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PD-L1 Inhibitor
TILT-123 + Avelumab for Melanoma (AVENTIL Trial)
Phase 1
Recruiting
Led By Tuomo Alanko
Research Sponsored by TILT Biotherapeutics Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 85 days
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the safety of a new treatment called oncolytic adenovirus TILT-123, along with a drug called avelumab, in patients with advanced solid tumors that have
Who is the study for?
This trial is for adults over 18 with certain advanced solid tumors (like melanoma or head and neck cancers) that have stopped responding to standard treatments, including anti-PD(L)1 immunotherapy. Participants need a tumor large enough for biopsy and injection, good liver function, no curative treatment options available, and must have completed prior PD-1/PDL-1 therapy.
What is being tested?
The study tests TILT-123 (an oncolytic adenovirus) combined with Avelumab in patients whose tumors are not responding to previous therapies. It's an early-phase trial designed to find out the safest dose of TILT-123 when used with Avelumab.
What are the potential side effects?
Possible side effects include typical reactions related to immune therapies such as fatigue, flu-like symptoms, skin reactions at the injection site, allergic responses, and potential changes in blood test results reflecting organ functions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 85 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~85 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants with Adverse Events assessed by 12- lead electrocardiograms (ECGs)
Number of Participants with abnormal laboratory values.
Number of Participants with any (serious and non-serious) Adverse Events.
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: TILT-123 and avelumabExperimental Treatment2 Interventions
Patients will receive multiple administrations of TILT-123 and avelumab.
Escalation to the next dose of TILT-123 level will occur when the safety data has been evaluated for all patients in the preceding dose level.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2017
Completed Phase 2
~2440
Find a Location
Who is running the clinical trial?
TILT Biotherapeutics Ltd.Lead Sponsor
4 Previous Clinical Trials
86 Total Patients Enrolled
1 Trials studying Melanoma
17 Patients Enrolled for Melanoma
Tuomo AlankoPrincipal InvestigatorDocrates Cancer Center