Actively Recruiting
Tiragolumab and Atezolizumab in Advanced Pan-cancer Patients
Led by Omico · Updated on 2024-11-15
96
Participants Needed
13
Research Sites
254 weeks
Total Duration
On this page
Sponsors
O
Omico
Lead Sponsor
H
Hoffmann-La Roche
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II study will explore the effect of 2 monoclonal antibodies, tiragolumab and atezolizumab, in patients with locally advanced solid cancers which cannot be removed by surgery or have spread. Their cancers will have characteristics which may predict immune response to the study treatment. PD-L1 and TIGIT are immune receptors which can help cancers grow by evading the immune response and inhibiting the action of some immune cells. By blocking these receptors, tiragolumab and atezolizumab may work together to re-activate the body's anti-tumour immune response and kill cancer cells.
CONDITIONS
Official Title
Tiragolumab and Atezolizumab in Advanced Pan-cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent
- Be 18 years of age or older
- Have histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor
- Have exhausted all available standard therapy or be unsuitable for standard therapy including targeted therapies
- Have an ECOG performance status score of 0 or 1
- Have sufficient and accessible tumor tissue for panel sequencing, PD-L1 and TIL testing
- Have tumor biomarker criteria predictive of immune response such as tumor mutation burden ≥10 mutations per megabase, PD-L1 amplification >6 copy number alterations, tumor PD-L1 expression TAP score ≥5%, or tumor infiltrating lymphocytes (CD3+CD8+) ≥5%
- Be willing to provide tumor biopsy samples on treatment at Week 4
- Have a life expectancy greater than 12 weeks
- Have measurable disease defined by iRECIST or RANO criteria
- Have adequate blood and biochemical test results including neutrophil count ≥1.0 x 10^9/L, hemoglobin ≥100 g/L, platelet count ≥100 x 10^9/L, serum bilirubin ≤1.5 x ULN (exceptions apply), ALT and AST ≤2.5x ULN or ≤5.0x ULN if liver metastases present, INR <1.3 without anticoagulation, and creatinine clearance >40 mL/min
- Have negative HIV test unless stable on antiretroviral therapy with CD4 ≥200 cells/mm3 and undetectable viral load
- Have negative hepatitis B surface antigen test
- Have positive hepatitis B surface antibody test or meet criteria regarding hepatitis B core antibody and HBV DNA levels
- Have negative hepatitis C antibody test or negative HCV RNA if antibody positive
- Women of childbearing potential must have a negative pregnancy test within 14 days prior to first dose
- Women of childbearing potential and men must use effective contraception or remain abstinent during the study and for 5 months after last dose
- Be able to comply with study visits and protocol requirements
You will not qualify if you...
- Be involved in planning or conducting the study
- Have non-small cell lung cancer
- Participated in another investigational study within 4 weeks before enrollment
- Have unresolved toxicity greater than grade 2 from prior cancer therapy except certain irreversible toxicities
- Have a QTc interval ≥470 ms on ECG
- Use systemic immunosuppressive medication within 2 weeks before treatment or anticipate needing it during treatment except certain low-dose corticosteroids
- Have symptomatic or active progressing central nervous system metastases
- Prior use of anti-TIGIT therapy
- Prior treatment with CD137 agonists or immune checkpoint therapies including anti-CTLA-4, anti-PD-1, or anti-PD-L1 antibodies
- Use systemic immunostimulatory agents within 4 weeks before treatment
- History of grade 3 or higher immune-related adverse events from prior immunotherapy or unresolved grade >1 events
- Active or history of autoimmune or immune deficiency diseases with some exceptions
- Active or prior inflammatory bowel disease requiring systemic treatment within 2 years
- History of primary immunodeficiency or allogeneic organ transplant
- Hypersensitivity to PD1/PD-L1 monoclonal antibodies or components
- Uncontrolled illnesses including infections, heart failure, hypertension, unstable angina, arrhythmia, active ulcers, bleeding disorders, uncontrolled pain, uncontrolled effusions, symptomatic hypercalcemia, psychiatric illness limiting consent
- Active tuberculosis
- Positive EBV viral capsid antigen IgM or positive EBV PCR
- History of leptomeningeal carcinomatosis
- History of severe allergic or hypersensitivity reactions to antibodies or fusion proteins
- History or evidence of active pneumonitis or related lung diseases
- Receipt of live attenuated vaccine within 30 days before or after study treatment
- Pregnant or breastfeeding
- Contraindications to study treatments as judged by treating clinician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Border Medical Oncology Research Unit
Albury, New South Wales, Australia, 2640
Actively Recruiting
2
Ramsay Health Care Australia Pty Ltd trading as The Border Cancer Hospital
Albury, New South Wales, Australia, 2640
Actively Recruiting
3
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, Australia, 2450
Actively Recruiting
4
Orange Base Hospital
Orange, New South Wales, Australia, 2800
Actively Recruiting
5
Port Macquarie Base Hospital
Port Macquarie, New South Wales, Australia, 2444
Actively Recruiting
6
Cairns Hospital
Cairns, Queensland, Australia, 4870
Not Yet Recruiting
7
Rockhampton Hospital
Rockhampton, Queensland, Australia, 4700
Not Yet Recruiting
8
Toowoomba Hospital
Toowoomba, Queensland, Australia, 4350
Not Yet Recruiting
9
Townsville Hospital
Townsville, Queensland, Australia, 4810
Actively Recruiting
10
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
Actively Recruiting
11
Bendigo Health
Bendigo, Victoria, Australia, 3550
Actively Recruiting
12
Barwon Health
Geelong, Victoria, Australia, 3220
Actively Recruiting
13
Fiona Stanley Hospital
Perth, Western Australia, Australia, 6150
Actively Recruiting
Research Team
S
Simone Jacoby
CONTACT
V
Vanessa Jones
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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