32 Participants Needed

Tremelimumab + Durvalumab for Liver Cancer

SA
EG
Overseen ByEpp Goodwin
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: The University of Texas Health Science Center at San Antonio
Must be taking: Antivirals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot use any immunosuppressive medication within 14 days before starting the trial drugs, except for certain low-dose steroids and specific types of steroid treatments.

What data supports the effectiveness of the drug combination of Tremelimumab and Durvalumab for liver cancer?

The combination of Tremelimumab and Durvalumab has been shown to improve overall survival in patients with liver cancer that cannot be removed by surgery, as demonstrated in the HIMALAYA study. This study found that patients receiving this drug combination lived longer on average compared to those receiving another treatment called sorafenib.12345

Is the combination of Tremelimumab and Durvalumab safe for humans?

The combination of Tremelimumab and Durvalumab has been studied for safety in various cancers, including liver cancer. Common side effects include rash, fatigue, diarrhea, itching, muscle pain, and abdominal pain. Serious side effects occurred in about 32.6% of patients, which is higher compared to using Durvalumab alone.12367

What makes the drug combination of Tremelimumab and Durvalumab unique for liver cancer?

The combination of Tremelimumab and Durvalumab is unique for liver cancer because it uses a dual immunotherapy approach, where Tremelimumab blocks CTLA-4 (a protein that downregulates the immune system) and Durvalumab blocks PD-L1 (a protein that helps cancer cells evade the immune system), enhancing the body's ability to fight cancer. This combination has shown improved overall survival compared to the standard treatment with sorafenib in patients with inoperable liver cancer.12378

What is the purpose of this trial?

This is a single-arm, phase II study of patients with advanced liver cancer or hepatocellular carcinoma (HCC) who are eligible for first-line treatment with T300+D. The invesitgators hypothesize that T300+D will be safe and tolerated in CP-B patients with HCC. HCC mostly affects disadvantaged populations with higher rates among racial/ethnic minorities, who are often not included in clinical trials (i.e., Hispanics, Blacks, underserved, low socioeconomic status) and present with more severe disease. Given there is not much data in the US patient cohort, this study provides a chance to gain that knowledge.

Research Team

Sukeshi Patel Arora, MD | UT Health San ...

Sukeshi P Arora, MD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Eligibility Criteria

This trial is for adults with advanced liver cancer or hepatocellular carcinoma who are fit for first-line treatment. It's especially aimed at those often underrepresented in trials, like racial/ethnic minorities and individuals from low socioeconomic backgrounds. Participants must have a specific level of liver impairment known as Child-Pugh-B cirrhosis.

Inclusion Criteria

I am willing and able to follow the study's treatment and visit schedule.
Must have a life expectancy of at least 12 weeks
I weigh more than 30 kilograms.
See 7 more

Exclusion Criteria

Active substance abuse or alcohol abuse at the time of consent or enrollment, which in the opinion of the treating physician would interfere with the safety of the patient and/or adherence to the study protocol
I don't have any other cancers that could affect this treatment's safety or results.
I have had treatment for advanced liver cancer before.
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks
1 visit (in-person)

Treatment

Priming dose of tremelimumab 300 mg IV once with durvalumab 1500 mg IV on Day 1 of each 4-week cycle. Patients will stay on study treatment until evidence of disease progression, unacceptable toxicity, or death.

Variable (until disease progression or unacceptable toxicity)
1 visit per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment. A repeat CT/MRI scan will be performed after 2 cycles to evaluate response. Serum tumor marker AFP and CT/MRI scans will be repeated at least every 2 cycles.

Up to 1 year
Every 8 weeks (in-person)

Treatment Details

Interventions

  • Tremelimumab and Durvalumab
Trial Overview The study tests the combination of two drugs, Tremelimumab and Durvalumab (T300+D), on patients with advanced liver cancer to see if it's safe and can be tolerated. This phase II trial does not compare against other treatments but aims to gather safety data specifically in a diverse patient population.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Stride (Single T Regular Interval D) ArmExperimental Treatment2 Interventions
Tremelimumab dosed once at the beginning of the first cycle, 300mg IV infusion and Durvalumab 1500mg IV dosed with the first dose of Tremelimumab and then once per cycle (every 4 weeks)

Tremelimumab and Durvalumab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Imjudo and Imfinzi for:
  • Unresectable hepatocellular carcinoma
  • Metastatic non-small cell lung cancer
🇪🇺
Approved in European Union as Imjudo and Imfinzi for:
  • Advanced liver cancer
  • Non-small cell lung cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials
486
Recruited
92,500+

AstraZeneca

Industry Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Findings from Research

The combination of durvalumab and tremelimumab showed improved disease control rates in patients with head and neck squamous cell carcinoma compared to tremelimumab alone, indicating its potential efficacy in this cancer type.
The combination therapy had a tolerable safety profile, with no significant increase in treatment-related adverse events compared to monotherapy, suggesting it is a safe option for patients.
Durvalumab and tremelimumab combination therapy versus durvalumab or tremelimumab monotherapy for patients with solid tumors: A systematic review and meta-analysis.Wang, BC., Li, PC., Fan, JQ., et al.[2022]
The FDA approved tremelimumab in combination with durvalumab for treating unresectable hepatocellular carcinoma based on the HIMALAYA study, which showed a significant improvement in overall survival (OS) compared to sorafenib, with a median OS of 16.4 months versus 13.8 months.
Common adverse reactions in patients receiving the combination treatment included rash, fatigue, diarrhea, and abdominal pain, occurring in 20% or more of patients, indicating the need for monitoring during treatment.
FDA Approval Summary: Tremelimumab in combination with durvalumab for the treatment of patients with unresectable hepatocellular carcinoma.Patel, TH., Brewer, JR., Fan, J., et al.[2023]
In the phase III HIMALAYA trial, patients with inoperable hepatocellular carcinoma who received a single dose of tremelimumab combined with monthly durvalumab showed improved overall survival compared to those treated with sorafenib.
This suggests that the combination therapy may be a more effective first-line treatment option for this type of liver cancer.
Dual Immunotherapy Makes Strides against HCC.[2022]

References

Durvalumab and tremelimumab combination therapy versus durvalumab or tremelimumab monotherapy for patients with solid tumors: A systematic review and meta-analysis. [2022]
FDA Approval Summary: Tremelimumab in combination with durvalumab for the treatment of patients with unresectable hepatocellular carcinoma. [2023]
Dual Immunotherapy Makes Strides against HCC. [2022]
Safety, Efficacy, and Pharmacodynamics of Tremelimumab Plus Durvalumab for Patients With Unresectable Hepatocellular Carcinoma: Randomized Expansion of a Phase I/II Study. [2022]
A phase II study of neoadjuvant chemotherapy plus durvalumab and tremelimumab in advanced-stage ovarian cancer: a Korean Gynecologic Oncology Group Study (KGOG 3046), TRU-D. [2020]
Adverse Events and Tolerability of Combined Durvalumab and Tremelimumab versus Durvalumab Alone in Solid Cancers: A Systematic Review and Meta-Analysis. [2023]
Tremelimumab: First Approval. [2023]
Durvalumab: First Global Approval. [2022]
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