National Cancer Institute (NCI)
Background: Immunotherapy is a type of treatment that works by making the body s own immune system stronger. These treatments are used for cancers such as non small cell lung cancer (NSCLC); thymic carcinoma (TC); or metastatic castrate-resistant prostate cancer (mCRPC). But these cancers may still come back after treatment. Objective: To test a new immunotherapy drug (STAR0602), alone or combined with an approved drug (nivolumab), in people with NSCLC, mCRPC, or TC. Eligibility: People aged 18 years or older with NSCLC, mCRPC, or TC that did not respond to treatment or returned after treatment. Design: Participants will be screened. They will have blood and urine tests. They will have imaging scans and a test of their heart function. STAR0602 and nivolumab are given through a needle inserted into a vein (infusion). Participants will be treated in 28-day cycles. They will receive infusions of 1 or both drugs on the first and 15th day of each cycle. They will remain in the hospital for up to 5 days after their first 2 infusions of STAR0602. Imaging scans, blood tests, and other tests may be repeated during study visits. Participants may opt to have tissue samples (biopsies) taken from their tumors. Some blood and tissue samples may be used for genetic tests. Participants may continue getting STAR0602 for up to 2 years and nivolumab for up to 6 months. Participants will have an end-of-study visit within 1 month, and follow-up phone calls 1 month and 3 months, after they stop the study drug. Long-term follow-up calls and visits will continue every 3 to 6 months for up to 5 years.
Background: * Non-small cell lung cancer (NSCLC), which encompasses three main histological subtypes (adenocarcinoma, squamous cell, large cell), accounts for approximately 85% of lung cancers. * Immunotherapy is utilized in the neoadjuvant and adjuvant settings for resectable NSCLC and is an integral component of frontline therapy for patients with metastatic disease. However, less than 50% of patients with advanced-stage NSCLC respond to immune checkpoint inhibitors (ICIs). * Among men in the United States, prostate cancer (PC) is the second leading cause of cancer-related mortality. Though…
* INCLUSION CRITERIA: * Participants must have histologically or cytologically confirmed NSCLC, mCRPC, or TC (by outside pathology report or via the NCI Laboratory of Pathology \[LP\]) that is unresectable, locally-advanced, or metastatic, and for which standard curative therapies do not exist or are no longer effective. Progressive disease must be documented prior to study entry. * The following tumor types and prior treatments will be included: * NSCLC: Participants must have received at least one prior approved line of standard therapy. Receipt of prior immune checkpoint inhibitors (ICI)…
STAR0602 is given intravenously (IV) on day 1 and 15 of every 28-day cycle for up to 24 months (24 cycles)
Nivolumab is given intravenously (IV) on day 1 and 15 of every 28-day cycle (with the exception of cycle 1 where nivolumab will only be administered on day 15) for up to 6 months (6 cycles)