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Monoclonal Antibodies

Immunotherapy + Chemotherapy + Surgery +/- Radiation for Mesothelioma

Phase 1

Waitlist Available

Led By Anne S Tsao

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

Patient must NOT have a known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation

Patients must not have active autoimmune disease that has required systemic treatment in past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment; autoimmune diseases include, but are not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis; this protocol includes an immunotherapy agent which can precipitate known autoimmune diseases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration of treatment and follow-up until death or 3 years post step 1 registration.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing immunotherapy, chemotherapy, and surgery with or without radiation therapy to see how well it works in treating pleural malignant mesothelioma.

Who is the study for?

This trial is for adults with stage I-III pleural malignant mesothelioma that can be removed by surgery. They must not have had prior immunotherapy or chemotherapy, severe infections, active tuberculosis, certain autoimmune diseases, or a history of significant allergic reactions to specific antibodies. Candidates should not have received any cancer treatments within the last 28 days and must meet various health criteria including organ function tests.

What is being tested?

The study is testing the effectiveness of combining atezolizumab (an immune system booster), pemetrexed disodium (a cell growth blocker), and cisplatin (chemotherapy) followed by surgery and possibly radiation therapy in treating patients with mesothelioma. The goal is to shrink tumors before removal and eliminate remaining cancer cells after surgery.

What are the potential side effects?

Potential side effects include typical chemotherapy-related issues like fatigue, nausea, hair loss; immune-related reactions such as inflammation in organs; surgical complications; and risks from radiation therapy if used.

Eligibility Criteria

Inclusion Criteria

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

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I am not allergic to medications made in Chinese hamster ovary cells or any part of atezolizumab.

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I haven't taken medication for an autoimmune disease in the last 2 years.

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I have never had lung conditions like pulmonary fibrosis or pneumonitis.

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I do not have active hepatitis B or C.

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My mesothelioma is confirmed by biopsy and is not sarcomatoid type.

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I had surgery to check for cancer spread in my chest and abdomen within the last 28 days.

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I haven't had any severe infections or been hospitalized for infection complications in the last month.

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I have not had a bone marrow or organ transplant.

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My lung function test shows I can breathe out more than 35% of air in one second.

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My lung function test shows a DLCO value greater than 35%.

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I do not have active tuberculosis.

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I've had specific lung cancer surgery within the last 42 days and my cancer is at an early to mid-stage.

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I do not have serious heart problems.

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I have early-stage mesothelioma and am planning surgery to remove it.

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I have not received immunotherapy or chemotherapy for mesothelioma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ duration of treatment and follow-up until death or 3 years post step 1 registration.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~duration of treatment and follow-up until death or 3 years post step 1 registration.

This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of treatment and follow-up until death or 3 years post step 1 registration. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Feasibility of Neoadjuvant Cisplatin-Pemetrexed-Atezolizumab, Surgery +/- Radiation, and Maintenance Therapy.

Safety of Neoadjuvant Cisplatin-Pemetrexed-Atezolizumab, Surgery +/- Radiation, and Maintenance Therapy.

Secondary study objectives

Overall Survival (OS)

Progression Free Survival (PFS)

Response Rate (RR)

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: Treatment (chemotherapy, surgery, RT)Experimental Treatment6 Interventions

NEOADJUVANT: Patients receive atezolizumab IV over 30-60 minutes, pemetrexed disodium IV over 10 minutes, and cisplatin IV over 2 hours on day 1. Cycles repeats every 21 days for 4 cycles in the absence of disease progression or unexpected toxicity. SURGERY: Within 21-90 days after completion of neoadjuvant therapy, patients undergo EPP or PD. Patients who undergo EPP will then undergo RT. MAINTENANCE: Within 90 days after completion of either PD or radiation (post-EPP), patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unexpected toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~3120

Radiation Therapy

2017

Completed Phase 3

~7250