Metastatic or recurrent melanoma
Conditions
Brief summary
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) following tissue procurement and administration of lymphodepletion agents, ATL001 (monotherapy or in combination with nivolumab) and IL-2
Detailed description
Percentage change from baseline in tumour size at 6 weeks, 12 weeks and best change from baseline, Overall Response Rate (ORR) (based on RECIST v1.1 and imRECIST), Time to response (based on RECIST v1.1 and imRECIST), Duration of response (based on RECIST v1.1 and imRECIST), Disease Control Rate (CR + PR + durable SD) (based on RECIST v1.1), Progression free survival (PFS) (based on RECIST v1.1 and imRECIST), Overall survival (OS)
Interventions
DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.
DRUGATL001
Sponsors
Achilles Therapeutics UK Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) following tissue procurement and administration of lymphodepletion agents, ATL001 (monotherapy or in combination with nivolumab) and IL-2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change from baseline in tumour size at 6 weeks, 12 weeks and best change from baseline, Overall Response Rate (ORR) (based on RECIST v1.1 and imRECIST), Time to response (based on RECIST v1.1 and imRECIST), Duration of response (based on RECIST v1.1 and imRECIST), Disease Control Rate (CR + PR + durable SD) (based on RECIST v1.1), Progression free survival (PFS) (based on RECIST v1.1 and imRECIST), Overall survival (OS) | — |
Countries
Spain
Outcome results
None listed