STRIDE (Durvalumab + Tremelimumab) With Lenvatinib vs STRIDE Alone in Unresectable Hepatocellular Carcinoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCanadian Cancer Trials Group

About this trial

The purpose of this study is to compare the effects on participants' and liver cancer by adding a drug that is used on its own to treat this disease to a combination of two other drugs which is also used to treat liver cancer, compared to the two-drug combination alone.

Eligibility criteria

Qualifiers

Age ≥ 18 years.

Body weight > 30 kg.

Life expectancy of at least 12 weeks.

Confirmed HCC based on histopathological findings from tumour tissues or clinically by AASLD criteria in cirrhotic participants.

Disqualifiers

Participants with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other tumours curatively treated with no evidence of disease for ≥ 5 years.

Any concurrent chemotherapy, study drug, or biologic or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.

Known fibrolamellar HCC, sarcomatoid HCC, infiltrative-type HCC or mixed cholangiocarcinoma and HCC.

Clinically meaningful ascites, defined as ascites requiring non-pharmacologic intervention

Trial design

Treatments tested in this trial

  • STRIDE (durvalumab + tremelimumab)
  • Durvalumab
  • Lenvatinib

Treatment groups

140 Participants
are divided into 2 treatment groups

Locations

12
Arthur J.E. Child Comprehensive Cancer CentreT2N 5G2, CalgaryAlberta, Canada
BCCA - VancouverV5Z 4E6, VancouverBritish Columbia, Canada
Juravinski Cancer Centre at Hamilton Health SciencesL8V 5C2, HamiltonOntario, Canada
Kingston Health Sciences CentreK7L 2V7, KingstonOntario, Canada

Sponsors and collaborators

Canadian Cancer Trials Group

Lead sponsor

AstraZeneca

Collaborator

National Cancer Institute, Naples

Collaborator