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

NCT04821570 | Unknown DMC

• 1 other identifier: IIT-2021-CANINE
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Lung Cancer; Melanoma (Skin)

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (21)

• Geometric median, minimum and maximum assay titer values for each cohort

  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

  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

  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

  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

  Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209

Study Arms (5)

Chemotherapy (IV and oral)

Biological: COVID-19 Vaccine

Immunotherapy

Biological: COVID-19 Vaccine

Chemotherapy + Immunotherapy

Biological: COVID-19 Vaccine

Cyclin- dependent kinase (CDK) 4/6 inhibitors

Biological: COVID-19 Vaccine

Stem Cell Transplant recipients

Biological: COVID-19 Vaccine

Interventions

COVID-19 Vaccine BIOLOGICAL

Per recommended dosing schedule

Chemotherapy (IV and oral); Chemotherapy + Immunotherapy; Cyclin- dependent kinase (CDK) 4/6 inhibitors; Immunotherapy; Stem Cell Transplant recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• \* Life expectancy of \< 12 months

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

The University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, 66205, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Melanoma

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Qamar Khan, MD

  University of Kansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 29, 2021
• Study Start: February 23, 2021
• Primary Completion: March 28, 2024
• Study Completion: March 28, 2025
• Last Updated: April 4, 2023

Record last verified: 2023-04

Locations

US (1)