NCT01265433

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

Completed Phase 2 Results posted Last updated 9 October 2024

What this trial tests

Phase 2 trial testing Galinpepimut-S + Montanide + GM-CSF in Malignant Pleural Mesothelioma in 41 participants. Completed in 25 July 2017.

Timeline

21 December 2010

Primary endpoint
30 November 2016

25 July 2017

Quick facts

Lead sponsor	Sellas Life Sciences Group
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	41
Start date	21 December 2010
Primary completion	30 November 2016
Estimated completion	25 July 2017
Sites	1 location across United States

Drugs / interventions tested

• Galinpepimut-S + Montanide + GM-CSF — full drug profile →
• Montanide + GM-CSF — full drug profile →

Conditions studied

• Malignant Pleural Mesothelioma — all drugs for Malignant Pleural Mesothelioma →

Sponsor

Sellas Life Sciences Group — full company profile →

Who can join

18 and older, any sex, with Malignant Pleural Mesothelioma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

1-year Progression-free Survival Primary · 1 year

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

Group	Value	95% CI
Galinpepimut-S	44
Control	33

Progression-free Survival Primary · Up to 5 years and 11 months

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.

Group	Value	95% CI
Galinpepimut-S	10.1	5.5 – 20.8
Control	7.4	2.8 – 14.6

Overall Survival Secondary · Uo to 5 years and 11 months

Median overall survival (OS) is estimated from time of randomization to all cause mortality

Group	Value	95% CI
Galinpepimut-S	22.8	9.1 – 37.6
Control	18.3	10.2 – 28

Immune Response Secondary · 12 weeks

Immunogenicity of galinpepimut-S and control from a subset of participants

CD4 Elispot

Group	Value	95% CI
Galinpepimut-S	4
Control	1
Galinpepimut-S	4
Control	8
Galinpepimut-S	2
Control	3

CD8 Elispot

Group	Value	95% CI
Galinpepimut-S	1
Control	1
Galinpepimut-S	1
Control	3
Galinpepimut-S	8
Control	8

Tetramer assay positive

Group	Value	95% CI
Galinpepimut-S	1
Control	2
Galinpepimut-S	0
Control	3
Galinpepimut-S	9
Control	7

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 5 years and 11 months, from either start of study or randomization, until primary completion (Nov 2016). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Galinpepimut-S

Serious: 1/20 (5%)

Deaths: 16/20

Control

Serious: 1/21 (5%)

Deaths: 20/21

Serious adverse events (1 terms)

Reaction	System	Galinpepimut-S	Control
Lymphopenia	Blood and lymphatic system disorders	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	Galinpepimut-S	Control
Injection site reaction	Surgical and medical procedures	—	—
Fatigue	General disorders	—	—
Fever	Immune system disorders	—	—
Arthralgias	Musculoskeletal and connective tissue disorders	—	—
Nausea	General disorders	—	—
Rash, maculopapular	Skin and subcutaneous tissue disorders	—	—
Lymphopenia	Blood and lymphatic system disorders	—	—

Most-reported serious reactions: Lymphopenia.

Data from ClinicalTrials.gov NCT01265433 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cancer immunotherapy beyond immune checkpoint inhibitors.
   Marin-Acevedo JA, Soyano AE, Dholaria B, Knutson KL, et al · · 2018 · cited 140× · PMID 29329556 · DOI 10.1186/s13045-017-0552-6
2. Immunotherapies for non-small-cell lung cancer and mesothelioma.
   Thomas A, Hassan R. · · 2012 · cited 87× · PMID 22748269 · DOI 10.1016/s1470-2045(12)70126-2
3. Scientific Advances and New Frontiers in Mesothelioma Therapeutics.
   Mutti L, Peikert T, Robinson BWS, Scherpereel A, et al · · 2018 · cited 85× · PMID 29966799 · DOI 10.1016/j.jtho.2018.06.011
4. Trial watch: Peptide vaccines in cancer therapy.
   Vacchelli E, Martins I, Eggermont A, Fridman WH, et al · · 2012 · cited 74× · PMID 23264902 · DOI 10.4161/onci.22428
5. New insights into understanding the mechanisms, pathogenesis, and management of malignant mesotheliomas.
   Mossman BT, Shukla A, Heintz NH, Verschraegen CF, et al · · 2013 · cited 63× · PMID 23395095 · DOI 10.1016/j.ajpath.2012.12.028
6. Latest developments in our understanding of the pathogenesis of mesothelioma and the design of targeted therapies.
   Bononi A, Napolitano A, Pass HI, Yang H, et al · · 2015 · cited 38× · PMID 26308799 · DOI 10.1586/17476348.2015.1081066
7. Hitting the Bull's-Eye: Mesothelin's Role as a Biomarker and Therapeutic Target for Malignant Pleural Mesothelioma.
   Yeo D, Castelletti L, van Zandwijk N, Rasko JEJ. · · 2021 · cited 26× · PMID 34439085 · DOI 10.3390/cancers13163932
8. New and emerging therapeutic options for malignant pleural mesothelioma: review of early clinical trials.
   Kotova S, Wong RM, Cameron RB. · · 2015 · cited 25× · PMID 25670913 · DOI 10.2147/cmar.s72814