What side effects are associated with this type of intervention?

Nivolumab, a PD-1 inhibitor used in the treatment of mesothelioma, is associated with side effects such as fatigue, rash, diarrhea, and more severe immune-related adverse events like pneumonitis, colitis, hepatitis, and endocrinopathies. Cancer vaccines like Galinpepimut-S can cause injection site reactions, flu-like symptoms, and other immune-related effects. When combined, these treatments may increase the risk of immune-related adverse events, necessitating close monitoring and management.

What prior FDA approvals exist?

The FDA has approved several immunotherapy treatments for Mesothelioma. Notably, Nivolumab, a PD-1 inhibitor, has been studied extensively and is used in combination with other agents like Ipilimumab (a CTLA-4 inhibitor) for treating malignant pleural mesothelioma. This combination has shown efficacy in improving progression-free survival and overall survival in patients. While Galinpepimut-S, a cancer vaccine, is still under investigation, the use of PD-1 inhibitors like Nivolumab represents a significant advancement in the immunotherapeutic approach to Mesothelioma treatment.

What other types of research exist?

Promising alternatives for Mesothelioma treatment include Pembrolizumab, which has shown clinical benefit in PD-L1-positive MPM patients, and the combination of Pemetrexed and Gemcitabine, which has demonstrated a disease control rate of 50% in peritoneal mesothelioma. Additionally, Bevacizumab added to standard chemotherapy has shown efficacy in pleural mesothelioma. These options should be discussed with a healthcare provider to determine the best course of action.

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Cancer Vaccine

Cancer Vaccine + Immunotherapy for Mesothelioma

Phase 1

Waitlist Available

Led By Michael Offin, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Pathologic diagnosis of malignant pleural mesothelioma at MSK

Has received and progressed or are refractory to pemetrexed based chemotherapy

Must not have

Prior receipt of checkpoint inhibition

Patients with known active hepatitis B or known active hepatitis C virus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety of using a cancer vaccine called Galinpepimut-S together with an immune-boosting drug called Nivolumab in patients with mesothelioma. Mesothelioma is a challenging cancer to treat, so new therapies are needed. The vaccine helps the immune system recognize cancer cells, while the drug enhances the immune response to attack these cells.

Who is the study for?

This trial is for adults over 18 with mesothelioma who've had pemetrexed chemotherapy but the cancer kept growing or didn't respond. They must have normal levels of bilirubin, liver enzymes, and creatinine, a performance status indicating they can care for themselves, and their tumors must test positive for WT-1 protein. Women of childbearing age need a negative pregnancy test and all participants should use birth control.

What is being tested?

The study is testing the safety of combining Galinpepimut-S (a cancer vaccine) with Nivolumab (an immunotherapy drug) in patients with mesothelioma. It aims to see if these treatments together can help manage this type of cancer more effectively than current options.

What are the potential side effects?

Possible side effects include immune-related reactions like inflammation in various organs, skin rash, hormone gland problems (like thyroid), fatigue, nausea, as well as potential injection site reactions from the vaccine.

Eligibility Criteria

Inclusion Criteria

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

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I was diagnosed with mesothelioma at MSK.

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My cancer did not respond or got worse after treatment with pemetrexed.

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My cancer can be measured or seen on tests.

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I am 18 years old or older.

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I am able to care for myself but may not be able to do active work.

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I have had pemetrexed-based chemotherapy before.

Exclusion Criteria

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

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I have previously received immunotherapy.

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I have active hepatitis B or C.

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I am taking more than 10 mg of prednisone or its equivalent daily.

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I have been treated with steroids for an autoimmune disease in the last 2 years.

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I currently have inflammation in my lungs.

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I do not have any severe illnesses or other active cancers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum tolerated dose

Side effects data

From 2017 Phase 1 & 2 trial • 20 Patients • NCT01827137

100%

Anemia

100%

Hyperglycemia

100%

Hypoalbuminemia

100%

Lymphocyte count decreased

100%

Neutrophil count decreased

100%

Platelet count decreased

100%

White blood cell decreased

95%

Hypocalcemia

70%

Alanine aminotransferase increased

60%

Aspartate aminotransferase increased

60%

Hypokalemia

50%

Hypomagnesemia

45%

Fatigue

45%

Hypophosphatemia

40%

Alkaline phosphatase increased

40%

Blood bilirubin increased

40%

Hyponatremia

35%

Hypernatremia

30%

Diarrhea

30%

Nausea

25%

Cholesterol high

25%

Creatinine increased

25%

Hypertriglyceridemia

25%

Hypoglycemia

20%

Anorexia

20%

INR increased

20%

Pruritus

20%

Rash maculo-papular

15%

Anxiety

15%

Back pain

15%

Hypermagnesemia

15%

Nervous system disorders - Other,

10%

Dehydration

10%

Dry skin

10%

Generalized muscle weakness

10%

Hyperkalemia

10%

Injection site reaction

10%

Myalgia

10%

Nasal congestion

10%

Peripheral sensory neuropathy

100%

80%

60%

40%

20%

Study treatment Arm

Galinpepimut-S + Montanide + GM-CSF

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: Malignant Pleural Mesothelioma (MPM)Experimental Treatment3 Interventions

Participants with previously treated Malignant Pleural Mesothelioma/MPM

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

Sargramostim

2006

Completed Phase 4

~880

Galinpepimut-S

2013

Completed Phase 2

~20

0 / 12Eligibility 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

Galinpepimut-S is a cancer vaccine that targets the WT1 protein, which is overexpressed in many cancers, including Mesothelioma. By stimulating the immune system to recognize and attack cells expressing WT1, it aims to reduce tumor growth. Nivolumab is a PD-1 inhibitor that blocks the programmed death-1 (PD-1) pathway, which tumors exploit to evade immune detection. By inhibiting this pathway, Nivolumab enhances the body's immune response against cancer cells. For Mesothelioma patients, these treatments are significant because they offer a targeted approach to boost the immune system's ability to fight the cancer, potentially improving outcomes and providing new therapeutic options.

Novel and Future Treatment Options in Mesothelioma: A Systematic Review.Tremelimumab for the treatment of malignant mesothelioma.