gevorderde en/of gemetastaseerde solide tumoren cancer solid tumors
Conditions
Interventions
Patients who are eligible will be treated with cergutuzumab amunaleukin in
combiantion with atezolizumab according the study specific schedule as shown in
appendix 1 of the protocol.
combination therapy
solid tumors
Sponsors
Roche Nederland B.V.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Adult patients, * 18 years of age;* Confirmed locally advanced and/or metastatic solid tumor, with at least one tumor lesion of non-critical location accessible to biopsy (with exception to NSCLC patients), and with confirmed progression at baseline that has progressed on, or patient is intolerant to, the standard of care therapy;* Radiologically measurable and clinically evaluable disease (as per response evaluation criteria in Solid Tumors [RECIST] v1.1) ;* Life expectancy, in the opinion of the investigator, of * 12 weeks;* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1;* All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade * 1, except alopecia (any grade) and Grade 2 peripheral neuropathy;* Adequate hematological, liver and renal function test results;* Negative serum pregnancy test within 7 days prior to study treatment in premenopausal women and women
Exclusion criteria
Exclusion criteria: * Active or untreated central nervous system (CNS) metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments * 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 >= 2 weeks prior to enrollment. * Leptomeningeal disease;* Patients with an active second malignancy . Patients who have a history of malignancy are not considered to have an active malignancy if they have completed therapy and are considered by their treating physician to be at 2, serious cardiac arrhythmia requiring treatment (except for patients with pleural effusion, who should have NYHA =470 ms, baseline resting bradycardia 100 beats per minute. *Pregnant or breast-feeding women.;* Known hypersensitivity to any of the components of, cergutuzumab amunaleukin en atezolizumab, hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies. *Investigational therapy (defined as treatment for which there is no regulatory authority approved indication) within 28 days prior to Cycle 1 Day 1. *Last dose with any of the following agents including but not limited to: etanercept, infliximab, tacrolimus, cyclosporine, mycophenolic acid, alefacept, or efalizumab <28 dyas prior to Cycle 1 Day 1.;* Last dose of prior immunotherapies including but not limited to: interferon alpha (IFN-a), int
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objectives of this study are: * To describe the safety and tolerability of cergutuzumab amunaleukin in combination with atezolizumab * To determine the MTD, if achieved, of cergutuzumab amunaleukin in combination with atezolizumab * To identify a recommended Phase II dose of cergutuzumab amunaleukin in combination with atezolizumab. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives for this study are as follows: * To obtain preliminary anti-tumor activity data of cergutuzumab amunaleukin in combination with atezolizumab in patients with locally advanced and/or metastatic solid tumors * To describe the pharmacodynamic (PD) effects of cergutuzumab amunaleukin in combination with atezolizumab * To describe the pharmacokinetics (PK) of cergutuzumab amunaleukin and atezolizumab when they are administered in combination | — |
Countries
Denmark, Netherlands, Spain, Switzerland, United States of America
Outcome results
None listed