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

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ClinicalTrials.gov Identifier: NCT04044859
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : August 24, 2022
Sponsor:
Collaborator:
ICON plc
Information provided by (Responsible Party):
Adaptimmune

Study Description
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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.

Condition or disease Intervention/treatment Phase
Endometrial Cancer Esophageal Cancer Esophagogastric Junction (EGJ) Gastric (Stomach) Cancer Head and Neck Cancer Melanoma Ovarian Cancer Non-small Cell Lung (NSCLC) Urothelial Cancer Genetic: Autologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks Phase 1

Detailed Description:

Conditions:

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation Study To Assess Safety And Efficacy Of ADP-A2M4CD8 As Monotherapy Or In Combination With Nivolumab In HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)
Actual Study Start Date : August 20, 2019
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : April 30, 2037

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arms and Interventions
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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
Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1 alone or in combination with nivolumab 480 mg IV every four weeks


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate safety and tolerability of ADP-A2M4CD8 as monotherapy or in combination with nivolumab [ Time Frame: 2.5 years ]
    Determination of incidence of dose-limiting toxicities, adverse events and tolerable dose

  2. To evaluate safety of ADP-A2M4CD8 as monotherapy or in combination with nivolumab [ Time Frame: 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 :
  1. 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. Anti-tumor activity: Best overall response (BOR) [ Time Frame: 2.5 years ]
    BOR is per RECIST V1.1.

  3. 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 nivolumab, the time taken to achieve a partial response or complete response (TTR) is assessed.

  4. 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 nivolumab, the DOR is the date of first response (including confirmation) up until disease progression per RECIST v 1.1 or death.

  5. 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

  6. 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 nivolumab up until the date of disease progression per RECIST v1.1 or death.

  7. Overall Survival (OS) [ Time Frame: 15 years ]
    OS is assessed from date of infusion of ADP-A2M4CD8 as monotherapy or in combination with nivolumab up until the date of patient death.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04044859


Contacts
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Contact: David Hong, MD 713-563-5844 dshong@madanderson.org

Locations
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Sponsors and Collaborators
Adaptimmune
ICON plc
Investigators
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Principal Investigator: David Hong, MD M.D. Anderson Cancer Center
More Information
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Responsible Party: Adaptimmune
ClinicalTrials.gov Identifier: NCT04044859    
Other Study ID Numbers: ADP-0055-001
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: August 24, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adaptimmune:
Cell Therapy
T Cell Therapy
SPEAR T Cell
MAGE-A4
Immuno-oncology
Metastatic
Urothelial
Head and Neck
 Gastric (stomach)
Esophagogastric Junction (EGJ)
Non-small Cell Lung (NSCLC)
Esophageal Cancer
Ovarian Cancer
Endometrial Cancer
Melanoma
Additional relevant MeSH terms:
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Melanoma
Ovarian Neoplasms
Esophageal Neoplasms
Endometrial Neoplasms
Stomach Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
 Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Uterine Neoplasms
Uterine Diseases
Stomach Diseases
Nivolumab