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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 have Zubrod performance status 0 or 1 documented within 28 days prior to step 1 registration
Patients must not have any anticancer therapy or investigational agent within 28 days prior to step 1 registration
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

Study 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.Check my eligibility
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.See study design
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 fully active or restricted in physically strenuous activity but can do light work.
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I haven't had any cancer treatment or experimental drugs in the last 28 days.
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I stopped radiation therapy early due to side effects or other reasons.
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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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I have not received a live flu vaccine within the last 4 weeks and won't during the study.
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My mesothelioma is confirmed by biopsy and is not sarcomatoid type.
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I've had a CT or PET/CT scan within the last 28 days.
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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've had a recent scan showing no cancer progression.
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I've seen a surgeon within the last 21 days who confirmed I can have surgery to remove my disease.
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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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I will be assessed by a radiation oncologist for therapy suitability within 14 days before my next registration step.
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I am fully active or restricted in physically strenuous activity but can do light work.
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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 have completed at least two rounds of a specific three-drug cancer treatment.
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I've had surgery for my condition and healed, with or without radiation, and it's been less than 90 days since treatment.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I do not have active tuberculosis.
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My cancer's size or presence is confirmed by CT or MRI within the required time.
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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 registered between 21 and 90 days after my last pre-surgery cancer treatment.
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I have early-stage mesothelioma and am planning surgery to remove it.
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I've had a recent scan showing no cancer progression.
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I haven't had major surgery or radiation in the last 28 days.
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I have not received immunotherapy or chemotherapy for mesothelioma.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of Neoadjuvant Cisplatin-Pemetrexed-Atezolizumab, Surgery +/- Radiation, and Maintenance Therapy.
Safety of Neoadjuvant Cisplatin-Pemetrexed-Atezolizumab, Surgery +/- Radiation, and Maintenance Therapy.
Secondary outcome measures
Overall Survival (OS)
Progression Free Survival (PFS)
Response Rate (RR)

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
~1940
Radiation Therapy
2017
Completed Phase 3
~7250
Atezolizumab
2016
Completed Phase 3
~6040
Pemetrexed Disodium
2015
Completed Phase 2
~280

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,603 Previous Clinical Trials
40,913,246 Total Patients Enrolled
Anne S TsaoPrincipal InvestigatorSWOG Cancer Research Network
5 Previous Clinical Trials
296 Total Patients Enrolled

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03228537 — Phase 1
Pleural Malignant Mesothelioma Research Study Groups: Treatment (chemotherapy, surgery, RT)
Pleural Malignant Mesothelioma Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT03228537 — Phase 1
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03228537 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the areas in North America where this research endeavor is taking place?

"At this time, 100 patients have enrolled in the study with locations including Saint Clare Hospital (Lakewood), OptumCare Cancer Care at MountainView (Las Vegas), and MD Anderson in Sugar Land. Additionally, there are an additional 100 sites recruiting participants."

Answered by AI

Has the FDA sanctioned Radiation Therapy for use in treatments?

"Due to the preliminary nature of Radiation Therapy, its safety was rated 1 in our Power assessment. This is due to limited clinical evidence backing both efficacy and security at this time."

Answered by AI

What medical conditions are typically treated with Radiation Therapy?

"Radiotherapy is commonly used in conjunction with pharmacological interventions to treat advanced testicular cancer, small cell lung cancer (SCLC), and other malignancies."

Answered by AI

Is there still an opportunity to participate in this experiment?

"The evidence on clinicaltrials.gov shows that this particular study is not currently searching for participants, despite being originally published in November of 2017 and edited last October. However, there are an abundance of other medical trials recruiting patients at the moment with a total number amounting to 2758."

Answered by AI

What other investigations have been conducted to assess the efficacy of Radiation Therapy?

"Currently, there are 1143 studies investigating Radiation Therapy of which 363 have entered Phase 3. The bulk of these trials can be found in Shanghai, but 64168 medical centres around the world are conducting research into this treatment."

Answered by AI

What is the current enrolment rate for this clinical experiment?

"This study is no longer accepting participants; it was first posted on November 3rd, 2017 and last updated on October 25th 2022. For those seeking alternative trials, 1615 studies are currently recruiting patients with Stage II Pleural Malignant Mesothelioma AJCC V7 and 1143 for Radiation Therapy."

Answered by AI
~4 spots leftby Mar 2025