Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Paclitaxel

Carboplatin

Pembrolizumab

Albumin-Bound Paclitaxel

Interleukin-12

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Intratumoral Tavokinogene Telseplasmid (tavo, pIL 12) plus Electroporation (ImmunoPulse) in Combination with Intravenous Pembrolizumab (Cohort enrollment completed)

Intratumoral Tavokinogene Telseplasmid (tavo, pIL 12) plus Electroporation (ImmunoPulse) in Combination with Intravenous Pembrolizumab along with treatment of an approved chemotherapy per standard of care (either nab-paclitaxel or gemcitabine plus carboplatin)

Intratumoral tavokinogene telseplasmid delivered by electroporation every 6 weeks

tavokinogene telseplasmid

Immunopulse

intravenous on days 1, 8 and 15 of each 28 day cycle

nab paclitaxel

intravenous on days 1 and 8 of every 21 days

gemcitabine plus carboplatin

Bridget O'Keeffe

This is a Phase 2, Multi-Cohort, Open-Label, Multi-Center Study. Cohort 1 will be a single-arm study of intratumoral tavokinogene telseplasmid (TAVO) plus electroporation (EP) in combination with pembrolizumab therapy. Cohort 2 will be a single-arm study of intratumoral TAVO-EP plus pembrolizumab along with treatment of an approved chemotherapy per standard of care (either nab-paclitaxel (Abraxane®) or gemcitabine (Gemzar®) plus carboplatin (Paraplatin®)) in participants with TNBC and no prior systemic therapy in the advanced or metastatic setting will be enrolled in this study.

The study will include a screening period, treatment period (up to 2 years), a long-term follow-up period, and a survival follow-up period. Participants will be followed for disease status and survival for up to a total duration of 5 years from the time of first dose of study treatment.

Eligible subjects with accessible lesions will be treated with TAVO-EP on Days 1, 5 and 8 every 6 weeks for up to 18 weeks. Pembrolizumab IV will be administered at a dose of 200 mg on Day 1 every 3-weeks for up to 35 cycles (Q3W) or 400 mg on Day 1 every 6 weeks for up to 18 cycles (Q6W).

Eligible subjects will be enrolled in one of the following cohorts.

* Cohort 1 is a single-arm study of intratumoral TAVO-EP and pembrolizumab (Q3W) in participants with TNBC and at least 1 line of prior systemic therapy in the advanced or metastatic setting.
* Cohort 2 is a single-arm study of intratumoral TAVO-EP and pembrolizumab along with treatment with an approved chemotherapy per standard of care (either nab-paclitaxel (Abraxane®)or gemcitabine (Gemzar®) plus carboplatin (Paraplatin®)) in participants with TNBC and no prior systemic therapy in the advanced or metastatic setting. Participants enrolled on or after Protocol Version 7 will have baseline disease PD-L1 negative status defined as Dako 22C3 assay CPS \<10.

For participants in Cohort 2 receiving nab-paclitaxel, the schedule for nab-paclitaxel is a separate 28-day cycle. The dosing regimen of nab-paclitaxel is 100 mg/m2 IV over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.

For participants in Cohort 2 receiving gemcitabine plus carboplatin, the dosing regimen is gemcitabine 1000 mg/m² plus carboplatin area under the curve (AUC) 2 IV on Days 1 and 8 every 21 days.

Phase 2, Multi-Cohort, Open-Label, Multi-Center Study

Tavo and Pembrolizumab With or Without Chemotherapy in Patients With Inoperable Locally Advanced or Metastatic TNBC

A Phase 2 Multi-Cohort, Open-Label Study of Intratumoral Tavokinogene Telseplasmid Plus Electroporation in Combination With Pembrolizumab +/- Chemotherapy in Patients With Inoperable Locally Advanced/Metastatic Triple-Negative Breast Cancer

ORR by Investigator review based on RECIST v1.1

Cohort 1 \& Cohort 2: DOR by Investigator based on RECIST v1.1

Cohort 1 \& Cohort 2: PFS by Investigator based on RECIST v1.1

Cohort 1 \& Cohort 2: iPFS by Investigator review based on iRECIST

Cohort 1 \& Cohort 2: iORR by Investigator review based on iRECIST

Cohort 1 \& Cohort 2: DCR by Investigator based on RECIST v1.1

Cohorts 1 and 2: Overall Survival for Cohorts

Merck Sharp & Dohme LLC

OncoSec Medical Incorporated

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Treatment of Albumin paclitaxel plus carboplatin

Treatment of Gemcitabine plus carboplatin

Patients receive carboplatin AUC=5 q3w and nab-p 135 mg/m2 weekly for 2 weeks (on days 1 and 8 of a 21-day cycle), followed by a week of rest.

Albumin paclitaxel plus carboplatin

Patients receive carboplatin AUC=5 q3w and gemcitabine 1250 mg/m2 weekly for 2 weeks (on days 1 and 8 of a 21-day cycle), followed by a week of rest.

Gemcitabine plus carboplatin

Wu Yilong, professor

This trial is to study the efficacy of nab-PC vs. GC and evaluate toxicity of nab-PC in advanced squamous cell cancer of lung. The correlation between the efficacy of nab-PC and some biomarkers is also to be evaluated.

Albumin-bound paclitaxel(nab-P) utilizes the albumin binding proteins,such as (gp60)/caveolin-1 (CAV1) and SPARC(secreted protein acidic and rich in cysteine), achieving high intratumoral paclitaxel accumulation. It is reported that CAV1 is overexpressed in squamous cell cancer(SQC), so it is possible that nab-PC is more highly active than GC in SQC of lung.

Nab-Paclitaxel Treatment in Advanced Squamous Cell Carcinoma of Lung

A Randomized Phase II Clinical Trial of Nab-Paclitaxel and Carboplatin Compared With Gemcitabine and Carboplatin as First-line Therapy in Advanced Squamous Cell Carcinoma of Lung

ORR is evaluated after at most 6 cycles of chemotherapy, which may cost 18 weeks.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tavo and Pembrolizumab With or Without Chemotherapy in Patients With Inoperable Locally Advanced or Metastatic TNBC	NCT03567720	Triple Negative...	tavokinogene te... Pembrolizumab Immunopulse nab paclitaxel gemcitabine plu...	18 Years -	OncoSec Medical Incorporated
Nab-Paclitaxel Treatment in Advanced Squamous Cell Carcinoma of Lung	NCT01236716	Carcinoma, Non-...	Albumin paclita... Gemcitabine plu...	18 Years - 85 Years	Chinese Society of Lung Cancer
Nab-Paclitaxel Treatment in Advanced Squamous Cell Carcinoma of Lung	NCT01236716	Carcinoma, Non-...	Albumin paclita... Gemcitabine plu...	18 Years - 85 Years	Chinese Society of Lung Cancer

Spots Global Cancer Trial Database for gemcitabine plus carboplatin