What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as tyrosine kinase inhibitors (e.g., cabozantinib) and PD-1 inhibitors (e.g., pembrolizumab), are associated with a range of side effects. Tyrosine kinase inhibitors often cause fatigue, diarrhea, hypertension, hand-foot syndrome, and liver toxicity. PD-1 inhibitors can lead to immune-related adverse effects including pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Patients undergoing these treatments should be closely monitored for these potential side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, including tyrosine kinase inhibitors and PD-1 inhibitors. For instance, pembrolizumab, a PD-1 inhibitor, has been approved for use in various cancers, including those with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR), which can include pancreatic cancer. However, specific tyrosine kinase inhibitors like cabozantinib have not been prominently featured in FDA approvals for pancreatic cancer, though they are being studied for their potential efficacy. Other approved treatments include chemotherapy regimens such as FOLFIRINOX and gemcitabine plus nab-paclitaxel.

What other types of research exist?

Promising novel alternatives for pancreatic cancer treatment in 2024 include: 1) PARP inhibitors like Olaparib, especially for patients with BRCA mutations, as they have shown efficacy in clinical trials. 2) Combination therapies involving immune checkpoint inhibitors such as Nivolumab or Atezolizumab with other agents like chemotherapy or targeted therapies. 3) Newer tyrosine kinase inhibitors or multi-kinase inhibitors that are currently under investigation in clinical trials. These alternatives offer potential benefits and should be discussed with a healthcare provider to tailor the best treatment plan.

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Tyrosine Kinase Inhibitor

Cabozantinib + Pembrolizumab for Metastatic Pancreatic Cancer

Phase 2

Waitlist Available

Led By Josepoh Kim, MD

Research Sponsored by Joseph Kim

Eligibility Criteria Checklist

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

Must have

Evidence of progression or intolerance to previous standard of care pancreatic cancer systemic or locoregional therapies

Diagnosis of pancreatic ductal adenocarcinoma

Must not have

Clinically significant cardiovascular disease

Inability to swallow tablets

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing cabozantinib and pembrolizumab for patients with advanced pancreatic cancer that has spread. Cabozantinib blocks cancer growth, and pembrolizumab helps the immune system fight the cancer.

Who is the study for?

This trial is for adults with metastatic pancreatic adenocarcinoma who've seen their cancer progress or didn't tolerate previous treatments. They must have good organ function and not have had recent radiation, other cancer therapies within the last 4 weeks, uncontrolled high blood pressure, trouble swallowing pills, serious heart disease, or be immunocompromised.

What is being tested?

The study tests cabozantinib and pembrolizumab in patients with advanced pancreatic cancer. It aims to see how well these drugs work together against this type of cancer after standard treatments haven't worked.

What are the potential side effects?

Possible side effects include fatigue, nausea, increased blood pressure from cabozantinib; immune-related reactions like skin rash or thyroid issues from pembrolizumab; as well as liver problems and diarrhea from both medications.

Eligibility Criteria

Inclusion Criteria

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

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My pancreatic cancer has worsened or I couldn't tolerate previous treatments.

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I have been diagnosed with pancreatic cancer.

Exclusion Criteria

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

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I have a serious heart condition.

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I cannot swallow pills.

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I have an autoimmune disease or am on long-term steroids.

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My high blood pressure is not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year 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

Change in overall response to therapy

Complete response

Overall participant survival rate

+1 more

Awards & Highlights

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: Cabozantinib and pembrolizumabExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Cabozantinib

2020

Completed Phase 2

~2360

0 / 6Eligibility 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

Cabozantinib, a tyrosine kinase inhibitor, targets multiple pathways involved in tumor growth and angiogenesis, such as MET, VEGFR, and AXL, thereby reducing tumor proliferation and disrupting its blood supply. Pembrolizumab, an immune checkpoint inhibitor, blocks the PD-1 receptor on T-cells, enhancing the immune system's ability to recognize and attack cancer cells. This combination is particularly promising for pancreatic cancer patients, as it addresses both tumor growth and immune evasion, potentially offering a more effective treatment for a cancer type that is often resistant to conventional therapies.