ATEZOLIZUMAB for Advanced cancer

Inclusion criteria

• {"criterion_text":"- Adult (age ≥ 18 years) patient with a histologically-confirmed locally advanced or metastatic cancer who is no longer benefitting from curative anti-cancer treatment or for whom no such treatment is available or indicated.\n- ECOG performance status 0-2\n- Patients must have acceptable organ function as defined below. However, specific inclusion/exclusion criteria specified in the drug-specific study manual will take precedence: a.\tAbsolute neutrophil count ≥ 1.5 x 109/l b.Hemoglobin > 8.0 mmol/l c.Platelets > 75 x 109/l For hematological patients: 3.c. is not applicable for hematological cancers as abnormal blood counts are often caused by advanced disease, and they normalize with successful therapy. d.Total bilirubin < 1.5 x ULN e.AST and ALT < 3 x institutional ULN (or < 5 x ULN in patients with known hepatic metastases) f.Serum creatinine ≤ 1.5 × ULN or calculated or measured creatinine clearance ≥ 40 mL/min/1.73 m2\n- Patients must have objectively evaluable or measurable disease (by physical, radiographic or laboratory examination, according to RECIST v1.1, Lugano, IWG and ELN-AML, IMWG, RANO, GCIG, iRESIST or PCWG3.\n- Results must be available from a tumor molecular profiling. Eligible tests may include any of the following technologies: fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), comparative genomic hybridization (CGH), next generation sequencing (NGS) or immunohistochemistry (IHC). The test may have been performed on the primary tumor or a metastatic lesion, in a diagnostic laboratory or within the context of another commercial platform (eg Foundation Medicine), and must reveal a potentially actionable variant as defined in Section 5. The test results (full pathology or molecular diagnostics report) must be uploaded in the eCRF\n- Patients must have a tumor profile for which treatment with one of the approved (or under revision for approval or for which otherwise sufficient safety data has been established) targeted anti-cancer drugs included in this study has potential clinical benefit based on preclinical data or clinical information (see section 5).\n- A new (obtained ≤6 months before inclusion after which no further anti-cancer therapy is allowed) fresh frozen and FFPE tumor biopsy specimen or liquid biopsy for extensive biomarker testing is mandatory before the start of treatment with a targeted agent included in the protocol. a.\tAn exception is made for patients, if the pre-treatment biopsy for biomarker analysis cannot safely be obtained: i)\tThe fresh frozen tumor biopsy sample may be replaced by fresh frozen tumor tissue, obtained earlier, as part of standard of care surgical procedure (i.e., performed at progression) ii)\tIf no fresh frozen tumor tissue is available for NGS, and the risk of obtaining a new tumor biopsy is considered too high, no biopsy will be required. A liquid biopsy is recommended in these cases.\n- Ability to understand and the willingness to sign a written or electronic informed consent document and comply to the protocol.\n- For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.\n- Because of the risks of drug treatment to the developing fetus, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation, and for four months following completion of study therapy. Male patients should avoid impregnating a female partner. Male patients, even if surgically sterilized, (i.e. post-vasectomy) must agree to one of the following: practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or completely abstain from sexual intercourse."}

Exclusion criteria

• {"criterion_text":"- Ongoing toxicity > grade 2, other than alopecia or > grade 1 neuropathy.\n- Patient is receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement). Required wash out period prior to starting study treatment is at least two weeks. An exception is made for: a.\tPatients suffering from CRPC are allowed to continue androgen deprivation therapy. b.\tMedications that are prescribed for supportive care but may potentially have an anti-cancer effect (e.g., megestrol acetate, bisphosphonates). These medications must have been started ≥ 1 week prior to enrollment on this study.\n- Patient is pregnant or nursing\n- Patients with known active progressive brain metastases. Patients with previously treated brain metastases are eligible, provided that the patient is clinically stable and off steroids for at least 4 weeks prior to study initiation.\n- Additional exclusion criteria specific for GBM patients: a.\tPatients who require anti-convulsant therapy must be taking non-enzyme inducing antiepileptic drugs (non-EIAED). EIAED are prohibited. Patients previously on EIAED must be switched to non-EIAED at least 2 weeks prior to randomization. b.\tNo radiotherapy within the three months prior to the diagnosis of progression unless for palliative intent to treat pain symptoms. c.\tNo radiotherapy with a dose over 65 Gy, stereotactic radiosurgery or brachytherapy unless the recurrence is histologically proven.\n- Patients with clinically significant preexisting cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure are not eligible.\n- Patients with known left ventricular ejection fraction (LVEF) < 45% are not eligible\n- Patients with stroke (including TIA) or acute myocardial infarction within 3 months before the first dose of study treatment are not eligible\n- Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements including, but not limited to: ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness/social situations."}

Primary endpoints

• {"endpoint_text":"- Disease control rate at 16 weeks after treatment initiation (defined as patients by CR, PR, SD)","definition_or_measurement_approach":"Defined in the endpoint text: disease control rate at 16 weeks after treatment initiation (defined as patients by CR, PR, SD)."}

Secondary endpoints

• {"endpoint_text":"- Duration of treatment on study (time on drug)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Treatment-related grade ≥3 and serious adverse events","definition_or_measurement_approach":""}
• {"endpoint_text":"- Best overall response (defined as patients by CR, PR, SD)","definition_or_measurement_approach":"Defined in the endpoint text: best overall response classified as CR, PR, SD."}
• {"endpoint_text":"- Progression free survival","definition_or_measurement_approach":""}
• {"endpoint_text":"- Overall survival","definition_or_measurement_approach":""}

Finland

Earliest CTIS Part Ii Submission Date

28-10-2024

Latest Decision Or Authorization Date

11-03-2026

Processing Time Days

499

Number Of Sites

5

Number Of Participants

250

Primary sponsor

Full Name

HUS-Yhtymae

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Finland

Third parties

• {"country":"","full_name":"Faron Pharmaceuticals Ltd.","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"Merck Healthcare KGaA","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"Incyte Biosciences International S.A.R.L.","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"Roche Oy","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"Lilly Oy","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"Janssen-Cilag Oy","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"Bayer Oy","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"Novartis Oy","duties_or_roles":"Monetary support","organisation_type":""}