MelanomaPhase 2NCT04785365
Long-Term Follow-Up Study of Patients Receiving ATL001
A Phase 2 study testing Biological: ATL001 in people with Melanoma and Advanced Non Small Cell Lung Cancer, run by Achilles Therapeutics UK Limited at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Advanced Non Small Cell Lung Cancer
- What is being tested?
- Biological: ATL001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2022to 18 Oct 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have given written informed consent to participate in the study.
- Patients must have received ATL001 in a previous Clinical Trial.
- Patients must be considered, in the opinion of the Investigator, capable of complying with the protocol requirements.
Who cannot join
- There are no exclusion criteria.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College London Hospital (UCLH) NHS Foundation Trust, University College Hospital
London, NW12PG
About this study
Official title: An Open-Label, Multi-Centre Phase II Study Evaluating the Long-Term Safety and Clinical Activity of Neoantigen Reactive T Cells in Patients Who Have Previously Received ATL001 in a Clinical Trial
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).
Read the 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.
- Conditions
- Melanoma, Advanced Non Small Cell Lung Cancer
- Being tested
- Biological: ATL001
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological: ATL001Other
No investigational product will be administered
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Biological: ATL001 |
| 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 Receives: Other: Biological: ATL001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Secondary outcomes (5)
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
Measured: Maximum 60 months.
Disease Assessment for Progression Free Survival (PFS)
Evaluate the endpoint of PFS as assessed by the Investigator and ICR, per RECIST v1.1
Measured: Maximum 60 months.
Disease Assessment for Time to First Subsequent anti-cancer Therapy (TFST)
Evaluate the endpoint of TFST
Measured: Maximum 60 months.
Assessment for Overall Survival (OS)
Evaluate the endpoint of OS by the Investigator
Measured: 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
Measured: Maximum 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Jun 2022
- Primary completion18 Oct 2023
- Study completion18 Oct 2023
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Achilles Therapeutics UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, MD, Study director, Achilles Therapeutics UK Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785365
- Sponsor's protocol ID
- ATX-LTFU-001
- Status last verified
- Nov 2023
- First submitted
- 1 Mar 2021
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Centre Phase II Study Evaluating the Long-Term Safety and Clinical Activity of Neoantigen Reactive T Cells in Patients Who Have Previously Received ATL001 in a Clinical Trial
- ClinicalTrials.gov ID
- NCT04785365
- Acronym / sponsor ID
- ATX-LTFU-001
- Conditions
- Melanoma, Advanced Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Achilles Therapeutics UK LimitedIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: ATL001 | Other | Other: Biological: ATL001Patients 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 | Other: Biological: ATL001Patients who have previously received ATL001 in study ATX-NS-001 or study ATX-ME-001 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have given written informed consent to participate in the study.
- Patients must have received ATL001 in a previous Clinical Trial.
- Patients must be considered, in the opinion of the Investigator, capable of complying with the protocol requirements.
Key exclusion criteria (1 listed)
- There are no exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological: ATL001No investigational product will be administered | Other | Experimental: ATL001, Patients who have previously received ATL001 in study ATX-NS-001 or study ATX-ME-001 |
Primary outcome
Assessment of adverse events to evaluate long-term Safety and Tolerability of ATL001
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
5 secondary outcomes
Disease Assessment for Duration of Response ( DoR)
Time frame: Maximum 60 months.
Disease Assessment for Progression Free Survival (PFS)
Time frame: Maximum 60 months.
Disease Assessment for Time to First Subsequent anti-cancer Therapy (TFST)
Time frame: Maximum 60 months.
Assessment for Overall Survival (OS)
Time frame: 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
Time frame: Maximum 60 months.
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- ATX-NS-001 Clinicaltrials.govLink provided by the sponsor.
- ATX-ME-001 Clinicaltrials.govLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor, MD study director
Achilles Therapeutics UK Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biological: ATL001 in people with Melanoma and Advanced Non Small Cell Lung Cancer, run by Achilles Therapeutics UK Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of adverse events to evaluate long-term Safety and Tolerability of ATL001 (time frame: 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.