Colorectal carcinoma
Conditions
Interventions
Treatment with PDR001 in combination with regorafenib.
PDR001 (intraveneus) - 400mg per 4 weken
Regorafenib (oraal): startdosering 120mg/ dag. Volgende dosisnieveau:
160mg/dag.
Colorectal carcinoma
PDR001
Phase Ib
regorafenib
Sponsors
Novartis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Metastatic microsatellite stable colorectal adenocarcinoma. 2. Subjects must provide a newly obtained or an archival tumor sample corresponding to CRC diagnosis (primary tumor) with sufficient tissue quality for analysis. 3. Subjects must provide a newly obtained tumor tissue sample from a metastatic site. 4. At least one measurable lesion. 5. Previously treated with two prior regimen as per standard of care and have experienced disease progression. 6. ECOG performance status 0-1
Exclusion criteria
Exclusion criteria: 1. High level Microsatellite Instable (MSI-H) colorectal adenocarcinoma as defined per local standard of care testing. 2. Metastatic disease amenable to be resected with potentially curative surgery. 3. Chemotherapy, radiation, or biological cancer therapy within 14 days prior to the first dose of study treatment. 4. Prior treatment with anti-PD-1, anti-PD-L1, anti-PDL2, anti-CTLA-4 antibodies, other checkpoint inhibitors. 5. Any untreated CNS lesion. Exceptions: see protocol page 39. 6. Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment. 7. Use of G-CSF and comparable, see protocol page 39 for details. 8. Systemic chronic steroid therapy (* 10mg/day prednisone or equivalent) or any immunosuppressive therapy 7 days prior to start of study treatment. 9. History of severe hypersensitivity reactions to other monoclonal antibodies, see protocol page 39 for details. 10. HIV positive, HBsAg positive, hepatitis positive. 11. Active, known or suspected autoimmune disease or a documented history of autoimmune disease, see protocol page 40 for details.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Escalation phase: Incidence of DLT during the first 8 weeks of treatment Expansion phase: ORR as per RECIST 1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR, adverse events, PK parameters, Antidrug antibodies, OS. | — |
Countries
Belgium, Canada, France, Germany, Hong Kong, Israel, Italy, Japan, Korea (the Republic of), Lebanon, Netherlands, Spain, Togo, United States of America
Outcome results
None listed