Purpose of this Study
To join this study, patients must have bladder cancer proven by a lab test. The cancer must be in stages called cT2 to T3 and must not have spread to the lymph nodes or other parts of the body. Before joining, patients need a surgery called TURBT to remove as much of the tumor as possible.
Patients also need scans of the chest, belly, and pelvis using CT or MRI to make sure the cancer has not spread. If any lymph nodes look big, they must be tested to show there is no cancer. Patients cannot have cancer that has spread or certain types of bladder cancer.
Patients must be 18 or older. They cannot have had radiation to the pelvis before. If they had other treatments, any side effects must be mostly gone.
Who Can Participate?
Eligibility
To join this study, patients must have a new diagnosis of cervical cancer confirmed by a lab test. The cancer can be one of these types: squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma. The cancer must be locally advanced, which means it has grown but has not spread far. It can be stage III or stage IVA.
Patients cannot have had their whole uterus removed for cervical cancer, but if part of the uterus was removed for another reason, they can still join. They cannot plan to have their uterus removed as part of their treatment. The cancer cannot have spread to certain lymph nodes high in the body.
Patients must not have had surgery, radiation, or medicine for cervical cancer before. They also cannot have had immunotherapy or radiation to the pelvis for any reason. Patients must be 18 or older.
Age Range
18-110
Sex/Genders
Female (cisgender)
Non-binary or gender fluid
Transgender male
Looking for Healthy Participants
No
What is Involved?
Description
The purpose of this study is to compare two ways of treating cancer. The first way uses the usual treatment: chemoradiation with pembrolizumab, followed by more pembrolizumab. The second way adds an extra step before the usual treatment. This extra step is called induction therapy and includes chemotherapy (carboplatin and paclitaxel) plus pembrolizumab. Adding this step might help shrink the cancer or stop it from coming back.
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
NRG-GY037, A Phase III study of induction pembrolizumab and chemotherapy followed by chemoradiation and pembrolizumab versus chemoradiation and pembrolizumab both followed by pembrolizumab for high risk locally advanced cervical cancer.
Principal Investigator
Diandra
Ayala-Peacock
Protocol Number
PRO00119327
NCT ID
NCT07061977
Phase
III
Enrollment Status
Pending Open to Enrollment