Clinical trial NCT03081494: Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Colorectal Cancer
Official title: Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Microsatellite Stable (MSS) Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Colorectal Cancer
Keywords: PDR001
MCC
immunotherapy
regorafenib
CRC
MMS
CMS4
ElevatION:CRC-102
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2017-03-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Phase 1b study, dose escalation (N=\~12). One single arm: PDR001 in combination with regorafenib
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Dose-limiting toxicity (DLT)
timeFrame: 8 Weeks
Secondary outcomes:
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Up to 150 days after last administration of PDR001
measure: Severity of AEs and SAEs
timeFrame: Up to 150 days after last administration of PDR001
Other outcomes:
Locations:
city: St Leonards
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Murdoch
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Tel Aviv
country: Israel
facility: Novartis Investigative Site
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Rozzano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Leiden
country: Netherlands
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Madrid
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: