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Checkpoint Inhibitor

Tremelimumab for Liver Metastases

Phase 1
Waitlist Available
Led By Michael J Overman
Research Sponsored by M.D. Anderson Cancer Center
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 up to 1.5 years
Awards & highlights

Study Summary

This trial is testing tremelimumab and durvalumab to see if they can treat colorectal cancer that has spread to the liver.

Eligible Conditions
  • Liver Metastases
  • Resectable Mass
  • Colorectal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility: number of patients who successfully go to surgery after treatments, scans, and biopsy
Incidence of adverse events

Side effects data

From 2019 Phase 2 trial • 33 Patients • NCT03007407
38%
Fatigue
21%
Diarrhea
17%
Pruritus
17%
Maculopapular rash
17%
Anorexia
17%
Nausea
17%
Fever
14%
Rash maculo-papular
14%
Constipation
10%
Itching
10%
Anemia
10%
Abdominal pain
7%
Cough
7%
Dry Skin
7%
Dehydration
7%
Hypothyroidism
7%
Non-cardiac chest pain
7%
Weight loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalumab and Tremelimumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (tremelimumab, durvalumab)Experimental Treatment4 Interventions
Patients receive tremelimumab IV over 1 hour and durvalumab IV over 4 hours during week 11. Between weeks 15 and 17, patients undergo liver surgery. Patients then receive durvalumab IV over 1 hour during weeks 21, 25, 29, and 33.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tremelimumab
2017
Completed Phase 2
~3380
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9850
Durvalumab
2017
Completed Phase 2
~3870

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,971 Previous Clinical Trials
1,787,194 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,467 Total Patients Enrolled
Michael J OvermanPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
296 Total Patients Enrolled

Frequently Asked Questions

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

Has this clinical trial been conducted before, or is it an innovative approach?

"Since its initial clinical study in 2007, sponsored by AstraZeneca and involving 37 participants, Tremelimumab has been approved for Phase 2 testing. Presently, it is being trialled at 340 sites across 1327 cities in 58 countries worldwide."

Answered by AI

How many individuals are involved in this experiment?

"This clinical trial is now closed to enrollment. It was initially posted on July 28th, 2016 and concluded its recruitment period after the last edit that occurred on September 7th 2022. However, if you are seeking similar trials there are currently 861 studies looking for participants with resectable mass and 340 trials accepting patients into their Tremelimumab program."

Answered by AI

Are there any associated dangers with the intake of Tremelimumab?

"Our assessment of tremelimumab's safety yielded a score of 1, indicating that there is limited data from clinical trials backing up this medication's efficacy and harmlessness."

Answered by AI

Are there any opportunities currently available to join this research?

"The study that is outlined on clinicaltrials.gov, which was initially posted in July 2016 and last edited in September 2022, is no longer recruiting candidates. However, there are 1201 other trials across the world for potential participants to consider at this time."

Answered by AI

What clinical indications is Tremelimumab most regularly employed for?

"Tremelimumab is typically prescribed to patients with stage III non-small cell lung cancer that cannot be surgically removed. It has also been utilized in cases of metastatic urothelial carcinoma and advanced directives, among other conditions."

Answered by AI

Are there any other trials that have studied the effects of Tremelimumab?

"Currently, 340 medical studies are testing the efficacy of Tremelimumab. Out those trials, 52 have progressed to Phase 3 and 13107 sites are conducting them across the world - with a particularly large concentration in Cordoba, Texas."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Tremelimumab and Durvalumab in Treating Patients With Colorectal Cancer With Liver Metastases That Can Be Removed by Surgery
2016. "Tremelimumab and Durvalumab in Treating Patients With Colorectal Cancer With Liver Metastases That Can Be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02754856.
~3 spots leftby Apr 2025
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