Sacituzumab Govitecan and Atezolizumab Treatment for Rare Genitourinary Tumors
This phase 2 study aims to evaluate the response rate to Sacituzumab Govitecan and Atezolizumab treatment in individuals with rare genitourinary tumors.
Sacituzumab govitecan
+ Atezolizumab
Carcinoma+2
+ Carcinoma, Transitional Cell
+ Neoplasms
Treatment Study
Summary
Study start date: August 1, 2024
Actual date on which the first participant was enrolled.This clinical trial is focused on finding better treatment options for people with rare types of genitourinary (GU) cancers, including certain aggressive bladder, urinary tract, kidney, and penile cancers. These rare cancers often have a more severe progression and lack established treatments, making them challenging to manage. The study investigates the effectiveness of a drug called sacituzumab govitecan (SG), used alone or together with another drug, atezolizumab, in patients who have these specific types of cancers. The trial aims to improve the response rate to these treatments, potentially offering new hope for patients with these difficult-to-treat conditions. Participants in the study must be adults with advanced or metastatic forms of these rare cancers. The study administers the treatments intravenously; SG is given on the first and eighth day of each 21-day cycle, while atezolizumab is given on the first day of each cycle. Participants who have not previously received certain types of immunotherapy may receive both drugs. The study will continue to treat participants until their cancer shows signs of progression or they experience severe side effects, for up to five years. This research could lead to more effective therapies for these rare and aggressive cancers, potentially improving outcomes for those affected.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institutes of Health Clinical Center
Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps