NCT04040231 is a Phase 1 clinical trial of Galinpepimut-S in Mesothelioma, sponsored by Memorial Sloan Kettering Cancer Center.

Who is sponsoring NCT04040231?

NCT04040231 is sponsored by Memorial Sloan Kettering Cancer Center.

What drugs are being tested in NCT04040231?

Interventions in NCT04040231: Galinpepimut-S, Nivolumab, Sargramostim.

What condition does NCT04040231 study?

NCT04040231 studies Mesothelioma, Pleural Mesothelioma, Wilms Tumor.

Is NCT04040231 still recruiting?

NCT04040231 is currently completed. Last updated 13 May 2025.

Last reviewed 2025-05-13 · How we verify

NCT04040231

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 13 May 2025

What this trial tests

Phase 1 trial testing Galinpepimut-S in Mesothelioma in 10 participants. Completed in 14 November 2024.

Timeline

24 July 2019

Primary endpoint
14 November 2024

14 November 2024

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	24 July 2019
Primary completion	14 November 2024
Estimated completion	14 November 2024
Sites	6 locations across United States

Drugs / interventions tested

Galinpepimut-S — full drug profile →
Nivolumab (nivolumab) — full drug profile →
Sargramostim (SARGRAMOSTIM) — full drug profile →

Conditions studied

Mesothelioma — all drugs for Mesothelioma →
Pleural Mesothelioma — all drugs for Pleural Mesothelioma →
Wilms Tumor — all drugs for Wilms Tumor →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

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

Sponsor's own description

The purpose of this study is to test whether it is safe to give Galinpepimut-S and Nivolumab together in patients with mesothelioma.

Publications & conference data

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

GM-CSF: A Double-Edged Sword in Cancer Immunotherapy.
Kumar A, Taghi Khani A, Sanchez Ortiz A, Swaminathan S. · · 2022 · cited 188× · PMID 35865534 · DOI 10.3389/fimmu.2022.901277
Emerging Treatments for Malignant Pleural Mesothelioma: Where Are We Heading?
Cantini L, Hassan R, Sterman DH, Sterman DH, et al · · 2020 · cited 47× · PMID 32226777 · DOI 10.3389/fonc.2020.00343
Peptide emulsions in incomplete Freund's adjuvant create effective nurseries promoting egress of systemic CD4<sup>+</sup> and CD8<sup>+</sup> T cells for immunotherapy of cancer.
Melssen MM, Fisher CT, Slingluff CL, Melief CJM. · · 2022 · cited 30× · PMID 36939214 · DOI 10.1136/jitc-2022-004709
Biological basis for novel mesothelioma therapies.
Obacz J, Yung H, Shamseddin M, Linnane E, et al · · 2021 · cited 18× · PMID 34226685 · DOI 10.1038/s41416-021-01462-2
Immunotherapeutic Approaches in Malignant Pleural Mesothelioma.
Terenziani R, Zoppi S, Fumarola C, Alfieri R, et al · · 2021 · cited 14× · PMID 34199722 · DOI 10.3390/cancers13112793
Tumor-Derived Antigenic Peptides as Potential Cancer Vaccines.
Sotirov S, Dimitrov I. · · 2024 · cited 11× · PMID 38732150 · DOI 10.3390/ijms25094934
Current State-of-the-Art Therapy for Malignant Pleural Mesothelioma and Future Options Centered on Immunotherapy.
Cedres S, Valdivia A, Iranzo P, Callejo A, et al · · 2023 · cited 10× · PMID 38136333 · DOI 10.3390/cancers15245787
Success of Checkpoint Blockade Paves the Way for Novel Immune Therapy in Malignant Pleural Mesothelioma.
Rondon L, Fu R, Patel MR. · · 2023 · cited 7× · PMID 37296902 · DOI 10.3390/cancers15112940

Verify or expand the search:

Other trials of Galinpepimut-S

Trials testing the same drug.

NCT01266083 — WT1 Vaccine Treatment of Patients in Remission From Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) · Phase 2 · completed
NCT05593185 — Expanded Access Program (EAP) for Galinpepimut-S (GPS) in Patients Diagnosed With AML or MDS · available

Other recruiting trials for Mesothelioma

Currently open trials in the same condition.

NCT07277413 — A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors · Phase 1 · recruiting
NCT07126509 — Partial Pleurectomy (Surgery) for Unresectable Pleural Mesothelioma · NA · recruiting
NCT06503146 — 18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection · Phase 2 · recruiting
NCT06996249 — Prospective Data Collection Initiative on Thoracic Malignancies · recruiting
NCT06885697 — Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Includi · Phase 1 · recruiting

Other Memorial Sloan Kettering Cancer Center trials

Trials by the same sponsor.

NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
NCT07507643 — A Study of Methylprednisolone in People Having Liver Surgery · Phase 3 · recruiting
NCT07483307 — A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer · Phase 2 · recruiting
NCT07459673 — HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term · Phase 2 · recruiting
NCT07449195 — A Study Comparing Two Optical Coherence Tomography Devices in People With Ocular Tumors · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04040231 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center
Last refreshed: 13 May 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04040231.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing