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Rollover Study for Participants Who Have Been Treated With and Are Continuing to Benefit From Opnurasib as a Single Agent or in Combination With Other Study Treatments
Sponsor: Novartis Pharmaceuticals
Summary
The purpose of this study is to allow continued access to opnurasib (JDQ443) to participants who are benefitting from treatment with opnurasib as a single agent or in combination with other study treatments in pre-defined Novartis-sponsored opnurasib studies and to continue to assess safety in these participants.
Official title: KontRASt-R: An Open-label, Multi-center, Rollover Study for Participants Who Have Been Previously Enrolled Into a Novartis-sponsored Opnurasib (JDQ443) Study and Are Continuing to Benefit From Opnurasib as a Single Agent or in Combination With Other Study Treatments
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-06-08
Completion Date
2029-09-11
Last Updated
2026-08-27
Healthy Volunteers
No
Conditions
Interventions
Opnurasib
Eligible participants will receive the same starting dose and regimen of opnurasib as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.
TNO155
Eligible participants will receive the same starting dose and regimen of any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.
trametinib
Eligible participants will receive the same starting dose and regimen of any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.
cetuximab
Eligible participants will receive the same starting dose and regimen of any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.
tislelizumab
Eligible participants will receive the same starting dose and regimen of any applicable combination drug as the last dose and regimen administered before completing the parent protocol at the time of transition to the rollover study.
Locations (15)
Novartis Investigative Site
Sint-Niklaas, Oost Vlaanderen, Belgium
Novartis Investigative Site
Leuven, Belgium
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Sherbrooke, Quebec, Canada
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Copenhagen, Denmark
Novartis Investigative Site
Bron, France
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Kashiwa, Chiba, Japan
Novartis Investigative Site
Koto Ku, Tokyo, Japan
Novartis Investigative Site
Kuching, Sarawak, Malaysia
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Pamplona, Navarre, Spain