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CLINICAL TRIAL

Atezolizumab for Malignancies

Recruiting · 18+ · All Sexes · Fukuoka, Japan

This study is evaluating whether a drug may help patients with lung cancer.

See full description

About the trial for Malignancies

Treatment Groups

This trial involves 2 different treatments. Atezolizumab 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 4 and have been shown to be safe and effective in humans.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.

Atezolizumab

DRUG

Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

FDA approved

Side Effect Profile for Docetaxel

Docetaxel

Show all side effects

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Dyspnoea

19%

Cough

16%

Myalgia

15%

Neutropenia

14%

Oedema peripheral

14%

Constipation

12%

Pyrexia

11%

Vomiting

11%

Stomatitis

11%

Neuropathy peripheral

10%

Arthralgia

9%

Neutrophil count decreased

9%

Rash

8%

Paraesthesia

8%

Headache

8%

Dysgeusia

7%

Peripheral sensory neuropathy

7%

Mucosal inflammation

7%

Insomnia

7%

Back pain

7%

Pain in extremity

6%

Dry skin

6%

Pneumonia

6%

Febrile neutropenia

6%

Lacrimation increased

6%

Abdominal pain

6%

Dizziness

5%

Haemoptysis

5%

Weight decreased

5%

Malaise

5%

Nail disorder

5%

Urinary tract infection

4%

Bronchitis

4%

Chest pain

4%

Nasopharyngitis

4%

Musculoskeletal pain

4%

Productive cough

3%

Pruritus

3%

Upper respiratory tract infection

2%

Influenza like illness

2%

Aspartate aminotransferase increased

2%

Alanine aminotransferase increased

1%

Acute kidney injury

1%

Depression

1%

Respiratory tract infection

1%

Dehydration

1%

Pleural effusion

1%

Syncope

1%

Atrial fibrillation

1%

Lower respiratory tract infection

1%

Lung infection

1%

Chronic obstructive pulmonary disease

1%

Musculoskeletal chest pain

0%

Hepatitis acute

0%

Pulmonary oedema

0%

Infectious pleural effusion

0%

Pulmonary sepsis

0%

Muscular weakness

0%

Pharyngitis

0%

Gastroenteritis viral

0%

Pulmonary haemorrhage

0%

Superior vena cava syndrome

0%

Diverticulitis

0%

Localised infection

0%

Cerebral artery embolism

0%

Generalised tonic-clonic seizure

0%

Mental status change

0%

Cellulitis

0%

Gastroenteritis

0%

Lower gastrointestinal haemorrhage

0%

Localised oedema

0%

Post procedural haematuria

0%

Haematuria

0%

Hypotension

0%

Tachycardia paroxysmal

0%

Tachycardia

0%

Appendicitis

0%

Burns third degree

0%

Pneumonia bacterial

0%

Device related infection

0%

Hip fracture

0%

Basal cell carcinoma

0%

Duodenal perforation

0%

Supraventricular tachycardia

0%

Rhabdomyolysis

0%

Emphysema

0%

Depressed level of consciousness

0%

Hepatitis

0%

Pleuritic pain

0%

Systemic inflammatory response syndrome

0%

Neutropenic sepsis

0%

Encephalopathy

0%

Overdose

0%

Aphasia

0%

Guillain-Barre syndrome

0%

Thrombosis

0%

Organising pneumonia

0%

Myocardial infarction

0%

Abdominal pain lower

0%

Oesophageal obstruction

0%

Colitis

0%

Intestinal obstruction

0%

Pleural infection

0%

Cholecystitis acute

0%

Infection

0%

Pericardial effusion

0%

Gastritis erosive

0%

Stress cardiomyopathy

0%

Pain

0%

Acute hepatic failure

0%

General physical health deterioration

0%

Gastrointestinal fungal infection

0%

Cancer pain

0%

Hypersensitivity

0%

Seizure

0%

Pneumocystis jirovecii pneumonia

0%

Cerebral thrombosis

0%

Benign prostatic hyperplasia

0%

Henoch-Schonlein purpura nephritis

0%

Faeces discoloured

0%

Sudden death

0%

Clostridium difficile colitis

0%

Upper gastrointestinal haemorrhage

0%

Bacterial sepsis

0%

Hypoxia

0%

Colon cancer

0%

Drug-induced liver injury

0%

Pericarditis

0%

Melaena

0%

Parotitis

0%

Radius fracture

0%

Pneumothorax

0%

Hemiparesis

0%

Interstitial lung disease

0%

Haemorrhage intracranial

0%

Dysphagia

0%

Leukoencephalopathy

0%

Ankle fracture

0%

Prostate cancer

0%

Cerebrovascular accident

0%

Neuralgia

0%

Pulmonary embolism

0%

Pleural fistula

0%

White blood cell count decreased

0%

Generalised oedema

0%

Subileus

0%

Cardiac failure congestive

0%

Abdominal pain upper

0%

Haematoma

0%

Gastrointestinal infection

0%

Death

0%

Confusional state

0%

Pancreatitis

0%

Abdominal sepsis

0%

Paronychia

0%

Cholecystitis

0%

Infected skin ulcer

0%

Sciatica

0%

Pneumonia aspiration

0%

Pseudomembranous colitis

0%

Fracture displacement

0%

Pneumonitis

0%

Pneumothorax spontaneous

0%

Haematochezia

0%

Chest discomfort

0%

Fall

0%

Spinal compression fracture

0%

Upper limb fracture

0%

Myocardial ischaemia

0%

Oesophageal fistula

0%

Clostridium difficile infection

0%

Oesophageal varices haemorrhage

0%

Deep vein thrombosis

0%

Neck pain

0%

Neoplasm malignant

0%

Small intestinal obstruction

0%

Leukocytosis

0%

Acute myocardial infarction

0%

Angina pectoris

0%

Arrhythmia

0%

Atrial flutter

0%

Cardiac arrest

0%

Cardiac tamponade

0%

Left ventricular dysfunction

0%

Retinopathy

0%

Encephalitis

0%

Enteritis infectious

0%

Febrile infection

0%

Infective exacerbation of chronic obstructive airways disease

0%

Influenza

0%

Meningitis

0%

Septic shock

0%

Skin infection

0%

Tonsillitis

0%

Upper respiratory tract infection bacterial

0%

Urosepsis

0%

Humerus fracture

0%

Infusion related reaction

0%

Lumbar vertebral fracture

0%

Sepsis

0%

Failure to thrive

0%

Hypercalcaemia

0%

Hyperglycaemia

0%

Hypoglycaemia

0%

Hypokalaemia

0%

Hyponatraemia

0%

Bone pain

0%

Cognitive disorder

0%

Renal failure

0%

Acute respiratory distress syndrome

0%

Acute respiratory failure

0%

Aspiration

0%

Atelectasis

0%

Bronchial obstruction

0%

Bronchospasm

0%

Respiratory distress

0%

Respiratory failure

0%

Tachypnoea

0%

Pemphigoid

0%

Pruritus generalised

0%

Femoral neck fracture

0%

Pyelonephritis

Fatigue

36%

Alopecia

35%

Diarrhoea

24%

Nausea

23%

Decreased appetite

23%

Anaemia

22%

Asthenia

20%

Dyspnoea

19%

Cough

19%

Myalgia

16%

Neutropenia

15%

Oedema peripheral

14%

Constipation

14%

Pyrexia

12%

Vomiting

11%

Stomatitis

11%

Neuropathy peripheral

11%

Arthralgia

10%

Neutrophil count decreased

9%

Rash

9%

Paraesthesia

8%

Headache

8%

Dysgeusia

8%

Peripheral sensory neuropathy

7%

Mucosal inflammation

7%

Insomnia

7%

Back pain

7%

Pain in extremity

7%

Dry skin

6%

Pneumonia

6%

Febrile neutropenia

6%

Lacrimation increased

6%

Abdominal pain

6%

Dizziness

6%

Haemoptysis

5%

Weight decreased

5%

Malaise

5%

Nail disorder

5%

Urinary tract infection

5%

Bronchitis

4%

Chest pain

4%

Nasopharyngitis

4%

Musculoskeletal pain

4%

Productive cough

4%

Pruritus

3%

Upper respiratory tract infection

3%

Influenza like illness

2%

Aspartate aminotransferase increased

2%

Alanine aminotransferase increased

2%

Acute kidney injury

1%

Depression

1%

Respiratory tract infection

1%

Dehydration

1%

Pleural effusion

1%

Syncope

1%

Atrial fibrillation

1%

Lower respiratory tract infection

1%

Lung infection

1%

Chronic obstructive pulmonary disease

1%

Musculoskeletal chest pain

1%

Hepatitis acute

0%

Pulmonary oedema

0%

Infectious pleural effusion

0%

Pulmonary sepsis

0%

Muscular weakness

0%

Pharyngitis

0%

Gastroenteritis viral

0%

Pulmonary haemorrhage

0%

Superior vena cava syndrome

0%

Diverticulitis

0%

Localised infection

0%

Cerebral artery embolism

0%

Generalised tonic-clonic seizure

0%

Mental status change

0%

Cellulitis

0%

Gastroenteritis

0%

Lower gastrointestinal haemorrhage

0%

Localised oedema

0%

Post procedural haematuria

0%

Haematuria

0%

Hypotension

0%

Tachycardia paroxysmal

0%

Tachycardia

0%

Appendicitis

0%

Burns third degree

0%

Pneumonia bacterial

0%

Device related infection

0%

Hip fracture

0%

Basal cell carcinoma

0%

Duodenal perforation

0%

Supraventricular tachycardia

0%

Rhabdomyolysis

0%

Emphysema

0%

Depressed level of consciousness

0%

Hepatitis

0%

Pleuritic pain

0%

Systemic inflammatory response syndrome

0%

Neutropenic sepsis

0%

Encephalopathy

0%

Overdose

0%

Aphasia

0%

Guillain-Barre syndrome

0%

Thrombosis

0%

Organising pneumonia

0%

Myocardial infarction

0%

Abdominal pain lower

0%

Oesophageal obstruction

0%

Colitis

0%

Intestinal obstruction

0%

Pleural infection

0%

Cholecystitis acute

0%

Infection

0%

Pericardial effusion

0%

Gastritis erosive

0%

Stress cardiomyopathy

0%

Pain

0%

Acute hepatic failure

0%

General physical health deterioration

0%

Gastrointestinal fungal infection

0%

Cancer pain

0%

Hypersensitivity

0%

Seizure

0%

Pneumocystis jirovecii pneumonia

0%

Cerebral thrombosis

0%

Benign prostatic hyperplasia

0%

Henoch-Schonlein purpura nephritis

0%

Faeces discoloured

0%

Sudden death

0%

Clostridium difficile colitis

0%

Upper gastrointestinal haemorrhage

0%

Bacterial sepsis

0%

Hypoxia

0%

Colon cancer

0%

Drug-induced liver injury

0%

Pericarditis

0%

Melaena

0%

Parotitis

0%

Radius fracture

0%

Pneumothorax

0%

Hemiparesis

0%

Interstitial lung disease

0%

Haemorrhage intracranial

0%

Dysphagia

0%

Leukoencephalopathy

0%

Ankle fracture

0%

Prostate cancer

0%

Cerebrovascular accident

0%

Neuralgia

0%

Pulmonary embolism

0%

Pleural fistula

0%

White blood cell count decreased

0%

Generalised oedema

0%

Subileus

0%

Cardiac failure congestive

0%

Abdominal pain upper

0%

Haematoma

0%

Gastrointestinal infection

0%

Death

0%

Confusional state

0%

Pancreatitis

0%

Abdominal sepsis

0%

Paronychia

0%

Cholecystitis

0%

Infected skin ulcer

0%

Sciatica

0%

Pneumonia aspiration

0%

Pseudomembranous colitis

0%

Fracture displacement

0%

Pneumonitis

0%

Pneumothorax spontaneous

0%

Haematochezia

0%

Chest discomfort

0%

Fall

0%

Spinal compression fracture

0%

Upper limb fracture

0%

Myocardial ischaemia

0%

Oesophageal fistula

0%

Clostridium difficile infection

0%

Oesophageal varices haemorrhage

0%

Deep vein thrombosis

0%

Neck pain

0%

Neoplasm malignant

0%

Small intestinal obstruction

0%

Leukocytosis

0%

Acute myocardial infarction

0%

Angina pectoris

0%

Arrhythmia

0%

Atrial flutter

0%

Cardiac arrest

0%

Cardiac tamponade

0%

Left ventricular dysfunction

0%

Retinopathy

0%

Encephalitis

0%

Enteritis infectious

0%

Febrile infection

0%

Infective exacerbation of chronic obstructive airways disease

0%

Influenza

0%

Meningitis

0%

Septic shock

0%

Skin infection

0%

Tonsillitis

0%

Upper respiratory tract infection bacterial

0%

Urosepsis

0%

Humerus fracture

0%

Infusion related reaction

0%

Lumbar vertebral fracture

0%

Sepsis

0%

Failure to thrive

0%

Hypercalcaemia

0%

Hyperglycaemia

0%

Hypoglycaemia

0%

Hypokalaemia

0%

Hyponatraemia

0%

Bone pain

0%

Cognitive disorder

0%

Renal failure

0%

Acute respiratory distress syndrome

0%

Acute respiratory failure

0%

Aspiration

0%

Atelectasis

0%

Bronchial obstruction

0%

Bronchospasm

0%

Respiratory distress

0%

Respiratory failure

0%

Tachypnoea

0%

Pemphigoid

0%

Pruritus generalised

0%

Femoral neck fracture

0%

Pyelonephritis

0%

This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT02008227) in the Docetaxel ARM group. Side effects include: Fatigue with 36%, Alopecia with 35%, Diarrhoea with 24%, Nausea with 23%, Decreased appetite with 23%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist

Mark “yes” if the following statements are true for you:

Eligible for continuing atezolizumab-based therapy at the time of roll-over from the parent study, as per the parent study protocol or Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study as per the parent study protocol, with no access to commercially available comparator agent

No

Unsure

Yes

Time between the last dose of treatment received in parent study and first dose in extension study is no longer than the interruption period allowed in the parent study. First dose of study treatment in this extension study will be received within 7 days of the treatment interruption window allowed by the parent study

No

Unsure

Yes

View All

Odds of Eligibility

Unknown<50%

Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient

Screening: ~3 weeks

Treatment: varies

Reporting: Day 1 up to 90 days after last dose of study treatment (last dose=until clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years)

Screening: ~3 weeks

Treatment: Varies

Reporting: Day 1 up to 90 days after last dose of study treatment (last dose=until clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years)

This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Day 1 up to 90 days after last dose of study treatment (last dose=until clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years).

View detailed reporting requirements

Connect with the researchersHop on a 15 minute call & ask questions about:

- What options you have available- The pros & cons of this trial

- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Atezolizumab will improve 1 primary outcome and 5 secondary outcomes in patients with Malignancies. Measurement will happen over the course of Day 1 up to maximum 10 years.

Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s)

DAY 1 UP TO MAXIMUM 10 YEARS

Number of Treatment Cycles