E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients eligible for, or under, or recently treated by chemotherapy (CT) and/or immune-checkpoint blockade (ICB) for the treatment of solid tumors or hematological malignancies. |
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E.1.1.1 | Medical condition in easily understood language |
Patients eligible for, or under, or recently treated by chemotherapy (CT) and/or immune-checkpoint blockade (ICB) for the treatment of solid tumors or hematological malignancies. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients (Part A).
To evaluate the Covid-19 disease mortality rate in cancer patients treated by hydroxychloroquine and azithromycin (Part B).
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety, Covid-19 disease severity, response to cancer treatment, Progression-free survival (PFS), cancer mortality, and Overall Survival (OS) of cancer patients infected by SARS-Cov2.
To follow the evolution of SARS-CoV-2 infection and viral load in different compartments (nasal epithelia, blood and urine) during the course of therapy.
To evaluate the impact of mutation shifts in SARS-CoV-2 genotype (in sever cases only).
To follow the humoral and cellular immune responses to the virus, to cancer and control antigens during infection with SARS-CoV-2.
To deconvolute SARS-CoV-2-specific MHC class I and II binding epitopes to follow T cell responses with tetramers and Elispot assays, as well as cancer antigens (NY-ESO-1, MAGEn, preprocalcitonin, actinin...)-specific responses.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• All types of locally advanced and metastatic malignancy
• Male/female participants
• Age>18 y.o.
• Signed informed consent for participation in the study
• No restriction on Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) Performance Status
• Subject should not have received a prior systemic anti-viral treatment for Covid19 disease.
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E.4 | Principal exclusion criteria |
• Patients with known allergy to hydroxychloroquine or chloroquine,
• Patients with known allergy to azithromycine, erythromycine, or all antibiotics belonging to the macrolide family.
• Patients currently treated with Tamoxifen
• Patients with known contra-indication to treatment with the study drug, including retinopathy, G6PD deficiency, QT prolongation and severe hepato-cellular insufficiency.
• Pregnant or breastfeeding women. Women of childbearing potential (WOCBP, as defined in appendix 2) should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoints of the study are for the:
o Part A: prevalence at first visit and 12 weeks cumulative incidence (in a competing risk model with mortality) of SARS-CoV-2 positive subjects (RT-PCR)
o Part B: Covid-19 disease specific mortality |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 weeks and 12 month (mortality) |
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E.5.2 | Secondary end point(s) |
Safety will be measured by the incidence of all treatment-related adverse events (CTCAE v.5 of any grade), serious adverse events (any cause), deaths (any cause). Covid-19 disease severity (ordinal score).
Objective response to Cancer Treatment (as per routine procedure).
Progression-free survival (PFS).
Short term cancer specific mortality.
Overall Survival (OS).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 11 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |