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Cancer Vaccine

Cancer Vaccine + Immunotherapy for Mesothelioma

Phase 1

Waitlist Available

Led By Marjorie Zauderer, 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial will test the safety of giving Galinpepimut-S and Nivolumab to patients with mesothelioma.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum tolerated dose

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

2014

Completed Phase 3

~4750

Sargramostim

2008

Completed Phase 4

~710

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,612 Total Patients Enrolled

19 Trials studying Mesothelioma

787 Patients Enrolled for Mesothelioma

Marjorie Zauderer, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

3 Previous Clinical Trials

340 Total Patients Enrolled

3 Trials studying Mesothelioma

340 Patients Enrolled for Mesothelioma

Media Library

Galinpepimut-S (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04040231 — Phase 1

Mesothelioma Research Study Groups: Malignant Pleural Mesothelioma (MPM)

Mesothelioma Clinical Trial 2023: Galinpepimut-S Highlights & Side Effects. Trial Name: NCT04040231 — Phase 1

Galinpepimut-S (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04040231 — Phase 1

Frequently Asked Questions

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

Is this investigation actively recruiting participants?

"At present, this trial is not actively enrolling participants. It was initially posted on July 24th 2019 and last modified on November 23rd 2022. If you're interested in similar studies, 189 trials focusing on mesothelioma are currently recruiting patients while 755 clinical trials are seeking individuals to test the efficacy of Galinpepimut-S."

Answered by AI

Has Galinpepimut-S been tested in other clinical trials previously?

"In 2001, Galinpepimut-S was first researched at the Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium. As of now 404 clinical trials have been completed and there are presently 755 active ones with multiple locations in Middletown, New york being used as study sites."

Answered by AI

What is the patient population for this clinical experiment?

"Presently, this clinical trial is not open for recruitment. It was first posted on July 24th 2019 and last updated November 23rd 2022. If desired, there are 189 trials recruiting patients with mesothelioma and 755 studies that need participants to test the safety of Galinpepimut-S."

Answered by AI

Has the FDA sanctioned Galinpepimut-S for clinical use?

"The safety of Galinpepimut-S was measured to be a 1 since this is an early phase trial, with only preliminary data validating its efficacy and security."

Answered by AI

How many health care centers are currently administering this experiment?

"As of now, 8 clinical trial sites are participating in this research. The areas located closest to Middletown, Uniondale and Commack have been selected along with an additional 8 locations. To ensure the least amount of burden on participants, it is recommended that they select a site close by for convenience."

Answered by AI

To what does Galinpepimut-S typically provide therapeutic benefit?

"Galinpepimut-S is frequently prescribed to treat malignant neoplasms, yet it also has curative effect on allogenic bone marrow transplantation therapy, inoperable melanoma, and squamous cell carcinoma."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Using a Targeted Cancer Vaccine (Galinpepimut-S) With Immunotherapy (Nivolumab) in Mesothelioma

2019. "Using a Targeted Cancer Vaccine (Galinpepimut-S) With Immunotherapy (Nivolumab) in Mesothelioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04040231.

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