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Long-Term Follow-Up Study of Patients Receiving ATL001

Phase 2
Terminated
Conditions
Advanced Non Small Cell Lung Cancer
Melanoma
Registration Number
NCT04785365
Lead Sponsor
Achilles Therapeutics UK Limited
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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
1
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.
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Exclusion Criteria

There are no exclusion criteria.

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Assessment of new malignanciesEvery 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 autoimmune adverse eventsEvery 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 the use of medications to manage ATL001-related toxicitiesEvery 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

Assessment of adverse events to evaluate long-term Safety and Tolerability of ATL001Every 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

Secondary Outcome Measures
NameTimeMethod
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

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

Assessment for cancer-related medical resourcesMaximum 60 months.

Evaluate the endpoint of cancer-related medical resourcesATL001 therapy

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 Time to First Subsequent anti-cancer Therapy (TFST)Maximum 60 months.

Evaluate the endpoint of TFST

Trial Locations

Locations (1)

University College London Hospital (UCLH) NHS Foundation Trust, University College Hospital

🇬🇧

London, United Kingdom

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