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 range18 Years
SexALL
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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
✓. ECOG PS 0 or 1
Exclusion criteria
✕. 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
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)
✕. 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