NCT04333914

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

A Prospective, Controlled, Randomized, Multicenter Study of the Efficacy of an Autophagy Inhibitor (GNS561), an Anti-NKG2A (Monalizumab) and an Anti-C5aR (Avdoralimab) Compared to the Standard of Care in Patients With Advanced or Metastatic Cancer and SARS-CoV-2 (COVID-19) Infection.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A prospective, controlled, randomized, multicenter study whose goal is to compare the efficacy of an autophagy inhibitor (GNS561), an anti-NKG2A (monalizumab) and an anti-C5aR (avdoralimab) versus standard of care in patients with advanced or metastatic cancer who have Sars-CoV-2 infection not eligible to a resuscitation unit. According to their severity level at the time of enrolment, eligible patients will be randomized into 2 different cohorts: * COHORT 1 (mild symptoms or asymptomatic): GNS561 vs anti-NKG2A vs standard of care (randomization ratio 1:1:1). * COHORT 2 (moderate/severe symptoms): anti-C5aR vs standard of care (randomization ratio 1:1).

Conditions

• SARS-CoV-2 (COVID-19) Infection
• Advanced or Metastatic Hematological or Solid Tumor

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-04-15
• Primary completion: 2021-07-06
• Completion: 2021-12-31
• First posted: 2020-04-03
• Last updated: 2022-09-30

Locations

12 sites across 1 country: France