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PD-L1/PD-1 Inhibitor

Immune Therapy + Bevacizumab for Advanced Liver Cancer

Phase 2

Waitlist Available

Research Sponsored by MedImmune LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years and older (Japan-20 years and older)

Immunotherapy-naïve

Must not have

Ascites requiring non-pharmacologic intervention (eg, paracentesis) to maintain symptomatic control, within 6 months prior to the first scheduled dose

Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety and effectiveness of different combinations of drugs for treating advanced liver cancer.

Who is the study for?

This trial is for adults with advanced liver cancer who have either not responded to, cannot tolerate, or chose not to use sorafenib or similar drugs. It's also open to those who haven't had any systemic therapy for their cancer. People can't join if they've had certain complications like ascites needing intervention, hepatic encephalopathy, major blood vessel thrombosis in the liver, active autoimmune diseases, recent immunosuppressive meds use, or gastrointestinal bleeding within the last year.

What is being tested?

The study is testing different treatments: Durvalumab alone; Tremelimumab alone; and combinations of Durvalumab with Tremelimumab or Bevacizumab. The goal is to see how safe these treatments are and how well they work against advanced liver cancer by monitoring tumor response and changes in the body's immune system.

What are the potential side effects?

Possible side effects include immune-related reactions that could affect organs like lungs or intestines (pneumonitis or colitis), infusion reactions during treatment administration, fatigue from treatment burden on the body, potential bleeding issues due to drug effects on blood vessels and clotting mechanisms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at least 18 years old (20 if in Japan).

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I have never received immunotherapy.

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My liver cancer diagnosis was confirmed through a biopsy or other methods.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I've needed a procedure to remove excess belly fluid in the last 6 months.

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I am not currently on any cancer treatments like chemotherapy or immunotherapy.

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I have not had brain function issues due to liver disease in the last year.

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I have been treated with immunotherapy before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 through the 12 months after the first dose of study drug given to the last participant enrolled in the study (approximately 61 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Abnormal Vital Signs Reported as TEAEs

Number of Participants With Clinically Important Changes in Hematology and Clinical Chemistry Parameters

Number of Participants With Dose Limiting Toxicities (DLTs)

+2 more

Secondary study objectives

Disease Control Rate (DCR) Based on Investigator Assessments and BICR

Duration of Response (DoR) Based on Investigator Assessments and BICR

Overall Objective Response Rate (ORR) Based on Investigator Assessments and Blinded Independent Central Review (BICR)

+4 more

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129

65%

Fatigue

63%

Abdominal pain

55%

Diarrhea

43%

Pain

40%

Weight loss

35%

Hypertension

30%

Anorexia

30%

Constipation

28%

Nausea

28%

Pruritus

25%

Vomiting

20%

Dyspnea

20%

Urinary tract infection

18%

Rash maculo-papular

15%

Cough

15%

Abdominal Pain

15%

Back pain

15%

Increased Urinary Frequency

15%

Weight gain

13%

Arthralgia

10%

Dizziness

10%

Anxiety

10%

Bladder infection

10%

Nasal congestion

10%

Vaginal discharge

Colitis

Dry mouth

Dry skin

Fever

Anal pain

Edema limbs

Flatulence

Headache

Hot flashes

Myalgia

Small intestinal obstruction

Thromboembolic event

Urinary frequency

Urinary tract pain

Confusion

Renal and urinary disorders - Other, specify

Adrenal insufficiency

Anemia

Ascites

Gastroesophageal reflux disease

Hypomagnesemia

Lymphedema

Memory impairment

Mucositis oral

Pneumonitis

Rash acneiform

Sinus bradycardia

Upper respiratory infection

Urinary urgency

Vaginal hemorrhage

Alanine aminotransferase increased

Aspartate aminotransferase increased

Alkaline phosphatase increased

Colonic perforation

Dysarthria

Blood bilirubin increased

CPK increased

Creatinine increased

Myositis

Rectal hemorrhage

Hypothyroidism

Left ventricular systolic dysfunction

Lethargy

Muscle weakness left-sided

Myocarditis

Rectal pain

Weight Loss

Fall

Generalized muscle weakness

Hyperglycemia

Hyperkalemia

Pain in extremity

Peripheral sensory neuropathy

Pleural effusion

Skin infection

100%

80%

60%

40%

20%

Study treatment Arm

Durvalubmab

Durvalubmab + Tremelimumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

9Treatment groups

Experimental Treatment

Group I: Parts 2 and 3: Tremelimumab 750 mgExperimental Treatment1 Intervention

Participants will receive tremelimumab 750 mg Q4W 7 doses followed by every 12 weeks (Q12W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.

Group II: Parts 2 and 3: Tremelimumab 75 mg + Durvalumab 1500 mgExperimental Treatment2 Interventions

Participants will receive tremelimumab 75 mg Q4W 4 doses and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first. Participant recruitment to this arm was closed following protocol amendment 5.

Group III: Parts 2 and 3: Tremelimumab 300 mg + Durvalumab 1500 mgExperimental Treatment2 Interventions

Participants will receive tremelimumab 300 mg 1 dose and durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow, or development of other reason for treatment discontinuation, whichever occurs first.

Group IV: Parts 2 and 3: Durvalumab 1500 mgExperimental Treatment1 Intervention

Participants will receive durvalumab 1500 mg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.

Group V: Part 4: Durvalumab 1120 mg + Bevacizumab 15 mg/kgExperimental Treatment2 Interventions

Participants will receive durvalumab 1120 mg and bevacizumab 15 mg/kg every 3 weeks (Q3W) until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first

Group VI: Part 1: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgExperimental Treatment2 Interventions

Participants in Part 1A (safety run-in cohort) and Part 1 B (efficacy-gating cohort) will receive tremelimumab 1 mg/kg every 4 weeks (Q4W) 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.

Group VII: China Cohort: Tremelimumab 10 mg/kgExperimental Treatment1 Intervention

Participants will receive tremelimumab 10 mg/kg Q4W 7 doses followed by Q12W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.

Group VIII: China Cohort: Tremelimumab 1 mg/kg + Durvalumab 20 mg/kgExperimental Treatment2 Interventions

Participants will receive tremelimumab 1 mg/kg Q4W 4 doses and durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.

Group IX: China Cohort: Durvalumab 20 mg/kgExperimental Treatment1 Intervention

Participants will receive durvalumab 20 mg/kg Q4W until confirmed progressive disease, withdrawal of consent, lost to follow-up, or development of other reason for treatment discontinuation, whichever occurs first.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3750

Bevacizumab

2013

Completed Phase 4

~5540