Hematopoietic and Lymphoid Cell NeoplasmPhase 2NCT04438382
Infliximab and Intravenous Immunoglobulin Therapy in Treating Patients With Steroid-Refractory Pneumonitis
A Phase 2 study testing Infliximab, Intravenous Immunoglobulin Therapy and Prednisone in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by ECOG-ACRIN Cancer Research Group at 18 sites in United States.
Trial summary
This phase II trial studies how well infliximab and intravenous immunoglobulin therapy work in treating patients with pneumonitis that does not respond to steroid treatment. Immunotherapy with monoclonal antibodies such as, infliximab, may induce changes in body's immune system and may interfere with the ability of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Steroid-Refractory Pneumonitis
- What is being tested?
- Infliximab, Intravenous Immunoglobulin Therapy and Prednisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 18 sitesUnited States
- Study dates
- 7 Jan 2021to 26 May 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be English-speaking and be able to provide informed consent
- Patient must be willing and able to undergo arterial blood gas assessment as per the treating investigator. Patient must not have contraindication for arterial blood gas assessment
- Women must not be pregnant or breast-feeding due to the potential risk to the fetus of infliximab or IVIG. All females of childbearing potential must have a blood test or urine test within 14 days prior to randomization to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method(s) of contraception or to abstain from sexual intercourse for a minimum of 56 days (the duration of their participation in the study)
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
- Patient may have received any number of lines of prior systemic therapy
Show all 16Show fewer
- Patient may have any solid tumor or hematologic malignancy is eligible
- Patient must have received treatment with an anti-PD-1/PD-L1 agent either alone or in combination with another anti-cancer agent, as their most recent therapy prior to development of pneumonitis
- Patient must have steroid-refractory pneumonitis defined as:
- Grade 2 pneumonitis that has not clinically improved by a Common Terminology Criteria for Adverse Events (CTCAE) grade in greater than 72 hours or maximum of 14 days or
- Grade 3 or higher pneumonitis that has not clinically improved by a CTCAE grade in greater than 48 hours or maximum of 14 days with high dose corticosteroids (methylprednisolone or prednisone 1-4 mg/kg/equivalent) as their most recent treatment for pneumonitis, as determined by the treating investigator
- Patient may have received anti-PD-1/PD-L1 therapy as standard-of-care or part of a clinical trial
- Patient must have had pathogen-negative infectious diagnostic evaluation within 14 days prior to randomization, and at a minimum these should include: blood culture, urine culture, sputum culture, and viral panel: rapid flu, respiratory syncytial virus (RSV), herpes simplex virus (HSV). Empiric antibiotics for culture negative infections are not an exclusion for study entry
- Patient must have had a pathogen-negative bronchoscopic assessment of BAL fluid within 14 days prior to randomization. A minimum assessment for pathogens on BAL must include: gram stain, fungal panel, viral panel
- Patient must have a negative tuberculosis assessment (TB spot test, quantiferon gold or tuberculin skin test) within 14 days prior to randomization
- Patient must have chest computed tomography (CT) scan without contrast performed =< 14 days before randomization. Patient must not have a contraindication for CT
Who cannot join
- Patient must not have clinical evidence of cardiac dysfunction (as determined by the treating investigator) as an alternative diagnosis to steroid-refractory pneumonitis
- Patient must not be receiving anti-PD-1/-PD-L1 agent in combination with any of the following anti-cancer agents: docetaxel, cyclophosphamide, gefitinib, erlotinib, osimertinib, crizotinib, bleomycin, afatinib
- Patient must not be receiving concurrent radiation therapy to the chest
- Patient must not be deemed to have radiation pneumonitis. Patients with a history of stable radiation pneumonitis not requiring corticosteroid therapy within the last 3 months prior to randomization will be allowed on study
- Patient must not have pre-existing interstitial lung disease or pneumonitis requiring corticosteroid therapy from any other cause, as determined by the treating investigator
- Patient must not have an absolute contraindication to IVIG or infliximab, including: clinical history of severe hypersensitivity reaction, selective IgA deficiency, active hepatitis B, active tuberculosis, active human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) where a study subject has a CD4 count of =< 200 at screening, or drug interaction
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
Bronson Battle Creek
Battle Creek, Michigan, 49017
Northwestern University
Chicago, Illinois, 60611
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Mercy Health Mercy Campus
Muskegon, Michigan, 49444
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Lakeland Hospital Niles
Niles, Michigan, 49120
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan, 49444
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Spectrum Health Reed City Hospital
Reed City, Michigan, 49677
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, 49085
Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085
Munson Medical Center
Traverse City, Michigan, 49684
Metro Health Hospital
Wyoming, Michigan, 49519
About this study
Official title: Optimizing Immunosuppression for Steroid-Refractory Anti-PD-1/PD-L1 Pneumonitis
This phase II trial studies how well infliximab and intravenous immunoglobulin therapy work in treating patients with pneumonitis that does not respond to steroid treatment. Immunotherapy with monoclonal antibodies such as, infliximab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Intravenous immunoglobulin therapy may improve pneumonitis. It is not yet known whether giving infliximab and intravenous immunoglobulin therapy will work better in treating patients with pneumonitis.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess pneumonitis response to additional immunosuppression (infliximab or intravenous immunoglobulin therapy [IVIG]) in patients with steroid-refractory pneumonitis at 28-days.
SECONDARY OBJECTIVES:
- To assess functional parameters of steroid-refractory pneumonitis at day 1, 14-days and 28-days after day 1 of receipt of additional immunosuppression (infliximab or IVIG).
II. To assess radiologic parameters of steroid-refractory pneumonitis at day 1, 14-days and 28-days after day 1 of receipt of additional immunosuppression (infliximab or IVIG).
III. To assess patient-reported outcomes of steroid-refractory pneumonitis at day 1, 14-days and 28-days after day 1 of receipt of additional immunosuppression (infliximab or IVIG).
IV. To assess death after additional immunosuppression. V. To assess the rate of infections in the 28-day period after additional immunosuppression.
EXPLORATORY OBJECTIVES:
- To examine lung tissue, bronchoalveolar lavage (BAL) and serial blood samples in patients who develop steroid-refractory pneumonitis.
II. To examine associations between BAL phenotypes and pneumonitis response, functional and radiologic parameters of pneumonitis.
III. To evaluate associations between pneumonitis and autoantibodies, T-cell expansion, and baseline cytokines in the blood.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive infliximab intravenously (IV) on day 1 followed by prednisone taper IV or orally (PO) for 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive an additional dose of infliximab IV on day 14 at the discretion of the treating physician.
ARM B: Patients receive intravenous immunoglobulin therapy IV over 2-5 days per institutional guidelines followed by prednisone taper IV or PO for 4-6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 28, 42 and 56 days.
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Steroid-Refractory Pneumonitis
- Being tested
- Infliximab, Intravenous Immunoglobulin Therapy, Prednisone, Methylprednisolone
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabBiological
Also called Remicade
Given IV
Intravenous Immunoglobulin TherapyBiological
Also called Gamma Globulin, Gamma Globulin Therapy, Immune Globulin, Immune Globulin Therapy
Given IV
PrednisoneDrug
Also called Deltasone, Orasone, Meticorten, Panasol-S
Given IV or PO
Also called Methylprednisolone sodium succinate (Solu-Medrol), methylprednisolone acetate (Depo-Medrol), Methylprednisolone (Medrol)
Given IV or PO
| Study group | Role | What they receive |
|---|---|---|
| Arm A (infliximab) | Experimental | Patients receive infliximab IV on day 1 followed by prednisone taper IV or PO for 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive an additional dose of infliximab IV on day 14 at the discretion of the treating physician. Receives: Biological: Infliximab; Drug: Prednisone; Drug: Methylprednisolone |
| Arm B (intravenous immunoglobulin therapy) | Experimental | Patients receive intravenous immunoglobulin therapy IV over 2-5 days per institutional guidelines followed by prednisone taper IV or PO for 4-6 weeks in the absence of disease progression or unacceptable toxicity. Receives: Biological: Intravenous Immunoglobulin Therapy; Drug: Prednisone; Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumonitis Response Rate
Pneumonitis response will be defined as an improvement in partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) of >= 20% measured by PaO2 and recording of the FiO2 received by the patient at the time of the arterial blood gas assessment, on day 28 compared with day 1.
Measured: At day 28
Secondary outcomes (7)
Proportion of Patients With Radiologic Response for Steroid-refractory Pneumonitis
Radiologic features of steroid-refractory pneumonitis will be assessed by percentage lung parenchyma involved, percentage of ground-glass opacity in lung parenchyma, and lung volume on computed tomography. The pneumonitis and lung volume will be graded "Definitely decreased", "Probably decreased", "No significant change", "Probably increased" and "Definitely increased". Response to study therapy will be defined by combining the categories "Definitely decreased" and "Probably decreased".
Measured: At days 1, 14, and 28
Functional Parameters of Steroid-refractory Pneumonitis by Spirometry
Functional features of pneumonitis will be assessed by spirometry (forced vital capacity, forced expiratory volume in one second). These quantitative measures will be reported descriptively (by median, mean, and range) by timepoints and treatment arms.
Measured: At days 1, 14, and 28
Functional Parameters of Steroid-refractory Pneumonitis by Diffusion Capacity
Functional features of pneumonitis will be assessed by diffusion capacity of the lung. These quantitative measures will be reported descriptively (by median, mean, and range) by timepoints and treatment arms.
Measured: At days 1, 14, and 28
Functional Parameters of Steroid-refractory Pneumonitis by Oxygen Saturation
Functional features of pneumonitis will be assessed by oxygen saturation on room air at rest, collected as part of the vital signs. These quantitative measures will be reported descriptively (by median, mean, and range) by timepoints and treatment arms.
Measured: At days 1, 14, and 28
Number of Deaths Within 28 Days
Death reported in the 28-day period will be tabulated by treatment arm, and classified as pneumonitis-related, immunosuppression related, disease-related or other.
Measured: Up to 28 days
Incidence of Adverse Events
Will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The number and severity of treatment-related adverse events from infections in any organ system by the CTCAE reported in the 28-day period after additional immunosuppression.
Measured: Up to 28 days
Total Score of Functional Assessment of Cancer Therapy - Lung Version 4
Patient-reported outcomes of steroid-refractory pneumonitis will be measured by questionnaires (Functional Assessment of Cancer Therapy - Lung version 4 [FACT-L]). FACT-L consists of 5 subscales and the total score is calculated by summing the scores of the 36 items. The score ranges between 0 and 136. The higher the score, the better the quality of life.
Measured: At days 1, 14, and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start7 Jan 2021
- Primary completion21 Dec 2023
- Study completion26 May 2026
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by ECOG-ACRIN Cancer Research GroupThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jarushka Naidoo, Principal investigator, ECOG-ACRIN Cancer Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438382
- Sponsor's protocol ID
- EAQ172
- Other IDs
- NCI-2018-02825, EAQ172, EAQ172, EAQ172, UG1CA189828
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2020
- Last updated
- 29 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.
Publications
Beattie J, Rizvi H, Fuentes P, Luo J, Schoenfeld A, Lin IH, Postow M, Callahan M, Voss MH, Shah NJ, Betof Warner A, Chawla M, Hellmann MD. Success and failure of additional immune modulators in steroid-refractory/resistant pneumonitis related to immune checkpoint blockade. J Immunother Cancer. 2021 Feb;9(2):e001884. doi: 10.1136/jitc-2020-001884.
PubMed 33568350
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Immunosuppression for Steroid-Refractory Anti-PD-1/PD-L1 Pneumonitis
- ClinicalTrials.gov ID
- NCT04438382
- Acronym / sponsor ID
- EAQ172
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Steroid-Refractory Pneumonitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- ECOG-ACRIN Cancer Research GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 26 May 2026 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Posted 26 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well infliximab and intravenous immunoglobulin therapy work in treating patients with pneumonitis that does not respond to steroid treatment. Immunotherapy with monoclonal antibodies such as, infliximab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Intravenous immunoglobulin therapy may improve pneumonitis. It is not yet known whether giving infliximab and intravenous immunoglobulin therapy will work better in treating patients with pneumonitis.
Detailed description
PRIMARY OBJECTIVE:
- To assess pneumonitis response to additional immunosuppression (infliximab or intravenous immunoglobulin therapy [IVIG]) in patients with steroid-refractory pneumonitis at 28-days.
SECONDARY OBJECTIVES:
- To assess functional parameters of steroid-refractory pneumonitis at day 1, 14-days and 28-days after day 1 of receipt of additional immunosuppression (infliximab or IVIG).
II. To assess radiologic parameters of steroid-refractory pneumonitis at day 1, 14-days and 28-days after day 1 of receipt of additional immunosuppression (infliximab or IVIG).
III. To assess patient-reported outcomes of steroid-refractory pneumonitis at day 1, 14-days and 28-days after day 1 of receipt of additional immunosuppression (infliximab or IVIG).
IV. To assess death after additional immunosuppression. V. To assess the rate of infections in the 28-day period after additional immunosuppression.
EXPLORATORY OBJECTIVES:
- To examine lung tissue, bronchoalveolar lavage (BAL) and serial blood samples in patients who develop steroid-refractory pneumonitis.
II. To examine associations between BAL phenotypes and pneumonitis response, functional and radiologic parameters of pneumonitis.
III. To evaluate associations between pneumonitis and autoantibodies, T-cell expansion, and baseline cytokines in the blood.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive infliximab intravenously (IV) on day 1 followed by prednisone taper IV or orally (PO) for 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive an additional dose of infliximab IV on day 14 at the discretion of the treating physician.
ARM B: Patients receive intravenous immunoglobulin therapy IV over 2-5 days per institutional guidelines followed by prednisone taper IV or PO for 4-6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 28, 42 and 56 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (infliximab) | Experimental | Biological: Infliximab, Drug: Prednisone, Drug: MethylprednisolonePatients receive infliximab IV on day 1 followed by prednisone taper IV or PO for 4-6 weeks in the absence of disease progression or unacceptable toxicity. Patients may receive an additional dose of infliximab IV on day 14 at the discretion of the treating physician. |
| Arm B (intravenous immunoglobulin therapy) | Experimental | Biological: Intravenous Immunoglobulin Therapy, Drug: Prednisone, Drug: MethylprednisolonePatients receive intravenous immunoglobulin therapy IV over 2-5 days per institutional guidelines followed by prednisone taper IV or PO for 4-6 weeks in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients must be English-speaking and be able to provide informed consent
- Patient must be willing and able to undergo arterial blood gas assessment as per the treating investigator. Patient must not have contraindication for arterial blood gas assessment
- Women must not be pregnant or breast-feeding due to the potential risk to the fetus of infliximab or IVIG. All females of childbearing potential must have a blood test or urine test within 14 days prior to randomization to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method(s) of contraception or to abstain from sexual intercourse for a minimum of 56 days (the duration of their participation in the study)
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
Key exclusion criteria (6 listed)
- Patient must not have clinical evidence of cardiac dysfunction (as determined by the treating investigator) as an alternative diagnosis to steroid-refractory pneumonitis
- Patient must not be receiving anti-PD-1/-PD-L1 agent in combination with any of the following anti-cancer agents: docetaxel, cyclophosphamide, gefitinib, erlotinib, osimertinib, crizotinib, bleomycin, afatinib
- Patient must not be receiving concurrent radiation therapy to the chest
- Patient must not be deemed to have radiation pneumonitis. Patients with a history of stable radiation pneumonitis not requiring corticosteroid therapy within the last 3 months prior to randomization will be allowed on study
- Patient must not have pre-existing interstitial lung disease or pneumonitis requiring corticosteroid therapy from any other cause, as determined by the treating investigator
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 |
|---|---|---|
| InfliximabAlso: RemicadeGiven IV | Biological | Arm A (infliximab) |
| Intravenous Immunoglobulin TherapyAlso: Gamma Globulin, Gamma Globulin Therapy, Immune Globulin, Immune Globulin TherapyGiven IV | Biological | Arm B (intravenous immunoglobulin therapy) |
| PrednisoneAlso: Deltasone, Orasone, Meticorten, Panasol-SGiven IV or PO | Drug | Arm A (infliximab), Arm B (intravenous immunoglobulin therapy) |
| MethylprednisoloneAlso: Methylprednisolone sodium succinate (Solu-Medrol), methylprednisolone acetate (Depo-Medrol), Methylprednisolone (Medrol)Given IV or PO | Drug | Arm A (infliximab), Arm B (intravenous immunoglobulin therapy) |
Primary outcome
Pneumonitis Response Rate
Time frame: At day 28
Pneumonitis response will be defined as an improvement in partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) of >= 20% measured by PaO2 and recording of the FiO2 received by the patient at the time of the arterial blood gas assessment, on day 28 compared with day 1.
7 secondary outcomes
Proportion of Patients With Radiologic Response for Steroid-refractory Pneumonitis
Time frame: At days 1, 14, and 28
Functional Parameters of Steroid-refractory Pneumonitis by Spirometry
Time frame: At days 1, 14, and 28
Functional Parameters of Steroid-refractory Pneumonitis by Diffusion Capacity
Time frame: At days 1, 14, and 28
Functional Parameters of Steroid-refractory Pneumonitis by Oxygen Saturation
Time frame: At days 1, 14, and 28
Number of Deaths Within 28 Days
Time frame: Up to 28 days
Incidence of Adverse Events
Time frame: Up to 28 days
Total Score of Functional Assessment of Cancer Therapy - Lung Version 4
Time frame: At days 1, 14, and 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33568350Beattie J, Rizvi H, Fuentes P, Luo J, Schoenfeld A, Lin IH, Postow M, Callahan M, Voss MH, Shah NJ, Betof Warner A, Chawla M, Hellmann MD. Success and failure of additional immune modulators in steroid-refractory/resistant pneumonitis related to immune checkpoint blockade. J Immunother Cancer. 2021 Feb;9(2):e001884. doi: 10.1136/jitc-2020-001884.
- Individual participant dataSharing planned: Yes. Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.
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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.
Jarushka Naidoo principal investigator
ECOG-ACRIN Cancer Research Group
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Infliximab, Intravenous Immunoglobulin Therapy and Prednisone in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by ECOG-ACRIN Cancer Research Group at 18 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 16 inclusion and 6 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 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pneumonitis Response Rate (time frame: At day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04438382, which also lists 1 linked publication.
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 29 Sep 2026.