Clinical trial NCT04821570: To Assess Immunogenicity of Coronavirus Disease 2019 (COVID-19) Vaccine in Cancer Patients Receiving Cancer Treatment
Official title: Cancer Therapy and Immunogenicity of COVID Vaccine (CANINE Trial)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lung Cancer
Melanoma (Skin)
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants undergoing treatment for breast cancer, lung cancer and melanoma with chemotherapy, immunotherapy and/or oral anticancer agents, or have undergone stem cell transplantation

Brief summary: This is a trial of prospective collection of serial blood samples after administration of COVID-19 vaccine in patients with cancer who are receiving active cancer treatment, planned to start therapy with 14 days of consent, or have had stem cell transplant. Cancer treatments and administration of vaccine are not controlled by the study.


Eligibility criteria: Inclusion Criteria:

* Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
* Males and females age ≥ 18 years
* Patients with breast cancer, lung cancer, malignant melanoma or who have undergone stem cell transplant or chimeric antigen receptor (CAR) T cell therapy for a hematologic malignancy.

Other cancer types including hematologic malignancies may be allowed if they are receiving treatments outlined in section 4.1.4

* Solid Tumor patients and those with hematologic malignancies: Currently receiving active anti-cancer therapy, or planned to start within 14 days, with intravenous cytotoxic chemotherapy (oral or intravenous), intravenous chemoimmunotherapy combination, immunotherapy alone, an oral CDK 4/6 inhibitor. (This does not apply to recipients of stem cell transplant and CAR T therapy)
* Therapy may be neo/adjuvant or for metastatic disease
* Eastern Cooperation Oncology Group (ECOG) Performance status (PS) of 0-2

Exclusion Criteria:

\* Life expectancy of \< 12 months

Primary outcomes:
measure: Geometric mean titer (GMT) with corresponding 95%confidence interval (CI) at each time point of the entire population and individually of all cohorts
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201.
measure: Geometric mean titer (GMT) with corresponding 95% CI at each time point of the entire population and individually of all cohorts
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
measure: Geometric mean titer (GMT) with corresponding 95% CI at each time point of the entire population and individually of all cohorts
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
measure: Geometric mean fold rise (GMFR) with corresponding 95% CI at each post-baseline timepoint over preinjection baseline
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
measure: Geometric mean fold rise (GMFR) with corresponding 95% CI at each post-baseline timepoint over preinjection baseline
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer baseline, Day 21, Day 51, Day 111, Day 201
measure: Geometric mean fold rise (GMFR) with corresponding 95% CI at each post-baseline timepoint over preinjection baseline
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
Secondary outcomes:
measure: Geometric median, minimum and maximum assay titer values for each cohort
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
measure: Geometric median, minimum and maximum assay titer values for each cohort
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201
measure: Geometric median, minimum and maximum assay titer values for each cohort
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
measure: The number of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
measure: The percentage of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
measure: The number of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
measure: The percentage of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
measure: The number of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
measure: The percentage of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209
measure: The number of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201
measure: The percentage of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201
measure: The number of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201
measure: The percentage of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201
measure: The number of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201
measure: The percentage of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201
measure: The number of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
measure: The percentage of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
measure: The number of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
measure: The percentage of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
measure: The number of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
measure: The percentage of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs
timeFrame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The University of Kansas Cancer Center, Westwood Campus
state: Kansas
Study officials:
affiliation: University of Kansas
name: Qamar Khan, MD
role: PRINCIPAL_INVESTIGATOR
References: