A phase II exploratory study of durvalumab (MEDI4736) in HIV-1 patients with advanced solid tumors - DURVAST

Spanish Lung Cancer Group (Grupo Español de Cáncer de Pulmón)0 sites20 target enrollmentJanuary 5, 2017

Conditionsadvanced solid tumors in HIV-1 infected patients Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: advanced solid tumors in HIV-1 infected patients
Sponsor: Spanish Lung Cancer Group (Grupo Español de Cáncer de Pulmón)
Enrollment: 20
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 5, 2017

End Date

March 29, 2021

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Spanish Lung Cancer Group (Grupo Español de Cáncer de Pulmón)

Eligibility Criteria

Inclusion Criteria

•1\. Written informed consent obtained from the subject prior to performing any protocolrelated
•procedures, including screening evaluations.
•2\. Age \> 18 years at time of study entry.
•3\. Eastern Cooperative Oncology Group (ECOG) 0\-2
•4\. Life expectancy of \> 16 weeks
•5\. Adequate normal organ and marrow function as defined below:
•\- Haemoglobin \= 9\.0 g/dL
•\- Absolute neutrophil count (ANC) \= 1\.5 x 109/L (\> 1500 per mm3\)
•\- Platelet count \= 100 x 109/L (\>100,000 per mm3\)
•\- Serum bilirubin \= 1\.5 x institutional upper limit of normal (ULN). This will not apply to subjects with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of haemolysis or hepatic pathology), who will be allowed only in consultation with their physician.

Exclusion Criteria

•1\. Involvement in the planning and/or conduct of the study. Previous enrollment in the present study.
•2\. Participation in another clinical study with an investigational product during the last 4 weeks.
•3\. Other untreated coexisting HIV related malignancies.
•4\. Any previous treatment with a PD1, PD\-L1 or PD\-L2 inhibitor, including durvalumab.
•5\. Receipt of the last dose of anti\-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) 28 days prior to the first dose of study drug.
•6\. Mean QT interval corrected for heart rate (QTc) \=470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia’s Correction.
•7\. Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid.
•8\. Any unresolved toxicity (CTCAE grade 2\) from previous anti\-cancer therapy. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy).
•9\. Any prior Grade \=3 immune\-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE \>Grade 1\.
•10\. Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.