Purpose of this Study
The study starts with a screening period that lasts about 4 weeks and includes 1 or 2 visits. Treatment can last up to about 2 years with up to 43 visits. After treatment ends, follow-up continues for about 1 year with up to 6 visits. The study medicine is given through an IV every 3 weeks, and each visit lasts about 60 minutes.
In Part 1 of the study, researchers test the medicine BMS 986525 by itself or with another medicine called nivolumab to find a safe dose. In Part 2, the chosen dose or doses are tested in larger groups. If more than one dose is available, a computer may randomly choose which dose a person receives.
Who Can Participate?
Eligibility
People can join this study if they are 18 years or older. They also must have a tumor sample from an earlier biopsy that can be used for testing.
Age Range
18-100
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study wants to learn if a medicine called BMS 986525 is safe, what side effects it may cause, and what dose works best. It is tested in people who have a type of lung cancer called relapsed or refractory small cell lung cancer. The medicine is given either by itself or with another medicine called nivolumab.
In Part 1, researchers try different doses to find the safest amount that still works well. In Part 2, they test the chosen dose or doses in larger groups to see how well people handle them and how the treatment works.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 1/2 Study of BMS-986525 as Monotherapy and in Combination with
Nivolumab in Participants with Relapsed/Refractory Small Cell Lung Cancer (CA258-0001)
Nivolumab in Participants with Relapsed/Refractory Small Cell Lung Cancer (CA258-0001)
Principal Investigator
Neal
Ready
Protocol Number
PRO00119463
NCT ID
NCT07325136
Phase
I/II
Enrollment Status
Pending Open to Enrollment