Tavo and Pembrolizumab With or Without Chemotherapy in Patients With Inoperable Locally Advanced … (NCT03567720) | Clinical Trial Compass
UnknownPhase 2
Tavo and Pembrolizumab With or Without Chemotherapy in Patients With Inoperable Locally Advanced or Metastatic TNBC
United States, Australia65 participantsStarted 2018-10-11
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects with histologically confirmed diagnosis of inoperable locally advanced or metastatic TNBC.
. The following prior cancer therapy requirements apply to specific cohorts:
. For Cohort 1 only, subjects must have received at least 1 prior line of systemic chemotherapy or immunotherapy that includes an approved regimen.
. For Cohort 2 only, subjects has had no prior systemic therapy in the advanced/metastatic setting and must not have progression or recurrence of disease within 6 months after the last dose of systemic neoadjuvant or adjuvant treatment, if applicable.
. Subjects must have TNBC defined as estrogen (ER) receptor and progesterone (PR) receptor staining \<10% and human epidermal growth factor receptor 2 (HER2) - negative defined as immunohistochemistry (IHC) 0 to 1+
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. For Cohort 2, the participant must meet each of the following criteria:
. Has baseline PD-L1 negative disease (defined as Dako 22C3 assay CPS\<10 \[or equivalent, per sponsor agreement\]) with results provided prior to start of study drug dosing: Historic results or new local PD-L1 testing from tissue collected within 6 months and without intervening therapy prior to Cycle 1 Day 1
. Can provide a separate core or punch tumor biopsy collected at screening or archival tissue collected within 6 months (and without intervening therapy) prior to Cycle 1 Day 1
Exclusion criteria
. Subject has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
. Subject has a clinically active brain metastases or leptomeningeal metastases. Participant who has a previously treated brain metastases or untreated asymptomatic brain metastases ≤5 mm may participate provided that they are radiologically stable (ie, without evidence of progression based on imaging during study screening), clinically stable, and without requirement of steroid treatment for at least 14 days prior to the first dose of study treatment.
. Subject has had an allogenic tissue/solid organ transplant.
. Subjects with electronic pacemakers or defibrillators.
. Subject who have a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
. Subject has active hepatitis B (defined as HBsAg reactive) or active hepatitis C (defined as HCV RNA \[qualitative\] is detected). Note: Participant with a history of HBV or HCV controlled by ongoing viral suppression therapy is allowed.
. Subject has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg/day of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
. Subject has an active autoimmune disease that required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs).