Advanced Non Small Cell Lung Cancer, Melanoma
Conditions
Brief summary
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).
Detailed description
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.
Interventions
OTHERBiological: ATL001
No investigational product will be administered
Sponsors
Achilles Therapeutics UK Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients must have given written informed consent to participate in the study. 2. Patients must have received ATL001 in a previous Clinical Trial. 3. Patients must be considered, in the opinion of the Investigator, capable of complying with the protocol requirements.
Exclusion criteria
There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of adverse events to evaluate long-term Safety and Tolerability of 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. | Evaluate the frequency and severity of adverse events related or possibly related to ATL001 |
| Assessment 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. | Evaluate the frequency and severity of autoimmune adverse events |
| Assessment 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. | Evaluate the frequency and severity of new malignancies |
| Assessment of 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. | Evaluate the use of medications to manage ATL001-related toxicities |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment for Overall Survival (OS) | 6 months until death or until the end of the study, whichever came first, assessed up to 84 months | Evaluate the endpoint of OS by the Investigator |
| Disease Assessment for Duration of Response ( DoR) | Maximum 60 months. | Evaluate the endpoint of DoR as assessed by the Investigator and Independent Central Review (ICR), per RECIST v1.1 |
| Disease Assessment for Progression Free Survival (PFS) | Maximum 60 months. | Evaluate the endpoint of PFS as assessed by the Investigator and ICR, per RECIST v1.1 |
| Disease Assessment for Time to First Subsequent anti-cancer Therapy (TFST) | Maximum 60 months. | Evaluate the endpoint of TFST |
| Assessment for cancer-related medical resources | Maximum 60 months. | Evaluate the endpoint of cancer-related medical resourcesATL001 therapy |
Countries
United Kingdom
Outcome results
None listed