Study Summary
This trial is testing the side effects of atezolizumab on patients who have had cancer and have had adoptive cell transfer.
Eligible Conditions
- Unresectable Malignant Solid Tumor
- Metastatic Cancer
- Blood Cancer
Treatment Effectiveness
Phase-Based Effectiveness
Phase 1
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: Up to 1 year
Up to 1 year
Anti-tumor activity
Biomarker analysis
Expansion of engrafted T cells following atezolizumab administration in the peripheral blood and within the tumor microenvironment
Phenotype and function of engrafted T cells following atezolizumab administration
Progression free survival
Survival outcomes
The response rate
Up to 6 weeks
Incidence of adverse events
Trial Safety
Phase-Based Safety
Side Effects for
Atezolizumab
27%Fatigue
25%Decreased appetite
24%Cough
19%Dyspnoea
19%Asthenia
18%Constipation
18%Nausea
18%Pyrexia
16%Diarrhoea
13%Arthralgia
12%Anaemia
12%Vomiting
11%Rash
11%Back pain
11%Musculoskeletal pain
10%Headache
9%Oedema peripheral
9%Weight decreased
9%Insomnia
9%Chest pain
9%Pruritus
9%Pain in extremity
8%Dizziness
7%Myalgia
7%Upper respiratory tract infection
7%Aspartate aminotransferase increased
7%Haemoptysis
6%Nasopharyngitis
6%Influenza like illness
6%Alanine aminotransferase increased
6%Bronchitis
6%Productive cough
5%Depression
5%Dry skin
5%Musculoskeletal chest pain
4%Abdominal pain
4%Urinary tract infection
4%Paraesthesia
4%Neuropathy peripheral
3%Pneumonia
3%Stomatitis
3%Dysgeusia
2%Pleural effusion
2%Neutropenia
2%Malaise
1%Sepsis
1%Respiratory tract infection
1%Peripheral sensory neuropathy
1%Lacrimation increased
1%Pneumonitis
1%Pulmonary embolism
1%Alopecia
1%Mucosal inflammation
1%Bone pain
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
1 Treatment Group
Treatment (atezolizumab)
1 of 1
Experimental Treatment
40 Total Participants · 1 Treatment Group
Primary Treatment: Atezolizumab · No Placebo Group · Phase 1
Treatment (atezolizumab)Experimental Group · 6 Interventions: Biospecimen Collection, Biopsy, Computed Tomography, Magnetic Resonance Imaging, Atezolizumab, Laboratory Biomarker Analysis · Intervention Types: Procedure, Procedure, Procedure, Procedure, Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 1
~810
Biopsy
2014
Completed Phase 4
~1120
Computed Tomography
2017
Completed Phase 2
~2710
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Atezolizumab
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,272 Previous Clinical Trials
41,230,688 Total Patients Enrolled
Marcus O ButlerPrincipal InvestigatorUniversity Health Network Princess Margaret Cancer Center LAO
Eligibility Criteria
Age 18+ · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You cannot have received certain immunotherapy treatments before starting the study drug atezolizumab.