A Study of Tiragolumab plus Atezolizumab and Atezolizumab Monotherapy in Patients with Metastatic and/or Recurrent PD-L1-Positive Cervical Cancer.
- Conditions
- Cervical cancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-004895-21-FR
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 160
- Age >= 18 years
- Life expectancy >= 12 weeks
- Ability to comply with the study protocol
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Histologically confirmed primary Stage IVB, recurrent, or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix after at least 1 line of prior therapy that is not amenable to curative treatment with systemic chemotherapy, surgery, and/or radiotherapy
- Measurable disease
- Formalin-fixed, paraffin-embedded (FFPE) cervical cancer tissue specimen that is programmed death-ligand 1 (PD-L1) positive, as determined by the Ventana PD-L1 (SP263) immunohistochemistry (IHC) assay, with positivity defined as tumor and tumor-infiltrating immune cells (TIC) >=5%, as determined by a central laboratory
- Adequate hematologic and end-organ function obtained within 14 days prior to randomization
- Negative HIV test and hepatitis B surface antigen (HBsAg) test at screening
- Positive hepatitis B core antibody (HBsAb) test at screening, or negative HBsAb at screening
- Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
- Recovery from the effects of surgery, radiotherapy, or chemoradiotherapy
- No active infection requiring systemic antibiotics
- For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs, women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 5 months after the final dose of tiragolumab and/or atezolizumab.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
- FFPE cervical cancer tissue specimens that is PD-L1 negative, as determined by the PD-L1 SP263 IHC assay, with positivity defined as TIC < 5%, as determined by a central laboratory
- More than two prior systemic lines of therapy in the metastatic/recurrent setting
- Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of tiragolumab and/or atezolizumab
- Treatment with investigational therapy with therapeutic intent within 28 days prior to randomization
- Planned surgery during the study
- Current treatment with anti-viral therapy for HBV or HCV
- Known HIV infection
- Substance abuse within 12 months prior to screening, in the investigator's judgment
- Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
- Bilateral hydronephrosis that cannot be alleviated by ureteral stents or percutaneous drainage
- History of other malignancy within 5 years prior to screening, except for those with an expected negligible risk for metastases or death after curative treatment
- Any central nervous system /brain metastases
- Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >= 1 week prior to randomization
- Leptomeningeal disease
- Uncontrolled or symptomatic hypercalcemia
- Known, clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease, or current alcohol abuse
- Active or history of autoimmune disease or immune deficiency, including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis
- Active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening
- Active tuberculosis
- Severe infection at the time of randomization, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
- Significant cardiovascular disease, such as New York Heart Association cardiac disease, myocardial infarction, or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina
- Major surgical procedure other than for diagnosis within 28 days prior to randomization or anticipation of need for a major surgical procedure during the study
- Prior allogeneic bone marrow transplantation or solid organ transplant
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk for treatment complications
- Illnesses or conditions that interfere with the patient’s capacity to understand, follow, and/or comply with study procedures
- Administration of a live, attenuated vaccine within 4 weeks before randomization or anticipation that such a live attenuated vaccine will be required during the study
- Prior treatment with CD137 agonists or immune
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method