CancerNCT04930055
Immune Responses in Oncology Patients to Novel Coronavirus Vaccines (IROC)
An observational study of Cancer, run by Indiana University at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- COVID-19 Vaccination
- Type of treatment
- Vaccines
- How many people
- 2,206 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jun 2021to 8 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with a current or previous cancer diagnosis
Who may be able to join
- Ability to provide written informed consent and HIPAA authorization
- Patients deemed eligible and willing to receive a COVID-19 vaccine by treating physician per standard of care.
- Subjects must be ≥ 18 years old at the time of consent.
- Diagnosis of cancer and fall into one of the groups below:
- Group 1: Patients with solid tumors receiving courses of cytotoxic therapy.
- Group 2: Patients with hematological cancers receiving courses of cytotoxic chemotherapy.
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- Group 3: Patients with solid tumors receiving tyrosine kinase inhibitors (TKIs) or other targeted therapies, but not cytotoxic regimens within 3 months.
- Group 4: Patients with hematologic cancers receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months.
- Group 5: Patients receiving immune checkpoint inhibitors.
- Group 6: Patients who underwent allogeneic stem cell transplant within 12 months.
- 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.
- Group 8: Patients in remission who have received cellular therapy more than 12 months in the past, including allogeneic, autologous or engineered cellular approaches.
- Group 9: Patients with cancer in remission for at least 2 years not receiving active cytotoxic cancer chemotherapy (hormonal therapy is permitted).
- Group 10: Patients who have undergone allogenic bone marrow transplant and are currently receiving immunosuppressants
- Group 11: Patients who have undergone allogenic bone marrow transplant who are not currently receiving immunosuppressants
- 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.
Who cannot join
- 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
- Unwilling or unable to follow protocol requirements.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
IU Health Joe and Shelly Schwarz Cancer Center
Carmel, Indiana, 46032
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
About this study
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.
- Conditions
- Cancer
- Being tested
- COVID-19 Vaccination
- Keywords
- COVID-19, Vaccine, Pfizer, Moderna, Janssen, COVID
- Medical subject headings
- Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 VaccinationBiological
Also called Moderna (mRNA-1273), Pfizer (BTN162b2), Janssen (Ad26.COV2.S)
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients with solid tumors receiving courses of cytotoxic therapy. Receives: Biological: COVID-19 Vaccination | |
| Group 2 | Patients with hematological cancers receiving courses of cytotoxic chemotherapy. Receives: Biological: COVID-19 Vaccination | |
| Group 3 | Patients with solid tumors receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months Receives: Biological: COVID-19 Vaccination | |
| Group 4 | Patients with hematologic cancers receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months Receives: Biological: COVID-19 Vaccination | |
| Group 5 | Patients receiving immune checkpoint inhibitors. Receives: Biological: COVID-19 Vaccination | |
| Group 6 | Patients who underwent allogeneic stem cell transplant within 12 months. Receives: Biological: COVID-19 Vaccination | |
| Group 7 | Patients who underwent cellular therapy, including CAR-T cells or T cells with engineered TCRs within 12 months. Receives: 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 Receives: 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). Receives: Biological: COVID-19 Vaccination | |
| Group 10 | Patients who have undergone allogenic bone marrow transplant and are currently receiving immunosuppressants Receives: Biological: COVID-19 Vaccination | |
| Group 11 | Patients who have undergone allogenic bone marrow transplant who are not currently receiving immunosuppressants Receives: Biological: COVID-19 Vaccination | |
| Group 12 | Patients who have a cancer diagnosis but do not fall into group 1-11 Receives: Biological: COVID-19 Vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event Collection
Measured: from date of vaccination until 2 months after full vaccination
Secondary outcomes (1)
Incidence of COVID-19 infection
Measured: from date of vaccination until 6 months after full vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start30 Jun 2021
- Primary completion1 Nov 2021
- Study completion8 Mar 2022
Why it stopped: PI had decided to terminate the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Utpal P. Davé, Indiana University
- Investigators
- Utpal Dave, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930055
- Sponsor's protocol ID
- CTO-IUSCCC-0759
- Status last verified
- May 2023
- First submitted
- 15 Jun 2021
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Responses in Oncology Patients to Novel Coronavirus Vaccines (IROC)
- ClinicalTrials.gov ID
- NCT04930055
- Acronym / sponsor ID
- CTO-IUSCCC-0759
- Conditions
- Cancer
- Keywords
- COVID-19, Vaccine, Pfizer, Moderna, Janssen, COVID
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI had decided to terminate the study
- Enrolment
- 2,206 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 8 Mar 2022 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Biological: COVID-19 VaccinationPatients with solid tumors receiving courses of cytotoxic therapy. |
| Group 2 | – | Biological: COVID-19 VaccinationPatients with hematological cancers receiving courses of cytotoxic chemotherapy. |
| Group 3 | – | Biological: COVID-19 VaccinationPatients with solid tumors receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months |
| Group 4 | – | Biological: COVID-19 VaccinationPatients with hematologic cancers receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months |
| Group 5 | – | Biological: COVID-19 VaccinationPatients receiving immune checkpoint inhibitors. |
| Group 6 | – | Biological: COVID-19 VaccinationPatients who underwent allogeneic stem cell transplant within 12 months. |
| Group 7 | – | Biological: COVID-19 VaccinationPatients who underwent cellular therapy, including CAR-T cells or T cells with engineered TCRs within 12 months. |
| Group 8 | – | Biological: COVID-19 VaccinationPatients in remission who have received cellular therapy more than 12 months in the past, including allogeneic, autologous or engineered cellular approaches |
| Group 9 | – | Biological: COVID-19 VaccinationPatients with cancer in remission for at least 2 years not receiving active cytotoxic cancer chemotherapy (hormonal therapy is permitted). |
| Group 10 | – | Biological: COVID-19 VaccinationPatients who have undergone allogenic bone marrow transplant and are currently receiving immunosuppressants |
| Group 11 | – | Biological: COVID-19 VaccinationPatients who have undergone allogenic bone marrow transplant who are not currently receiving immunosuppressants |
| Group 12 | – | Biological: COVID-19 VaccinationPatients who have a cancer diagnosis but do not fall into group 1-11 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a current or previous cancer diagnosis
Key inclusion criteria (17 listed)
- Ability to provide written informed consent and HIPAA authorization
- Patients deemed eligible and willing to receive a COVID-19 vaccine by treating physician per standard of care.
- Subjects must be ≥ 18 years old at the time of consent.
- Diagnosis of cancer and fall into one of the groups below:
- 3. Estimated survival of 8 weeks or more following enrollment on the study.
Key exclusion criteria (2 listed)
- 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
- Unwilling or unable to follow protocol requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 VaccinationAlso: Moderna (mRNA-1273), Pfizer (BTN162b2), Janssen (Ad26.COV2.S)Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care | Biological | Group 1, Group 10, Group 11, Group 12, Group 2, Group 3, Group 4, Group 5, Group 6, Group 7, Group 8, Group 9 |
Primary outcome
Adverse Event Collection
Time frame: from date of vaccination until 2 months after full vaccination
1 secondary outcome
Incidence of COVID-19 infection
Time frame: from date of vaccination until 6 months after full vaccination
Results and safety
The study was stopped early (reason given: PI had decided to terminate the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Utpal Dave, MD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI had decided to terminate the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event Collection (time frame: from date of vaccination until 2 months after full vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.