Trial details

Trial short name: TIME

Official title: Tumor Immunotherapy and MicrobiomE Analysis

Principal Investigator: Dr. Rosanna Pezo

Cancer type: Melanoma
Cancer location: Melanoma
Disease stage: Advanced Cancer
Trial phase: Other
Intervention: None (Sample Collection Only)

Registration #:

Trial description:
The purpose of this study is to look at the role of gut bacteria in the intestines of patients and how the bacteria responds to anti-cancer drugs. Adult patients who are being treated or about to be treated with immunotherapy for advanced/unresectable or metastatic solid tumors and who also meet certain other criteria may be able to participate. All patients participating in this study will be asked to consent and provide blood and stool samples.

Eligibility Criteria: • Must provide signed informed consent. Adult patients ≥ 18 years of age. Eastern Cooperative Oncology Group performance status 0 or 1 • Histologic diagnosis of advanced/unresectable or metastatic solid tumor (including but not limited to melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, bladder, Merkel cell carcinoma and squamous cell carcinoma of skin) • Measurable disease as per RECIST 1.1 criteria • Be suitable for treatment or receiving treatment with immune checkpoint inhibitor therapy (anti-CTLA-4 and/or anti-PD-1/PD-L1) for advanced/unresectable or metastatic solid tumor. • Receipt of prior immune checkpoint inhibitor in the adjuvant setting is allowed • Patients who receive immune checkpoint inhibitors as standard of care or as part of a clinical trial at our institution will be eligible for study participation • Be able to perform stool sample collection as required and to undergo phlebotomy procedures • No history of inflammatory bowel disease, chronic diarrhea or malabsorption syndromes and no prior bowel resection • Must be able to undergo phlebotomy and stool sample collection