Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Microsatellite Stable (MSS) Colorectal Cancer
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Incidence of Dose-limiting toxicity (DLT)
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
spartalizumab (PDR001) + regorafenib
Subjects with metastatic MSS CRC received a combination of spartalizumab and regorafenib.
Intervention: spartalizumab (PDR001) (Drug)
spartalizumab (PDR001) + regorafenib
Subjects with metastatic MSS CRC received a combination of spartalizumab and regorafenib.
Intervention: regorafenib (Drug)
Outcomes
Primary Outcomes
Incidence of Dose-limiting toxicity (DLT)
Time Frame: 8 Weeks
A dose-limiting toxicity (DLT) was defined as (1) an adverse event or abnormal laboratory value (assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications) that occurred within the first 8 weeks (56 days) of treatment with PDR001 in combination with regorafenib during dose escalation part and (2) met any of the pre-defined criteria.
Secondary Outcomes
- Incidence of adverse events (AEs) and serious adverse events (SAEs)(Up to 150 days after last administration of PDR001)
- Severity of AEs and SAEs(Up to 150 days after last administration of PDR001)