Galinpepimut-S (WT-1 Analog Peptide) Vaccine in Malignant Pleural Mesothelioma After Combined Modality Therapy

NCT01265433 | Completed Phase 2 Results DMC

• 1 other identifier: 10-134
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Study of galinpepimut-S, a Wilms Tumor-1 (WT1) vaccine, to see if it delays or prevents the mesothelioma from growing back after surgery. WT1 is a protein in cancer cells that regulates gene expression and causes cell growth.

Conditions

Malignant Pleural Mesothelioma

Keywords

GM-CSF; MONTANIDE ISA 51; WT1 PEPTIDE SPECIFIC T CELLS; Vaccine; 10-134; Galinpepimut-S

Outcome Measures

Primary Outcomes (2)

• 1-year Progression-free Survival

  Progression free survival (PFS) rate will be calculated from the time of randomization to first evidence of disease recurrence or death of any cause.

  1 year

• Progression-free Survival

  Median progression free survival (PFS) is where PFS are assessed from the time of randomization to first evidence of disease recurrence or death of any cause.

  Up to 5 years and 11 months

Secondary Outcomes (2)

• Overall Survival

  Uo to 5 years and 11 months

• Immune Response

  12 weeks

Study Arms (2)

Galinpepimut-S + Montanide + GM-CSF

EXPERIMENTAL

Galinpepimut-S emulsified with Montanide adjuvant (1:1 ratio) 1 mL and GM-CSF 70 mcg

Biological: Galinpepimut-S + Montanide + GM-CSF

Montanide + GM-CSF

PLACEBO COMPARATOR

Montanide adjuvant 1 mL and GM-CSF 70 mcg

Biological: Montanide + GM-CSF

Interventions

Galinpepimut-S + Montanide + GM-CSF BIOLOGICAL

Patients will receive 6 injections over 12 weeks. Treatment will be administered on weeks 0, 2, 4, 6, 8, and 10. All patients will receive Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 and -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) on day -2 if they have been appropriately instructed on SQ injection administration. Patients will be informed of the expected reactions such as irritation at the injection site. Patients will keep a logbook noting the time and placement of the injection. Patients will also receive 1.0 ml of emulsion with Montanide alone or with WT-1 peptides plus Montanide. It will be administered by a nurse (it may not be self administered) subcutaneously to the same anatomical site as the GM-CSF. This site will be marked by the patient or treating healthcare professional by a permanent marker pen.

Galinpepimut-S + Montanide + GM-CSF

Montanide + GM-CSF BIOLOGICAL

Patients will receive 6 injections over 12 weeks. Treatment will be administered on weeks 0, 2, 4, 6, 8, and 10. All patients will receive Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 and -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) on day -2 if they have been appropriately instructed on SQ injection administration. Patients will be informed of the expected reactions such as irritation at the injection site. Patients will keep a logbook noting the time and placement of the injection. Patients will also receive 1.0 ml of emulsion with Montanide alone or with WT-1 peptides plus Montanide. It will be administered by a nurse (it may not be self-administered)subcutaneously to the same anatomical site as the GM-CSF. This site will be marked by the patient or treating healthcare professional by a permanent marker pen.

Montanide + GM-CSF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologic diagnosis of malignant pleural mesothelioma (MPM) confirmed at participating institution.
• Positive immunohistochemical staining for WT-1 (greater than 10% of cells).
• Completion of multimodality therapy. This must include surgical resection by either pleurectomy/decortication or extrapleural pneumonectomy. The surgery should be performed with the intent of complete resection, though patients with an R1 resection will still be eligible. Patients should have also received treatment with chemotherapy and/or radiation. Patients with an R2 resection are also eligible as long as the site of residual disease is treated post-operatively with radiotherapy.
• weeks since completion of combined modality therapy.
• Age \> or = to 18 years
• Karnofsky performance status \> or = to 70%
• Hematologic parameters: Absolute neutrophil count \> or = to 1000/mcL, Platelets \> or = to 50K/mcL.
• Biochemical parameters: Total bilirubin \< or = to 2.0 mg/dl, AST and ALT \< or = to 2.5 x upper limits of normal, Creatinine \< or = to 2.0 mg/dl.

You may not qualify if:

• Pregnant or lactating women.
• Patients with active infection requiring systemic antibiotics, antiviral, or antifungal treatments.
• Patients with a serious unstable medical illness or another active cancer.
• Patients taking systemic corticosteroids.
• Patients with an immunodeficiency syndrome.

Sponsors & Collaborators

• Sellas Life Sciences Group: lead
• United States Department of Defense: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

• Zauderer MG, Tsao AS, Dao T, Panageas K, Lai WV, Rimner A, Rusch VW, Adusumilli PS, Ginsberg MS, Gomez D, Rice D, Mehran R, Scheinberg DA, Krug LM. A Randomized Phase II Trial of Adjuvant Galinpepimut-S, WT-1 Analogue Peptide Vaccine, After Multimodality Therapy for Patients with Malignant Pleural Mesothelioma. Clin Cancer Res. 2017 Dec 15;23(24):7483-7489. doi: 10.1158/1078-0432.CCR-17-2169. Epub 2017 Sep 28.

  PMID: 28972039 RESULT

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Monatide (IMS 3015); Granulocyte-Macrophage Colony-Stimulating Factor

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Dr. Dragan Cicic
• Organization: Sellas Life Sciences

info@sellaslife.com

646-200-5278

Study Officials

• Marjorie Zauderer, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2010
• First Posted: December 23, 2010
• Study Start: December 21, 2010
• Primary Completion: November 30, 2016
• Study Completion: July 25, 2017
• Last Updated: October 9, 2024
• Results First Posted: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)