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PD-L1 Inhibitor

Cabozantinib + Atezolizumab for Liver Cancer (COSMIC-312 Trial)

Phase 3
Waitlist Available
Research Sponsored by Exelixis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 20 months after the first subject is randomized.
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is testing a new combo therapy for liver cancer vs the standard of care. The new therapy includes a drug called cabozantinib.

Who is the study for?
This trial is for adults with advanced liver cancer (HCC) who haven't had systemic anticancer treatments. They should have a specific level of liver function (Child-Pugh Score A), measurable disease, and be in certain stages of the disease (BCLC B or C). Participants must be able to perform daily activities with little assistance (ECOG status 0 or 1). Those with particular types of HCC, previous systemic treatments for advanced HCC, brain metastases not stable post-treatment, recent radiation therapy, or on certain blood thinners can't join.
What is being tested?
The study compares cabozantinib combined with atezolizumab against sorafenib as standard care in treating advanced liver cancer. It also assesses cabozantinib alone to understand its individual effect. This Phase 3 trial aims to determine which treatment is safer and more effective for patients who are new to systemic anticancer therapies.
What are the potential side effects?
Potential side effects include high blood pressure, tiredness, loss of appetite, gastrointestinal issues like diarrhea and nausea; hand-foot skin reactions; increased risk of bleeding; changes in voice quality; taste alterations; weight loss; elevated liver enzymes indicating possible liver damage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 20 months after the first subject is randomized.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 20 months after the first subject is randomized. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Duration of Progression Free Survival (PFS) for the experimental arm vs. the control arm
Secondary study objectives
Duration of Progression Free Survival (PFS) for the single-agent arm vs. the control arm

Side effects data

From 2022 Phase 2 trial • 45 Patients • NCT02101736
95%
HYPOTHYROIDISM
73%
DIARRHEA
55%
WEIGHT LOSS
50%
FATIGUE
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
VOMITING
41%
ANOREXIA
41%
NAUSEA
36%
HEADACHE
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
36%
PAIN IN EXTREMITY
36%
HYPERTENSION
32%
PROTEINURIA
32%
PAIN
27%
White Blood Cell Count Decreased
27%
ABDOMINAL PAIN
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Decreased Platelet Count
23%
Platelet Count Decreased
23%
Skin Hypopigmentation
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
HAIR COLOR CHANGE
18%
Upper Respiratory Infection
18%
HEMOGLOBIN INCREASED
18%
HYPOKALEMIA
18%
HYPOPHOSPHATEMIA
18%
Alopecia
18%
Hyperkalemia
14%
Rash Acneiform
14%
Pruritis
14%
HYPOGLYCEMIA
14%
HYPERGLYCEMIA
14%
Rash Maculopapular
14%
BILIRUBIN INCREASED
14%
ACNEIFORM RASH
14%
Cough
14%
Blood Bilirubin Increased
14%
DIZZINESS
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
14%
CONSTIPATION
14%
Fever
9%
TUMOR PAIN
9%
Papulopustular Rash
9%
ALKALINE PHOSPHATASE INCREASED
9%
LIPASE INCREASED
9%
Creatinine Increased
9%
Back Pain
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
Paresthesia
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
ORAL PAIN
9%
LYMPHOCYTE COUNT DECREASED
9%
NASAL CONGESTION
9%
WEIGHT GAIN
9%
HYPOCALCEMIA
9%
DRY SKIN
5%
Hypotension
5%
Hypertension
5%
SERUM AMYLASE INCREASED
5%
Investigations - Other, Eosinophilia
5%
Sore Throat
5%
Allergic Rhinitis
5%
Muscle Weakness Lower Limb
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
ANXIETY
5%
Hypermagnesemia
5%
Rash Ezcematoid
5%
Behaviour Disturbance
5%
Scalp Pain
5%
Neuropathy
5%
Psychiatric Disorders - Other, Mood Swings
5%
URINARY URGENCY
5%
Sinus Tachycardia
5%
Periodontal Disease
5%
Peripheral Sensory Neuropathy
5%
Myalgia
5%
Tooth Infection
5%
RASH
5%
Peripheral Motor Neuropathy
5%
Tachycardia
5%
URINARY FREQUENCY
5%
Conjunctivitis
5%
Sinusitis
5%
Syncope
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Activated Partial Thromboplastin Time Prolonged
5%
Breast Pain
5%
JOINT RANGE OF MOTION DECREASED
5%
INSOMNIA
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
HEMATURIA
5%
Investigations - Other, International Normalized Ration Increased
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Joint Range Of Motion Decreased
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
Scalp Lesion
5%
Stomach Pain
5%
TENDONITIS
5%
SKIN INFECTION
5%
HYPOMAGNESEMIA
5%
Muscle Weakness Upper Limb
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
Infections And Infestations - Other, Covid-19
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
SINUS BRADYCARDIA
5%
HYPERTHYROIDISM
5%
Creatine Phosphokinase Increased
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
5%
Urine Discoloration
5%
SPINAL CORD COMPRESSION
5%
ANEMIA
5%
PARONYCHIA
5%
BRUISING
5%
HYPOALBUMINEMIA
5%
Ear And Labyrinth Disorders - Other, Impacted Cerumen
5%
Ear Pain
5%
Elevated Amylase
5%
Facial Pain
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Hoarseness
5%
Laryngitis
5%
Leg Pain
5%
Localized Edema
5%
Lung Infection
5%
Metabolism And Nutrition Disorders - Other, Decreased Oral Intake
5%
Metabolism Other - Decreased Vitamin D
5%
Metbolism And Nutrition Disorders - Other, Hyperchloremia
5%
Mucositis Oral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort B
Cohort A

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Single-Agent Cabozantinib armExperimental Treatment1 Intervention
Subjects with advanced HCC will receive cabozantinib 60 mg qd
Group II: Experimental armExperimental Treatment2 Interventions
Subjects with advanced HCC will receive cabozantinib 40 mg oral, qd + atezolizumab 1200 mg infusion, q3w
Group III: Control armActive Control1 Intervention
Subjects with advanced HCC will receive sorafenib 400 mg bid (twice a day)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
2020
Completed Phase 2
~2360
Atezolizumab
2016
Completed Phase 3
~5860

Find a Location

Who is running the clinical trial?

ExelixisLead Sponsor
120 Previous Clinical Trials
19,293 Total Patients Enrolled
1 Trials studying Liver Cancer

Media Library

Atezolizumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03755791 — Phase 3
Liver Cancer Research Study Groups: Experimental arm, Control arm, Single-Agent Cabozantinib arm
Liver Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT03755791 — Phase 3
Atezolizumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03755791 — Phase 3
~113 spots leftby Nov 2025
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