Tremelimumab for Cholangiocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cholangiocarcinoma+7 More
Tremelimumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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
  • Liver carcinoma
  • Bile Duct Carcinoma
  • Liver Cancer
  • Biliary Tract Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 6 month

6 month
Progression free survival
Day 60
Safety
Month 89
Number of Grades 1-5 Adverse Events Related to Tremelimumab and Durvalumab
At 6 months
6 Month Progression Free Survival (PFS)
Month 62
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Durvalumab and Tremelimumab
38%Fatigue
21%Diarrhea
17%Maculopapular rash
17%Fever
17%Pruritus
17%Nausea
17%Anorexia
14%Rash maculo-papular
14%Constipation
10%Itching
10%Abdominal pain
10%Anemia
7%Weight loss
7%Dehydration
7%Cough
7%Dry Skin
7%Hypothyroidism
7%Non-cardiac chest pain
This histogram enumerates side effects from a completed 2019 Phase 2 trial (NCT03007407) in the Durvalumab and Tremelimumab ARM group. Side effects include: Fatigue with 38%, Diarrhea with 21%, Maculopapular rash with 17%, Fever with 17%, Pruritus with 17%.

Trial Design

8 Treatment Groups

1/A1
1 of 8
2/A2
1 of 8
4/A4
1 of 8
3/A3
1 of 8
1/A1-Durvalumab + Tremelimumab
1 of 8
4/A4 - Durvalumab + Tremelimumab+ Cryoablation
1 of 8
2/A2 - Durvalumab + Tremelimumab + Trans-arterial Catheter Chemoembolization (TA...
1 of 8
3/A3 - Durvalumab + Tremelimumab+ Radiofrequency Ablation (RFA)
1 of 8

Experimental Treatment

54 Total Participants · 8 Treatment Groups

Primary Treatment: Tremelimumab · No Placebo Group · Phase 2

1/A1Experimental Group · 2 Interventions: Tremelimumab, Durvalumab · Intervention Types: Drug, Drug
2/A2Experimental Group · 3 Interventions: Tremelimumab, TACE, Durvalumab · Intervention Types: Drug, Procedure, Drug
4/A4Experimental Group · 3 Interventions: Tremelimumab, Cryoablation, Durvalumab · Intervention Types: Drug, Procedure, Drug
3/A3Experimental Group · 3 Interventions: Tremelimumab, RFA, Durvalumab · Intervention Types: Drug, Procedure, Drug
1/A1-Durvalumab + TremelimumabExperimental Group · 2 Interventions: Tremelimumab, Durvalumab · Intervention Types: Drug, Drug
4/A4 - Durvalumab + Tremelimumab+ CryoablationExperimental Group · 3 Interventions: Tremelimumab, Cryoablation, Durvalumab · Intervention Types: Drug, Procedure, Drug
2/A2 - Durvalumab + Tremelimumab + Trans-arterial Catheter Chemoembolization (TACE)Experimental Group · 3 Interventions: Tremelimumab, Durvalumab, Trans-arterial Catheter Chemoembolization (TACE) · Intervention Types: Drug, Drug, Procedure
3/A3 - Durvalumab + Tremelimumab+ Radiofrequency Ablation (RFA)Experimental Group · 3 Interventions: Radiofrequency Ablation (RFA), Tremelimumab, Durvalumab · Intervention Types: Procedure, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiofrequency Ablation (RFA)
2016
N/A
~70
Tremelimumab
Not yet FDA approved
Cryoablation
2016
Completed Phase 2
~930
TACE
2019
Completed Phase 3
~3250
RFA
2014
Completed Phase 2
~1650
Durvalumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 month

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,005 Previous Clinical Trials
41,301,873 Total Patients Enrolled
91 Trials studying Cholangiocarcinoma
7,289 Patients Enrolled for Cholangiocarcinoma
Tim F Greten, M.D.Principal InvestigatorNational Cancer Institute (NCI)
20 Previous Clinical Trials
1,406 Total Patients Enrolled
3 Trials studying Cholangiocarcinoma
541 Patients Enrolled for Cholangiocarcinoma

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be between the ages of 18 and 65 years old.\n
You have liver cirrhosis.
leukocytes greater than or equal to 3,000/mcL.
Platelets greater than or equal to 60,000/mcL.
You have a performance status of 0-2.
Absolute neutrophil count greater than or equal to 1,000/mcL.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 6th, 2021

Last Reviewed: November 16th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References