CompletedPhase 2

Intratumoral Injection of LTX-315 in Combination With Pembrolizumab in Advanced Melanoma

United States, France23 participantsStarted 2021-06-01

Plain-language summary

ATLAS-IT-05 is an open-label, single-arm study in patients with advanced melanoma accessible for injections (cutaneous, subcutaneous, lymph node, or intramuscular tumors) and who have either exhausted treatment options or are not eligible for, suitable for, or willing to undergo such treatments.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Have one of the following confirmed histologically:
✕. The patients should have had radiologically PD after the most recent line of systemic therapy (no more than two prior lines in the metastatic setting). Adjuvant or Neoadjuvant therapy is not considered as a prior line of treatment for eligibility purposes. Anti-PD-1 or anti-PD-L1 does not need to be the most recent line of therapy prior to study entry.
✕. Disease that is not amenable to further radiotherapy or surgery for cancer treatment.
✕. Have at least one superficial, non-visceral tumor lesion accessible for injection via cutaneous, subcutaneous, or intramuscular route. Note, lymph nodes with metastatic disease may be selected for injection if they are superficial, but not if deep-seated; visceral lesions must not be selected for injection. The lesion must not be located close to airways, defined as close enough to jeopardize the patient's safety, in the opinion of the Investigator, in the event of a local reaction to LTX-315 injection (for example, if such a reaction has the potential to interfere with swallowing or result in hemorrhaging into the airways). The size of the lesion(s) selected for injection must be ≤2 cm in the mean longest perpendicular diameter. For larger lesions or conglomerate lesions, approval from the sponsor's Medical Monitor is needed prior to enrollment.
✕. At least one measurable target lesion evaluable according to RECIST version 1.1 that is not planned to be injected with LTX-315 or biopsied. The location of this noninjected tumor may be superficial, deep-seated, or visceral.
✕. Have a life expectancy ≥3 months.
✕. Are males or females aged 18 years or older.
✕. Have an ECOG performance status of 0 or 1.

What they're measuring

Objective response rate (ORR)

Timeframe: Through study completion, an average of 6 months

Clinical benefit rate (CBR)

Timeframe: Through study completion, an average of 6 months

Overall survival (OS)

Timeframe: Through study completion, an average of 6 months

Trial details

NCT IDNCT04796194

SponsorLytix Biopharma AS

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-03

View on ClinicalTrials.gov More Advanced Melanoma trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Have one of the following confirmed histologically:
✕. The patients should have had radiologically PD after the most recent line of systemic therapy (no more than two prior lines in the metastatic setting). Adjuvant or Neoadjuvant therapy is not considered as a prior line of treatment for eligibility purposes. Anti-PD-1 or anti-PD-L1 does not need to be the most recent line of therapy prior to study entry.
✕. Disease that is not amenable to further radiotherapy or surgery for cancer treatment.
✕. Have at least one superficial, non-visceral tumor lesion accessible for injection via cutaneous, subcutaneous, or intramuscular route. Note, lymph nodes with metastatic disease may be selected for injection if they are superficial, but not if deep-seated; visceral lesions must not be selected for injection. The lesion must not be located close to airways, defined as close enough to jeopardize the patient's safety, in the opinion of the Investigator, in the event of a local reaction to LTX-315 injection (for example, if such a reaction has the potential to interfere with swallowing or result in hemorrhaging into the airways). The size of the lesion(s) selected for injection must be ≤2 cm in the mean longest perpendicular diameter. For larger lesions or conglomerate lesions, approval from the sponsor's Medical Monitor is needed prior to enrollment.
✕. At least one measurable target lesion evaluable according to RECIST version 1.1 that is not planned to be injected with LTX-315 or biopsied. The location of this noninjected tumor may be superficial, deep-seated, or visceral.
✕. Have a life expectancy ≥3 months.
✕. Are males or females aged 18 years or older.
✕. Have an ECOG performance status of 0 or 1.