Neoplasms

Digestive System Diseases

All Conditions

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Esophageal Neoplasms

Melanoma

Head and Neck Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endometrial Neoplasms

Stomach Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Uterine Neoplasms

Uterine Diseases

Stomach Diseases

Esophageal Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Stomach Cancer

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Nivolumab

Pembrolizumab

Calcium Carbonate

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1 alone or in combination with either nivolumab 480 mg IV every four weeks or pembrolizumab 400mg IV every 6 weeks

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

David Hong, MD

Sajeve S Thomas, MD

Donald P Lawrence

Donald Lawrence, MD

Rebecca Munsch

Brian Van Tine, MD

David Aggen, MD

Alex Guess

Jeffrey M Clarke, MD

Silas Day

Adam Asch

Nurse Navigators

Melissa L Johnson, MD

Jessica Neumann

John A Charlson, MD

Genevieve Mendiola

Marcus Butler, MD

Concha Hernandez

Jon Zugazagoitia Fraile, MD

Mariano Ponz-Sarvisé, MD PhD

Mariano Ponz-Sarvisé, MD

Inma Blasco

Andres Cervantes Ruiperez, MD

Elena G Cabanas, MD

Victor Moreno, MD

Esther Ordoñez

Emiliano Calvo Aller, MD

Esperanza Muñoz

Reyes Bernabe Caro, MD

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.

Conditions:

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

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

A Phase 1 Dose Escalation Study To Assess Safety And Efficacy Of ADP-A2M4CD8 As Monotherapy Or In Combination With Either Nivolumab Or Pembrolizumab In HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)

Determination of incidence of dose-limiting toxicities, adverse events and tolerable dose

Incidence of patients with Replication-competent Retrovirus, persistence of ADP-A2M4CD8 T-cells and incidence of insertional oncogenesis.

ORR is defined as incidence of complete responses or partial responses as assessed by RECIST v1.1

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.

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

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

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.

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.

ICON plc

Adaptimmune

Spots Global Cancer Trial Database for gastric (stomach)