Study comparing the efficacy of a chloroquine analog (GNS561), anti PD-1 (nivolumab) and anti-interleukine-6 receptor (tocilizumab) versus standard of care in advanced or metastatic cancer patients with SARS-CoV-2 (COVID-19) infectio

Phase 1

• Conditions: Patients with advanced or metastatic cancer who have Sars-CoV-2 infection not eligible to a resuscitation unit; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-001373-70-FR
• Lead Sponsor: Centre Léon Bérard

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-29
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 273

Inclusion Criteria

I1. Age 18 or older at the time of enrolment.
I2. Histologically or cytologically confirmed diagnosis of advanced or metastatic hematological or solid tumor (hematological or solid tumor, any type and any localization).
I3. Documented diagnosis of COVID-19 (diagnostic test performed in a certified laboratory) or symptoms of COVID-19 associated with radiological signs of pneumonia as described by Shi et al.;
I4. Cohort 2: patients with pneumonia confirmed by chest imaging, and an oxygen saturation (Sao2) of 94% or less while they are breathing ambient air or a ratio of the partial pressure of oxygen (Pao2) to the fraction of inspired oxygen (Fio2) (Pao2:Fio2) at or below 300 mg Hg.
...See the protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 147
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 126

Exclusion Criteria

E1. For cohort 1 only : Patient currently receiving therapy with an anti- PD-1, anti- PD-L1, or anti-CTLA4.
E2. For cohort 2 only: Patient currently receiving therapy with an anti- IL-6 or anti-IL-6R.
E3. Contraindication to treatment with nivolumab (cohort 1 only) or to tocilizumab (cohort 2 only) as per respective SPC, including known hypersensitivity to one of these study drugs or severe hypersensitivity reaction to any monoclonal antibody.
E4. Patient known to have intolerance or hypersensitivity to chloroquine or any quinoline derivates (e.g., quinine, chloroquine, mefloquine).
...See the protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified