Hemopurifier Plus Pembrolizumab in Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT04453046|
Recruitment Status : Recruiting
First Posted : July 1, 2020
Last Update Posted : October 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma of the Head and Neck||Device: Hemopurifier Drug: Pembrolizumab 200mg IV||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This trial will evaluate the use of the Hemopurifier in combination with pembrolizumab (Keytruda) in patients with advanced and/or metastatic head and neck cancer. The Hemopurifier is a blood filtration device similar to a kidney dialysis cartridge which is designed to remove small particles called exosomes from the blood. Exosomes are believed to be involved in suppression of the immune system in cancer patients. The study will evaluate whether pretreatment with the Hemopurifier before administration of pembrolizumab is safe and well tolerated and results in lower numbers of exosomes in the blood.|
|Masking:||None (Open Label)|
|Official Title:||Depleting Exosomes to Improve Response to Immune Therapy in Head and Neck Squamous Cell Cancer: An Early Feasibility Phase I Clinical Trial|
|Actual Study Start Date :||October 22, 2020|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||July 2023|
Experimental: Hemopurifier and Pembrolizumab
In this clinical trial, the exosome-depleting device, the Hemopurifier, will be combined with standard of care therapy, Pembrolizumab. The purpose of the combination is to more effectively reduce immune suppression and provide a combined benefit of immune restoration for patients with recurrent/metastatic HNSCC. Therapy with the Hemopurifier will be initiated on the same day as and prior to Pembrolizumab infusion. The Hemopurifier treatment will be 4h. The subject treated with the Hemopurifier will remain in the Hemopurifier treatment area for the duration of the treatment. Pembrolizumab infusion will take place shortly after Hemopurifier treatment and may take place through the next day if needed.
Two Hemopurifier treatments on Day 1 and Day 21
Drug: Pembrolizumab 200mg IV
Pembrolizumab 200mg IV will be administered every 21 days. One cycle is 21 days. All patients will be treated with Pembrolizumab for up to 34 cycles
- Safety as measured by adverse events [ Time Frame: Through study completion - Safety assessments will be completed at each study visits and up to two years after entry on protocol or until disease progression ]Safety will be determined in an Early Feasibility Phase I clinical trial for patients with recurrent/metastatic HNSCC who will undergo therapy with first line Pembrolizumab per standard of care combined with Hemopurifier treatments . All patients will be treated with Pembrolizumab every 21 days and, during active treatment, imaging will be done after every 3rd cycle as per standard of care. As part of the first two cycles of Pembrolizumab patients will receive Hemopurifier therapy immediately prior to Pembrolizumab infusion. The Hemopurifier therapy will last 4h and patients will receive their Pembrolizumab dose as soon as logistically possible, after Hemopurifier therapy on the same day.
- Adverse Events [ Time Frame: Day 1, Day 21, through study completion, up to two years ]Adverse events will be graded using CTCAE v5. The proportion of patients experiencing serious adverse events at least possibly related to treatment with Hemopurifier plus Pembrolizumab will be estimated with an exact 95% binomial confidence interval. Toxicity will be assessed continuously, and the trial will be paused if any patient experiences a treatment-related Grade 3 or worse adverse event. The rule is based on a beta-binomial model with an uninformative prior (α=1, β=1), where the trial is paused if P(P(Toxicity|Data and Prior)>0.3)>0.75.
- Levels of exosomes [ Time Frame: Through study completion - up to two years after entry on protocol or until disease progression ]Kinetics of exosome depletion will be studied by drawing venous blood hourly starting immediately before, hourly during and immediately after each Hemopurifier treatment until Pembrolizumab treatment begins, for measuring total exosome protein level (TEP) and immunoinhibitory protein and miRNA profiles in the systemic circulation. Kinetics of exosome recovery will be studied by measuring TEP levels immediately prior to Pembrolizumab administration, and on days 7 and 14 after the first 2 cycles where patients are treated with Hemopurifier plus Pembrolizumab. Blood will be collected prior to each Hemopurifier treatment and each Pembrolizumab infusion for serial monitoring of TEP levels and immunoinhibitory protein and miRNA profiles.
- Tumor response [ Time Frame: Through study completion- up to two years or until disease progression ]CT imaging will be done after every 3rd cycle as per standard of car. If the patient 2 years of treatment and remains with CR/PR or SD, patient will undergo imaging every 3 months or sooner at the discretion of the treating physician. If a patient is taken off the study for progression, adverse events, or any other reason they will be seen 30 days afterwards for follow up followed by survival follow up every 3 months in the first year and every 6 months in the second year after withdrawal from study.
- Survival [ Time Frame: Through study completion - up to two years or until disease progression ]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): NCT04453046
|Contact: Jennifer Ruth, RNemail@example.com|
|Contact: Lisa Boswellfirstname.lastname@example.org|
|United States, Pennsylvania|
|UPMC Hillman Cancer Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Contact: Jennifer Ruth, RN, BSN, CCRP 412-623-8963 email@example.com|
|Principal Investigator: Dan Zandberg, MD|
|Principal Investigator:||Dan Zandberg, MD||UPMC Hillman Cancer Center|