Vaccination against cOvid In CancEr

Phase 1

• Conditions: solid tumors; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-000872-13-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-27
• Last Update Posted: 17 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 873

Inclusion Criteria

To be eligible to participate in this study, a subject must meet all of the following criteria:
• Age of 18 years or older
• Life expectancy > 12 months
• Ability to provide informed consent

Additional criteria for cohort A:
• Partner of a participating patient

Additional criteria for cohort B:
• Histological diagnosis of a solid malignancy
• Treatment with monotherapy immune checkpoint inhibitor (ICI) against Programmed Death 1 (PD1) or its ligand PD-L1 (in curative or non-curative setting)
• Last ICI administration within 3 months of vaccination

Additional criteria for cohort C:
• Histological diagnosis of a solid malignancy
• Treatment with cytotoxic chemotherapy (monotherapy and combination chemotherapy is allowed, as well as a combination with radiotherapy, in curative or non-curative setting)
• Last chemotherapy administration within 4 weeks of vaccination

Additional criteria for cohort D:
• Histological diagnosis of a solid malignancy
• Treatment with a PD1 or PD-L1 antibody in combination with cytotoxic chemotherapy (in curative or non-curative setting)
• Last chemotherapy administration within 4 weeks of vaccination
• Last ICI administration within 3 months of vaccination
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 436
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 435

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Confirmed SARS-CoV-2 infection (current or previous)
• Women who are pregnant or breastfeeding
•Active hematologic malignancy
• Any immune deficiency not related to cancer or cancer treatment (e.g. inherited immune deficiency or known infection with Human Immunodeficiency Virus)
• Systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medication within 14 days of vaccination. Inhaled or topical steroids, and adrenal replacement steroids (> 10 mg daily prednisone equivalent) are permitted. In addition, standard of care with short course steroids to prevent nausea and allergic reactions from chemotherapy or iodinated CT contrast is allowed.

Additional criteria for cohort A:
• Current or previous diagnosis of a solid malignancy, unless treated with curative intent >5 years before enrolment and without signs of recurrence during proper follow-up
• Previous history of a hematologic malignancy

Additional criteria for cohort B:
• Treatment with cytotoxic chemotherapy within 4 weeks of vaccination

Additional criteria for cohort C:
• Treatment with an ICI within 3 months of vaccination

Study & Design

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