NCT04761744

A Phase II Study of Nivolumab in Patients With Genetic Alterations in DNA Damage Repair and Response Who Progressed After Standard Treatment for Metastatic Solid Cancers

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Korean Cancer Study Group · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

A Phase II Study of Nivolumab in Patients with Genetic alterations in DNA Damage repair and response Who Progressed after Standard treatment for Metastatic Solid Cancers

Detailed description

All the patients will be included in the final analysis, with a total of 48 patients to be enrolled. Treatment will occur until disease progression, unacceptable toxicity or patient withdrawal. Study treatment consists of nivolumab 3mg/kg, and will be repeated every 2 weeks. Response evaluation will be performed every 6 weeks (+/- 1 week window period is allowed).

Conditions

• DDR Gene Mutation
• Metastatic Solid Tumor

Interventions

Type	Name	Description
DRUG	Nivolumab	Study treatment consists of nivolumab 3mg/kg, and will be repeated every 2 weeks.

Timeline

• Start date: 2019-06-14
• Primary completion: 2021-03-01
• Completion: 2021-12-01
• First posted: 2021-02-21
• Last updated: 2021-02-21

Locations

2 sites across 1 country: South Korea