NCT03132675

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

A Multicenter Phase 2, Open Label Study of Intratumoral Tavokinogene Telseplasmid (Tavo, pIL-12) + Electroporation With Pembrolizumab in Patients With Stage 3/4 Melanoma Who Are Progressing on Either Pembrolizumab or Nivolumab Treatment

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 143 (estimated)
• Sponsor: OncoSec Medical Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Keynote 695 is 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 either pembrolizumab or nivolumab.

Detailed description

The study will be comprised of a screening period, a treatment period (up to 2 years), a long term follow-up period, and a survival follow-up period. Eligible subjects will be treated with TAVO-EP to the accessible lesions on days 1, 5, and 8 every 6 weeks and with IV pembrolizumab (200 mg) on Day 1 of each 3-week cycle for up to 18 TAVO-EP cycles and 35 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, as long as the size of each lesion is greater than 0.3 cm × 0.3 cm. Long-term Follow-up: All subjects will be followed after End of Treatment (EOT) visit for SAEs (through 90 days from last dose of study drug). Subjects who discontinue treatment will enter the long-term follow-up period unless they have started a new anti-cancer therapy (or other local anticancer immunotherapy) or have withdrawn consent for non-survival assessments. They will have scans, photographs, and investigator-assessed disease evaluation per RECIST v1.1 collected every 3 months until disease progression, or the subject receives a new systemic anti-cancer treatment (or other local anticancer immunotherapy). Survival Follow-up: Once a subject receives a new systemic anti-cancer treatment (or other local anticancer immunotherapy), they will move into survival follow-up. All subjects will be followed for survival and disease status, every 3 months up to a total duration of 5 years, withdrawal of consent, or until Sponsor terminates the study.

Conditions

• Stage III/IV Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	tavokinogene telseplasmid	Intratumoral tavokinogene telseplasmid (tavo, pIL-12) delivered by electroporation every 6 weeks
BIOLOGICAL	Pembrolizumab	Intravenous 3 weekly treatments
DEVICE	ImmunoPulse	Device that electroporates the tavokinogene telseplasmid

Timeline

• Start date: 2017-10-03
• Primary completion: 2023-03-31
• Completion: 2024-07-31
• First posted: 2017-04-28
• Last updated: 2023-03-27

Locations

33 sites across 5 countries: United States, Australia, Canada, Italy, Switzerland

Regulatory

• FDA-regulated drug study
• FDA-regulated device study