What is the mechanism of action of this treatment?

Common treatments for pancreatic cancer, such as cabozantinib and atezolizumab, work by targeting specific mechanisms that contribute to tumor growth and immune evasion. Cabozantinib is a tyrosine kinase inhibitor that disrupts tumor growth and angiogenesis by targeting receptors like VEGFRs, c-MET, and RET. Atezolizumab is an immune checkpoint inhibitor that enhances the immune system's ability to attack cancer cells by blocking the PD-L1 protein. These targeted therapies are crucial for pancreatic cancer patients, as they offer new strategies to combat a disease that is often resistant to traditional treatments.

What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as the combination of Cabozantinib and Atezolizumab, have known side effects. Cabozantinib can cause fatigue, hypertension, diarrhea, hand-foot syndrome, and liver enzyme abnormalities. Atezolizumab may lead to immune-related side effects including colitis, hepatitis, pneumonitis, endocrinopathies, and skin reactions. When combined, these treatments may result in overlapping toxicities, requiring careful monitoring and management.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically combining a tyrosine kinase inhibitor like cabozantinib and an immune checkpoint inhibitor like atezolizumab for pancreatic cancer. However, treatments such as gemcitabine and nab-paclitaxel, as well as FOLFIRINOX (a combination of fluorouracil, leucovorin, irinotecan, and oxaliplatin), are commonly used for advanced pancreatic cancer. These treatments focus on chemotherapy rather than targeted therapy or immunotherapy. The combination of cabozantinib and atezolizumab is currently being studied for its potential efficacy and safety in treating metastatic, refractory pancreatic cancer.

What other types of research exist?

Promising novel alternatives to Cabozantinib + Atezolizumab for pancreatic cancer patients include: 1) Niraparib plus Nivolumab or Niraparib plus Ipilimumab, which have shown efficacy in platinum-sensitive advanced pancreatic cancer. 2) Nanoparticle Albumin-Bound Paclitaxel in combination with Gemcitabine, which has demonstrated safety and efficacy in patients with an ECOG Performance Status of 2. 3) Pembrolizumab, particularly for patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) tumors, as it has shown significant efficacy in this subset of patients.

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PD-L1 Inhibitor

Atezolizumab + Cabozantinib for Pancreatic Cancer

Phase 2

Recruiting

Led By Rachna Shroff, MD

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

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

Must have

Stage IV pancreatic adenocarcinoma, confirmed by histology or cytology

ECOG performance status ≤ 1

Must not have

Uncontrolled tumor-related pain

Known history of infection with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or a known positive test for tuberculosis due to tuberculosis infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, at 9 weeks, at end of treatment (approx. 6 months), and after disease progression (assessed up to 100 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of two drugs to treat pancreatic cancer. The drugs will be given to patients with cancer that has spread and who have not responded to other treatments. The goal is to see if the combination is safe and works better than other treatments.

Who is the study for?

Adults over 18 with stage IV pancreatic adenocarcinoma that has spread and is resistant to certain chemotherapies. They must have measurable disease, be in good physical condition (ECOG ≤1), and recovered from previous treatments' side effects. Participants need functioning organs/marrow, can't be pregnant or breastfeeding, must use contraception, and not have had specific prior treatments like cabozantinib or immune therapies.

What is being tested?

The trial tests a combination of Cabozantinib + Atezolizumab for metastatic pancreatic cancer patients who haven't responded to standard treatments. It measures how well the treatment works (response rate), controls the disease, extends life without progression, overall survival time, safety/tolerability and examines immune changes before/after treatment.

What are the potential side effects?

Potential side effects include liver problems, high blood pressure, fatigue, mouth sores; hand-foot syndrome; diarrhea; decreased appetite; nausea; vomiting; weight loss; voice changes or hoarseness may occur. If any of these effects persist or worsen tell your doctor promptly.

Eligibility Criteria

Inclusion Criteria

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

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My pancreatic cancer is at stage IV.

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

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It has been over two weeks since my last cancer treatment.

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I am 18 years old or older.

Exclusion Criteria

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

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I have pain from my cancer that isn't relieved by treatment.

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I have a history of HIV/AIDS or tested positive for tuberculosis.

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I have a serious wound, ulcer, or bone fracture that isn't healing.

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I cannot swallow pills.

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I have had a previous transplant of stem cells or an organ.

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I have previously been treated with specific immune therapies.

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I haven't had cancer treatment in the last 2 weeks.

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I have high calcium levels in my blood that are causing symptoms.

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I have been treated with cabozantinib before.

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My heart's electrical activity (QTcF) is not over 500 ms.

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I have not had a live vaccine recently and do not plan to get one soon.

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I have symptoms of underactive thyroid that aren't treated.

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My liver is not working well.

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I have a history of specific lung conditions or signs of lung inflammation on a CT scan.

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I am currently taking blood thinners.

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I do not have any severe ongoing illnesses like heart or stomach issues.

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I frequently need procedures to remove excess fluid from my chest or abdomen.

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I do not have any other cancer that needs treatment right now.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, at 9 weeks, at end of treatment (approx. 6 months), and after disease progression (assessed up to 100 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, at 9 weeks, at end of treatment (approx. 6 months), and after disease progression (assessed up to 100 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, at 9 weeks, at end of treatment (approx. 6 months), and after disease progression (assessed up to 100 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

Overall Response Rate or Stable Disease

Secondary study objectives

Adverse Event

Disease Control Rate

Survival

+1 more

Other study objectives

Immune System Effects

T2 Signal

Tumor Response

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 40mg + Atezolizumab 1200mgExperimental Treatment1 Intervention

Cabozantinib 40 mg, tablets, oral administration, once daily, continuously. Atezolizumab 1200 mg, administered intravenously, on Day 1 of every 21 day cycle.

0 / 22Eligibility 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

Common treatments for pancreatic cancer, such as cabozantinib and atezolizumab, work by targeting specific mechanisms that contribute to tumor growth and immune evasion. Cabozantinib is a tyrosine kinase inhibitor that disrupts tumor growth and angiogenesis by targeting receptors like VEGFRs, c-MET, and RET. Atezolizumab is an immune checkpoint inhibitor that enhances the immune system's ability to attack cancer cells by blocking the PD-L1 protein. These targeted therapies are crucial for pancreatic cancer patients, as they offer new strategies to combat a disease that is often resistant to traditional treatments.

Drug Repurposing, an Attractive Strategy in Pancreatic Cancer Treatment: Preclinical and Clinical Updates.Current and Emerging Therapies in Metastatic Pancreatic Cancer.Pancreatic Cancer: Promises and Failures of Target Therapies.