Status:
UNKNOWN
PD-L1 Inhibitor Rechallenge After PD-1 Immunotherapy for Patients With Solid Tumor Beyond Lung Cancer
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Conditions:
Efficacy
Safety
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 a...
Eligibility Criteria
Inclusion
- 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.
- Liver function tests meeting one of the following criteria:
- AST or ALT ≤ 2.5 × upper limit of normal (ULN), with alkaline phosphatase
- ≤ 2.5 × ULN or AST and ALT ≤ 1.5 × ULN in conjunction with alkaline phosphatase \> 2.5 × ULN Serum bilirubin ≤ 1.5 × ULN Patients with known Gilbert's disease who have serum bilirubin level ≤ 3 × ULN may be enrolled. INR and aPTT ≤ 1.5 × ULN This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose for at least 1 week prior to randomization. Creatinine clearance ≥ 30 mL/min Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration, or Modification of Diet in Renal Disease formulas may be used for creatinine clearance calculation. Note that 24-hour urine collection is not required but is allowed.
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05325684
Start Date
April 1 2022
End Date
December 1 2023
Last Update
April 13 2022
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