Intratumoral Injection of LTX-315 in Combination With Pembrolizumab in Advanced Melanoma (NCT04796194) | Clinical Trial Compass
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.
1This trial used a combination of an intratumoral injection called LTX-315 directly into the tumor along with the immunotherapy pembrolizumab — can you help me understand how injecting something directly into the tumor works differently from a standard systemic treatment, and whether that approach might be relevant to my situation?
2Since this was a Phase 2 trial that has already completed, has any data or results been published yet, and if so, what did the objective response rate and overall survival findings suggest about how well this combination worked in advanced melanoma?
3Pembrolizumab is already an approved treatment for advanced melanoma — would it make more sense for me to consider pembrolizumab on its own as a standard-of-care option first, rather than a combination that was still being studied in this trial?
4Because LTX-315 is injected directly into the tumor, what does that process actually involve in terms of clinic visits, procedures, and recovery, and how realistic would that schedule be for someone in my circumstances?
5Now that this trial is completed, are there other open trials or next-step studies building on this LTX-315 and pembrolizumab combination that might be worth looking into if this approach seems promising for my case?
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
1
Objective response rate (ORR)
Timeframe: Through study completion, an average of 6 months
2
Clinical benefit rate (CBR)
Timeframe: Through study completion, an average of 6 months
3
Overall survival (OS)
Timeframe: Through study completion, an average of 6 months
. 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.