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Monoclonal Antibodies
RP2/RP3 + Atezolizumab + Bevacizumab for Colorectal Cancer
Phase 2
Waitlist Available
Research Sponsored by Replimune Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from documented response to documented progression of disease (up to 3 years)
Awards & highlights
Study Summary
This trial tests a combo of 3 drugs to treat advanced colorectal cancer.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include typical reactions to immunotherapy such as fatigue, skin reactions, inflammation in organs like the liver or lungs; bleeding due to bevacizumab; plus risks associated with injection into the tumor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from documented response to documented progression of disease (up to 3 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from documented response to documented progression of disease (up to 3 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Complete Response Rate
Duration of Clinical Benefit
Duration of Response
+3 moreTrial Design
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
atezolizumab
2016
Completed Phase 2
~160
bevacizumab
2002
Completed Phase 3
~3360
Find a Location
Who is running the clinical trial?
Replimune Inc.Lead Sponsor
10 Previous Clinical Trials
1,331 Total Patients Enrolled
Roche Pharma AGIndustry Sponsor
408 Previous Clinical Trials
395,792 Total Patients Enrolled
Jaroslaw Jac, MDStudy ChairReplimune Inc.
1 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive.I have not received a live vaccine in the last 28 days.I have undergone more than 3 treatments for colorectal cancer.I do not have any infections that aren't responding to treatment.My colorectal cancer cannot be removed by surgery or has spread.I am 18 years old or older.I've had treatments aimed directly at liver tumors.My cancer is identified as MSI-H/dMMR.I haven't had a serious infection or needed IV antibiotics in the last 14 days.I have had serious herpes infections or complications.I have or had cancer spread to my brain or spinal cord.I have an autoimmune disease that needs treatment.I have had lung inflammation caused by medication that needed steroids.I haven't taken immunosuppressive drugs in the last 30 days.I haven't taken herbal supplements or traditional medicines in the last 2 weeks.My liver tumors affect more than one-third of my liver.My tumor can be injected and is at least 1cm big in total.My liver is functioning well according to specific blood test levels.My kidney function is within the required range.I am fully active or can carry out light work.I've had severe side effects from previous immune therapy that are not expected to happen again.I do not have serious heart conditions like severe heart failure, recent heart attack, or unstable angina.I haven't had major surgery in the last 28 days and don't plan any while on the study.I am taking antiviral medication regularly for herpes.I cannot safely stop my blood thinner medication for procedures, or my medication keeps my blood too thin to reduce safely.My blood counts meet the required levels for treatment.My cancer progressed or I couldn't tolerate treatments with irinotecan and oxaliplatin. I may have had EGFR or VEGFR therapies.My cancer has spread into major blood vessels.I haven't had any cancer except for minor skin, bladder, prostate, cervix, or breast cancers in the last 3 years.I agree to use effective birth control during and after treatment for the specified times.
Research Study Groups:
This trial has the following groups:- Group 1: RP2 and atezolizumab plus bevacizumab in advanced MSS and pMMR CRC
- Group 2: RP3 and atezolizumab plus bevacizumab in advanced MSS and pMMR CRC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many healthcare locations are currently hosting this experiment?
"This clinical trial is now running in 6 locations, three of which are Tampa, Cincinnati and Philadelphia. To reduce travel burdens for participants it would be best to select the closest site for enrollment."
Answered by AI
Are there any unfilled positions available within this clinical experiment?
"Clinicaltrials.gov reports that this study, which began on June 1st 2023 and was recently amended in February of the same year, is no longer recruiting patients for participation. Nevertheless, 862 other trials are still accepting applicants at present."
Answered by AI
Is the combination of RP3 and atezolizumab plus bevacizumab for use in advanced MSS and pMMR colorectal cancer authorized by the FDA?
"Data from Phase 2 trials has indicated that RP3 and atezolizumab plus bevacizumab are likely safe for use in patients with advanced MSS and pMMR CRC, so we have assigned this medication a score of 2."
Answered by AI
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