Trials / Completed
CompletedNCT03081494
Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Colorectal Cancer
Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Microsatellite Stable (MSS) Colorectal Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This was a phase Ib study of PDR001 in combination with regorafenib in adult patients with previously treated metastatic microsatellite stable (MSS) colorectal cancer. The study assessed primarily the safety and tolerability of PDR001 in combination with regorafenib.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | spartalizumab (PDR001) | 100 mg lyophilisate in vial received 400 mg every 4 weeks |
| DRUG | regorafenib | 120 mg once daily first 21 days of each 28-day cycle (=4 weeks) |
Timeline
- Start date
- 2017-06-09
- Primary completion
- 2019-05-07
- Completion
- 2019-05-07
- First posted
- 2017-03-16
- Last updated
- 2020-12-11
Locations
11 sites across 8 countries: Australia, Canada, Israel, Italy, Netherlands, Singapore, South Korea, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03081494. Inclusion in this directory is not an endorsement.