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

Official Title

A Multicentre Phase 2, Open Label Study of Intratumoural Tavokinogene Telseplasmid (Tavo, pIL-12) Plus Electroporation in Combination With Intravenous Pembrolizumab in Patients With Stage III/IV Melanoma Who Are Progressing on Either Pembrolizumab or Nivolumab Treatment (Keynote 695)

Summary:

Keynote 695 will be a Phase 2 study of intratumoural 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.

Trial Description

Primary Outcome:

• Overall Response Rate (ORR)

Secondary Outcome:

• Objective Response rate (ORR)
• Duration of Response (DOR)
• Progression free survival (PFS)
• Immune Progression Free Survival (iPFS)
• Immune Overall Response Rate (iORR)
• Overall survival (OS)

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 patients will be treated with intratumoural 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 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 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) Treatment visit for SAEs (through 90 days from last dose of study drug). Subjects who discontinue treatment due to disease progression will directly enter the survival follow-up period following the End of Study Treatment visit. Subjects who discontinue treatment for any reason other than disease progression or withdrawal of consent enter the long-term follow-up period. They will have scans, photographs, and investigator-assessed disease evaluation per RECIST v1.1 collected every 3 months until disease progression, subject receives a new anti-cancer treatment (with the exception of maintenance pembrolizumab). Information on all subjects' first new anti-cancer therapy will also be collected. Survival Follow-up: Once a subject receives a new anti-cancer treatment or progresses during long-term follow-up, they will move into survival follow-up. All subjects will be followed for survival and disease status-, every 3 months until treatment period, long-term follow-up period, and survival follow-up period reaches a total duration of 5 years, withdrawal of consent, or until Sponsor terminates the study.

View this trial on ClinicalTrials.gov