What side effects are associated with this type of intervention?

The most common treatments for Mesothelioma, particularly immune checkpoint inhibitors such as Nivolumab and Ipilimumab, are associated with a range of side effects. These include immune-related toxicities such as pneumonitis, rash, pruritus, diarrhea, and hepatitis. Severe adverse events can occur, including grade 3 or 4 toxicities like pneumonia and hypertension. Patients may also experience general symptoms like fatigue and endocrine disorders requiring additional treatments such as steroids or other immunosuppressive agents.

What prior FDA approvals exist?

The FDA has approved several treatments for mesothelioma, including immune checkpoint inhibitors. Nivolumab and ipilimumab, both monoclonal antibodies, have shown efficacy in treating malignant pleural mesothelioma. These drugs work by enhancing the body's immune response against cancer cells. Clinical trials, such as the IFCT-1501 MAPS2 and INITIATE, have demonstrated the potential benefits of these drugs, leading to their use in various treatment regimens for mesothelioma. Additionally, pembrolizumab, another immune checkpoint inhibitor, has been evaluated for its safety and activity in mesothelioma patients.

What other types of research exist?

Promising novel alternatives to Nivolumab and Ipilimumab for Mesothelioma patients include: 1) Tremelimumab combined with Durvalumab, which has shown activity and a good safety profile in mesothelioma. 2) Avelumab, a PD-L1 inhibitor, which demonstrated durable responses in a phase Ib trial. 3) Emerging therapies such as Chimeric Antigen Receptor (CAR)-T cell therapy and TIGIT blockade, which are under investigation and hold potential for future treatment options.

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Checkpoint Inhibitor

Pre-Surgery Immunotherapy for Mesothelioma

Phase 2

Recruiting

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

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

Must have

Age >= 18 years

STEP 2 ELIGIBILITY CRITERIA: Completion of at least 1 cycle of treatment and not have an unresolved adverse event that would preclude surgery

Must not have

No patients with chest wall invasion, peritoneal spread, contralateral pleural involvement, mediastinal organ involvement, vertebral involvement, or metastases to contralateral intrathoracic lymph nodes, or any supraclavicular nodes

No patients deemed to be unresectable or poor surgical candidates

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if giving immunotherapy drugs can better control disease in patients with a specific type of mesothelioma. The drugs help the immune system attack cancer cells, which may stop the cancer from growing and spreading.

Who is the study for?

This trial is for adults with stage I-IIIa sarcomatoid mesothelioma who haven't had prior treatments affecting the primary tumor. Candidates must have a stable HIV, no active infections or autoimmune diseases (with some exceptions), and an ECOG performance status of <=2 or Karnofsky >=60%. Pregnant or nursing women are excluded, as well as those with certain heart conditions or other health issues that could interfere with surgery.

What is being tested?

The trial tests if giving immunotherapy drugs nivolumab and ipilimumab before surgery can better control sarcomatoid mesothelioma compared to immunotherapy alone. These drugs may boost the immune system's ability to fight cancer by targeting specific proteins on tumor cells.

What are the potential side effects?

Potential side effects from nivolumab and ipilimumab include fatigue, diarrhea, skin rash, itching, hormone gland problems (like thyroid dysfunction), liver inflammation, lung issues like pneumonitis, colitis in the digestive tract, and possible infusion-related reactions.

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've completed at least 1 treatment cycle and am fit for surgery.

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I do not have any active infections needing treatment and I tested negative for hepatitis B and C.

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I don't have conditions that need TNFalpha or immunosuppressant treatments.

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My cancer is mostly sarcomatoid mesothelioma.

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I am mostly self-sufficient and can carry out daily activities.

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I am not pregnant or breastfeeding.

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My cancer is at an early to mid-stage according to UICC standards.

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I can take care of myself but might not be able to do active work.

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My cancer has not progressed to a stage that makes surgery impossible.

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My kidney function, measured by creatinine levels or clearance, is within the normal range.

Exclusion Criteria

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

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My cancer has not spread to my chest wall, abdomen, opposite lung side, mid-chest organs, spine, or above my collarbone.

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I am considered a good candidate for surgery.

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I have never had symptomatic interstitial lung disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Progression free survival (PFS)

Surgery Rate

Secondary study objectives

Incidence of adverse events

Major pathologic response

Objective response rate

+1 more

Other study objectives

Biomarkers

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 (nivolumab, ipilimumab, surgery)Experimental Treatment6 Interventions

Patients receive nivolumab IV, ipilimumab IV, and may undergo surgery on study. Patients also undergo CT or MRI and PET throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

2015

Completed Phase 3

~3420

Surgical Procedure

2020

Completed Phase 2

~160

Magnetic Resonance Imaging

2017

Completed Phase 3

~1160

Positron Emission Tomography

2011

Completed Phase 2

~2200

Computed Tomography

2017

Completed Phase 2

~2740

Nivolumab

2015

Completed Phase 3

~4010

0 / 14Eligibility 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

The most common treatments for Mesothelioma include chemotherapy, radiation therapy, and immune checkpoint inhibitors. Immune checkpoint inhibitors, such as Nivolumab and Ipilimumab, work by blocking proteins that prevent the immune system from attacking cancer cells. Nivolumab targets the PD-1 protein, while Ipilimumab targets the CTLA-4 protein. By inhibiting these checkpoints, these drugs enhance the body's immune response against cancer cells. This is particularly important for Mesothelioma patients as it offers a novel approach to control the disease, especially in cases where traditional treatments are ineffective. These therapies can potentially improve survival rates and quality of life for patients with this aggressive cancer.

Novel and Future Treatment Options in Mesothelioma: A Systematic Review.