Efficacy and Safety of PD-L1 Inhibitor in Patients With Advanced Solid Tumors Beyond Lung Cancer: a PhaseⅠB Clinical Study
Overview
- Phase
- Phase 1
- Intervention
- PD-L1 inhibitor
- Conditions
- Efficacy
- Sponsor
- The Affiliated Hospital of Qingdao University
- Enrollment
- 30
- Primary Endpoint
- DCR
- Last Updated
- 4 years ago
Overview
Brief Summary
Anti-PD-L1 immune checkpoint inhibitor, is approved for the treatment of patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy, or as first-line treatment of patients with ES-SCLC in combination with etoposide and either carboplatin or cisplatin in China. The clinical data regarding the PD-L1 inhibitor in other solid tumors are limited.Investigators would observe and analyze the effectiveness and safety of PD-L1 inhibitor for patients with advanced - solid tumors beyond lung cancer after muti-line therapy to explore the synergistic effect of PD-L1 inhibitor rechallenge after PD-1immunotherapy.
Investigators
zhangxiaochun
director
The Affiliated Hospital of Qingdao University
Eligibility Criteria
Inclusion Criteria
- •Signed Informed Consent Form
- •Ability to comply with protocol
- •Aged ≥ 18 years
- •Histologically documented advanced solid tumor beyond lung cancer
- •Disease progression during or following at least one line treatment containing PD-1 immunotherapy.
- •Measurable disease, as defined by RECIST v1.1
- •ECOG performance status of 0 or 1
- •Life expectancy ≥ 12 weeks
- •Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment:
- •ANC ≥ 1.5 × 109/L (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility) WBC counts \> 2.5 × 109/L and \< 15 × 109/L Lymphocyte count ≥ 0.5 × 109/L Serum albumin ≥ 2.5 g/dL Platelet count ≥ 100 × 109/L (without transfusion within 2 weeks of laboratory test used to determine eligibility) Hemoglobin ≥ 9.0 g/dL Patients may be transfused or receive erythropoietic treatment to meet this criterion.
Exclusion Criteria
- •Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
- •Leptomeningeal disease
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- •Uncontrolled hypertension
- •Autoimmune disease
- •Had undergone a serious anaphylactic reaction in previous immunotherapy
Arms & Interventions
PD-L1 rechallenge
Intervention: PD-L1 inhibitor
Outcomes
Primary Outcomes
DCR
Time Frame: At the end of Cycle 3 (each cycle is 21 days)".
Disease Control Rate
PFS
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
progression-free survival
Secondary Outcomes
- AE(hrough study completion, an average of 1 year)
- OS(From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months)