Tavo and Pembrolizumab in Patients With Stage III/IV Melanoma Progressing on Either Pembrolizumab or Nivolumab Treatment (Keynote-695)
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|ClinicalTrials.gov Identifier: NCT03132675|
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : December 23, 2022
|Condition or disease||Intervention/treatment||Phase|
|Stage III/IV Melanoma||Biological: tavokinogene telseplasmid Biological: Pembrolizumab Device: ImmunoPulse||Phase 2|
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follow-up period unless they have started a new anti-cancer therapy (or other local anticancer immunotherapy) or have withdrawn consent for non-survival assessments.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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||143 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
Cohort 1A_Locally advanced/metastatic melanoma: pathological diagnosis of unresectable or metastatic melanoma with progression on pembrolizumab or nivolumab, confirmed according to RECIST v1.1. BRAF V600 mutation-positive melanoma could have received standard of care targeted therapy for advanced or metastatic disease (eg, BRAF/MEK inhibitor, alone or in combination) prior to enrolling on this study; however, progression is not required.
Cohort 1B_Locally advanced/metastatic melanoma: Subjects will be enrolled in order to collect safety data using the GenPulse generator. Eligibility for enrollment will be the same as that for Cohort 1A.
Cohort 2_Locally advanced/metastatic melanoma with prior exposure to ipilimumab alone or in combination with nivolumab (or other drug(s)/agent(s)): Eligible subjects will be those with pathological diagnosis of unresectable or metastatic melanoma who have been exposed to ipilimumab alone or in combination with nivolumab (or other drug/agent)
|Masking:||None (Open Label)|
|Masking Description:||Blinded Independent Central Review|
|Official Title:||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|
|Actual Study Start Date :||October 3, 2017|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2025|
Experimental: tavo-EP plus IV pembrolizumab
Intratumoral Tavokinogene Telseplasmid (tavo, pIL 12) plus Electroporation (ImmunoPulse) in Combination with Intravenous Pembrolizumab
Biological: tavokinogene telseplasmid
Intratumoral tavokinogene telseplasmid (tavo, pIL-12) delivered by electroporation every 6 weeks
Intravenous 3 weekly treatments
Other Name: Keytruda
Device that electroporates the tavokinogene telseplasmid
Other Name: tavo-EP
- Objective Response Rate (ORR) [ Time Frame: approximately 2 years ]ORR by blinded independent central review (BICR) based on RECIST v1.1
- Objective Response rate (ORR) [ Time Frame: approximately 2 years ]ORR by investigator assessment based on RECIST v1.1
- Duration of Response (DOR) [ Time Frame: approximately 2 years ]DOR by Investigator assessment and BICR based on RECIST v1.1
- Progression free survival (PFS) [ Time Frame: approximately 2 years ]PFS by investigator assessment and BICR based on RECIST v1.1
- Immune Progression Free Survival (iPFS) [ Time Frame: approximately 2 years ]iPFS by Investigator assessment and BICR based on iRECIST
- Immune Overall Response Rate (iORR) [ Time Frame: approximately 2 years ]iORR by Investigator assessment and BICR based on iRECIST
- Overall survival (OS) [ Time Frame: approximately 2 years ]Overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132675
|Contact: Gina Weaverfirstname.lastname@example.org|
|Contact: Matthew Sieberemail@example.com|
|Study Director:||Bridget O'Keeffe, PhD||OncoSec Medical Incorporated|