What side effects are associated with this type of intervention?

Common treatments for mesothelioma, such as pembrolizumab (an immune checkpoint inhibitor) and image-guided resection (a precision surgical technique), have distinct side effect profiles. Pembrolizumab can cause immune-related adverse events including pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Image-guided resection may involve surgical risks such as infection, bleeding, and anesthesia-related complications. Patients should discuss these potential side effects with their healthcare provider to make informed treatment decisions.

What prior FDA approvals exist?

The FDA has approved several treatments for Mesothelioma, including immune checkpoint inhibitors like Pembrolizumab. Pembrolizumab has shown antitumor activity and an acceptable safety profile in various cancers, including Mesothelioma. Additionally, other immune checkpoint inhibitors such as Nivolumab, alone or in combination with Ipilimumab, have been studied for Mesothelioma, showing promising results in clinical trials. While specific FDA approvals for image-guided resection in Mesothelioma are not detailed, precision surgical techniques are commonly used in conjunction with systemic therapies to improve outcomes.

What other types of research exist?

Promising alternatives to Pembrolizumab and Image-Guided Resection for Mesothelioma patients include: 1) Nivolumab, either alone or in combination with Ipilimumab, which has shown efficacy in several trials. 2) Avelumab, another PD-L1 inhibitor, which has demonstrated durable responses in some patients. 3) Tremelimumab, targeting CTLA-4, although its efficacy is less clear, it remains a potential option. These alternatives offer different mechanisms of action and may provide additional options for patients.

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Alkylating agents

Pembrolizumab + Chemotherapy for Mesothelioma

Phase 1

Recruiting

Led By Corey Langer, MD

Research Sponsored by Abramson Cancer Center of the University of Pennsylvania

Eligibility Criteria Checklist

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

Must have

Have a performance status of 0 or 1 on the ECOG Performance Scale

Be 18 years of age on day of signing informed consent

Must not have

Evidence of interstitial lung disease

Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up each subject will be assessed for os from the time of their first study treatment until the date when they have documented disease progression or death (whichever comes first), or until the study is completed (estimated 2 years for study completion)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for patients with lung lining cancer. It combines an immune-boosting drug and precise surgery with standard treatments to see if it works better.

Who is the study for?

This trial is for adults with malignant pleural mesothelioma who are in good physical condition, have proper organ function, and can provide a recent tumor tissue sample. They must not have other active cancers or serious health conditions that could interfere with the study, no recent immunosuppressive treatments, and agree to use contraception.

What is being tested?

The trial tests pembrolizumab (an immune therapy) combined with chemotherapy (cisplatin and pemetrexed) and image-guided surgery using Indocyanine Green (ICG). It aims to assess safety, feasibility, and initial effectiveness of this combination treatment approach.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as inflammation in various organs, infusion-related reactions from pembrolizumab or ICG dye used during surgery. Chemotherapy may cause nausea, fatigue, blood cell count changes increasing infection risk.

Eligibility Criteria

Inclusion Criteria

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

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I can carry out all my usual activities without help.

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I am at least 18 years old.

Exclusion Criteria

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

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I have been diagnosed with interstitial lung disease.

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I have had pneumonitis treated with steroids or have it now.

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I have been diagnosed with HIV.

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I have an active tuberculosis infection.

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I have not taken high-dose steroids or immunosuppressants in the last week.

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I have an autoimmune disease treated with medication in the last 2 years.

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I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks.

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My cancer has spread and cannot be removed with surgery.

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I am currently being treated for an infection.

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I have not received a live vaccine in the last 30 days.

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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ each subject will be assessed for os from the time of their first study treatment until the date when they have documented disease progression or death (whichever comes first), or until the study is completed (estimated 2 years for study completion)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~each subject will be assessed for os from the time of their first study treatment until the date when they have documented disease progression or death (whichever comes first), or until the study is completed (estimated 2 years for study completion)

This trial's timeline: 3 weeks for screening, Varies for treatment, and each subject will be assessed for os from the time of their first study treatment until the date when they have documented disease progression or death (whichever comes first), or until the study is completed (estimated 2 years for study completion) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Study related adverse events (AEs)

Secondary study objectives

Overall survival (OS)

Progression-free survival (PFS)

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

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: Pembrolizumab with image-guided surgery and chemotherapyExperimental Treatment4 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

Cisplatin

2013

Completed Phase 3

~3120

Pemetrexed

2014

Completed Phase 3

~5550

0 / 13Eligibility 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 immune checkpoint inhibitors like Pembrolizumab and precision surgical techniques such as image-guided resection. Immune checkpoint inhibitors enhance the body's immune response by blocking proteins that inhibit immune cells from attacking cancer cells, thereby allowing the immune system to target and destroy the tumor more effectively. Image-guided resection uses advanced imaging technologies to accurately locate and remove cancerous tissues, reducing damage to surrounding healthy tissues and improving surgical outcomes. These targeted approaches are crucial for Mesothelioma patients as they offer the potential for better treatment efficacy and reduced side effects.

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