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TerminatedNCT04930055Updated May 19, 2023

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

An observational study in Cancer, sponsored by Indiana University. Terminated at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-19.

Sponsored by Indiana University · Observational

Why this study was terminated
PI had decided to terminate the study
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,206
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cancer

Keywords

  • COVID-19
  • Vaccine
  • Pfizer
  • Moderna
  • Janssen
  • COVID
03

In context

Coronavirus Infections

929 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.

This study's enrollment of 2,206 is above the median of 300 across 334 observational studies indexed under Coronavirus Infections.

Browse Coronavirus Infections studies →

Lead sponsor

Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.

Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with a current or previous cancer diagnosis

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,206 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Group 1

    Patients with solid tumors receiving courses of cytotoxic therapy.

    Biological: COVID-19 Vaccination

  • Group 2

    Patients with hematological cancers receiving courses of cytotoxic chemotherapy.

    Biological: COVID-19 Vaccination

  • Group 3

    Patients with solid tumors receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months

    Biological: COVID-19 Vaccination

  • Group 4

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

    Biological: COVID-19 Vaccination

  • Group 5

    Patients receiving immune checkpoint inhibitors.

    Biological: COVID-19 Vaccination

  • Group 6

    Patients who underwent allogeneic stem cell transplant within 12 months.

    Biological: COVID-19 Vaccination

  • Group 7

    Patients who underwent cellular therapy, including CAR-T cells or T cells with engineered TCRs within 12 months.

    Biological: COVID-19 Vaccination

  • Group 8

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

    Biological: COVID-19 Vaccination

  • Group 9

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

    Biological: COVID-19 Vaccination

  • Group 10

    Patients who have undergone allogenic bone marrow transplant and are currently receiving immunosuppressants

    Biological: COVID-19 Vaccination

  • Group 11

    Patients who have undergone allogenic bone marrow transplant who are not currently receiving immunosuppressants

    Biological: COVID-19 Vaccination

  • Group 12

    Patients who have a cancer diagnosis but do not fall into group 1-11

    Biological: COVID-19 Vaccination

Interventions

  • BiologicalCOVID-19 Vaccination

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

    Also known as: Moderna (mRNA-1273), Pfizer (BTN162b2), Janssen (Ad26.COV2.S)

06

What researchers measure

Primary outcomes

  1. Adverse Event Collection

    Time frame: from date of vaccination until 2 months after full vaccination

Secondary outcomes

  1. Incidence of COVID-19 infection

    Time frame: from date of vaccination until 6 months after full vaccination

07

Study locations

2 sites
  • IU Health Joe and Shelly Schwarz Cancer Center
    Carmel, Indiana 46032, United States
  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center
    Indianapolis, Indiana 46202, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04930055
Lead sponsor
Indiana University
Responsible party
Utpal P. Davé (Associate Professor Department of Medicine Division of Hematology/Oncology, Indiana University) — Principal investigator
First posted
Jun 18, 2021
Start date
Jun 30, 2021
Primary completion
Nov 1, 2021
Completion
Mar 8, 2022
Last update
May 19, 2023

Study contacts

Utpal Dave, MD
principal investigator · Indiana University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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