RP2/RP3 + Atezolizumab + Bevacizumab for Colorectal Cancer

Recruiting in Palo Alto (17 mi)

+24 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Replimune Inc.

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults with advanced colorectal cancer that's spread or can't be removed by surgery, who've had progression after treatment with irinotecan and oxaliplatin. They must have a measurable tumor, adequate organ function, agree to use effective contraception if of childbearing potential, and not have other active cancers or significant heart disease.

Inclusion Criteria

Capable of giving signed informed consent which includes willingness to comply with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

My colorectal cancer cannot be removed by surgery or has spread.

I am 18 years old or older.

+11 more

Exclusion Criteria

Had a significant bleeding event within the last 12 months that places the patient at unjustifiable risk for bleeding from deep intratumoral injection procedures based on Investigator assessment or interventional radiologist assessment

I am HIV positive.

I have not received a live vaccine in the last 28 days.

+24 more

Participant Groups

The trial is testing the combination of RP2/RP3 oncolytic immunotherapies with atezolizumab (a drug that helps the immune system fight cancer) and bevacizumab (which inhibits blood vessel growth in tumors), for patients whose colorectal cancer has resisted standard treatments.

2Treatment groups

Experimental Treatment

Group I: RP3 and atezolizumab plus bevacizumab in advanced MSS and pMMR CRCExperimental Treatment3 Interventions

RP3 will be injected by direct (including via colonoscope) or image-guided injection into injectable tumors (including subcutaneous, visceral, and nodal tumors).

Group II: RP2 and atezolizumab plus bevacizumab in advanced MSS and pMMR CRCExperimental Treatment3 Interventions

RP2 will be injected by direct (including via colonoscope) or image-guided injection into injectable tumors (including subcutaneous, visceral, and nodal tumors).

Atezolizumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tecentriq for: