Advanced Malignant Solid NeoplasmPhase 2NCT06470971
Siltuximab for the Prevention of Severe Immune-Related Adverse Events During Immune Checkpoint Inhibitor Rechallenge in Patients With Advanced Cancer, CIRES Trial
A Phase 2 study testing Anti-PD-L1 Monoclonal Antibody, Anti-PD1 Monoclonal Antibody and Biopsy in people with Advanced Malignant Solid Neoplasm and Hematopoietic and Lymphatic System Neoplasm, run by Yuanquan Yang at 1 site in United States.
Trial summary
This phase II trial studies how well giving siltuximab during the reintroduction (rechallenge) of immune checkpoint inhibitor (ICI) therapy works in preventing severe immune-related adverse events (irAEs) in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm
- What is being tested?
- Anti-PD-L1 Monoclonal Antibody, Anti-PD1 Monoclonal Antibody and Biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2024to 31 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Males or females aged ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Patients with any advanced cancer types who would benefit from anti-PD1 or anti-PD-L1 therapy rechallenge at the investigator's discretion
- Patients must have had prior severe irAE while on ICI monotherapy or in combination with other anticancer treatment. Severe irAE is defined as any grade 2 or higher irAE requiring treatment discontinuation and prednisone > 0.5 milligrams (mg)/kilogram (kg)/day (or equivalent) followed by a taper ≥ 4 weeks. Patients with history of grade 4 severe irAE need to carefully weigh the risks and benefits and might be eligible on a case-by-case basis after discussion with principal investigator (PI)
- Recovery from prior irAEs to ≤ grade 1
- Patients who are on prednisone ≤ 10 mg/day (d) or equivalent are allowed
Show all 20Show fewer
- Hemoglobin > 7 g/dL and < 17 g/dL
- Absolute neutrophil count (ANC) ≥ 1000 per mm^3
- Platelet count ≥ 75 × 10^9/L
- Serum bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 × institutional ULN or ≤ 5 × ULN for patients with liver metastases
- Measured or calculated creatinine clearance (CL) ≥ 30 mL/min except patients with end-stage renal disease on hemodialysis
- Cycle 1 day 1 of the study treatment should be at least 2 weeks since prior systemic therapy, radiotherapy, or surgery
- Estimated life expectancy, in the judgment of the investigator, of at least 12 weeks
- Subjects of childbearing potential must have a negative serum pregnancy test at screening
- Subjects of childbearing potential must be willing to completely abstain or agree to use a highly effective method of contraception (i.e., less than 1% failure rate), from the time of signing informed consent and for the duration of study participation through 3 months following the last dose of study drug
- Childbearing potential is defined by the following criteria: 1. Subject has not undergone a hysterectomy or bilateral oophorectomy; or 2. has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
- Highly effective birth control methods (less than 1% failure rate per year if used consistently and correctly) include but are not limited to: 1. Oral, injected, or implanted hormonal method of contraception; 2. Place of intrauterine device (IUD) or system (IUS); 3. Tubal ligation (tubes tied) or a sterile partner (effective bilateral vasectomy)
- Subjects must not breastfeed a child during the study and for 3 months after the last dose of study drug
- Ability to understand and willingness to sign the written informed consent document
Who cannot join
- Women who are pregnant or breastfeeding
- Any ≥ grade 3 irAEs in which the risks outweigh the benefits per investigator's discretion (these may include but are not limited to myocarditis, myasthenia gravis, Guillain-Barré syndrome, encephalitis, myelitis, or other life-threatening events)
- Has active autoimmune disease or irAE requiring systemic treatment with steroids (> 10 mg daily doses of prednisone or equivalent) or other immunosuppressive agents or any condition that, in the investigator's judgment, precludes treatment with anti-PD-1/PD-L1 therapy
- Cycle 1 day 1 of the study treatment must be at least 2 weeks beyond high dose systemic corticosteroids (prednisone > 0.5 mg/kg/day or equivalent); chronic steroid use up to 10 mg daily prednisone (or equivalent) is permitted
- Other concurrent anticancer therapy except for palliative radiation and hormone therapy
- Has a known history of HIV-1/2 with detectable viral load and/or CD4 (cluster of differentiation 4) count < 300/mL within the previous 3 months
Show all 14Show fewer
- Has detectable hepatitis B virus (HBV) or hepatitis C virus (HCV) viral load polymerase chain reaction (PCR) if there is a known history of active hepatitis B or hepatitis C
- High risk for bowel perforation per the investigator's judgment, such as history of severe diverticulitis or active ulcers or extensive gastrointestinal (GI) involvement by the tumor
- Presence of a transplanted solid organ (with the exception of a corneal transplant more than 3 months prior to screening) or having received an allogeneic bone marrow transplant or an allogeneic peripheral blood stem cell transplant
- Uncontrolled concomitant illness including, but not limited to, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable angina pectoris, myocardial infarction within 1 month prior to enrollment, uncontrolled cardiac arrhythmias, uncontrolled seizures, or severe noncompensated hypertension (systolic blood pressure > 180mmHg or diastolic blood pressure > 120mmHg)
- Patients with a current severe infection
- Known unmanageable allergies, hypersensitivity, intolerance to monoclonal antibodies, to murine, chimeric, human proteins or their excipients
- Prior failure of interleukin-6 or interleukin-6 receptor targeted therapies. Prior IL-6 or IL-6 receptor-targeted therapies are permitted if the response was favorable
- Received any investigational drug within 30 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Cener contact
United States1 site, 1 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Yuanquan Yang, 614-366-2485, Yuanquan.Yang@osumc.edu
Yuanquan Yang
About this study
Official title: Immune Checkpoint Inhibitor Rechallenge in Combination With Siltuximab Prophylaxis for Patients Who Had Prior Immune-Related Adverse Event (CIRES Trial)
This phase II trial studies how well giving siltuximab during the reintroduction (rechallenge) of immune checkpoint inhibitor (ICI) therapy works in preventing severe immune-related adverse events (irAEs) in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Immune checkpoint inhibitors, such as anti-PD1 and anti-PD-L1 monoclonal antibodies, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The use of ICI therapy may lead to severe irAEs that can affect essentially any organ system in the body. Severe irAEs may lead to the early stopping of life saving treatment. Most patients that stop ICI therapy early will eventually progress and require additional treatment. Sometimes the decision is made to rechallenge with ICI therapy. Many patients who developed severe irAEs during initial ICI therapy are at risk for developing severe irAEs again during the rechallenge. Siltuximab is a monoclonal antibody that binds to receptors for a protein called interleukin-6 (IL-6). This may help lower the body's immune response and reduce inflammation. Giving siltuximab during ICI rechallenge may help prevent severe irAEs in patients with advanced cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine whether siltuximab prophylaxis reduces rates of de novo or recurrent severe irAE within 24 weeks of anti-PD-1/PD-L1 therapy rechallenge.
SECONDARY OBJECTIVE:
- To assess the preliminary anti-tumor activity of this combination including overall response rate (ORR), progression-free survival (PFS) and overall survival (OS).
EXPLORATORY OBJECTIVES:
- To evaluate potential predictive biomarkers such as baseline serum IL-6 level, C-reactive protein (CRP) suppression level, tissue IL-6 expression, stool microbiome, and antibody clearance rate.
II. To assess changes in immune cell infiltration of irAE site pre- and post-treatment by multiomics profiling.
III. To assess patient-reported outcomes by Patient-Reported Outcomes Measurement Information System (PROMIS) instruments.
IV. To correlate circulating tumor deoxyribonucleic acid (ctDNA) levels with treatment responses.
OUTLINE:
Patients receive anti-PD1 or anti-PD-L1 monoclonal antibody therapy either every 3 or 6 weeks, or every 2 or 4 weeks per physicians choice. Patients also receive siltuximab intravenously (IV) over 1 hour on day 1 of each cycle prior to the administration of anti-PD1 or anti-PD-L1 therapy. Treatment repeats either every 3 weeks for up to 8 doses or every 4 weeks for up to 6 doses in the absence of disease progression or unacceptable toxicity. Patients may undergo biopsy and bone scan on study, as well as blood sample collection and computed tomography (CT) or magnetic resonance imaging (MRI) throughout the study.
After completion of study treatment, patients are followed up at day 28, every 12 weeks for up to 2 years, and then every 6 months until 5 years following registration.
- Being tested
- Anti-PD-L1 Monoclonal Antibody, Anti-PD1 Monoclonal Antibody, Biopsy, Biospecimen Collection, Bone Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-PD-L1 Monoclonal AntibodyBiological
Receive anti-PD-L1 monoclonal antibody therapy
Anti-PD1 Monoclonal AntibodyBiological
Also called Anti-PD-1 Monoclonal Antibody
Receive anti-PD1 monoclonal antibody therapy
BiopsyProcedure or surgery
Also called BIOPSY_TYPE, Bx
Undergo biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
Bone ScanProcedure or surgery
Also called Bone Scintigraphy
Undergo bone scan
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan
Undergo MRI
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
SiltuximabBiological
Also called Anti-IL-6 Chimeric Monoclonal Antibody, cCLB8, CNTO 328, CNTO-328
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (PD1 antibody, PD-L1 antibody, Siltuximab) | Experimental | Patients receive anti-PD1 or anti-PD-L1 monoclonal antibody therapy either every 3 or 6 weeks, or every 2 or 4 weeks per physicians choice. Patients also receive siltuximab IV over 1 hour on day 1 of each cycle prior to the administration of anti-PD1 or anti-PD-L1 therapy. Treatment repeats either every 3 weeks for up to 8 doses or every 4 weeks for up to 6 doses in the absence of disease progression or unacceptable toxicity. Patients may undergo biopsy and bone scan on study, as well as blood sample collection and CT or MRI throughout the study. Receives: Biological: Anti-PD-L1 Monoclonal Antibody; Biological: Anti-PD1 Monoclonal Antibody; Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Other: Quality-of-Life Assessment; Biological: Siltuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe immune-related adverse event (irAE)
Will be assessed per National Cancer Institute Common Terminology Criteria for Adverse Events version (v) 5.0. irAEs are defined as AEs of immune nature (i.e., inflammatory) in the absence of a clear alternative etiology. The investigators will determine if an AE should be classified as irAE (yes/no). Will be defined as ≥ grade 2 requiring treatment discontinuation and prednisone > 0.5 milligrams/kilogram/day or equivalent followed by a taper ≥ 4 weeks) within 24 weeks of ICI rechallenge.
Measured: Within 24 weeks of immune checkpoint inhibitor (ICI) rechallenge
Secondary outcomes (3)
Overall response rate
Will be determined per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Will be calculated as the percentage of patients achieving complete response or partial response. The exact binomial 95% confidence interval (CI) will be provided.
Measured: Up to 5 years
Median progression-free survival
Will be determined per RECIST v1.1. Survival will be analyzed using Kaplan-Meier methods, resulting in median survival times with 95% CI.
Measured: Initiation of therapy to time of progression or death, whichever occurs first, assessed up to 5 years
Overall survival
Will be determined per RECIST v1.1. Survival will be analyzed using Kaplan-Meier methods, resulting in median survival times with 95% CI.
Measured: Initiation of therapy to death, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start9 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid NeoplasmStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuanquan Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuanquan Yang, Ohio State University Comprehensive Cancer Center
- Investigators
- Yuanquan Yang, MD, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470971
- Sponsor's protocol ID
- OSU-23393
- Other IDs
- NCI-2024-04853
- Status last verified
- Aug 2026
- First submitted
- 17 Jun 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Checkpoint Inhibitor Rechallenge in Combination With Siltuximab Prophylaxis for Patients Who Had Prior Immune-Related Adverse Event (CIRES Trial)
- ClinicalTrials.gov ID
- NCT06470971
- Acronym / sponsor ID
- OSU-23393
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yuanquan YangUniversity, hospital or other
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 24 Jun 2024 (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.
This phase II trial studies how well giving siltuximab during the reintroduction (rechallenge) of immune checkpoint inhibitor (ICI) therapy works in preventing severe immune-related adverse events (irAEs) in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Immune checkpoint inhibitors, such as anti-PD1 and anti-PD-L1 monoclonal antibodies, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The use of ICI therapy may lead to severe irAEs that can affect essentially any organ system in the body. Severe irAEs may lead to the early stopping of life saving treatment. Most patients that stop ICI therapy early will eventually progress and require additional treatment. Sometimes the decision is made to rechallenge with ICI therapy. Many patients who developed severe irAEs during initial ICI therapy are at risk for developing severe irAEs again during the rechallenge. Siltuximab is a monoclonal antibody that binds to receptors for a protein called interleukin-6 (IL-6). This may help lower the body's immune response and reduce inflammation. Giving siltuximab during ICI rechallenge may help prevent severe irAEs in patients with advanced cancer.
Detailed description
PRIMARY OBJECTIVE:
- To determine whether siltuximab prophylaxis reduces rates of de novo or recurrent severe irAE within 24 weeks of anti-PD-1/PD-L1 therapy rechallenge.
SECONDARY OBJECTIVE:
- To assess the preliminary anti-tumor activity of this combination including overall response rate (ORR), progression-free survival (PFS) and overall survival (OS).
EXPLORATORY OBJECTIVES:
- To evaluate potential predictive biomarkers such as baseline serum IL-6 level, C-reactive protein (CRP) suppression level, tissue IL-6 expression, stool microbiome, and antibody clearance rate.
II. To assess changes in immune cell infiltration of irAE site pre- and post-treatment by multiomics profiling.
III. To assess patient-reported outcomes by Patient-Reported Outcomes Measurement Information System (PROMIS) instruments.
IV. To correlate circulating tumor deoxyribonucleic acid (ctDNA) levels with treatment responses.
OUTLINE:
Patients receive anti-PD1 or anti-PD-L1 monoclonal antibody therapy either every 3 or 6 weeks, or every 2 or 4 weeks per physicians choice. Patients also receive siltuximab intravenously (IV) over 1 hour on day 1 of each cycle prior to the administration of anti-PD1 or anti-PD-L1 therapy. Treatment repeats either every 3 weeks for up to 8 doses or every 4 weeks for up to 6 doses in the absence of disease progression or unacceptable toxicity. Patients may undergo biopsy and bone scan on study, as well as blood sample collection and computed tomography (CT) or magnetic resonance imaging (MRI) throughout the study.
After completion of study treatment, patients are followed up at day 28, every 12 weeks for up to 2 years, and then every 6 months until 5 years following registration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (PD1 antibody, PD-L1 antibody, Siltuximab) | Experimental | Biological: Anti-PD-L1 Monoclonal Antibody, Biological: Anti-PD1 Monoclonal Antibody, Procedure: Biopsy, Procedure: Biospecimen Collection, Procedure: Bone Scan, Procedure: Computed Tomography, Procedure: Magnetic Resonance Imaging, Other: Quality-of-Life Assessment, Biological: SiltuximabPatients receive anti-PD1 or anti-PD-L1 monoclonal antibody therapy either every 3 or 6 weeks, or every 2 or 4 weeks per physicians choice. Patients also receive siltuximab IV over 1 hour on day 1 of each cycle prior to the administration of anti-PD1 or anti-PD-L1 therapy. Treatment repeats either every 3 weeks for up to 8 doses or every 4 weeks for up to 6 doses in the absence of disease progression or unacceptable toxicity. Patients may undergo biopsy and bone scan on study, as well as blood sample collection and CT or MRI throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Males or females aged ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Patients with any advanced cancer types who would benefit from anti-PD1 or anti-PD-L1 therapy rechallenge at the investigator's discretion
- Patients must have had prior severe irAE while on ICI monotherapy or in combination with other anticancer treatment. Severe irAE is defined as any grade 2 or higher irAE requiring treatment discontinuation and prednisone > 0.5 milligrams (mg)/kilogram (kg)/day (or equivalent) followed by a taper ≥ 4 weeks. Patients with history of grade 4 severe irAE need to carefully weigh the risks and benefits and might be eligible on a case-by-case basis after discussion with principal investigator (PI)
- Recovery from prior irAEs to ≤ grade 1
Key exclusion criteria (14 listed)
- Women who are pregnant or breastfeeding
- Any ≥ grade 3 irAEs in which the risks outweigh the benefits per investigator's discretion (these may include but are not limited to myocarditis, myasthenia gravis, Guillain-Barré syndrome, encephalitis, myelitis, or other life-threatening events)
- Has active autoimmune disease or irAE requiring systemic treatment with steroids (> 10 mg daily doses of prednisone or equivalent) or other immunosuppressive agents or any condition that, in the investigator's judgment, precludes treatment with anti-PD-1/PD-L1 therapy
- Cycle 1 day 1 of the study treatment must be at least 2 weeks beyond high dose systemic corticosteroids (prednisone > 0.5 mg/kg/day or equivalent); chronic steroid use up to 10 mg daily prednisone (or equivalent) is permitted
- Other concurrent anticancer therapy except for palliative radiation and hormone therapy
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 |
|---|---|---|
| Anti-PD-L1 Monoclonal AntibodyReceive anti-PD-L1 monoclonal antibody therapy | Biological | Treatment (PD1 antibody, PD-L1 antibody, Siltuximab) |
| Anti-PD1 Monoclonal AntibodyAlso: Anti-PD-1 Monoclonal AntibodyReceive anti-PD1 monoclonal antibody therapy | Biological | Treatment (PD1 antibody, PD-L1 antibody, Siltuximab) |
| BiopsyAlso: BIOPSY_TYPE, BxUndergo biopsy | Procedure or surgery | Treatment (PD1 antibody, PD-L1 antibody, Siltuximab) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Treatment (PD1 antibody, PD-L1 antibody, Siltuximab) |
| Bone ScanAlso: Bone ScintigraphyUndergo bone scan | Procedure or surgery | Treatment (PD1 antibody, PD-L1 antibody, Siltuximab) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Treatment (PD1 antibody, PD-L1 antibody, Siltuximab) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging ScanUndergo MRI | Procedure or surgery | Treatment (PD1 antibody, PD-L1 antibody, Siltuximab) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Treatment (PD1 antibody, PD-L1 antibody, Siltuximab) |
| SiltuximabAlso: Anti-IL-6 Chimeric Monoclonal Antibody, cCLB8, CNTO 328, CNTO-328Given IV | Biological | Treatment (PD1 antibody, PD-L1 antibody, Siltuximab) |
Primary outcome
Incidence of severe immune-related adverse event (irAE)
Time frame: Within 24 weeks of immune checkpoint inhibitor (ICI) rechallenge
Will be assessed per National Cancer Institute Common Terminology Criteria for Adverse Events version (v) 5.0. irAEs are defined as AEs of immune nature (i.e., inflammatory) in the absence of a clear alternative etiology. The investigators will determine if an AE should be classified as irAE (yes/no). Will be defined as ≥ grade 2 requiring treatment discontinuation and prednisone > 0.5 milligrams/kilogram/day or equivalent followed by a taper ≥ 4 weeks) within 24 weeks of ICI rechallenge.
3 secondary outcomes
Overall response rate
Time frame: Up to 5 years
Median progression-free survival
Time frame: Initiation of therapy to time of progression or death, whichever occurs first, assessed up to 5 years
Overall survival
Time frame: Initiation of therapy to death, assessed up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- The JameslineLink provided by the sponsor.
Related trials for Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingObservational study
Clinical Experience and Real-world Safety and Effectiveness of Envafolimab: Patient Access Program
Advanced Solid Tumor
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
The Ohio State University Comprehensive Cancer Cener contact
Yuanquan Yang, MD, PhD principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anti-PD-L1 Monoclonal Antibody, Anti-PD1 Monoclonal Antibody and Biopsy in people with Advanced Malignant Solid Neoplasm and Hematopoietic and Lymphatic System Neoplasm, run by Yuanquan Yang at 1 site 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 20 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 28 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 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact The Ohio State University Comprehensive Cancer Cener (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of severe immune-related adverse event (irAE) (time frame: Within 24 weeks of immune checkpoint inhibitor (ICI) rechallenge). 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 28 Sep 2026.