Status:
ACTIVE_NOT_RECRUITING
Vaccination Against COVID-19 in Cancer
Lead Sponsor:
University Medical Center Groningen
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will collect information on immune response and adverse events after vaccination against coronavirus disease (COVID-19) in a vulnerable patient cohort. Understanding the ability or disabili...
Detailed Description
Rationale: Patients with cancer have an increased risk of adverse outcome of COVID-19, which is determined by their underlying disease and/or cancer treatment. Therefore, vaccination of cancer patien...
Eligibility Criteria
Inclusion
- 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
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
January 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2025
Estimated Enrollment :
791 Patients enrolled
Trial Details
Trial ID
NCT04715438
Start Date
January 8 2021
End Date
April 1 2025
Last Update
May 3 2024
Active Locations (3)
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1
NKI-AvL
Amsterdam, Netherlands
2
UMCG
Groningen, Netherlands, 9700 RB
3
Erasmus MC
Rotterdam, Netherlands