Trial record 1 of 1 for:
ADP-0055-001
ADP-A2M4CD8 as Monotherapy or in Combination With Either Nivolumab or Pembrolizumab in HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS)
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| ClinicalTrials.gov Identifier: NCT04044859 |
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Recruitment Status :
Recruiting
First Posted : August 5, 2019
Last Update Posted : February 16, 2024
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Sponsor:
Adaptimmune
Collaborator:
ICON plc
Information provided by (Responsible Party):
Adaptimmune
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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 or pembrolizumab every 6 weeks | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 120 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 Either Nivolumab Or Pembrolizumab In HLA-A2+ Subjects With MAGE-A4 Positive Tumors (SURPASS) |
| Actual Study Start Date : | August 20, 2019 |
| Estimated Primary Completion Date : | December 23, 2025 |
| Estimated Study Completion Date : | April 30, 2037 |
Resource links provided by the National Library of Medicine
| 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 |
Primary Outcome Measures :
- 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
- 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.
Secondary Outcome Measures :
- 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
- Anti-tumor activity: Best overall response (BOR) [ Time Frame: 2.5 years ]BOR is per RECIST V1.1.
- 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.
- 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
- 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
- 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.
- 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.
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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.
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
| Contact: David Hong, MD | 713-563-5844 | dshong@madanderson.org |
Locations
Show 22 study locations
Sponsors and Collaborators
Adaptimmune
ICON plc
Investigators
| Principal Investigator: | David Hong, MD | M.D. Anderson Cancer Center |
| 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: | February 16, 2024 |
| Last Verified: | February 2024 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Adaptimmune:
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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 Skin Neoplasms Neoplasms by Site Skin Diseases |
Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Neoplasms, Female Urogenital Neoplasms Genital Diseases Endocrine System Diseases Gonadal Disorders Head and Neck Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms |