Description:
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.
Title
- Brief Title: 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
Clinical Trial IDs
- ORG STUDY ID:
CPDR001I2102
- SECONDARY ID:
2017-000466-30
- NCT ID:
NCT03081494
Conditions
- Metastatic Colorectal Cancer
Interventions
Drug | Synonyms | Arms |
---|
spartalizumab (PDR001) | PDR001 | spartalizumab (PDR001) + regorafenib |
regorafenib | | spartalizumab (PDR001) + regorafenib |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
spartalizumab (PDR001) + regorafenib | Experimental | Subjects with metastatic MSS CRC received a combination of spartalizumab and regorafenib. | - spartalizumab (PDR001)
- 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of Dose-limiting toxicity (DLT) |
Time Frame: | 8 Weeks |
Safety Issue: | |
Description: | 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
Measure: | Incidence of adverse events (AEs) and serious adverse events (SAEs) |
Time Frame: | Up to 150 days after last administration of PDR001 |
Safety Issue: | |
Description: | Incidence of all treatment-emergent adverse events (including clinically significant changes in laboratory values, vital signs and ECG), as assessed by CTCAE v4.03. |
Measure: | Severity of AEs and SAEs |
Time Frame: | Up to 150 days after last administration of PDR001 |
Safety Issue: | |
Description: | Severity including dose interruptions and reductions. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Novartis Pharmaceuticals |
Trial Keywords
- PDR001
- MCC
- immunotherapy
- regorafenib
- CRC
- MMS
- CMS4
- ElevatION:CRC-102
Last Updated
December 11, 2020