CompletedPhase 2

Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients

United States17 participantsStarted 2020-12-22

Plain-language summary

This is a Phase 2 open-label, single-arm study of neoadjuvant treatment of intratumoral tavo-EP plus nivolumab IV infusion. Eligible participants will be those with pathological diagnosis of operable locally-regionally advanced melanoma.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Primary melanoma with clinically apparent regional lymph node metastases, confirmed by pathological diagnosis.
✓. Clinically detected recurrence of melanoma at regional lymph node basin(s), confirmed by pathological diagnosis.
✓. Clinically or histologically detected primary melanoma involving multiple regional nodal groups, confirmed by pathological diagnosis.
✓. Clinically detected single site of nodal metastatic melanoma arising from an unknown primary, confirmed by pathological diagnosis.
✓. Participants with in transit or satellite metastases with or without lymph node involvement are allowed if they are considered surgically resectable at Screening by the treating surgical oncologist.

Exclusion criteria

✕. Accessible for electroporation
✕. Must be measured in at least one dimension (longest diameter in the plane of measurement is to be recorded)
✕. Greater than 3 mm

What they're measuring

Pathologic Complete Response

Timeframe: At least four weeks after the last dose of nivolumab at End of Study (EOS) visit

Trial details

NCT IDNCT04526730

SponsorH. Lee Moffitt Cancer Center and Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-26

Results submitted2025-03-25

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