STRIDE (durvalumab + Tremelimumab) with Lenvatinib Vs STRIDE Alone in Unresectable Hepatocellular Carcinoma
Launched by CANADIAN CANCER TRIALS GROUP · Mar 11, 2025
Trial Information
Current as of April 30, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The STRIDE clinical trial is studying a combination of three medications to see if they can improve treatment outcomes for patients with a type of liver cancer called unresectable hepatocellular carcinoma (HCC). This trial will compare the effects of two drugs together with an additional medication against just the two drugs alone. The goal is to determine if adding this third medication can help patients with their liver cancer treatment.
To participate in this trial, participants need to be at least 18 years old and have a confirmed diagnosis of HCC that cannot be surgically removed. They should not have received previous treatments for this type of cancer, and they must meet certain health criteria. Participants can expect to be closely monitored throughout the study, including regular check-ups and tests to measure the cancer's response to the treatment. It's important to note that this trial is still in the planning stages and has not started recruiting patients yet. If you or someone you know is interested in participating, you can discuss this with a healthcare provider to see if it might be a good option.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- • Must not have received prior systemic therapy for HCC.
- • Must not be eligible for locoregional therapy for unresectable HCC. For patients who progressed after locoregional therapy for HCC, locoregional therapy must have been completed ≥28 days prior to the baseline scan of the abdomen and pelvis for the current study.
- • Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C.
- • Child-Pugh Score class A or B7 based on low albumin (albumin 25-27 g/L) only.
- • Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- • At least 1 measurable lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have a short axis ≥15 mm) with computerized tomography (CT) or magnetic resonance imaging (MRI), and that is suitable for accurate repeated measurements as per RECIST 1.1 guidelines. A lesion which progressed after previous ablation or TACE could be measurable if it meets these criteria.
- * Participants with active HBV infection \[characterized by positive hepatitis B virus surface antigen (HBsAg) and/or positive hepatitis B core antibodies (anti-HBcAb) with detectable HBV deoxyribonucleic acid (DNA) (≥10 IU/mL or above the limit of detection per local lab standard)\] are eligible if:
- • The participant is being treated with antiviral therapy, as per institutional practice. The HBV antiviral therapy must be initiated prior to randomization, and the participant must remain on antiviral therapy for the study duration and for 6 months after the last dose of study medication.
- • The participant must show evidence of HBV stabilization or signs of viral response (eg, reduction of HBV DNA levels) prior to enrollment
- • Participants who test positive for HBsAg or anti-hepatitis B core (HBc) with undetectable HBV DNA (\< 10 IU/mL or under the limit of detection per local lab standard) are eligible and do not require antiviral therapy prior to randomization.
- • These participants will be tested at every cycle to monitor HBV DNA levels and initiate antiviral therapy if HBV DNA is detected (≥ 10 IU/mL or above the limit of detection per local lab standard).
- • If HBV DNA becomes detectable during study treatment, antiviral therapy must be initiated, and the participant must remain on antiviral therapy during the study treatment period and for 6 months after the last dose of study medication.
- • Participants with active HCV infection (as characterized by the presence of detectable HCV ribonucleic acid \[RNA\] or anti-HCV antibody \[anti-HCV\]) must be managed per local institutional practice for the study and for 6 months after the last dose of study treatment.
- • Adequate organ and marrow function, within 14 days prior to enrollment.
- • Participants of childbearing potential must have agreed to use a highly effective contraceptive method from enrollment to 90 days after the last dose of durvalumab or 180 days after the last dose of tremelimumab (whichever date is later).
- • Participants must agree not to donate blood for at least 90 days following the last infusion of durvalumab or tremelimumab, or until 7 days after the last dose of lenvatinib, whichever is longest.
- Exclusion Criteria:
- • 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
- • Uncontrolled arterial hypertension defined by a systolic pressure ≥ 150 mm Hg or diastolic pressure ≥ 90 mm Hg or other hypertensive cardiovascular complications despite standard medical management.
- • Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab, or an anti-CTLA4, including tremelimumab.
- • History of primary immunodeficiency, history of organ transplant or prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy.
- • Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).
- • Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- • Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab
- • Active or prior documented autoimmune or inflammatory disorders including inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), diverticulitis (with the exception of diverticulosis), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.
- • Patients with active or uncontrolled intercurrent illness
- • History of leptomeningeal carcinomatosis.
- • Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids.
- • Major surgical procedure (as defined by the Investigator) within 28 days prior to enrollment.
- • Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart).
- • Receipt of live attenuated vaccination (examples include, but are not limited to, vaccines for measles, mumps, and rubella, live attenuated influenza vaccine (nasal), chicken pox vaccine, oral polio vaccine, rotavirus vaccine, yellow fever vaccine, BCG vaccine, typhoid vaccine and typhus vaccine) within 30 days prior to enrollment.
- • Lactating participants.
- • Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.
- • Receipt of radiotherapy within four weeks of first planned dose of durvalumab or tremelimumab, except for a single dose of radiation up to 8 Gray (equal to 800 RAD) delivered with palliative intent for pain control up to 14 days before enrollment.
- • Active or prior documented GI bleeding (e.g. esophageal varices or ulcer bleeding) within 6 months. (Note: For patients with a history of GI bleeding more than 6 months prior or assessed as high risk for esophageal varices by the Investigator or main trunk portal vein thrombosis (Vp4), adequate endoscopic assessment and treatment of varices as per institutional standards is required prior to enrollment.)
About Canadian Cancer Trials Group
The Canadian Cancer Trials Group (CCTG) is a leading clinical research organization dedicated to advancing cancer treatment through innovative clinical trials. Based at Queen’s University in Kingston, Ontario, CCTG collaborates with a network of healthcare professionals, institutions, and patients across Canada to design and implement trials that evaluate new therapies, improve patient outcomes, and enhance the understanding of cancer biology. Committed to excellence in research, CCTG fosters a multidisciplinary approach, engaging experts in various fields to ensure rigorous methodologies and ethical standards. By prioritizing patient-centered care and accessibility, CCTG plays a pivotal role in shaping the future of cancer care in Canada and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Vincent Tam
Study Chair
Arthur J.E. Child Comprehensive Cancer Centre, Calgary AB, Canada
Jennifer Knox
Study Chair
University Health Network-OCI/Princess Margaret Hospital, Toronto, ON Canada
Marilina Piccirillo
Study Chair
NCI-Naples, Italy
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported