NCT05601752

ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in HLA-A2+ Subjects With MAGE-A4 Positive Ovarian Cancer (SURPASS-3)

A Phase 2, Open-Label, Randomized, Non-Comparative Clinical Trial of ADP-A2M4CD8 Monotherapy and in Combination With Nivolumab in Subjects With Recurrent Ovarian Cancers

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: USWM CT, LLC · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2, open-label, randomized, non-comparative clinical trial to evaluate the clinical outcome of ADP A2M4CD8 as monotherapy and in combination treatment with nivolumab in human leukocyte antigen (HLA) A2+ subjects with recurrent ovarian cancer positive for MAGE-A4.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
GENETIC	Autologous genetically modified ADP-A2M4CD8 cells	Infusion of autologous genetically modified ADP-A2M4CD8 cells on Day 1
COMBINATION_PRODUCT	Autologous genetically modified ADP-A2M4CD8 cells in combination with Nivolumab	Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1 followed by nivolumab 480 mg IV at Week 4 and then every four weeks

Timeline

• Start date: 2023-06-26
• Primary completion: 2026-08-12
• Completion: 2026-08-12
• First posted: 2022-11-01
• Last updated: 2026-02-25

Locations

23 sites across 5 countries: United States, Canada, France, Spain, United Kingdom

Regulatory

• FDA-regulated drug study