Last updated on March 2020

Tavo and Pembrolizumab in Patients With Stage III/IV Melanoma Progressing on Pembrolizumab or Nivolumab Treatment

Brief description of study

Keynote 695 will be a Phase 2 study of intratumoral tavokinogene telseplasmid (tavo; pIL-12) Electroporation (EP) plus IV Pembrolizumab. Eligible patients will be those with pathological diagnosis of unresectable or metastatic melanoma who are progressing or have progressed on pembrolizumab or nivolumab.

Detailed Study Description

The study will be comprised of a screening period, a treatment period (up to 2 years) and a long term follow-up.

Eligible patients will be treated with intratumoral tavo-EP to the accessible lesions on Days 1, 5 and 8 every 6 weeks and with IV pembrolizumab (200mg) on Day 1 of each 3-week cycle for 17 tavo-EP cycles and 33 pembrolizumab cycles (from baseline) of continued treatment (approximately 2 years), or until disease progression. As many accessible lesions may be treated as deemed feasible by the treating physician assuming the size of each lesion is greater than 0.3 cm x 0.3 cm.

Long-term Follow-up: All subjects will be followed after End of Study (EOS) visit for SAEs (through 90 days from last dose of study drug) and long term survival status. EOS visit will occur 4 weeks after last study treatment administration.

Clinical Study Identifier: NCT03132675

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University of Toledo

Toledo, OH United States
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Atlantic Health System

Morristown, NJ United States
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Health Quest Systems, Inc.

Poughkeepsie, NY United States
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Gabrail Cancer Center

Canton, OH United States
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Huntsman Cancer Institute

Salt Lake City, UT United States
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Westmead Hospital

Westmead, Australia
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Box Hill Hospital

Box Hill, Australia
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The Alfred Hospital

Melbourne, Australia
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Moffit Cancer Center

Tampa, FL United States
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Texas Oncology/Baylor

Dallas, TX United States
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