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The goal of this study is determine the safety and tolerability of orally taken probiotic (R-5780) in patients currently on a PD-1 Pathway Checkpoint Inhibitor (checkpoint protein on immune cells called T cells) with Solid Tumors.
Patients will take an oral dosage of probiotic (R-5780 and provide patient reported overall feeling and physician scored measure of their tumors. Blood and fecal evaluations of inflammation and assessment of probiotic (R-5780) on fecal levels will also be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open Label | Other | R-5780 Probiotic |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R-5780 | Drug | Probiotic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events and their relationship to R-5780 (probiotic) administration | To assess the number of participants with treatment-related adverse events after taking R-5780 (probiotic) | Baseline through Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Scale (QOLS) | Collect how the patient is feeling on each study visit on the Quality of Life Scale of 30 questions. The Quality of Life scores are summed so that a higher score indicates higher quality of life. | Baseline through End of Study Day 112 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Janet Stephens, PhD | Contact | 650-417-8556 | jstephens@risetherapeutics.com | |
| Christian Freguia, PhD | Contact | 215-923-1818 | cfreguia@risetherapeutics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarah Cannon Research Institute | Recruiting | Nashville | Tennessee | 37203 | United States |
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Single Group Assignment
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018295 | Neoplasms, Basal Cell |
| D018307 | Neoplasms, Squamous Cell |
| D000236 | Adenoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009375 | Neoplasms, Glandular and Epithelial |
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