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Checkpoint Inhibitor

Tremelimumab for Cholangiocarcinoma

Phase 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 at 6 months
Awards & highlights

Study Summary

This trial will evaluate the combination of tremelimumab and durvalumab (with ablative therapies) in patients with advanced hepatocellular carcinoma (HCC) and biliary tract carcinomas (BTC).

Eligible Conditions
  • Cholangiocarcinoma
  • Bile Duct Cancer
  • Biliary Tract Cancer
  • Liver Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 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
6 Month Progression Free Survival (PFS)
Secondary outcome measures
Number of Grades 1-5 Adverse Events Related to Tremelimumab and Durvalumab
Other outcome measures
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

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

4Treatment groups
Experimental Treatment
Group I: 4/A4 - Durvalumab + Tremelimumab+ CryoablationExperimental Treatment3 Interventions
Durvalumab + Tremelimumab+ Cryoablation
Group II: 3/A3 - Durvalumab + Tremelimumab+ Radiofrequency Ablation (RFA)Experimental Treatment3 Interventions
Durvalumab + Tremelimumab+ RFA
Group III: 2/A2 - Durvalumab + Tremelimumab + Trans-arterial Catheter Chemoembolization (TACE)Experimental Treatment3 Interventions
Durvalumab + Tremelimumab + TACE
Group IV: 1/A1-Durvalumab + TremelimumabExperimental Treatment2 Interventions
Durvalumab + Tremelimumab
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
Trans-arterial Catheter Chemoembolization (TACE)
2016
Completed Phase 2
~60
Radiofrequency Ablation (RFA)
2016
Completed Phase 2
~130
Cryoablation
2016
Completed Phase 2
~1040

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,648 Previous Clinical Trials
40,931,690 Total Patients Enrolled
101 Trials studying Cholangiocarcinoma
9,716 Patients Enrolled for Cholangiocarcinoma
Tim F Greten, M.D.Principal InvestigatorNational Cancer Institute (NCI)
20 Previous Clinical Trials
1,411 Total Patients Enrolled
3 Trials studying Cholangiocarcinoma
513 Patients Enrolled for Cholangiocarcinoma

Frequently Asked Questions

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

Is this the pioneering effort of its kind?

"Globally, there are 340 ongoing studies involving Tremelimumab in 1327 cities and 58 countries. This drug was first trialed back in 2007 by AstraZeneca with 37 participants for Phase 2 approval. Over the last 14 years, 168 of these trials have been finalized."

Answered by AI

Are there any possible risks associated with Tremelimumab treatments?

"Tremelimumab has shown some promise in terms of safety, earning a score of 2. Nonetheless, there is yet to be any clinical data demonstrating its efficacy on humans."

Answered by AI

Is there still capacity for volunteers in this research endeavor?

"The records on clinicaltrials.gov indicate that this trial is no longer in need of recruits. The study first went live on July 5th 2016 and was last updated March 1st 2022, but there are 3229 other trials actively seeking patients right now."

Answered by AI

Has Tremelimumab been previously investigated in any other research?

"Currently, 340 live clinical trials are researching Tremelimumab worldwide. Of those, 52 have entered Phase 3 testing and the majority of these can be found in Cordoba, Texas. However, there is a total of 13083 locations hosting studies for this medication."

Answered by AI

In what medical contexts is Tremelimumab commonly employed?

"Tremelimumab is a valuable treatment option for many patients with unresectable stage iii non-small cell lung cancer, as well as those suffering from previously untreated metastatic ureter urothelial carcinoma and advanced directives."

Answered by AI

How many volunteers are currently enrolled in this medical research study?

"Unfortunately, this clinical trial is not presently enrolling new patients. It was initially listed on July 5th 2016 with the most recent update occurring in March 2021. Fortunately, there are 2889 studies seeking cholangiocarcinoma patients and 340 trials conducting research into Tremelimumab that are actively recruiting participants."

Answered by AI
Recent research and studies
~6 spots leftby Apr 2025