RP2/RP3 in Combination With Atezolizumab and Bevacizumab for the Treatment of Patients With CRC (NCT05733611) | Clinical Trial Compass
TerminatedPhase 2
RP2/RP3 in Combination With Atezolizumab and Bevacizumab for the Treatment of Patients With CRC
Stopped: Business reasons.
United States5 participantsStarted 2023-06-29
Plain-language summary
This is an open-label, Phase 2 clinical trial evaluating therapy with an oncolytic immunotherapy (RP2 or RP3) in combination with atezolizumab and bevacizumab in patients with advanced Microsatellite Stable and Mismatch Repair Proficient Colorectal Carcinoma.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female ≥18 years of age.
✓. Histological or cytologic diagnosis of colorectal adenocarcinoma that is unresectable or metastatic.
✓. Have had disease progression or were intolerant to treatment protocols that included irinotecan and oxaliplatin. Epidermal growth factor receptor (EGFR) or vascular endothelial growth factor receptor (VEGFR) directed therapies are allowed as part of the previous therapy if indicated.
✓. Has at least 1 measurable tumor of ≥1 cm in longest diameter (or ≥1.5cm shortest diameter for lymph nodes).
✓. Has injectable tumor(s) of at least 1cm in aggregate total diameter.
✓. Must be willing to consent to provide archival tumor biopsy samples obtained within 90 days prior to Screening, or a fresh tumor biopsy collected on Day 1 of treatment or earlier.
✓. Has adequate hematologic function, including:
✓. Has adequate hepatic function, including:
Exclusion criteria
✕. Prior treatment with regorafenib, trifluridine/tipiracil, fruquintinib, and immunotherapies.
✕. Has received more than 3 lines of therapy for CRC.
✕. Has microsatellite instability-high (MSI-H)/deficient DNA mismatch repair (dMMR)disease or BRAF V600E mutation.
✕
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: From Day 1 to documented progression of disease (up to 3 years)
. Acute or chronic hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or acute or chronic hepatitis C virus (HCV; defined as HCV RNA \[qualitative\] is detected).
✕. Known human immunodeficiency virus (HIV) infection.
✕. Had systemic infection requiring intravenous (IV) antibiotics or other serious infection within 14 days prior to dosing.
✕. With active significant herpetic infections or prior complications of HSV-1 infection (eg, herpetic keratitis or encephalitis).
✕. Active or history of central nervous system (CNS) metastases and/or carcinomatous meningitis.