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Virus Therapy

Tremelimumab for 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

Study 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

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

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
~3870
Tremelimumab
2017
Completed Phase 2
~3380
Pexa-Vec
2017
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,657 Previous Clinical Trials
40,933,633 Total Patients Enrolled
Tim F Greten, M.D.Principal InvestigatorNational Cancer Institute (NCI)
20 Previous Clinical Trials
1,431 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers are taking part in this trial?

"This clinical trial is not presently enrolling patients. Initially posted on December 7th 2017 and most recently updated January 13th 2022, further research into other trials may be necessary. Of the available studies related to colorectal cancer, there are currently 1090 recruiting participants while 342 of those are investigating Tremelimumab's efficacy."

Answered by AI

To what extent has Tremelimumab been explored in academic research?

"Currently, there are 342 trials researching Tremelimumab. Of these, 52 have advanced to Phase 3 clinical trials. The bulk of the studies for this medication can be found in Cordoba, Texas; however, it is also being tested internationally at 13120 sites worldwide."

Answered by AI

Is this the initial attempt at testing this treatment?

"Since 2007, AstraZeneca has sponsored research into the potential benefits of Tremelimumab. The initial trial involved 37 people and following its success, Phase 2 approval was granted. Now there are 342 active trials for this medication taking place in 1327 cities across 58 nations."

Answered by AI

Is there an ongoing call for volunteers in this investigation?

"At present, this specific medical study is not recruiting participants. According to the clinicaltrials.gov posting dated December 7th 2017 and updated on January 13th 2022, there are currently 1432 other trials in search of volunteers."

Answered by AI

What therapeutic benefits does Tremelimumab typically provide?

"Tremelimumab is a preferred treatment for advanced non-small cell lung cancer and metastatic ureteral carcinoma. It can also be used to treat other ailments such as unresectable stage iii disease or advance directives."

Answered by AI

What potential results are researchers expecting to observe from this trial?

"The main objective of this trial, evaluated over a 30 day period after the last treatment administration, is to measure Grade 1-5 Adverse Events in patients. Secondary outcomes include Response Rate which reflects variations in tumor size and metastasis presence/absence; Overall Progression-Free Survival (PFS) calculated as median survival time without disease progression following intervention; Percentage of Participants With 5 Month PFS determined by evaluating the median survival timeframe free from disease advancement at five months post-treatment; Disease Progression defined by an increase greater than 20% observed between smallest sum on study (including baseline if applicable) and current sum."

Answered by AI
~5 spots leftby Apr 2025