Metastatic Malignant Solid NeoplasmPhase 2NCT04957615
Nivolumab for the Treatment of Metastatic or Unresectable Solid Tumors With ARID1A Mutation and CXCL13 Expression
A Phase 2 study testing Nivolumab in people with Metastatic Malignant Solid Neoplasm and Unresectable Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies the effect of nivolumab in treating patients with solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable) with RID1A mutation and CXCL13 expression. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastatic Malignant Solid Neoplasm, Unresectable Solid Neoplasm
- What is being tested?
- Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2021to 31 May 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient will have a tumor harboring genomic mutation of ARID1A
- Histological or cytological evidence of metastatic or surgically unresectable disease harboring ARID1A mutation
- All subjects must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- Evaluable tumor tissue (archived or new biopsy) must be provided for biomarker analysis as formalin-fixed paraffin-embedded (FFPE) tumor block or minimum of 10 slides. Archived tissue may be from prior biopsy of unresectable or metastatic disease or from prior surgical resection
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Prior palliative radiotherapy must have been completed at least 2 weeks prior to study drug administration. Patients must have measurable disease outside the radiation field to be eligible. Patients with progression in a previously radiated field will also be eligible
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- White blood cell (WBC) >= 2000/uL (obtained within 7 days prior to first dose)
- Neutrophils >= 1500/uL (obtained within 7 days prior to first dose)
- Platelets >= 100 x 1 x 10^3/uL (obtained within 7 days prior to first dose)
- Hemoglobin >= 9.0 g/dL (obtained within 7 days prior to first dose)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x upper limit of normal (ULN) (or =< 5 X ULN for participants with liver metastases) (obtained within 7 days prior to first dose)
- Total bilirubin =< 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL) (obtained within 7 days prior to first dose)
- Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 30 mL/min (using the Cockcroft-Gault formula) (obtained within 7 days prior to first dose)
- Re-enrollment: This study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (ie, subject has not been treated). If re-enrolled, the subject must be re-consented and inclusion/exclusion criteria reassessed
- Patients are required to participate in PA13-0291 for correlative studies. Patients will need to consent for biopsy and peripheral blood collection as documented in the study calendar
- Patients must be ≥18 years of age at enrollment.
Who cannot join
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
- Active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 4 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. Where MRI is contraindicated CT scan is acceptable. Cases must be discussed with the medical monitor. Brain lesions are not considered measurable disease. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration
- Any serious or uncontrolled medical disorder, that in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results
- Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, prostate cancer without evidence of prostate specific antigen (PSA) progression or carcinoma in situ such as the following: gastric, prostate, cervix, colon, melanoma, or breast for example
- Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism, due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
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- All toxicities attributed to prior anti-cancer therapy other than neuropathy, alopecia and fatigue must have resolved to grade 1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] version 5) or baseline before administration of study drug. Subjects with toxicities attributed to prior anti-cancer therapy which are not expected to resolve and result in long lasting sequelae, such as neuropathy after platinum based therapy, are permitted to enroll. Neuropathy must have resolved to grade 2 (NCI CTCAE version 5)
- Treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 28 days of first administration of study treatment. Prior palliative radiotherapy must have been completed at least 2 weeks prior to study drug administration as indicated in inclusion criteria
- Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (RNA) or hepatitis C antibody (HCV antibody) indicating acute or chronic infection
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- Patients that are pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Clinical Trial to Investigate ARID1A Mutation and CXCL13 Expression in the Pre-Treatment Tumor Samples as a Combinatorial Predictive Biomarker for Immune Checkpoint Therapy in Metastatic Solid Tumors
This phase II trial studies the effect of nivolumab in treating patients with solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable) with RID1A mutation and CXCL13 expression. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab may help to control the disease.
Read the detailed description
PRIMARY OBJECTIVES:
- To estimate objective response rate (ORR) and overall survival (OS) in patients with ARID1A mutations receiving nivolumab therapy.
II. To estimate objective response rate (ORR) and overall survival (OS) in patients with ARID1A mutations plus CXCL13-high expression and ARID1A mutations plus CXCL13-low expression, receiving nivolumab therapy.
SECONDARY OBJECTIVES:
- To estimate progression free survival (PFS) in subjects with harboring ARID1A mutation treated with nivolumab monotherapy.
II. To estimate progression free survival (PFS) in subjects with ARID1A mutations plus CXCL13-high expression and ARID1A mutations plus CXCL13-low expression, treated with nivolumab monotherapy.
III. To assess peripheral and tumor infiltrating immune cell sub-populations in patients with ARID1A mutations, ARID1A plus CXCL13-high and ARID1A plus CXCL13-low expression, to determine predictors of response and resistance.
IV. To determine expression pattern of CXCL13 in ARID1A mutant tumors.
OUTLINE:
Patients receive nivolumab and relatlimab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) or magnetic resonance imaging (MRI), tissue biopsy and blood sample collection during screening and on the trial.
- Being tested
- Nivolumab
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabBiological
Also called BMS-936558, CMAB819, MDX-1106, NIVO
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (nivolumab) | Experimental | Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Defined as the rate of confirmed complete responses (CR) + partial responses (PR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and as assessed by the investigator. Will estimate ORR along with the 95% exact confidence interval (CI)
Measured: Up to 2 years
Overall survival (OS)
Kaplan-Meier method will be used to estimate the median OS and 1-year Survival Rate; the 95% CI of the 1-year survival rate will also be reported. Censoring for the survival endpoint will be assigned on the date of the last on-study follow-up that the patient is reported to be alive.
Measured: From date of first study treatment to death due to any cause, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start21 Sep 2021
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Funda Meric-Bernstam, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957615
- Sponsor's protocol ID
- 2021-0207
- Other IDs
- NCI-2021-06371, 2021-0207
- Status last verified
- Oct 2026
- First submitted
- 1 Jul 2021
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial to Investigate ARID1A Mutation and CXCL13 Expression in the Pre-Treatment Tumor Samples as a Combinatorial Predictive Biomarker for Immune Checkpoint Therapy in Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT04957615
- Acronym / sponsor ID
- 2021-0207
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 12 Jul 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.
This phase II trial studies the effect of nivolumab in treating patients with solid tumors that have spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable) with RID1A mutation and CXCL13 expression. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab may help to control the disease.
Detailed description
PRIMARY OBJECTIVES:
- To estimate objective response rate (ORR) and overall survival (OS) in patients with ARID1A mutations receiving nivolumab therapy.
II. To estimate objective response rate (ORR) and overall survival (OS) in patients with ARID1A mutations plus CXCL13-high expression and ARID1A mutations plus CXCL13-low expression, receiving nivolumab therapy.
SECONDARY OBJECTIVES:
- To estimate progression free survival (PFS) in subjects with harboring ARID1A mutation treated with nivolumab monotherapy.
II. To estimate progression free survival (PFS) in subjects with ARID1A mutations plus CXCL13-high expression and ARID1A mutations plus CXCL13-low expression, treated with nivolumab monotherapy.
III. To assess peripheral and tumor infiltrating immune cell sub-populations in patients with ARID1A mutations, ARID1A plus CXCL13-high and ARID1A plus CXCL13-low expression, to determine predictors of response and resistance.
IV. To determine expression pattern of CXCL13 in ARID1A mutant tumors.
OUTLINE:
Patients receive nivolumab and relatlimab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) or magnetic resonance imaging (MRI), tissue biopsy and blood sample collection during screening and on the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (nivolumab) | Experimental | Biological: NivolumabPatients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Patient will have a tumor harboring genomic mutation of ARID1A
- Histological or cytological evidence of metastatic or surgically unresectable disease harboring ARID1A mutation
- All subjects must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- Evaluable tumor tissue (archived or new biopsy) must be provided for biomarker analysis as formalin-fixed paraffin-embedded (FFPE) tumor block or minimum of 10 slides. Archived tissue may be from prior biopsy of unresectable or metastatic disease or from prior surgical resection
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Key exclusion criteria (11 listed)
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
- Active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 4 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. Where MRI is contraindicated CT scan is acceptable. Cases must be discussed with the medical monitor. Brain lesions are not considered measurable disease. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration
- Any serious or uncontrolled medical disorder, that in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results
- Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, prostate cancer without evidence of prostate specific antigen (PSA) progression or carcinoma in situ such as the following: gastric, prostate, cervix, colon, melanoma, or breast for example
- Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism, due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
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 |
|---|---|---|
| NivolumabAlso: BMS-936558, CMAB819, MDX-1106, NIVOGiven IV | Biological | Treatment (nivolumab) |
Primary outcome
Objective response rate (ORR)
Time frame: Up to 2 years
Defined as the rate of confirmed complete responses (CR) + partial responses (PR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and as assessed by the investigator. Will estimate ORR along with the 95% exact confidence interval (CI)
Overall survival (OS)
Time frame: From date of first study treatment to death due to any cause, assessed up to 2 years
Kaplan-Meier method will be used to estimate the median OS and 1-year Survival Rate; the 95% CI of the 1-year survival rate will also be reported. Censoring for the survival endpoint will be assigned on the date of the last on-study follow-up that the patient is reported to be alive.
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 6 Oct 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Funda Meric-Bernstam principal investigator
M.D. Anderson 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 Nivolumab in people with Metastatic Malignant Solid Neoplasm and Unresectable Solid Neoplasm, run by M.D. Anderson Cancer Center 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 16 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 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?
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?
Objective response rate (ORR) (time frame: Up to 2 years). The study lists 2 primary outcomes in all. 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 6 Oct 2026.