CompletedPhase 2

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

United States, France, Norway23 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 range

18 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years

Sex

ALL

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.