Immune Responses in Oncology Patients to Novel Coronavirus Vaccines (IROC)

Cancer Clinical Trial

Official title:

Immune Responses in Oncology Patients to Novel Coronavirus Vaccines (IROC)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04930055
• Other study ID #: CTO-IUSCCC-0759
• Status: Terminated
• Start date: June 30, 2021
• Est. completion date: March 8, 2022

Study information

• Verified date: May 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goals of this study are to assess initial or booster vaccine performance (safety and efficacy) and to collect serum and peripheral blood mononuclear cells (PBMCs) pre and post-vaccination to assess immune and other response parameters following immunization in cancer patients receiving either the Pfizer (BTN162b2), Moderna (mRNA-1273), or the Janssen (Ad26.COV2.S) vaccines.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2206
• Est. completion date: March 8, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Ability to provide written informed consent and HIPAA authorization

2. Patients deemed eligible and willing to receive a COVID-19 vaccine by treating physician per standard of care.

3. Subjects must be = 18 years old at the time of consent.

4. Diagnosis of cancer and fall into one of the groups below:

1. Group 1: Patients with solid tumors receiving courses of cytotoxic therapy.

2. Group 2: Patients with hematological cancers receiving courses of cytotoxic chemotherapy.

3. Group 3: Patients with solid tumors receiving tyrosine kinase inhibitors (TKIs) or other targeted therapies, but not cytotoxic regimens within 3 months.

4. Group 4: Patients with hematologic cancers receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months.

5. Group 5: Patients receiving immune checkpoint inhibitors.

6. Group 6: Patients who underwent allogeneic stem cell transplant within 12 months.

7. Group 7: Patients who underwent cellular therapy, including Chimeric antigen receptor t-cells (CAR-T) cells or t-cells with engineered t-cell receptors (TCRs) within 12 months.

8. Group 8: Patients in remission who have received cellular therapy more than 12 months in the past, including allogeneic, autologous or engineered cellular approaches.

9. Group 9: Patients with cancer in remission for at least 2 years not receiving active cytotoxic cancer chemotherapy (hormonal therapy is permitted).

10. Group 10: Patients who have undergone allogenic bone marrow transplant and are currently receiving immunosuppressants

11. Group 11: Patients who have undergone allogenic bone marrow transplant who are not currently receiving immunosuppressants

12. Group 12: Patients who have a cancer diagnosis but do not fall into group 1-11

3. Estimated survival of 8 weeks or more following enrollment on the study.

Exclusion Criteria:

1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active COVID-19 infection or influenza-like-illness. If subjects have previously tested positive for COVID-19 infection, they are eligible to participate in this study after 90 days

2. Unwilling or unable to follow protocol requirements.

Related Conditions & MeSH terms

• Cancer
• Coronavirus Infections

Intervention

Biological:
• COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care

Locations

Country	Name	City	State
United States	IU Health Joe and Shelly Schwarz Cancer Center	Carmel	Indiana
United States	Indiana University Melvin and Bren Simon Comprehensive Cancer Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event Collection		from date of vaccination until 2 months after full vaccination
Secondary	Incidence of COVID-19 infection		from date of vaccination until 6 months after full vaccination