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Virus Therapy

A Phase I/II Study of Pexa-Vec Oncolytic Virus in Combination With Immune Checkpoint Inhibition in Refractory Colorectal Cancer

Phase 1 & 2
Waitlist Available
Led By Tim F Greten, M.D.
Research Sponsored by National Cancer Institute (NCI)
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 every 2 months until disease progression or intolerable toxicity, approximately 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether Pexa-Vec, a thymidine kinase gene-inactivated oncolytic vaccinia virus, can enhance the anti-tumor immunity induced by Pexa-Vec oncolytic viral therapy when combined with immune checkpoint inhibition.

Eligible Conditions
  • Colorectal Cancer
  • Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 2 months until disease progression or intolerable toxicity, approximately 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 2 months until disease progression or intolerable toxicity, approximately 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Grade 1-5 Adverse Events
Secondary study objectives
Number of Participants With Response
Overall Progression-free Survival
Overall Survival
+1 more
Other study objectives
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.3)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: 4/Arm B2Experimental Treatment3 Interventions
MTD of Pexa-Vec after the MTD is established+Durvalumab + Tremelimumab
Group II: 3/Arm B1 Pexa-Vec + Durvalumab +TremelimumabExperimental Treatment3 Interventions
Pexa-Vec escalation dose levels + Durvalumab +Tremelimumab
Group III: 2/Arm A2 Pexa-Vec +DurvalumabExperimental Treatment2 Interventions
Maximum tolerated dose (MTD) of Pexa-Vec after the MTD is established +Durvalumab
Group IV: 1/Arm A1 Pexa-Vec + DurvalumabExperimental Treatment2 Interventions
Pexa-Vec escalation dose levels + Durvalumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3750
Tremelimumab
2017
Completed Phase 2
~3070
Pexa-Vec
2017
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,957 Previous Clinical Trials
41,112,053 Total Patients Enrolled
Tim F Greten, M.D.Principal InvestigatorNational Cancer Institute (NCI)
20 Previous Clinical Trials
1,431 Total Patients Enrolled
~4 spots leftby Dec 2025
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