Prospective Study in Patients With Advanced or Metastatic Cancer and SARS-CoV-2 Infection

PHASE2CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

April 15, 2020

Primary Completion Date

July 6, 2021

Study Completion Date

December 31, 2021

Conditions
SARS-CoV-2 (COVID-19) InfectionAdvanced or Metastatic Hematological or Solid Tumor
Interventions
DRUG

Autophagy inhibitor (GNS651)

Cohort 1 (arm B): 200mg q.d. orally for 10 consecutive days. If for any reason a treatment is not given within the allowed treatment window (± 12h) it will be cancelled (i.e., missed for that time point), and treatment will be resumed at the next dosing day.

OTHER

Standard of care

"In cohorts 1 and 2, patients allocated in the standard of care arms should receive best supportive care, as per the investigator's discretion and the local routine practices. With regards to the respiratory symptoms and medical resoures at investigational site, the following should be given according to the patient's condition: oxygen supplementation, non-invasive ventilation, invasive ventilation, antibiotherapy, vasopressor support, renal replacement therapy, or extracorporeal membrane oxygenation.~Additional care and medications should be administered in the patient's best interest."

DRUG

Avdoralimab

Cohorte 2 (arm H): 500mg, intravenously, at Day 1 then 200mg once daily every 2 days during 14 Days

DRUG

Monalizumab

Cohorte 2 (arm G) : 50mg (flat dose),intravenously, single infusion at Day 1.

Trial Locations (12)

59020

Centre Oscar Lambret, Lille

63000

Centre Jean Perrin, Clermont-Ferrand

67200

Institut de cancérologie Strasbourg Europe (ICANS), Strasbourg

69373

Centre Léon Bérard, Lyon

75012

AP-HP Hôpital Saint Antoine, Paris

75013

AP-HP La Pitié Salpétrière, Paris

75014

Hôpital Saint-Joseph, Paris

75248

AP-HP Tenon, Paris

75877

AP-HP Hôpital Bichat Claude Bernard, Paris

75960

GH Diaconesses Croix Saint Simon, Paris

94805

Institut Gustave Roussy, Villejuif

690003

CHU Clermont Ferrand, Clermont-Ferrand

All Listed Sponsors
lead

Centre Leon Berard

OTHER

NCT04333914 - Prospective Study in Patients With Advanced or Metastatic Cancer and SARS-CoV-2 Infection | Biotech Hunter | Biotech Hunter