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Monoclonal Antibodies

Guadecitabine + Durvalumab for Liver and Pancreatic Cancer

Phase 1

Waitlist Available

Led By Anthony El-Khoueiry, MD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

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

Must have

Serum creatinine clearance (CL) > 40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance

Hepatocellular carcinoma cohort specific criteria: Patients must have a histologically proven diagnosis of hepatocellular carcinoma that is not amenable to curative surgical therapeutic options

Must not have

Any prior grade >= 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE > grade 1

Active or prior documented inflammatory bowel disease (e.g., Crohn?s disease, ulcerative colitis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of treatment to time of progression per recist 1.1 or death whichever comes first, assessed up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects and best dosage of a new cancer drug, guadecitabine, when given with another drug, durvalumab. Guadecitabine works by blocking enzymes needed for cell growth, and durvalumab works by targeting certain cells. The hope is that the two drugs will work better together than either does alone in treating liver, pancreatic, bile duct, or gallbladder cancer.

Who is the study for?

This trial is for adults with advanced liver, pancreatic, bile duct, or gallbladder cancer that has spread. Participants must be able to follow the study plan and have certain blood counts and organ functions within specific ranges. They should not be pregnant or breastfeeding and must use contraception. People who've had certain other treatments or conditions like inflammatory bowel disease, another primary malignancy within 3 years, uncontrolled brain metastases, or a history of severe immune-related side effects from previous immunotherapy are excluded.

What is being tested?

The trial is testing the combination of guadecitabine (which may block enzymes needed for tumor cell growth) with durvalumab (a monoclonal antibody targeting cancer cells). It aims to determine the best dose and assess how well these drugs work together against various types of advanced cancers when they have spread beyond their original location.

What are the potential side effects?

Potential side effects include reactions related to the immune system attacking normal organs (immune-related adverse events), infusion reactions due to drug administration into a vein, fatigue, digestive issues such as nausea or diarrhea, changes in blood counts leading to increased risk of infections or bleeding complications.

Eligibility Criteria

Inclusion Criteria

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

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My kidney function, measured by creatinine clearance, is good.

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I have liver cancer that cannot be cured with surgery.

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My pancreatic cancer cannot be removed by surgery or has spread.

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I am a woman who could still become pregnant.

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My cancer originates from the bile ducts or gallbladder and cannot be surgically removed.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I have had severe side effects from previous immunotherapy.

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I have or had Crohn's disease or ulcerative colitis.

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I do not have any severe illnesses that could interfere with the study.

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I have been previously diagnosed with tuberculosis.

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I have brain metastases that need treatment.

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I have fluid in my abdomen that isn't controlled by medicine or needed draining recently.

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I have or had pneumonitis.

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I have never had cancer spread to the lining of my brain or uncontrolled seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment to time of progression per recist 1.1 or death whichever comes first, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment to time of progression per recist 1.1 or death whichever comes first, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment to time of progression per recist 1.1 or death whichever comes first, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of adverse events

Tumor response (dose expansion)

Secondary study objectives

Overall survival

Progression-free survival

Side effects data

From 2020 Phase 3 trial • 417 Patients • NCT02907359

20%

Pyrexia

20%

Thrombocytopenia

18%

Anaemia

17%

Epistaxis

16%

Febrile Neutropenia

16%

Neutropenia

16%

Diarrhoea

14%

Pneumonia

12%

Nausea

11%

Oedema Peripheral

10%

Leukopenia

10%

Constipation

10%

Asthenia

Fatigue

Dyspnoea

Contusion

Aspartate Aminotransferase Increased

Dizziness

Headache

Oedema

Alanine Aminotransferase Increased

Cough

Nasopharyngitis

Rash

Upper Respiratory Tract Infection

Urinary Tract Infection

Pain In Extremity

Stomatitis

Vomiting

Weight Decreased

Abdominal Pain

Hypokalaemia

Arthralgia

Fall

Decreased Appetite

Hypomagnesaemia

Blood Creatinine Increased

Insomnia

Haematoma

Haemorrhoids

Cellulitis

Sepsis

Cardiac Failure

Transfusion Reaction

Haemorrhage Intracranial

Acute Kidney Injury

Back Pain

Musculoskeletal Pain

Petechiae

Pruritus

General Physical Health Deterioration

Death

Septic Shock

Oropharyngeal Pain

Erythema

Rectal Haemorrhage

Hypotension

Atrial Fibrillation

Bone Marrow Failure

Agranulocytosis

Cardiac Arrest

Angina Pectoris

Melaena

Retroperitoneal Haematoma

Device Related Infection

Streptococcal Infection

Candida Infection

Lower Respiratory Tract Infection

Femur Fracture

Hyperkalaemia

Osteoporotic Fracture

Central Nervous System Leukaemia

Central Nervous System Haemorrhage

Cerebral Infarction

Renal Impairment

Pulmonary Mass

Disseminated Intravascular Coagulation

Gastrointestinal Haemorrhage

Aphthous Ulcer

Intestinal Obstruction

Megacolon

Infection

Brain Abscess

Pyelonephritis Acute

Nocardiosis

Arthritis

Bone Pain

Tumour Associated Fever

Cerebrovascular Accident

Syncope

Haematuria

Shock Haemorrhagic

Mouth Haemorrhage

Non-Cardiac Chest Pain

Pleural Effusion

Bacteraemia

Clostridium Bacteraemia

Erysipelas

Gastroenteritis

Toxicity To Various Agents

Lumbar Vertebral Fracture

Rib Fracture

Rhabdomyolysis

Sciatica

Respiratory Failure

Bronchopneumopathy

Choking

Haemothorax

Injection Site Reaction

Febrile Bone Marrow Aplasia

100%

80%

60%

40%

20%

Study treatment Arm

Treatment Choice

Guadecitabine

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (guadecitabine, durvalumab)Experimental Treatment2 Interventions

Patients receive guadecitabine SC QD on days 1-5 and durvalumab IV over 60 minutes on day 8. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3750

Guadecitabine

2014

Completed Phase 3

~730