ADP-A2M4CD8 As Monotherapy or in Combination with Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects with MAGE-A4 Positive Tumors (SURPASS)

Phase 1

Active, not recruiting

• Conditions: Melanoma; Gastric (Stomach) Cancer; Esophageal Cancer; Esophagogastric Junction (EGJ); Head and Neck Cancer; Urothelial Cancer; Endometrial Cancer; Ovarian Cancer; Non-small Cell Lung (NSCLC)
• Interventions: Genetic: Autologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks or pembrolizumab every 6 weeks

• Registration Number: NCT04044859
• Lead Sponsor: Adaptimmune

Brief Summary

This study will investigate the safety and tolerability of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and MAGE-A4 tumor antigen. Tumor indications include endometrial, esophageal, esophagogastric junction (EGJ), gastric, head and neck, melanoma, non-small cell lung (NSCLC), ovarian or urothelial cancer.

Detailed Description

Conditions:

Endometrial Esophageal Cancer Esophagogastric Junction (EGJ) Gastric (stomach) Head and Neck Melanoma Non-small Cell Lung (NSCLC) Ovarian Cancer

Study Timeline

• Study First Submitted: 2019-07-03
• Study First Submitted QC: 2019-08-01
• Study First Posted: 2019-08-05
• Study Start: 2019-08-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-13
• Primary Completion: 2025-12-23
• Study Completion: 2037-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous genetically modified ADP-A2M4CD8 cells	Autologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks or pembrolizumab every 6 weeks	-

Primary Outcome Measures

Name	Time	Method
To evaluate safety and tolerability of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab	2.5 years	Determination of incidence of dose-limiting toxicities, adverse events and tolerable dose
To evaluate safety of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab	Up to 15 years	Incidence of patients with Replication-competent Retrovirus, persistence of ADP-A2M4CD8 T-cells and incidence of insertional oncogenesis.

Secondary Outcome Measures

Name	Time	Method
Time to response (TTR)	2.5 years	For patients who are observed to respond to ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab, the time taken to achieve a partial response or complete response (TTR) is assessed.
Anti-tumour activity: Overall Response Rate (ORR)	2.5 years	ORR is defined as incidence of complete responses or partial responses as assessed by RECIST v1.1
Anti-tumor activity: Best overall response (BOR)	2.5 years	BOR is per RECIST V1.1.
Duration of Response (DOR)	2.5 years	For patients who are observed to respond to ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab, the DOR is the date of first response (including confirmation) up until disease progression per RECIST v 1.1 or death
Duration of stable disease (DoSD)	2.5 years	For patients who are observed to have stable disease by RECIST v 1.1, the duration of period of stable disease until disease progression or death
Overall Survival (OS)	15 years	OS is assessed from date of infusion of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab up until the date of patient death.
Progression Free Survival (PFS)	2.5 years	PFS is assessed from date of infusion of ADP-A2M4CD8 as monotherapy or in combination with either nivolumab or pembrolizumab up until the date of disease progression per RECIST v1.1 or death.

Trial Locations

Locations (17)

Name of Institution: Orlando Health Cancer Institute; 🇺🇸 Orlando, Florida, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Washington University - School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Duke University Medical Center, Duke Cancer Institute; 🇺🇸 Durham, North Carolina, United States

OU Health Stephenson Cancer Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

M.D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Froedtert Hospital and the Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

Hospital Universitario 12 De Octubre; 🇪🇸 Madrid, Avenida de Cordoba s/n, Spain

Clinica Universitaria de Navarra; 🇪🇸 Pio, Pamplona, Spain

Hospital Clinico de Valencia; 🇪🇸 Ibanez, Valencia, Spain

Hospital Universitario Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain

Hospital Universitario HM Sanchinarro CIOCC; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen del Rocio; 🇪🇸 Sevilla, Spain