Not provided
Not provided
Not provided
Not provided
Not provided
The long-term follow-up of patients is being migrated to the original (parent) study protocols (Trial ID: ATX-NS-001 / NCT: NCT04032847;Trial ID: ATX-ME-001 / NCT: NCT03997474). Consequently, the ATX-LTFU-001 study is being terminated by the Sponsor.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an Open-Label, Multi-Centre Phase II study to evaluate the long-term safety and clinical activity of ATL001, previously administered intravenously to patients in Study ATX-NS-001 (NCT04032847) or Study ATX-ME-001 (NCT03997474).
Up to 90 patients with advanced non-small cell lung cancer ( NSCLC) or metastatic or recurrent melanoma will be enrolled after either: completing 2 years of follow-up visits in study ATX-NS-001 or study ATX-ME-001; or voluntary withdrawal from these studies prior to the completion of the 2 year of follow-up period.
Each patient will be followed up for a minimum period of 5 years, or until death if sooner, in this Long-Term Follow Up Protocol.
For patients who are still alive after 5 years of follow-up, survival data will continue to be collected until the end of the study, which will occur when the last patient has completed 5 years of follow-up withdraws from study or has died.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: ATL001 | Other | Patients who have previously received ATL001 in a clinical trial will be evaluated in this trial for long-term safety and clinical activity. |
|
| Patients who have previously received ATL001 in study ATX-NS-001 or study ATX-ME-001 | Other | Patients who have previously received ATL001 in study ATX-NS-001 or study ATX-ME-001 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological: ATL001 | Other | No investigational product will be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of adverse events to evaluate long-term Safety and Tolerability of ATL001 | Evaluate the frequency and severity of adverse events related or possibly related to ATL001 | Every 4 months to 60 months; then every 6 months until death or until the end of the study, whichever came first, assessed up to 84 months. |
| Assessment of autoimmune adverse events | Evaluate the frequency and severity of autoimmune adverse events | Every 4 months to 60 months; then every 6 months until death or until the end of the study, whichever came first, assessed up to 84 months. |
| Assessment of new malignancies | Evaluate the frequency and severity of new malignancies | Every 4 months to 60 months; then every 6 months until death or until the end of the study, whichever came first, assessed up to 84 months. |
| Assessment of the use of medications to manage ATL001-related toxicities | Evaluate the use of medications to manage ATL001-related toxicities | Every 4 months to 60 months; then every 6 months until death or until the end of the study, whichever came first, assessed up to 84 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Assessment for Duration of Response ( DoR) | Evaluate the endpoint of DoR as assessed by the Investigator and Independent Central Review (ICR), per RECIST v1.1 | Maximum 60 months. |
| Disease Assessment for Progression Free Survival (PFS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
There are no exclusion criteria.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor, MD | Achilles Therapeutics UK Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College London Hospital (UCLH) NHS Foundation Trust, University College Hospital | London | NW12PG | United Kingdom |
Not provided
| Label | URL |
|---|---|
| ATX-NS-001 Clinicaltrials.gov | View source |
| ATX-ME-001 Clinicaltrials.gov | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Evaluate the endpoint of PFS as assessed by the Investigator and ICR, per RECIST v1.1
| Maximum 60 months. |
| Disease Assessment for Time to First Subsequent anti-cancer Therapy (TFST) | Evaluate the endpoint of TFST | Maximum 60 months. |
| Assessment for Overall Survival (OS) | Evaluate the endpoint of OS by the Investigator | 6 months until death or until the end of the study, whichever came first, assessed up to 84 months |
| Assessment for cancer-related medical resources | Evaluate the endpoint of cancer-related medical resourcesATL001 therapy | Maximum 60 months. |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |