Durvalumab for Mesothelioma

Phase-Based Estimates
1
Effectiveness
2
Safety
Rutgers Cancer Institute of New Jersey, New Brunswick, NJ
Mesothelioma+2 More
Durvalumab - Drug
Eligibility
18+
All Sexes
Eligible conditions
Mesothelioma

Study Summary

This study is evaluating whether a drug called durvalumab can improve survival for people with pleural mesothelioma.

See full description

Eligible Conditions

  • Mesothelioma
  • Mesothelioma, Malignant
  • Pleural Mesotheliomas

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Durvalumab will improve 1 primary outcome and 4 secondary outcomes in patients with Mesothelioma. Measurement will happen over the course of From randomization until end of treatment, up to 15 months.

Month 32
Overall Survival (OS)
Month 32
Progression-Free Survival (PFS)
Month 15
Objective Response Rate (ORR)
Month 32
Time to Progression (TTP) on Durvalumab
Month 15
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Side Effects for

MEDI0680 20 mg/kg
Fatigue
100%
Nausea
75%
Pyrexia
50%
Skin lesion
25%
Back pain
25%
Pain in jaw
25%
Pathological fracture
25%
Hypothyroidism
25%
Haemoptysis
25%
Cholecystitis
25%
Metastases to central nervous system
25%
Diplopia
25%
Urinary tract infection
25%
Anaemia
25%
Hyperthyroidism
25%
Asthenia
25%
Oedema peripheral
25%
Aspartate aminotransferase increased
25%
Blood creatine increased
25%
Electrocardiogram qt prolonged
25%
Neutrophil count decreased
25%
Arthralgia
25%
Dysgeusia
25%
Cough
25%
Dermatitis acneiform
25%
Night sweats
25%
Scar pain
25%
Hypertension
25%
Abdominal pain
25%
Hyponatraemia
25%
Seizure
25%
Angina pectoris
25%
Adrenal insufficiency
25%
Eyelid ptosis
25%
Photophobia
25%
Vision blurred
25%
Vomiting
25%
Chest pain
25%
Non-cardiac chest pain
25%
Oedema
25%
Cholelithiasis
25%
Contusion
25%
Cystitis radiation
25%
Alanine aminotransferase increased
25%
Amylase increased
25%
Blood creatinine increased
25%
Lipase increased
25%
Musculoskeletal chest pain
25%
Dizziness
25%
Headache
25%
Hypotension
25%
Blood creatine phosphokinase increased
0%
Muscular weakness
0%
Chills
0%
Scratch
0%
Pancreatitis
0%
Weight decreased
0%
Laryngeal obstruction
0%
Pneumonia
0%
Fall
0%
Rib fracture
0%
Pain in extremity
0%
Contrast media reaction
0%
Arthritis
0%
Rhinorrhoea
0%
Haematemesis
0%
Oral disorder
0%
Gastrointestinal haemorrhage
0%
Hyperuricaemia
0%
Colitis microscopic
0%
Abdominal pain lower
0%
Pneumonitis
0%
Feeling hot
0%
Gastrooesophageal reflux disease
0%
Conjunctivitis
0%
Rash papular
0%
Acidosis
0%
Tumour pain
0%
Pruritus genital
0%
Mood altered
0%
Dehydration
0%
Odynophagia
0%
Liver disorder
0%
Hypomagnesaemia
0%
Urinary incontinence
0%
Painful respiration
0%
Osteoarthritis
0%
International normalised ratio increased
0%
Epigastric discomfort
0%
Sensory disturbance
0%
Abdominal mass
0%
Bronchitis
0%
Pulmonary haemorrhage
0%
Osteomyelitis
0%
Chronic obstructive pulmonary disease
0%
Dysphagia
0%
Leukocytosis
0%
Mass
0%
Blood phosphorus decreased
0%
Skin abrasion
0%
Lethargy
0%
Hepatotoxicity
0%
Blood testosterone decreased
0%
Rash
0%
Wheezing
0%
Pericardial effusion
0%
Hypercalcaemia of malignancy
0%
Diarrhoea
0%
Small intestinal obstruction
0%
Pain
0%
Hepatic haemorrhage
0%
Device related infection
0%
Hepatocellular injury
0%
Postoperative wound infection
0%
Humerus fracture
0%
Hypercalcaemia
0%
Failure to thrive
0%
Myalgia
0%
Spinal pain
0%
Procedural pain
0%
Encephalitis autoimmune
0%
Benign prostatic hyperplasia
0%
Pleural effusion
0%
Iron deficiency anaemia
0%
Lymphopenia
0%
Cardiac failure congestive
0%
Sinus tachycardia
0%
Ear disorder
0%
Tinnitus
0%
Hypoacusis
0%
Conjunctival haemorrhage
0%
Episcleritis
0%
Eye pain
0%
Lacrimation increased
0%
Periorbital swelling
0%
Abdominal distension
0%
Colitis
0%
Ascites
0%
Gingival bleeding
0%
Axillary pain
0%
Blood alkaline phosphatase increased
0%
Nodule
0%
Blood fibrinogen decreased
0%
Gastrointestinal fungal infection
0%
Blood glucose increased
0%
Lower respiratory tract infection bacterial
0%
Tooth infection
0%
Viral upper respiratory tract infection
0%
Anaemia postoperative
0%
Blood triglycerides increased
0%
Electrocardiogram t wave abnormal
0%
General physical condition abnormal
0%
Influenza b virus test positive
0%
Glucose tolerance impaired
0%
Hyperglycaemia
0%
Hyperkalaemia
0%
Hypoalbuminaemia
0%
Musculoskeletal pain
0%
Muscle spasms
0%
Basal cell carcinoma
0%
Oesophageal adenocarcinoma
0%
Seborrhoeic keratosis
0%
Facial paralysis
0%
Hyperaesthesia
0%
Neuropathy peripheral
0%
Paraesthesia
0%
Peripheral sensory neuropathy
0%
Tremor
0%
Agitation
0%
Micturition urgency
0%
Renal tubular necrosis
0%
Erectile dysfunction
0%
Galactorrhoea
0%
Dry throat
0%
Dyspnoea exertional
0%
Lung disorder
0%
Paranasal sinus hypersecretion
0%
Rales
0%
Rhinitis allergic
0%
Acne
0%
Palmar-plantar erythrodysaesthesia syndrome
0%
Pruritus
0%
Rash maculo-papular
0%
Skin discolouration
0%
Skin fissures
0%
Xeroderma
0%
Flushing
0%
Hot flush
0%
Atrial fibrillation
0%
Immune-mediated pancreatitis
0%
Chemical burn of skin
0%
Squamous cell carcinoma of skin
0%
Cerebrovascular accident
0%
Aphasia
0%
Haemorrhage intracranial
0%
Intracranial mass
0%
Mental status changes
0%
Diabetic foot
0%
Dry eye
0%
Ocular hyperaemia
0%
Abdominal discomfort
0%
Abdominal pain upper
0%
Constipation
0%
Dyspepsia
0%
Faeces soft
0%
Infusion related reaction
0%
Haemorrhoids
0%
Immune-mediated enterocolitis
0%
Catheter site pruritus
0%
Gait disturbance
0%
Influenza like illness
0%
Infusion site pain
0%
Malaise
0%
Mucosal inflammation
0%
Secretion discharge
0%
Allergy to arthropod sting
0%
Abscess
0%
Bronchiolitis
0%
Gingivitis
0%
Herpes zoster
0%
Kidney infection
0%
Lower respiratory tract infection
0%
Oral herpes
0%
Otitis media
0%
Rhinitis
0%
Sinusitis
0%
Tooth abscess
0%
Arthropod bite
0%
Wound
0%
Activated partial thromboplastin time prolonged
0%
Blood bilirubin increased
0%
Blood iron decreased
0%
Blood thyroid stimulating hormone increased
0%
Blood urea increased
0%
Gamma-glutamyltransferase increased
0%
Hypoaesthesia
0%
Platelet count decreased
0%
Procalcitonin increased
0%
Tri-iodothyronine free abnormal
0%
Hyposmia
0%
Weight increased
0%
White blood cell count increased
0%
Decreased appetite
0%
Hypertriglyceridaemia
0%
Neuralgia
0%
Hypophosphataemia
0%
Flank pain
0%
Groin pain
0%
Joint range of motion decreased
0%
Joint swelling
0%
Musculoskeletal stiffness
0%
Somnolence
0%
Delirium
0%
Insomnia
0%
Dysuria
0%
Nocturia
0%
Pollakiuria
0%
Proteinuria
0%
Urinary tract pain
0%
Urine abnormality
0%
Breast mass
0%
Dyspnoea
0%
Epistaxis
0%
Hiccups
0%
Hypoxia
0%
Nasal congestion
0%
Oropharyngeal discomfort
0%
Productive cough
0%
Sneezing
0%
Upper-airway cough syndrome
0%
Ecchymosis
0%
Erythema
0%
Macule
0%
Pain of skin
0%
Urticaria
0%
Vitiligo
0%
Aortic aneurysm
0%
Aortic occlusion
0%
Embolism
0%
Eye irritation
0%
Aphthous ulcer
0%
Cellulitis
0%
Spinal cord infection
0%
Hip fracture
0%
Transaminases increased
0%
Bone pain
0%
Metastases to bone
0%
Cerebrospinal fluid leakage
0%
Peripheral ischaemia
0%
Neutropenia
0%
Palpitations
0%
Tachycardia
0%
Ear discomfort
0%
Ear pain
0%
Asthenopia
0%
Conjunctivitis allergic
0%
Eye pruritus
0%
Keratitis
0%
Visual impairment
0%
Dry mouth
0%
Duodenitis
0%
Flatulence
0%
Gingival pain
0%
Inguinal hernia
0%
Oral pain
0%
Rectal haemorrhage
0%
Stomatitis
0%
Cyst
0%
Facial pain
0%
Inflammation
0%
Temperature intolerance
0%
Hypermagnesaemia
0%
Ear infection
0%
Eye infection
0%
Hordeolum
0%
Influenza
0%
Nasopharyngitis
0%
Oral candidiasis
0%
Oral fungal infection
0%
Rash pustular
0%
Respiratory tract infection
0%
Upper respiratory tract infection
0%
Viral infection
0%
Post procedural oedema
0%
Radiation skin injury
0%
Spinal compression fracture
0%
Sunburn
0%
Amylase decreased
0%
Blood urine present
0%
C-reactive protein increased
0%
Eastern cooperative oncology group performance status worsened
0%
Lymphocyte count decreased
0%
Urinary retention
0%
Platelet count increased
0%
Prothrombin time prolonged
0%
Serum ferritin decreased
0%
White blood cell count decreased
0%
Gout
0%
Hypocalcaemia
0%
Hypoglycaemia
0%
Hypokalaemia
0%
Metabolic alkalosis
0%
Type 2 diabetes mellitus
0%
Bone lesion
0%
Limb discomfort
0%
Neck pain
0%
Tendon disorder
0%
Squamous cell carcinoma
0%
Head discomfort
0%
Memory impairment
0%
Sciatica
0%
Anxiety
0%
Confusional state
0%
Depression
0%
Dysphonia
0%
Oropharyngeal pain
0%
Sinus congestion
0%
Alopecia
0%
Dermatitis
0%
Dry skin
0%
Papule
0%
Perioral dermatitis
0%
Rash pruritic
0%
Skin ulcer
0%
Deep vein thrombosis
0%
Vena cava embolism
0%
This histogram enumerates side effects from a completed 2020 Phase 1 & 2 trial (NCT02118337) in the MEDI0680 20 mg/kg ARM group. Side effects include: Fatigue with 100%, Nausea with 75%, Pyrexia with 50%, Skin lesion with 25%, Back pain with 25%.

Trial Design

2 Treatment Groups

Control
Durvalumab

This trial requires 55 total participants across 2 different treatment groups

This trial involves 2 different treatments. Durvalumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Durvalumab
Drug
Pemetrexed/cisplatin will be given for up to six 3-week cycles with the addition of concurrent durvalumab every 3 weeks. The first 6 patients who are enrolled and commence treatment will be monitored for safety of the combination. Use of carboplatin in place of cisplatin will be permitted for patients who are ineligible for cisplatin due to impaired renal function at screening. For patients that receive cisplatin, carboplatin may also be substituted after Cycle 1 for cisplatin related toxicity (e.g., grade 3 ototoxicity, grade 3 nausea) at the investigator's discretion. After completion of Cycle 6 of concurrent therapy, patients with stable or responding disease per modified RECIST for malignant mesothelioma will continue on single agent durvalumab every 3 weeks until progression. Maximum duration of durvalumab treatment is 12 months starting from Cycle 1 of concurrent treatment (inclusive of any treatment delays or missed treatments).
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from randomization until death, up to 32 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from randomization until death, up to 32 months for reporting.

Closest Location

Rutgers Cancer Institute of New Jersey - New Brunswick, NJ

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Mesothelioma or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
A disease that is not able to be surgically removed. show original
A person's absolute neutrophil count (ANC) must be ≥ 1500/mm³ in order to donate blood. show original
A tumor that is found on the lining of the chest cavity and is confirmed to be a type of mesothelioma cancer. show original
At least one lesion that is measurable at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for repeated assessment is considered to be a measurable disease. show original
The ability to understand and willingness to sign Institutional Review Board (IRB)-approved informed consent is required for participating in this study. show original
The patient has a good performance status, according to the Eastern Cooperative Oncology Group (ECOG), with a score of 0-1. show original
Hemoglobin ˃9.0 g/dL
We will provide archived tumor tissue and blood samples to be used for research. show original
Available unstained archived tumor tissue sample in sufficient quantity to allow for analyses. At least fifteen unstained slides or a tumor block (preferred). NOTE: A fine needle aspiration sample is not sufficient to make the patient eligible for enrollment. Given the complexity of mesothelioma pathological diagnosis and that these will be newly diagnosed patients it is expected that they will have a core needle biopsy or surgical tumor biopsy as part of their initial diagnostic work up.
Must be at least 18 years old. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get mesothelioma a year in the United States?

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around 2 to 3 million people develop mesothelioma a year in the United States. mesothelioma accounts for a minority of all of cancer deaths among men in the U.S.

Unverified Answer

What causes mesothelioma?

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Results from a recent clinical trial suggest that mesotheliomas may develop from asbestos-induced malignant mesothelioma or may arise from the malignant transformation of malignant adenocarcinoma with mixed mesenchymal differentiation. The development of lung cancers from pleural mesothelioma also requires a pleural precursor.

Unverified Answer

What are the signs of mesothelioma?

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Patients with malignant pleural mesothelioma most commonly present with cough. In the absence of coughing the chest X-ray is a less useful exam. Chest radiography and CT of the chest can detect pleural malignancies and may be recommended in the work-up of patients with pleural effusion. The most reliable exam is chest CT where it is often the first choice.

Unverified Answer

Can mesothelioma be cured?

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The survival outcomes show the need for a new treatment strategy for mesothelioma, such as increased dose and novel chemotherapy regimens. With careful evaluation of this disease subtype and its rarity, there may indeed be a chance to find patients who could potentially benefit from the novel chemotherapy regimens. If future trials confirm this and/or show greater survival outcomes, then we could consider abandoning the current standard of care chemotherapies, which, at present, appear to work only in a subset of patients.

Unverified Answer

What is mesothelioma?

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Mesothelioma is an aggressive cancer of the mesothelium which is generally thought to be under-recognized. We have shown why this cancer is less well understood, but we have highlighted the importance of studying this cancer as it continues to claim its victims every year.

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What are common treatments for mesothelioma?

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The two main lines of chemotherapy used for mesothelioma are platinum-based combinations. The addition of gemcitabine to chemotherapy offers patients a greater chance of survival. For malignant pleural mesothelioma, a combination of chemotherapy with intrapleural hyperthermic perfusion therapy (IPHPT) followed by surgery and adjuvant chemotherapy improves survival. A multidisciplinary approach is also preferred for small, early mesothelioma. Radiation therapy can also be applied with good results, especially in the setting of localized disease.

Unverified Answer

What is the average age someone gets mesothelioma?

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As a whole, the average age at diagnosis of mesothelioma cases in U.S. is 64 years of age and the average age of death is 68 years of age. However, the average age of death is much lower than what could be explained on the basis of the average age at time of diagnosis which is 61 years.

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What is the latest research for mesothelioma?

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mesothelioma is a deadly cancer. Mesothelioma was identified on October 19, 2004. A report in the Journal of the American Society For Clinical Oncology published this result. A study of the National Cancer Institute of the National Library of Medicine at the National Institutes of Health released two major findings. Mesothelioma is a rare cancer. Mesothelioma can occur in people who have never smoked. However, a link has been found between asbestos and mesothelioma in people who have smoked and have had exposure to airborne and/or insoluble fibers from asbestos. Mesothelioma is also related to long term exposure to asbestos fibers in the family.

Unverified Answer

Have there been other clinical trials involving durvalumab?

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At this time, there is no evidence that durvalumab is beneficial in treating patients with metastatic or locally advanced mesothelioma.Durvalumab, when used in combination with pembrolizumab or nivolumab, has a very good risk-benefit profile. There is strong evidence for its safety (i.e. no discernible adverse effects) in combination with pembrolizumab or nivolumab used for the treatment of metastatic pancreatic cancer. Given this information, further studies are justified to assess durvalumab's efficacy (i.e.

Unverified Answer

What are the common side effects of durvalumab?

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Recent findings, subjects receiving durvalumab had more than twice the frequency of subjects developing serious adverse events vs. subjects receiving placebo. In addition, subjects treated with durvalumab were three times as likely to have an infusion-related reaction as subjects treated with placebo.Durvalumab has been FDA approved to treat melanoma in patients 6 years of age and older with unresectable or metastatic uveal melanoma.\n\nAs of 2016, there are no curative treatments for mesothelioma. Instead, patients receive multimodality treatment. While chemotherapy may be used in initial treatment for early stages, treatment usually involves surgery in order to remove the cancer as often as possible.

Unverified Answer

How quickly does mesothelioma spread?

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For Stage 4, most of the patients’ health conditions and chemotherapy regimens improved their quality of life and made it possible for them to continue with daily activities. The doctors’ intervention enabled patients to spend more time, both with family and with friends, exercising, going to massages, clubs, and museums. This is particularly important for patients with an active social life, who are more likely to get stuck in their daily routines and become even more depressed and depressed in the long term if they have to miss such activities. Mesothelioma has an unpredictable growth pattern, meaning it can’t be determined whether the cancer will grow or shrink throughout the period of time that a patient is treated.

Unverified Answer

Does durvalumab improve quality of life for those with mesothelioma?

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Durvalumab substantially improved quality of life in patients with metastatic/inoperable/progressive Mmeso compared with placebo. Recent findings may benefit patients through diminished pain, improved appetite, improved nutritional status, and decreased fatigue.

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See if you qualify for this trial
Get access to this novel treatment for Mesothelioma by sharing your contact details with the study coordinator.