A study of Cabozantinib (XL184) in combination with Atezolizumab compared to Sorafenib in patients with hepatocellular carcinoma
Résumé de l'étude
This clinical study aims to investigate a new treatment for advanced liver cancer (hepatocellular carcinoma) in patients who have not received prior treatment. Participants in this study will receive the study medication Cabozantinib alone or with Atezolizumab or Sorafenib alone. The aim of this study is to find out whether Cabozantinib with Atezolizumab is effective for liver cancer, compared to Sorafenib alone in patients who have not been treated previously. This study will also investigate how well liver cancer patients, who have not received prior treatment, tolerate Cabozantinib alone and how effective it is in treating cancer. This is an open-label study. This means that the study doctor and study staff know which treatments the patients are receiving. Patients who meet all eligibility criteria and agree to participate in the study will be randomly assigned by a computer program to one of the following treatment groups: Cabozantinib (two tablets of 20 mg once daily by mouth) + Atezolizumab (1200 mg infusion into a vein, once every 3 weeks); Sorafenib alone (two tablets of 200 mg twice a day); Cabozantinib alone (60 mg, one tablet once daily). The probability is approximately 50% (2 out of 4) that the participant will receive Cabozantinib with Atezolizumab, 25% (1 out of 4) that the participant will receive Sorafenib alone, and 25% (1 out of 4) that the participant will receive Cabozantinib alone. It is estimated that participants will take the study medications for an average of about 6 months. However, the study doctor will continue to monitor the patients to see how they are doing after they have stopped taking the study medications. Approximately 840 participants will be enrolled in this study worldwide. In Switzerland, about 8 patients will participate in 4 trial centers.
(BASEC)
Intervention étudiée
This study aims to examine the efficacy of the study medication Cabozantinib in combination with the drug Atezolizumab compared to the standard treatment with Sorafenib in patients with advanced liver cancer who have not received prior cancer treatment.
Another treatment group will be included, in which participants will receive treatment with Cabozantinib alone, to determine its efficacy compared to Sorafenib in the current population.
(BASEC)
Maladie en cours d'investigation
Hepatocellular carcinoma, patients have not received systemic anticancer therapy prior to study start
(BASEC)
1. Women or men aged eighteen years or older on the day of the informed consent. 2. Confirmed diagnosis of advanced liver cancer (hepatocellular carcinoma) 3. The patient's disease does not respond to other drug treatment approaches or locoregional therapy. 4. ECOG performance status (Eastern Cooperative Oncology Group) 0 or 1 (BASEC)
Critères d'exclusion
1. Other forms of liver cancer 2. Previous systemic anticancer therapy for advanced liver cancer including chemotherapy, low molecular weight kinase inhibitors, and ICI. 3. Radiation therapy for bone metastases within 2 weeks, any other external radiation therapy within 8 weeks prior to study enrollment. 4. Known brain metastases or a brain hemorrhage, unless appropriately treated with radiation therapy and/or surgery (including radiosurgery) and stable for at least 8 weeks prior to study enrollment. 5. Concomitant administration of a drug to inhibit coagulation with oral anticoagulants 6. For women: pregnancy or breastfeeding 7. Participants who have previously had COVID-19 must be completely asymptomatic for at least 30 days prior to study enrollment. (BASEC)
Lieu de l’étude
Bâle, Berne, St-Gall, Zurich
(BASEC)
Sponsor
PRA Switzerland AG Lange Gasse 15, 4002 Basel, Switzerland
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Dr. med. luliana Pompilia Radu
+41 31 664 00 62
iuliana-pompilia.radu@clutterinsel.chInselspital, Universitätsklinik für Viszerale Chirurgie und Medizin Freiburgstrasse 10, 3010 Bern
(BASEC)
Informations scientifiques
1-888-EXELIXIS (888-393-5494)
iuliana-pompilia.radu@clutterinsel.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
13.06.2019
(BASEC)
Identifiant de l'essai ICTRP
NCT03755791 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
A Randomized, Controlled Phase 3 Study of Cabozantinib (XL184) in Combination with Atezolizumab versus Sorafenib in Subjects with Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy (BASEC)
Titre académique
A Randomized, Controlled Phase 3 Study of Cabozantinib (XL184) in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy (ICTRP)
Titre public
Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced HCC Who Have Not Received Previous Systemic Anticancer Therapy (ICTRP)
Maladie en cours d'investigation
Hepatocellular Carcinoma (ICTRP)
Intervention étudiée
Drug: Cabozantinib;Drug: Cabozantinib;Drug: Sorafenib;Drug: Atezolizumab (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Histological or cytological diagnosis of HCC or clinical diagnosis of HCC in cirrhotic
patients by CT or MRI per the AASLD 2018 or EASL 2018 guidelines.
- The subject has disease that is not amenable to a curative treatment approach (eg,
transplant, surgery, ablation therapy) or locoregional therapy (eg, TACE).
- Measurable disease per RECIST 1.1 as determined by the Investigator.
- Barcelona Clinic Liver Cancer (BCLC) stage Category B or C.
- Child-Pugh Score of A.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria:
- Known fibrolamellar carcinoma, sarcomatoid HCC or mixed hepatocellular
cholangiocarcinoma.
- Prior systemic anticancer therapy for advanced HCC including but not limited to
chemotherapy, small molecule kinase inhibitors, and immune checkpoint inhibitors
(ICIs). Subjects who have received local intratumoral or arterial chemotherapy are
eligible; local anticancer therapy within = 28 days before randomization
- Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy
within 8 weeks prior to randomization.
- Known brain metastases or cranial epidural disease unless adequately treated with
radiotherapy and/or surgery (including radiosurgery) and stable for at least 8 weeks
prior to randomization.
- Concomitant anticoagulation with oral anticoagulants
(ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Duration of Progression Free Survival (PFS) for the experimental arm vs. the control arm;Duration of Overall Survival (OS) for the experimental arm vs. the control arm (ICTRP)
Duration of Progression Free Survival (PFS) for the single-agent arm vs. the control arm (ICTRP)
Date d'enregistrement
26.11.2018 (ICTRP)
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Exelixis Clinical Trials, druginfo@exelixis.com, 1-888-EXELIXIS (888-393-5494) (ICTRP)
ID secondaires
XL184-312 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT03755791 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible