To Assess Immunogenicity of Coronavirus Disease 2019 (COVID-19) Vaccine in Cancer Patients Receiving Cancer Treatment

Study Overview
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Brief Summary
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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.

Official Title
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Cancer Therapy and Immunogenicity of COVID Vaccine (CANINE Trial)

Conditions
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Breast Cancer, Lung Cancer, Melanoma (Skin)

Intervention / Treatment
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* Biological: COVID-19 Vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chemotherapy (IV and oral)<br> | Biological: COVID-19 Vaccine<br>* Per recommended dosing schedule<br>|
| Immunotherapy<br> | Biological: COVID-19 Vaccine<br>* Per recommended dosing schedule<br>|
| Chemotherapy + Immunotherapy<br> | Biological: COVID-19 Vaccine<br>* Per recommended dosing schedule<br>|
| Cyclin- dependent kinase (CDK) 4/6 inhibitors<br> | Biological: COVID-19 Vaccine<br>* Per recommended dosing schedule<br>|
| Stem Cell Transplant recipients<br> | Biological: COVID-19 Vaccine<br>* Per recommended dosing schedule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean titer (GMT) with corresponding 95%confidence interval (CI) at each time point of the entire population and individually of all cohorts | Elecsys Anti severe acute respiratory syndrome (SARS) coronavirus 2 (CoV 2) S quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201. | 
| Geometric mean titer (GMT) with corresponding 95% CI at each time point of the entire population and individually of all cohorts | Elecsys Anti SARS CoV 2 S quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 | 
| Geometric mean titer (GMT) with corresponding 95% CI at each time point of the entire population and individually of all cohorts | Elecsys Anti SARS CoV 2 S quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209 | 
| Geometric mean fold rise (GMFR) with corresponding 95% CI at each post-baseline timepoint over preinjection baseline | Elecsys Anti SARS CoV 2 S quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 | 
| Geometric mean fold rise (GMFR) with corresponding 95% CI at each post-baseline timepoint over preinjection baseline | Elecsys Anti SARS CoV 2 S quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer baseline, Day 21, Day 51, Day 111, Day 201 | 
| Geometric mean fold rise (GMFR) with corresponding 95% CI at each post-baseline timepoint over preinjection baseline | Elecsys Anti SARS CoV 2 S quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric median, minimum and maximum assay titer values for each cohort | Elecsys Anti SARS CoV 2 S quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 | 
| Geometric median, minimum and maximum assay titer values for each cohort | Elecsys Anti SARS CoV 2 S quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201 | 
| Geometric median, minimum and maximum assay titer values for each cohort | Elecsys Anti SARS CoV 2 S quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209 | 
| The number of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 | 
| The percentage of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 | 
| The number of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 | 
| The percentage of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 | 
| The number of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 | 
| The percentage of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 | 
| The number of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201 | 
| The percentage of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201 | 
| The number of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201 | 
| The percentage of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201 | 
| The number of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201 | 
| The percentage of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201 | 
| The number of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209 | 
| The percentage of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209 | 
| The number of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209 | 
| The percentage of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209 | 
| The number of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209 | 
| The percentage of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs | Elecsys Anti SARS CoV 2 quantitative assay | Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209 |