I am 18 years old or older.

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My diagnosis is advanced pancreatic cancer that cannot be surgically removed.

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I am a woman who can have children and my pregnancy test is negative.

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I have not received treatments targeting immune checkpoints.

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My cancer can be measured or evaluated by specific criteria.

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My hemoglobin level is above 9.0 g/dL without recent blood transfusions.

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My kidney function, measured by creatinine levels, is within the required range.

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I've had initial cancer treatment for over 16 weeks and my disease hasn't worsened.

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My liver enzyme (ALT) levels are within the required range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My blood pressure is not controlled even with medication.

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I am not using, nor plan to use, drugs that strongly affect liver enzyme CYP3A4.

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I have had or currently have lung inflammation treated with steroids.

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I have an active tuberculosis infection.

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I am not taking any medications known to affect heart rhythm.

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I am currently being treated for an infection.

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I have a bleeding or clotting disorder, or I'm at high risk for severe bleeding.

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I have received an organ or tissue transplant from another person.

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I have not received a live vaccine in the last 30 days.

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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.

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I am not taking strong drugs that affect liver enzymes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression free survival

Secondary study objectives

Incidence of adverse events

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (pembrolizumab, lenvatinib mesylate)Experimental Treatment2 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1 and lenvatinib mesylate PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenvatinib

FDA approved

Pembrolizumab

FDA approved

0 / 21Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Lenvatinib and Pembrolizumab are promising treatments for pancreatic cancer due to their complementary mechanisms of action. Lenvatinib inhibits multiple receptor tyrosine kinases, blocking pathways essential for tumor growth and angiogenesis. Pembrolizumab, an immune checkpoint inhibitor, enhances the immune system's ability to detect and attack cancer cells by targeting the PD-1/PD-L1 pathway. This dual approach is significant for pancreatic cancer patients as it not only directly inhibits tumor proliferation but also boosts the body's immune response, potentially leading to more effective and comprehensive cancer control.