Himalaya Early Access Program for Liver Cancer Treatment

Sponsor: AstraZeneca

Expanded Access
Approved for Marketing
Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05345678

Provider View

This program offers early access to a new treatment for patients with liver cancer that cannot be surgically removed. It involves a combination of two drugs, tremelimumab and durvalumab, given through an IV.

Patient Parameters

Program Overview

The Himalaya Early Access Program is designed to provide patients with liver cancer that cannot be surgically removed access to a new treatment before it is officially approved. The treatment includes two drugs: tremelimumab, given once at the start, and durvalumab, given every four weeks. This program is available in different countries based on local regulations and will continue until the treatment is officially approved. Patients will receive the drugs for free during the program.

Description

This program allows patients with advanced liver cancer to receive a combination of two drugs, tremelimumab and durvalumab, before they are officially approved for use. The treatment starts with a single dose of tremelimumab, followed by regular doses of durvalumab every four weeks. The program is open to patients who meet specific criteria and will continue until the drugs are approved for general use. Patients will receive the treatment for free and can continue as long as they benefit from it and do not experience severe side effects. The program is available in various countries, depending on local rules, and will close to new patients once the drugs are approved or reimbursed. If approval is not granted, arrangements will be made to ensure patients who are benefiting from the treatment can continue to receive it.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Weigh more than 30 kg.
  • Have confirmed liver cancer that cannot be surgically removed.
  • Have not received previous systemic therapy for liver cancer.
  • Not eligible for local treatments for liver cancer.
  • Have specific stages of liver cancer (BCLC stage B or C).
  • Have a Child-Pugh Score Class A or certain Class B scores.
  • If infected with hepatitis B, must be on antiviral therapy.
  • If infected with hepatitis C, must have a confirmed diagnosis.
  • Have at least one measurable tumor that can be tracked.
  • Have adequate organ and bone marrow function.
  • Women must not be pregnant and must have a negative pregnancy test.
  • Must have a life expectancy of at least 12 weeks.
  • Willing to follow the program's requirements and provide informed consent.

Exclusion Criteria

  • Currently enrolled in another clinical study.
  • Have received an investigational product recently.
  • Have unresolved side effects from previous cancer treatments.
  • Currently receiving other cancer treatments.
  • Allergic to the program's drugs.
  • Have certain liver conditions or have had major surgery recently.
  • Have a history of organ transplantation.
  • Have uncontrolled health conditions or infections.
  • Have a history of other cancers or brain metastases.
  • Have certain autoimmune or inflammatory disorders.
  • Have received live vaccines recently.
  • Pregnant or breastfeeding women, or those not using effective birth control.
  • Have previously participated in similar studies or received similar treatments.

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