Regorafenib in Combination With Pembrolizumab or Pembrolizumab for MSI-H Colorectal Cancer (NCT06006923) | Clinical Trial Compass
TerminatedPhase 2
Regorafenib in Combination With Pembrolizumab or Pembrolizumab for MSI-H Colorectal Cancer
Stopped: Terminated per directive from Bayer due to funding.
United States1 participantsStarted 2024-06-26
Plain-language summary
This is a trial of Regorafenib in combination with pembrolizumab for patients with MSI-H colorectal cancer consisting of lead-in phase examining preliminary efficacy and safety, followed by a randomized phase to further examine efficacy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Histologically confirmed mismatch repair deficient or microsatellite instability high advanced stage colorectal cancer
✓. Measurable disease (per RECIST v1.1)
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
✓. Age \> 18
✓. The patient must be able to swallow oral medication.
✓. Adequate organ function based on the following lab assessments:
✓. ANC must be ≥ 1500/mm3
✓. platelet count must be ≥ 100,000/mm3
Exclusion criteria
✕. Prior anti-programmed death 1 (anti-PD-1) or anti-cytotoxic T-lymphocyte-associated antigen 4 (anti-CTLA-4) based therapy
✕. More than 3 cycles of chemotherapy or progression of disease on first line therapy excluding adjuvant treatment and any systemic anticancer treatment within 2 weeks or 5 half-lives (whichever is shorter) prior to start of study treatment
✕. Active autoimmune disease
✕. Pregnant or lactating females
✕. Uncontrolled human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV); patients with undetectable viral load and CD4 count \> 200 will be eligible for enrollment
✕. Uncontrolled hypertension (HTN: systolic pressure \> 150 mmHg or diastolic pressure \> 90 mmHg on repeated measurements) and cardiovascular events within 12 months of start of treatment
✕. Active infection or chronic infection requiring chronic suppressive antibiotics