Study of Intratumoral CV8102 in cMEL, cSCC, hnSCC, and ACC (NCT03291002) | Clinical Trial Compass
UnknownPhase 1
Study of Intratumoral CV8102 in cMEL, cSCC, hnSCC, and ACC
Austria, France, Germany98 participantsStarted 2017-09-25
Plain-language summary
This study evaluates intratumoral administration of CV8102 in patients with advanced melanoma, squamous cell carcinoma of the skin, squamous cell carcinoma of the head and neck, or adenoid cystic carcinoma.
Patients will receive CV8102 as single agent or in combination with SoC anti-PD-1 therapy.
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.
Inclusion criteria
. Patients enrolled into Cohorts A and B (single agent CV8102) must have:
. Patients enrolled into Cohort C (CV8102 in combination with anti-PD-1 therapy) must have
. Patients enrolled into Cohort D1 (CV8102 in combination with anti-PD-1 therapy) must have
. Patients enrolled into Cohort D2 (CV8102 in combination with anti-PD-1 therapy) must have
. Presence of at least one injectable tumor lesion that is measurable according to RECIST 1.1
. Recovered from prior toxicities to CTCAE grade ≤ 1 or grade ≤ 2
. Resolution of CPI-related adverse effects, if applicable (including irAEs) back to CTCAE grade 0/1
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
1
Dose determination for dose escalation cohorts
Timeframe: 2 weeks
2
Incidence of treatment related (Serious) Adverse Events (Tolerability and Safety profile)
. Rapidly progressing multi-focal metastatic or acutely life threatening disease
. Prior use of topical/localTLR-7/8 agonists within the past 6 months
. Clinically active central nervous system metastases and/or carcinomatous meningitis (patients with stable brain metastases are eligible)
. Ocular and mucosal melanoma
. Prior anti-cancer therapy within specified time-periods depending on the indication
. Tumor lesions that are to be injected close to major blood vessels or nerves, or whose injection could potentially result in clinical adverse effects if post-treatment tumor swelling or inflammation were to occur
. Lesions that are to be injected in previously irradiated areas unless progressive tumor growth has been demonstrated (no prior irradiation of injected lesions on patients with melanoma)
. History of active coagulation or bleeding disorder or need for ongoing therapeutic anticoagulation that cannot be safely interrupted at th etime of IT injection or biopsy du eto Underlying medical conditions; patients with melanoma and cutaneous squamous cell carcinoma with controlled oral anticoagulation are eligible