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

February 15, 2024 updated by: Adaptimmune

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Conditions:

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

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Bruxelles, Belgium
        • Withdrawn
        • Cliniques Universitaires Saint-Luc
      • Edegem, Belgium
        • Withdrawn
        • University Hospital Antwerp
      • Gent, Belgium
        • Withdrawn
        • Universitair Ziekenhuis Gent
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:
        • Principal Investigator:
          • Marcus Butler, MD
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d'Hebron
        • Contact:
        • Principal Investigator:
          • Elena G Cabanas, MD
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundación Jiménez Díaz
        • Principal Investigator:
          • Victor Moreno, MD
        • Contact:
      • Madrid, Spain, 28050
        • Recruiting
        • Hospital Universitario HM Sanchinarro CIOCC
        • Contact:
        • Principal Investigator:
          • Emiliano Calvo Aller, MD
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocío
        • Contact:
        • Principal Investigator:
          • Reyes Bernabe Caro, MD
    • Avenida De Cordoba S/n
      • Madrid, Avenida De Cordoba S/n, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
        • Principal Investigator:
          • Jon Zugazagoitia Fraile, MD
    • Pamplona
      • Pio, Pamplona, Spain, 31008
        • Recruiting
        • Clinica Universitaria De Navarra
        • Contact:
          • Mariano Ponz-Sarvisé, MD PhD
          • Phone Number: +34 948 25 54 00
          • Email: mponz@unav.es
        • Principal Investigator:
          • Mariano Ponz-Sarvisé, MD
    • Valencia
      • Ibanez, Valencia, Spain, 46010
        • Recruiting
        • Hospital Clínico de Valencia
        • Contact:
        • Principal Investigator:
          • Andres Cervantes Ruiperez, MD
  • United States
    • Florida
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Name of Institution: Orlando Health Cancer Institute
        • Contact:
        • Principal Investigator:
          • Sajeve S Thomas, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Donald Lawrence, MD
        • Contact:
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University - School of Medicine
        • Principal Investigator:
          • Brian Van Tine, MD
        • Contact:
    • New York
      • Buffalo, New York, United States, 14040
        • Withdrawn
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
        • Principal Investigator:
          • David Aggen, MD
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center, Duke Cancer Institute
        • Principal Investigator:
          • Jeffrey M Clarke, MD
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • OU Health Stephenson Cancer Center
        • Contact:
        • Principal Investigator:
          • Adam Asch
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Withdrawn
        • Thomas Jefferson University Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute
        • Contact:
          • Nurse Navigators
          • Phone Number: 615-329-7274
        • Principal Investigator:
          • Melissa L Johnson, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M.D. Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • David Hong, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert Hospital and the Medical College of Wisconsin
        • Principal Investigator:
          • John A Charlson, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

  • Key Inclusion criteria
  • Age ≥18 and ≤ 75 years
  • Subject is positive for at least 1 HLA-A*02 inclusion allele
  • Histologically or cytogenetically confirmed diagnosis of urothelial cancer, esophageal, esophagogastric junction (EGJ) cancer, gastric cancer, non-small cell lung carcinoma (NSCLC), head and neck or ovarian cancer, endometrial cancer, melanoma
  • Measurable disease according to RECIST v1.1 prior to leukapheresis and lymphodepletion.
  • Tumor shows MAGE-A4 expression as confirmed by central laboratory
  • ECOG Performance Status of 0 or 1.
  • Left ventricular ejection fraction (LVEF) ≥50% or the institutional lower limit of normal range, whichever is lower Note: other protocol defined Inclusion/Exclusion criteria may apply
  • Subjects must have ≥ 90% room air oxygen saturation at rest at Screening (within 7 days of leukapheresis) and at Baseline.

Key exclusion criteria

  • Positive for any HLA-A*02 allele other than: one of the inclusion alleles
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to fludarabine, cyclophosphamide or other agents used in the study
  • Active autoimmune or immune mediated disease
  • Leptomeningeal disease, carcinomatous meningitis or symptomatic CNS metastases
  • Other prior malignancy that is not considered by the Investigator to be in complete remission. Clinically significant cardiovascular disease
  • Uncontrolled intercurrent illness
  • Active infection with human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or human T cell leukemia virus
  • Pregnant or breastfeeding

Note: other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autologous genetically modified ADP-A2M4CD8 cells
Genetic: Autologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks or pembrolizumab every 6 weeks
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-tumour activity: Overall Response Rate (ORR)
Time Frame: 2.5 years
ORR is defined as incidence of complete responses or partial responses as assessed by RECIST v1.1
2.5 years
Anti-tumor activity: Best overall response (BOR)
Time Frame: 2.5 years
BOR is per RECIST V1.1.
2.5 years
Duration of stable disease (DoSD)
Time Frame: 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
2.5 years
Time to response (TTR)
Time Frame: 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.
2.5 years
Duration of Response (DOR)
Time Frame: 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
2.5 years
Progression Free Survival (PFS)
Time Frame: 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.
2.5 years
Overall Survival (OS)
Time Frame: 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.
15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adaptimmune

Collaborators

ICON plc

Investigators

  • Principal Investigator: David Hong, MD, M.D. Anderson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2019

Primary Completion (Estimated)

December 23, 2025

Study Completion (Estimated)

April 30, 2037

Study Registration Dates

First Submitted

July 3, 2019

First Submitted That Met QC Criteria

August 1, 2019

First Posted (Actual)

August 5, 2019

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADP-0055-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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