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

Sponsor
Centre Leon Berard
Study ID
NCT04333914
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Autophagy inhibitor (GNS651) — DRUG
    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.
  • Standard of care — OTHER
    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.
  • Avdoralimab — DRUG
    Cohorte 2 (arm H): 500mg, intravenously, at Day 1 then 200mg once daily every 2 days during 14 Days
  • Monalizumab — DRUG
    Cohorte 2 (arm G) : 50mg (flat dose),intravenously, single infusion at Day 1.

Study Details

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).

Key Dates

Start date
Apr 15, 2020
Status verified
Aug 2021
Primary completion
Jul 6, 2021
Completion
Dec 31, 2021

Study Design

Enrollment
19 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Autophagy inhibitor (GNS651)
  • Other: Standard of care
  • Experimental: anti-NKG2A (Monalizumab)
  • Experimental: anti-C5aR (Avdoralimab)

Primary Outcome Measure

28-day survival rate [ Time Frame: 28 days from randomization ]

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