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

Metastatic Colorectal Cancer Clinical Trial

Official title:

Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Microsatellite Stable (MSS) Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03081494
• Other study ID #: CPDR001I2102
• Secondary ID: 2017-000466-30
• Status: Completed
• Phase: Phase 1
• Start date: June 9, 2017
• Est. completion date: May 7, 2019

Study information

• Verified date: December 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 7, 2019
• Est. primary completion date: May 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key inclusion criteria:

1. Patients with metastatic colorectal adenocarcinoma.

2. Patients must provide a newly obtained or an archival tumor sample corresponding to CRC diagnosis (primary tumor) with sufficient tissue quality (qualified) for analysis

3. Patients must provide a newly obtained tumor tissue sample from a metastatic site

4. Patients with the presence of at least one lesion with measurable disease as per RECIST

5. Patients previously treated with two prior regimen as per standard of care and have experienced disease progression (including -VEGF and EGFR targeted therapies (if KRAS wild).

6. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Key exclusion criteria:

1. Patients with MSI-H colorectal adenocarcinoma as defined per local assessment using standard of care testing

2. Patients with metastatic disease amenable to be resected with potentially curative surgery

3. Patients who have had chemotherapy, radiation, or biological cancer therapy within 14 days prior to the first dose of study treatment

4. Patients with a history of prior treatment with anti-PD-1, anti-PD-L1, anti-PDL2, anti- CTLA-4 antibodies, other checkpoint inhibitors

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• spartalizumab (PDR001)
100 mg lyophilisate in vial received 400 mg every 4 weeks
• regorafenib
120 mg once daily first 21 days of each 28-day cycle (=4 weeks)

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Murdoch	Western Australia
Australia	Novartis Investigative Site	St Leonards	New South Wales
Canada	Novartis Investigative Site	Montreal	Quebec
Israel	Novartis Investigative Site	Tel Aviv
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Rozzano	MI
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Netherlands	Novartis Investigative Site	Leiden
Singapore	Novartis Investigative Site	Singapore
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Canada,  Israel,  Italy,  Korea, Republic of,  Netherlands,  Singapore,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Dose-limiting toxicity (DLT)	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.	8 Weeks
Secondary	Incidence of adverse events (AEs) and serious adverse events (SAEs)	Incidence of all treatment-emergent adverse events (including clinically significant changes in laboratory values, vital signs and ECG), as assessed by CTCAE v4.03.	Up to 150 days after last administration of PDR001
Secondary	Severity of AEs and SAEs	Severity including dose interruptions and reductions.	Up to 150 days after last administration of PDR001

External Links

•   A Plain Language Trial Summary is available on novartisclinicatrials.com
•   Novartis results database