Phased Avelumab combined with chemotherapy as first-line treatment for patients with advanced small-cell lung cancer (SCLC) - PAVE

Hellenic Cooperative Oncology Group (HeCOG)0 sites55 target enrollmentMarch 13, 2018

DrugsBavencio 20 mg/ml concentrate for solution for infusion

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Hellenic Cooperative Oncology Group (HeCOG)
Enrollment: 55
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 13, 2018

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Hellenic Cooperative Oncology Group (HeCOG)

Eligibility Criteria

Inclusion Criteria

•Signed written informed consent
•Male or female patients aged more than or equal to (\=) 18 years
•With Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry
•At least 1 measurable tumor lesion by RECIST 1\.1
•With histologically confirmed metastatic (Stage IV) small cell lung cancer (SCLC)
•Patients must not have received any previous systemic treatment for small cell lung cancer
•Patients must have an estimated life expectancy of more than 12 weeks
•Patients must have an available recently\-obtained, formalin\-fixed, paraffin\-embedded (FFPE) tissue sample containing tumor (biopsy preferably within 6 months) or a minimum number of 10 unstained slides, suitable for PD\-L1 expression assessment.
•PHYSIOLOGIC FUNCTION:
•Hematologic: Absolute neutrophil count (ANC) \= 1\.5 × 109/L, platelet count \= 100 × 109/L, and hemoglobin \= 9 g/dL (may have been transfused)

Exclusion Criteria

•Patients with brain metastases are excluded, except those with brain metastases that have been treated with surgery or radiation and are clinically stable for at least 2 weeks prior to registration. Subjects must be either off steroids or on a stable or decreasing dose of \=10 mg daily prednisone (or equivalent), and should not have ongoing neurological symptoms that are related to the brain disease.
•Prior therapy with any antibody or drug targeting T cell co\-regulatory proteins, concurrent anticancer treatment, or immunosuppressive agents
•Patients on current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra\-articular injection); b. Systemic corticosteroids at physiologic doses \= 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).”
•Known severe hypersensitivity reactions to monoclonal antibodies (Grade \= 3 NCI CTCAE v 4\.03\), history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma), and persisting toxicity related to prior therapy of Grade \> 1 NCI\-CTCAE v 4\.03\.
•Patients with active autoimmune disease that might deteriorate when receiving an immuno\-stimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo\- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
•Patients with prior organ transplantation including allogenic stem\-cell transplantation are excluded.
•Patients with an active infection requiring systemic therapy are excluded.
•Patients positive for HIV or known acquired immunodeficiency syndrome are excluded. HIV\- positive patients with undetectable viral load may be included in the study provided they meet all other inclusion criteria and their HIV care practitioner has consented.
•Also excluded are patients with Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti\-HCV antibody screening test positive).Patients with a recent (pre\-enrollment) HBV negative viral load may be eligible for the study if they meet all the other inclusion criteria and HBV or HCV infection is remitted with or without antiviral treatment based on written proof by the treating hepatologist.
•Vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines.