Trials / Terminated
TerminatedNCT05733611
RP2/RP3 in Combination With Atezolizumab and Bevacizumab for the Treatment of Patients With CRC
A Phase 2 Clinical Trial Investigating Oncolytic Immunotherapy in Combination With Atezolizumab and Bevacizumab for the Treatment of Patients With Advanced Microsatellite Stable and Mismatch Repair Proficient Colorectal Carcinoma
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Replimune, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
RP2 and RP3 are selectively replication competent herpes simplex viruses 1 (HSV-1) that express exogenous genes (RP2: GM-CSF, GALV, and anti-CTLA-4; RP3: GALV, and anti-CTLA-4 hCD40L, and h4-1BBL) intended for direct injection into suitable nonneurological solid tumors. They are genetically engineered to provide direct oncolytic tumor destruction combined with the induction of a systemic antitumor immune response. This study will evaluate whether the use of oncolytic immunotherapy, either with RP2 or RP3, can provide meaningful efficacy in combination with an anti-PD-L1 therapy (atezolizumab) and anti-VEGF therapy (bevacizumab) in patients with advanced MSS and pMMR CRC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | RP2 | Genetically modified herpes simplex type 1 virus |
| BIOLOGICAL | RP3 | Genetically modified herpes simplex type 1 virus |
| BIOLOGICAL | atezolizumab | anti-PD-L1 monoclonal antibody |
| BIOLOGICAL | bevacizumab | anti-VEGF therapy |
Timeline
- Start date
- 2023-06-29
- Primary completion
- 2025-08-18
- Completion
- 2025-08-18
- First posted
- 2023-02-17
- Last updated
- 2026-02-02
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05733611. Inclusion in this directory is not an endorsement.