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Platinum-based Chemotherapy

Chemotherapy + Immunotherapy for Mesothelioma

Phase 2

Recruiting

Led By Aaron S Mansfield

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Age >= 18 years

No prior systemic therapy for peritoneal mesothelioma is allowed. No concurrent radiotherapy is allowed

Must not have

For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from study entry to the first of either disease progression or death from any cause, where disease progression will be determined based on response evaluation criteria in solid tumors (recist) 1.1 criteria, assessed up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing immunotherapy (atezolizumab) in addition to the usual treatment of surgery or chemotherapy in patients with peritoneal mesothelioma.

Who is the study for?

Adults with untreated malignant peritoneal mesothelioma, without a history of central nervous system disease, significant bleeding disorders, or severe heart conditions. They must have functioning major organs and no autoimmune diseases (with some exceptions like controlled thyroid issues). Women must not be pregnant or nursing and agree to use birth control.

What is being tested?

The trial is testing the effectiveness of adding immunotherapy (atezolizumab) to the usual treatment for peritoneal mesothelioma which includes surgery and chemotherapy drugs like carboplatin and pemetrexed. The goal is to see if atezolizumab helps the immune system fight cancer better than standard treatments alone.

What are the potential side effects?

Potential side effects include allergic reactions to medication, increased risk of infection due to immune system suppression, bleeding complications, high blood pressure from bevacizumab, liver function changes, fatigue, nausea from chemotherapy drugs, and possible organ inflammation from atezolizumab.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have not had any treatment for peritoneal mesothelioma.

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I haven't had major blood vessel problems like aneurysms or clots in the last 6 months.

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I have untreated malignant peritoneal mesothelioma, not the well-differentiated or multicystic type.

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I have not had a transplant of stem cells or any organs from another person.

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I haven't had major heart issues or strokes in the past year.

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I am not on IV antibiotics for an infection.

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I do not have any serious wounds, ulcers, or untreated bone fractures.

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I haven't had any major stomach or intestine issues in the last 6 months.

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I don't have a history of bleeding disorders.

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I haven't coughed up a noticeable amount of blood recently.

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My brain metastases were treated and I'm on a low dose of steroids.

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I am fully active or can carry out light work.

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I have never had lung scarring or inflammation not caused by infections.

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I have never had a hypertensive crisis or brain issues due to high blood pressure.

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My kidney function is sufficient, with a creatinine clearance rate of at least 45 mL/min.

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I have never had a severe blood clot.

Exclusion Criteria

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

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My hepatitis B is under control with treatment.

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I had hepatitis C but am cured, or I'm being treated with no detectable virus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from study entry to the first of either disease progression or death from any cause, where disease progression will be determined based on response evaluation criteria in solid tumors (recist) 1.1 criteria, assessed up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from study entry to the first of either disease progression or death from any cause, where disease progression will be determined based on response evaluation criteria in solid tumors (recist) 1.1 criteria, assessed up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from study entry to the first of either disease progression or death from any cause, where disease progression will be determined based on response evaluation criteria in solid tumors (recist) 1.1 criteria, assessed up to 3 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Response rate

Secondary study objectives

Completeness of cytoreduction

Conversion rate to surgical resection among those not deemed to be surgical candidates

Incidence of adverse events

+3 more

Other study objectives

Megakaryocytes

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (carboplatin, pemetrexed, bevacizumab, atezolizumab)Experimental Treatment9 Interventions

Patients receive atezolizumab IV over 60 minutes, bevacizumab IV over 30-90 minutes, carboplatin IV over 30 minutes, and pemetrexed IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 4-8 weeks, patients undergo cytoreductive surgery and HIPEC. Patients not eligible for surgery may receive atezolizumab and bevacizumab in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and PET scan on study. Patients also undergo blood and tissue sample collection on study.

Group II: Arm II (carboplatin, pemetrexed, bevacizumab)Active Control8 Interventions

Patients receive bevacizumab IV over 30-90 minutes, carboplatin IV over 30 minutes, and pemetrexed IV over 10 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Within 4-8 weeks, patients undergo cytoreductive surgery and HIPEC. Patients not eligible for surgery may receive bevacizumab with or without atezolizumab at the discretion of the investigator in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan and PET scan on study. Patients also undergo blood and tissue sample collection on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2790

Bevacizumab

2013

Completed Phase 4

~5540