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Closed (no longer recruiting)Last updated: 31 January 2024

COSMIC: This phase III trial is comparing the safety and effectiveness of a chemotherapy (cabozantinib) and immunotherapy drug (atezolizumab) combination, with a standard of care chemotherapy drug (sorafenib), in patients with advanced hepatocellular (liver) cancer who have not received prior treatmentA 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

Clinical summary

Summary

Patients in this trial will be randomised into one of three treatment arms; the experimental arm, active comparator or the exploratory arm. In the experimental arm, patients with advanced hepatocellular cancer (HCC) will be given 40mg of oral cabozantinib daily and a 1200 mg intravenous dose atezolizumab every three weeks. In the comparator arm, patients will receive 400mg of oral sorafenib twice a day. Patients in the exploratory arm will be given 60mg of oral cabozantinib once daily.

Conditions

This trial is treating patients with hepatocellular (liver) cancer.

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Phase

III

Trial Acronym

COSMIC

More information

Trial Identifiers

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Trial sponsor

Exelixis

Scientific Title

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

Eligibility

Inclusion

  • 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

  • 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 must be completed ≥ 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

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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