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Virus Therapy
LTX-315 + Pembrolizumab for Advanced Melanoma (ATLAS-IT-05 Trial)
Phase 2
Waitlist Available
Led By Sarina Piha-Paul, MD PhD
Research Sponsored by Lytix Biopharma AS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Disease that is not amenable to further radiotherapy or surgery for cancer treatment
At least 1 measurable tumor 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 6 months
Awards & highlights
ATLAS-IT-05 Trial Summary
This trial is testing a new treatment for advanced melanoma that has spread to other parts of the body. The treatment will be given to patients who have no other options or who are not eligible for other treatments.
Who is the study for?
Adults with advanced melanoma that's not removable by surgery or treatable with radiation, who've tried and progressed after anti-PD-1/PD-L1 therapy. They must have a life expectancy of at least 3 months, be willing to undergo biopsies, use contraception if of childbearing potential, and cannot be pregnant or breastfeeding. Excluded are those with ocular/mucosal melanoma, excessive tumor burden, certain allergies/hypersensitivities, serious illnesses like HIV/hepatitis B/C (unless treated), heart issues, CNS metastases/meningitis.Check my eligibility
What is being tested?
The trial is testing LTX-315 injections directly into the tumor in combination with pembrolizumab for patients whose melanoma has spread and isn't responding to standard treatments. It's an open-label study meaning everyone knows what treatment they're getting; there's no placebo group.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site for LTX-315 and typical immune-related adverse events from pembrolizumab such as fatigue, skin rash or itching. There may also be risks associated with organ inflammation due to immune system activation.
ATLAS-IT-05 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer cannot be treated with more surgery or radiation.
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I have at least one tumor that can be measured and won't be treated with LTX-315 or biopsied.
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I am not pregnant or breastfeeding, and I have a negative pregnancy test.
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My melanoma is advanced and has not responded to specific immune therapies.
Select...
I agree to use two effective birth control methods if I can have children.
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My heart's pumping ability is within the normal range.
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I am willing to have a tumor biopsy.
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I am fully active or restricted in physically strenuous activity but can do light work.
ATLAS-IT-05 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical benefit rate (CBR)
Objective response rate (ORR)
Overall survival (OS)
ATLAS-IT-05 Trial Design
1Treatment groups
Experimental Treatment
Group I: LTX-315 in combination with pembrolizumabExperimental Treatment1 Intervention
LTX-315 will be injected directly into the selected tumor lesion(s).
Pembrolizumab will be dispensed and administered as an IV infusion.
Find a Location
Who is running the clinical trial?
CovanceIndustry Sponsor
119 Previous Clinical Trials
12,796 Total Patients Enrolled
1 Trials studying Melanoma
3 Patients Enrolled for Melanoma
Lytix Biopharma ASLead Sponsor
7 Previous Clinical Trials
370 Total Patients Enrolled
1 Trials studying Melanoma
80 Patients Enrolled for Melanoma
Laboratory Corporation of AmericaIndustry Sponsor
27 Previous Clinical Trials
9,865 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I may need surgery or radiation to relieve my cancer symptoms.I have a skin or muscle tumor that can be safely injected and is the right size.My cancer cannot be treated with more surgery or radiation.I have at least one tumor that can be measured and won't be treated with LTX-315 or biopsied.I am not pregnant or breastfeeding, and I have a negative pregnancy test.You are allergic to certain types of medications used to treat allergies and stomach issues.My melanoma is advanced and has not responded to specific immune therapies.I haven't had cancer immunotherapy in the last 4 weeks or have recovered from its side effects.My heart's electrical cycle is longer than normal.I have had a severe allergic reaction to a monoclonal antibody treatment.I am not expected to start any other cancer treatments during the study.I haven't had chemotherapy or radiotherapy in the last 4 weeks.I agree to use two effective birth control methods if I can have children.I have been treated with anti-PD-1 or anti-PD-L1, and if I have melanoma with a BRAF mutation, I've either completed or refused BRAF inhibitor therapy.I have HIV or hepatitis B/C but it's under control.You need to meet specific health test results.I refused standard cancer treatment except for anti-PD-1/PDL-1 therapy, and my reasons are documented.I am 18 years old or older.I have had severe lung inflammation in the past or have it now.My heart's pumping ability is within the normal range.My side effects from previous treatments or disease are mild, except for hair loss or mild nerve pain.I have more than 10 large cancer spots or my doctor thinks my cancer spread is too much.I do not have eye or mucosal melanoma.I am not allergic to pembrolizumab, LTX-315, or their ingredients.My cancer has spread to my bones, brain, or caused meningitis.You have a history of serious heart or blood vessel problems, and the doctor thinks you might be at risk for complications from a sudden drop in blood pressure.I haven't taken BRAF/MEK inhibitors in the last 3 weeks and my disease is not rapidly worsening.I haven't taken immunosuppressive drugs or steroids in the last 28 days.I am willing to have a tumor biopsy.I have been treated for an autoimmune disease within the last 3 months.You are expected to live for at least 3 more months.I have a history of lung scarring or fibrosis.I am fully active or restricted in physically strenuous activity but can do light work.My cancer has worsened after treatment, but I've had no more than 3 treatments.
Research Study Groups:
This trial has the following groups:- Group 1: LTX-315 in combination with pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the collaborative utilization of LTX-315 and pembrolizumab certified by the FDA?
"The safety of the pairing LTX-315 and pembrolizumab receives a rating of 2 since there is evidence to support it's safety but not yet efficacy, as this is only Phase 2."
Answered by AI
Are there vacancies for participants in this medical experiment?
"The trial, which was initially published on June 1st 2021, is currently accepting applicants. The information has been refreshed as recently as November 21st 2022."
Answered by AI
What medical condition is the pairing of LTX-315 and pembrolizumab usually prescribed for?
"LTX-315 in combination with pembrolizumab is a viable treatment option for malignant neoplasms, unresectable melanoma and other forms of microsatellite instability high."
Answered by AI
What research has been conducted to determine the efficacy of LTX-315 in tandem with pembrolizumab?
"Presently, 963 trials concerned with LTX-315 in combination with pembrolizumab are underway, of which 122 are at the phase 3 level. Most of these studies are situated in Houston, Texas; however there is a total of 35731 research centres running related experiments worldwide."
Answered by AI
How many participants is the research team looking to include in this experiment?
"Affirmative. Clinicaltrials.gov verifies that this clinical trial is presently looking for participants, which were first shared on June 1st 2021 and most recently updated on November 21st 2022. The research seeks to enrol 20 patients across two medical centres."
Answered by AI
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