Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Colorectal Cancer

Phase 1

Completed

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: spartalizumab (PDR001); Drug: regorafenib

• Registration Number: NCT03081494
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-10
• Study First Submitted QC: 2017-03-10
• Study First Posted: 2017-03-16
• Study Start: 2017-06-09
• Primary Completion: 2019-05-07
• Study Completion: 2019-05-07
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-09
• Last Update Posted: 2020-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
spartalizumab (PDR001) + regorafenib	spartalizumab (PDR001)	Subjects with metastatic MSS CRC received a combination of spartalizumab and regorafenib.
spartalizumab (PDR001) + regorafenib	regorafenib	Subjects with metastatic MSS CRC received a combination of spartalizumab and regorafenib.

Primary Outcome Measures

Name	Time	Method
Incidence of Dose-limiting toxicity (DLT)	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 Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs) and serious adverse events (SAEs)	Up to 150 days after last administration of PDR001	Incidence of all treatment-emergent adverse events (including clinically significant changes in laboratory values, vital signs and ECG), as assessed by CTCAE v4.03.
Severity of AEs and SAEs	Up to 150 days after last administration of PDR001	Severity including dose interruptions and reductions.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇪🇸 Madrid, Spain