Autoimmune Disease · Crohn Disease · Dermatomyositis · Hematopoietic and Lymphoid Cell Neoplasm · Inflammatory Bowel Disease · Malignant Solid Neoplasm · Multiple Sclerosis · Psoriasis · Psoriatic Arthritis · Rheumatoid Arthritis · Sjogren Syndrome · Systemic Lupus Erythematosus · Systemic Scleroderma · Ulcerative Colitis
Nivolumab-Based Cancer Treatment in Adults With Autoimmune Disorders
This study examines the safety, side effects, and anticancer activity of nivolumab alone or with other treatments in adults who have cancer and an autoimmune disorder.
Registry title: Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO
41 recruiting U.S. sites ↓Study at a glance
- Age
- 18 Years and older
- Treatment
- Biospecimen Collection or Cabozantinib
- Design
- Not provided
- Sponsor
- National Cancer Institute (NCI)
Research question
What safety effects, toxicities, autoimmune-disease changes, and anticancer activity occur when nivolumab is given alone or in approved combinations to people with cancer and autoimmune disorders?
Participant snapshot
Who the study is looking for
- The study is looking for adults age 18 or older who have both a qualifying cancer and an autoimmune disorder.
- Qualifying cancers may include metastatic or unresectable cancers and cancers for which PD-1 or PD-L1 treatment is approved in an adjuvant, neoadjuvant, or perioperative setting.
- The autoimmune-disease cohorts include inflammatory bowel disease, rheumatoid arthritis, lupus, multiple sclerosis, psoriasis or psoriatic arthritis, Sjögren syndrome, dermatomyositis or systemic sclerosis, and certain other autoimmune diseases.
- Participants must have an Eastern Cooperative Oncology Group performance status of 0 to 2 and a life expectancy longer than 12 weeks.
- Autoimmune-disease activity and permitted treatments vary by cohort, so the study team must confirm the applicable cohort-specific requirements.
Participation overview
What participation may involve
Participants enter one of 11 cancer-specific arms and receive intravenous nivolumab alone or with ipilimumab, cabozantinib, or chemotherapy. Treatment schedules and maximum duration depend on the arm and clinical setting. What participation may involve: - Receive nivolumab intravenously over 30 minutes on an arm-specific schedule. - Depending on the assigned arm, receive ipilimumab intravenously, cabozantinib by mouth, or fluoropyrimidine and platinum-containing chemotherapy. - Provide blood, cerebrospinal fluid, tissue, stool, and urine samples throughout the trial. - Undergo assessments of adverse events, autoimmune-disease status, tumor response, immune markers, and other clinical measures. - After treatment, participants without disease progression are followed for 100 days; those with progression are followed every 12 weeks for up to 5 years. Treatment duration varies by arm and indication: some regimens last three cycles or up to three months, one year, or two years, while some treatment may continue until disease progression or unacceptable toxicity. Follow-up may extend up to five years for participants with disease progression.
Study interventions
What participants may receive or do
- Biospecimen Collection: Participants undergo collection of blood, cerebrospinal fluid, tissue, stool, and urine samples during the study.
- Cabozantinib: Cabozantinib is taken by mouth in an optional treatment combination for some participants in the advanced renal cell carcinoma arm.
- Fluoropyrimidine: Fluoropyrimidine chemotherapy is given with nivolumab and platinum-containing chemotherapy in specified esophageal, gastric, and gastroesophageal junction cancer arms.
- Ipilimumab: Ipilimumab is given intravenously with nivolumab in several cancer-specific treatment arms.
- Nivolumab: Nivolumab is given intravenously, either alone or with other treatments, in all 11 study arms.
- Platinum Compound: Platinum-containing chemotherapy is given in certain esophageal, gastric, and gastroesophageal junction cancer treatment combinations.
- Platinum Doublet: Platinum doublet chemotherapy is given with nivolumab, with or without ipilimumab, in specified non-small cell lung cancer arms.
Study design
How the comparison works
This open-label phase 1 treatment study has 11 parallel experimental arms. The treatment regimen differs according to cancer type and clinical setting. The study uses no masking, so participants and study staff know which treatment is given.
Reported activities
Procedures and tests
- Collection of blood, cerebrospinal fluid, tissue, stool, and urine samples.
- Blood testing may be used to confirm required blood-cell counts and liver and kidney function during screening.
- Screening may include testing for human immunodeficiency virus, hepatitis B, and hepatitis C as applicable.
- Participants who could become pregnant must have a serum or urine pregnancy test within 24 hours before starting nivolumab.
- Tumor imaging and response assessments are used to evaluate cancer status and response.
- Ulcerative colitis and Crohn disease cohorts require a complete colonoscopy with biopsies during screening, within eight weeks before or four weeks after the first nivolumab dose.
- For Crohn disease previously affecting the stomach or small intestine, recent upper endoscopy, capsule endoscopy, computed tomography enterography, or magnetic resonance enterography may be required.
- Participants in the multiple sclerosis cohort must be able to undergo gadolinium-enhanced magnetic resonance imaging.
- The study measures autoimmune-disease activity, adverse events, serum chemokines, circulating immune cells, and gene expression in normal and malignant tissue.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must have a qualifying cancer that is metastatic or unresectable, or a cancer setting in which PD-1 or PD-L1 treatment is approved as adjuvant, neoadjuvant, or perioperative care.
- Participants must be age 18 or older.
- An Eastern Cooperative Oncology Group performance status of 0 to 2, equivalent to a Karnofsky score of at least 60, is required.
- Required laboratory values include leukocytes of at least 1,000/mcL, neutrophils of at least 500/mcL, platelets of at least 50,000/mcL, and specified liver and kidney function.
- Prior cytokine immunotherapy requires at least a four-week washout, while prior anti-CTLA-4 treatment requires a six-week washout.
- Ulcerative colitis and Crohn disease cohorts require a complete colonoscopy with biopsies during screening, within eight weeks before or four weeks after the first nivolumab dose.
- Ulcerative colitis cohorts require disease activity and medication use to fit one of the specified mild, moderate, or severe cohort definitions.
- Crohn disease cohorts require disease activity and medication use to fit one of the specified mild, moderate, or severe cohort definitions.
- Participants of reproductive potential must follow the study's contraception requirements; those who could become pregnant need a negative pregnancy test within 24 hours before nivolumab.
Possible reasons someone may not be able to join
- Prior treatment with an anti-PD-1 or anti-PD-L1 therapy is not allowed.
- Recent chemotherapy or radiotherapy is generally excluded, with specified washout periods and a limited exception for qualifying palliative radiation.
- People receiving another investigational anticancer agent are excluded.
- A prior allogeneic blood-forming stem-cell transplant is excluded.
- Uncontrolled illness, including active infection or certain unstable heart, psychiatric, or social conditions that limit compliance, is excluded.
- For the ulcerative colitis cohort, prior ipilimumab, prior colectomy, concurrent primary sclerosing cholangitis, or empiric immunosuppression without a clinical workup is excluded; primary sclerosing cholangitis may instead be considered in another autoimmune cohort.
- For the Crohn disease cohort, untreated abscesses, untreated symptomatic strictures, short-gut physiology, isolated jejunal disease, prior ipilimumab, or empiric immunosuppression without a clinical workup is excluded.
- People in the multiple sclerosis cohort cannot have a medical contraindication to gadolinium-enhanced magnetic resonance imaging.
Important unknowns
What the record does not make clear
- The registry gives drug-dosing intervals for each arm but does not provide a complete visit calendar or expected visit count.
- Treatment and follow-up durations vary substantially by cancer type, arm, disease progression, and clinical setting, so an individual's expected total participation time is not stated.
- Permitted autoimmune treatments differ across disease-severity cohorts, and the registry does not provide one general background-treatment rule.
- The registry states washout periods for several prior therapies, but the applicable timing for every medication is not provided.
- The registry does not describe rescue treatment for autoimmune flares or treatment-related side effects.
- The registry does not state which study drugs, tests, procedures, or routine-care costs are paid by the study or billed to insurance.
- The registry does not state whether participants receive compensation.
- The registry does not describe reimbursement or support for transportation, lodging, or meals.
- The registry does not say whether any visits, laboratory tests, imaging, or follow-up can occur remotely or near home.
- The registry does not explain whether study treatment can continue after study participation ends.
- The study is listed as recruiting overall, but sites have mixed statuses and the registry does not identify which disease and treatment cohorts are open at each site.
Before contacting the site
Questions for the study team
- Which cancer-specific arm and autoimmune-disease severity cohort would the team evaluate for me, and is that cohort open at my preferred site?
- What is the complete schedule of screening, infusions, oral treatment, imaging, sample collection, and follow-up for that arm?
- Which current cancer and autoimmune medications could continue, and what washout periods would apply to the others?
- How would an autoimmune flare or immune-related side effect be monitored and treated, and could treatment be paused or stopped?
- Which blood, cerebrospinal fluid, tissue, stool, and urine samples would actually be collected in my arm, and how often?
- If I am considered for an inflammatory bowel disease cohort, when would colonoscopy and biopsies occur, and would additional upper endoscopy or intestinal imaging be required?
- Which expenses are covered, and are compensation or travel assistance available?
- Can any study activities be coordinated with my local oncology and autoimmune-disease specialists or completed closer to home?
Before changing care
Questions for your gastroenterologist
- How stable is my inflammatory bowel disease now, and how does my current disease activity compare with the trial's cohort definitions?
- Could my current inflammatory bowel disease medicines continue during the study, and what risks could come from changing or interrupting them?
- What approved cancer-treatment alternatives should I discuss with my oncologist if nivolumab could worsen my autoimmune disease or conflict with my current care?
- What symptoms or test results would suggest an inflammatory bowel disease flare, immune-related colitis, or another complication requiring urgent evaluation?
- How should my gastroenterology care be coordinated with the oncology and research teams for colonoscopy, biopsies, medication decisions, and flare management?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
This phase Ib trial studies the side effects of nivolumab and to see how well it works alone and in combination with other treatments, such as ipilimumab, cabozantinib, platinum containing therapy, and fluoropyrimidine, in treating patients with autoimmune disorders and cancer that has spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced), to other places in the body (metastatic) or cannot removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Cabozantinib is a type of tyrosine kinase inhibitor and a type of angiogenesis inhibitor. Chemotherapy drugs, such as platinum containing therapies and fluoropyrimidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab alone and in combination with other treatments, including ipilimumab, cabozantinib, platinum containing therapy, or fluoropyrimidine, may be safe, tolerable, and/or effective in treating patients with autoimmune disorders and advanced, metastatic, or unresectable cancer.
PRIMARY OBJECTIVES: I. To assess the overall safety, and toxicities associated with the use of the anti-programmed death 1 (PD-1) antibody nivolumab in patients with varying severity of dermatomyositis (DM)/systemic sclerosis (SSc), rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), inflammatory bowel disease (IBD) (ulcerative colitis \[UC\] and Crohn's disease \[CD\]), multiple sclerosis (MS), Sjogren's syndrome \[SjS\], psoriasis (PsO)/psoriatic arthritis (PsA), and other autoimmune diseases. II. To assess the overall safety, and toxicities associated with the use of the anti-programmed death 1 (PD-1) antibody nivolumab and other Food and Drug Administration (FDA)-approved combinations for given oncologic indications in patients with varying severity of DM/SSc, RA, SLE, IBD (ulcerative colitis \[UC\] and Crohn's disease \[CD\]), MS, Sjogren's syndrome \[SjS\], psoriasis (PsO)/psoriatic arthritis (PsA), and other autoimmune diseases. SECONDARY OBJECTIVES: I. To evaluate the efficacy of nivolumab in terms of objective response rates (ORRs), progression-free survival (PFS), and overall survival (OS) in patients with cancer and DM/SSc, RA, SLE, IBD (UC and CD), MS, SjS, PsO/PsA, and other autoimmune diseases. II. To observe and record anti-tumor activity. III. To propose dosing recommendations for anti-PD-1 antibodies based on the severity of the autoimmune disorder. IV. To evaluate the impact of nivolumab on the disease severity indices for: DM/SSc, RA, SLE, IBD: UC and CD, not specified (NS), MS, SjS, PsO/PsA. V. To identify biomarkers of response and toxicity. OUTLINE: Patients are assigned to 1 of 11 arms. ARM I (MONOTHERAPY): Patients may receive single agent nivolumab intravenously (IV) over 30 minutes every 4 weeks for up to 2 years for patients with metastatic indications, for up to 1 year for adjuvant indications or for up to 3 months after surgery for neoadjuvant indications in the absence of disease progression or unacceptable toxicity. ARM II (UNRESECTABLE OR METASTATIC MELANOMA): Patients receive nivolumab IV over 30 minutes every 2 or 4 weeks in combination with ipilimumab IV every 3 weeks for up to 4 doses of combination therapy in the absence of disease progression or unacceptable toxicity. Treatment with nivolumab may continue every 4 weeks in the absence of disease progression or unacceptable toxicity. ARM III (NEOADJUVANT TREATMENT OF RESECTABLE NON-SMALL CELL LUNG CANCER \[NSCLC\]): Patients receive nivolumab IV over 30 minutes in combination with platinum doublet therapy every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. ARM IV (METASTATIC PD-L1 POSITIVE NSCLC): Patients receive nivolumab IV over 30 minutes every 3 weeks and ipilimumab IV every 6 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. ARM V (METASTATIC OR RECURRENT NSCLC): Patients receive nivolumab IV over 30 minutes every 3 weeks, ipilimumab IV every 6 weeks and platinum doublet therapy every 3 weeks for up to 2 cycles of combination therapy. Treatment with nivolumab and ipilimumab repeats for up to 2 years in the absence of disease progression or unacceptable toxicity. ARM VI (MALIGNANT PLEURAL MESOTHELIOMA): Patients receive nivolumab IV over 30 minutes every 3 weeks and ipilimumab IV every 6 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. ARM VII (ADVANCED RENAL CELL CARCINOMA \[RCC\]): Patients receive nivolumab IV over 30 minutes in combination with ipilimumab IV every 3 weeks for up to 4 doses of combination therapy in the absence of disease progression or unacceptable toxicity. Patients may continue to receive single agent nivolumab every 2 or 4 weeks in the absence of disease progression or unacceptable toxicity. Patients may optionally receive nivolumab IV every 2 or 4 weeks in combination with cabozantinib orally (PO) once daily (QD) for up to 2 years of combination therapy in the absence of disease progression or unacceptable toxicity. Treatment with single agent cabozantinib may continue in the absence of disease progression or unacceptable toxicity. ARM VIII (MICROSATELLITE INSTABILITY-HIGH \[MSI-H\] OR MISMATCH REPAIR DEFICIENT \[dMMR\] METASTATIC COLORECTAL CANCER): Patient receive nivolumab IV over 30 minutes every 2 or 4 weeks in combination with ipilimumab IV every 3 weeks for up to 4 doses of combination therapy in the absence of disease progression or unacceptable toxicity. Patients may continue to receive single agent nivolumab every 2 or 4 weeks in the absence of disease progression or unacceptable toxicity. ARM IX (HEPATOCELLULAR CARCINOMA \[HCC\]): Patients receive nivolumab IV over 30 minutes in combination with ipilimumab IV every 3 weeks for up to 4 doses of combination therapy. Patients may continue to receive single agent nivolumab every 2 or 4 weeks in the absence of disease progression or unacceptable toxicity. ARM X (ESOPHAGEAL SQUAMOUS CELL CARCINOMA): Patients receive nivolumab IV over 30 minutes every 2 or 4 weeks in combination with fluoropyrimidine and platinum-containing chemotherapy for up to 2 years in the absence of disease progression or unacceptable toxicity OR receive nivolumab IV every 2 or 3 weeks in combination with ipilimumab IV every 6 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may then continue receiving fluoropyrimidine and platinum-containing chemotherapy in the absence of disease progression or unacceptable toxicity. ARM XI (GASTRIC CANCER, GASTROESOPHAGEAL JUNCTION CANCER, AND ESOPHAGEAL ADENOCARCINOMA): Patients receive nivolumab IV over 30 minutes in combination with fluoropyrimidine and platinum-containing chemotherapy every 2 or 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood, cerebrospinal fluid (CSF), tissue, stool, and urine samples throughout the trial. After completion of study treatment, patients without disease progression are followed for 100 days, and patients with disease progression are followed every 12 weeks for up to 5 years.
Study design and administration
- Organization
- National Cancer Institute (NCI)
- Organization class
- Nih
- Organization study ID
- NCI-2019-00241
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor class
- Nih
- Enrollment type
- Estimated
- Allocation
- Na
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Arm I (nivolumab)
Patients may receive single agent nivolumab IV over 30 minutes every 4 weeks for up to 2 years for patients with metastatic indications, for up to 1 year for adjuvant indications or for up to 3 months after surgery for neoadjuvant indications in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood, CSF, tissue, stool, and urine samples throughout the trial.
Interventions: Procedure: Biospecimen Collection, Biological: Nivolumab
Experimental
Arm II (nivolumab, ipilimumab)
Patients with unresectable or metastatic melanoma receive nivolumab IV over 30 minutes every 2 or 4 weeks in combination with ipilimumab IV every 3 weeks for up to 4 doses of combination therapy in the absence of disease progression or unacceptable toxicity. Treatment with nivolumab may continue every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood, CSF, tissue, stool, and urine samples throughout the trial.
Interventions: Procedure: Biospecimen Collection, Biological: Ipilimumab, Biological: Nivolumab
Experimental
Arm III (nivolumab, platinum doublet)
Patients receiving neoadjuvant treatment of resectable NSCLC receive nivolumab IV over 30 minutes in combination with platinum doublet therapy every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood, CSF, tissue, stool, and urine samples throughout the trial.
Interventions: Procedure: Biospecimen Collection, Biological: Nivolumab, Drug: Platinum Doublet
Experimental
Arm IV (nivolumab, ipilimumab)
Patients with metastatic PD-L1 positive NSCLC receive nivolumab IV over 30 minutes every 3 weeks and ipilimumab IV every 6 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood, CSF, tissue, stool, and urine samples throughout the trial.
Interventions: Procedure: Biospecimen Collection, Biological: Ipilimumab, Biological: Nivolumab
Experimental
Arm IX (nivolumab, ipilimumab)
Patients with HCC receive nivolumab IV over 30 minutes in combination with ipilimumab IV every 3 weeks for up to 4 doses of combination therapy. Patients may continue to receive single agent nivolumab every 2 or 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood, CSF, tissue, stool, and urine samples throughout the trial.
Interventions: Procedure: Biospecimen Collection, Biological: Ipilimumab, Biological: Nivolumab
Experimental
Arm V (nivolumab, ipilimumab, platinum doublet therapy)
Patients with metastatic or recurrent NSCLC receive nivolumab IV over 30 minutes every 3 weeks, ipilimumab IV every 6 weeks and platinum doublet therapy every 3 weeks for up to 2 cycles of combination therapy. Treatment with nivolumab and ipilimumab repeats for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood, CSF, tissue, stool, and urine samples throughout the trial.
Interventions: Procedure: Biospecimen Collection, Biological: Ipilimumab, Biological: Nivolumab, Drug: Platinum Doublet
Experimental
Arm VI (nivolumab, ipilimumab)
Patients with malignant pleural mesothelioma receive nivolumab IV over 30 minutes every 3 weeks and ipilimumab IV every 6 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood, CSF, tissue, stool, and urine samples throughout the trial.
Interventions: Procedure: Biospecimen Collection, Biological: Ipilimumab, Biological: Nivolumab
Experimental
Arm VII (nivolumab, ipilimumab, cabozantinib)
Patients with advanced RCC receive nivolumab IV over 30 minutes in combination with ipilimumab IV every 3 weeks for up to 4 doses of combination therapy in the absence of disease progression or unacceptable toxicity. Patients may continue to receive single agent nivolumab every 2 or 4 weeks in the absence of disease progression or unacceptable toxicity. Patients may optionally receive nivolumab IV every 2 or 4 weeks in combination with cabozantinib PO QD for up to 2 years of combination therapy in the absence of disease progression or unacceptable toxicity. Treatment with single agent cabozantinib may continue in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood, CSF, tissue, stool, and urine samples throughout the trial.
Interventions: Procedure: Biospecimen Collection, Drug: Cabozantinib, Biological: Ipilimumab, Biological: Nivolumab
Experimental
Arm VIII (nivolumab, ipilimumab)
Patients with MSI-H or dMMR metastatic colorectal cancer receive nivolumab IV over 30 minutes every 2 or 4 weeks in combination with ipilimumab IV every 3 weeks for up to 4 doses of combination therapy in the absence of disease progression or unacceptable toxicity. Patients may continue to receive single agent nivolumab every 2 or 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood, CSF, tissue, stool, and urine samples throughout the trial.
Interventions: Procedure: Biospecimen Collection, Biological: Ipilimumab, Biological: Nivolumab
Experimental
Arm X (nivolumab, fluoropyrimidine, platinum, ipilimumab)
Patients with esophageal squamous cell carcinoma receive nivolumab IV over 30 minutes every 2 or 4 weeks in combination with fluoropyrimidine and platinum-containing chemotherapy for up to 2 years in the absence of disease progression or unacceptable toxicity OR receive nivolumab IV every 2 or 3 weeks in combination with ipilimumab IV every 6 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may then continue receiving fluoropyrimidine and platinum-containing chemotherapy in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood, CSF, tissue, stool, and urine samples throughout the trial.
Interventions: Procedure: Biospecimen Collection, Drug: Fluoropyrimidine, Biological: Ipilimumab, Biological: Nivolumab, Drug: Platinum Compound
Experimental
Arm XI (nivolumab, fluoropyrimidine, platinum)
Patients with gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma receive nivolumab IV over 30 minutes in combination with fluoropyrimidine and platinum-containing chemotherapy every 2 or 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood, CSF, tissue, stool, and urine samples throughout the trial.
Interventions: Procedure: Biospecimen Collection, Drug: Fluoropyrimidine, Biological: Nivolumab, Drug: Platinum Compound
Interventions
Procedure
Biospecimen Collection
Undergo collection of blood, CSF, tissue, stool and urine samples
Drug
Cabozantinib
Given PO
Drug
Fluoropyrimidine
Given fluoropyrimidine
Biological
Ipilimumab
Given IV
Biological
Nivolumab
Given IV
Drug
Platinum Compound
Given platinum containing chemotherapy
Drug
Platinum Doublet
Given platinum doublet
Eligibility
18 Years and older
All
Not accepted
Inclusion criteria (47)
- Patients can have either histologically confirmed malignancy that is radiologically evaluable and metastatic or unresectable, or have a malignancy for which a PD-1/PD-L1 inhibitor has been approved in the adjuvant setting, as well as the neoadjuvant or perioperative setting in which such treatment is considered standard of care or has been approved. Eligible tumor types include solid tumors and malignancies in which there is known evidence of clinical activity for single agent PD-1 or PD-L1 antibodies. Nivolumab or other PD1/PD-L1 inhibitors are FDA-approved for the treatment of melanoma, non-small cell lung cancer (NSCLC), Merkel cell cancer, bladder cancer, renal cell carcinoma (RCC), gastric cancer, hepatocellular carcinoma (HCC), cervical cancer, head and neck cancer, Hodgkin lymphoma (HL), metastatic small cell lung cancer (SCLC), and any solid tumor with microsatellite instability (MSI)-high status confirmed. Patients with HL are eligible but must follow standard response criteria. Additional tumor types may be eligible on a case by case basis upon discussion with principal investigator (PI)Registry-derived · unreviewed
- Patients enrolling on the trial for adjuvant use will be restricted to those with histology for which a PD-1/PD-L1 inhibitor has been approved in the adjuvant setting including but not limited to NSCLC, melanoma, RCC, cervical cancer, and bladder cancerRegistry-derived · unreviewed
- Patients enrolled on the study can receive Nivolumab with other FDA-approved combinations according to the FDA package insert, including, but not limited to ipilimumab, cabozantinib or chemotherapyRegistry-derived · unreviewed
- Patients who have previously received other forms of immunotherapy (high-dose \[HD\] IL-2, IFN, CTLA-4) are allowed. Patients must not have received cytokine immunotherapy for at least 4 weeks before nivolumab administration. Patients who have received prior anti-CTLA4 will be allowed and the washout period is 6 weeksRegistry-derived · unreviewed
- Age \>= 18 years; children are excluded from this study but may be eligible for future pediatric phase 1 combination trialsRegistry-derived · unreviewed
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Karnofsky \>= 60)Registry-derived · unreviewed
- Life expectancy of greater than 12 weeksRegistry-derived · unreviewed
- Leukocytes \>= 1,000/mcLRegistry-derived · unreviewed
- Absolute neutrophil count \>= 500/mcLRegistry-derived · unreviewed
- Platelets \>= 50,000/mcLRegistry-derived · unreviewed
- Total bilirubin =\< 2 x institutional upper limit of normal (ULN)Registry-derived · unreviewed
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 5 x institutional ULN or =\< 8 x institutional ULN for patients with liver metastases or an autoimmune disease that is contributing to the elevation of these valuesRegistry-derived · unreviewed
- Creatinine ULN OR glomerular filtration rate (GFR) \>= 30 mL/min (if using the Cockcroft-Gault formula)Registry-derived · unreviewed
- Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trialRegistry-derived · unreviewed
- If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicatedRegistry-derived · unreviewed
- If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral loadRegistry-derived · unreviewed
- Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required for at least 4 weeks (or scheduled assessment after the first cycle of treatment), and a risk-benefit analysis (discussion) by the patient and the investigator favors participation in the clinical trialRegistry-derived · unreviewed
- The effects of nivolumab on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 5 months after the last dose of investigational product. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational productRegistry-derived · unreviewed
- Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 24 hours prior to the start of nivolumab. Women must not be breastfeeding. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraceptionRegistry-derived · unreviewed
- WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), tubal ligation, or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mLRegistry-derived · unreviewed
- These durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days, and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 daysRegistry-derived · unreviewed
- Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately. Patients can resume treatment upon termination of a pregnancy or the completion of a successful pregnancyRegistry-derived · unreviewed
- Ability to understand and the willingness to sign a written informed consent documentRegistry-derived · unreviewed
- Patients with more than one autoimmune disease are eligible. The treating physician would determine which autoimmune disease is dominant and the patient would be treated under that specific cohort (Please note: Patients with more than one autoimmune disease should receive assessments for all previously diagnosed autoimmune diseases. For example, a patient with psoriasis and IBD might be enrolled in the IBD cohort. Disease assessments for both psoriasis and IBD should be obtained, as per protocol. Case report forms \[CRFs\] for all relevant autoimmune diseases should be utilized. However, all additional cohort requirements will be considered optional and only the assessments from the assigned cohort will be considered mandatory)Registry-derived · unreviewed
- DM/SSc-SPECIFIC INCLUSION: Patients with known SSc or DM according to updated classification criteria (Van den Hoogan et al., Arthritis Rheum 2013;65(11):2737-47; Lundberg et al., A\&R in press). Overlap features are permitted, but patients must meet criteria for a "primary diagnosis" of DM or SScRegistry-derived · unreviewed
- RA-SPECIFIC INCLUSION: Rheumatologist-diagnosed RA requiring prior treatment with disease-modifying antirheumatic drugs (DMARDs) before patient was diagnosed with current malignancy. We recommend, but do not require, documentation for meeting 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RARegistry-derived · unreviewed
- SLE-SPECIFIC INCLUSION: SLE diagnosed by a rheumatologist. The patient should meet the revised 1997 American College of Rheumatology (ACR) classification criteria for SLE, but this is not mandatoryRegistry-derived · unreviewed
- UC-SPECIFIC INCLUSION: Complete colonoscopy with biopsies during study screening, within 8 weeks before initial nivolumab administration, or within 4 weeks after initial nivolumab administrationRegistry-derived · unreviewed
- UC-SPECIFIC INCLUSION: Patients must test negative for hepatitis B (antigen \[Ag\] negative, antibody \[core (c)Ab\] negative, antibody \[surface (s)Ab\] positive or negative) and Mycobacterium tuberculosis (purified-protein- derivative \[PPD\] or enzyme-linked immunospot assay \[ELISpot or T-spot\]) or be on appropriate anti-microbial treatment for these infectionsRegistry-derived · unreviewed
- UC-SPECIFIC INCLUSION: Mild Disease Cohort: Patients must be in clinical remission, defined as a Mayo Clinic score (MCS) of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 either without medications, or treated with 5-ASA derivative, probiotic, or prior fecal transplantRegistry-derived · unreviewed
- UC-SPECIFIC INCLUSION: Moderate Disease Cohort: Patients must be in clinical remission, defined as a MCS of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 on 6-mercaptopurine, azathioprine, methotrexate, or rectal hydrocortisone, budesonide, or one of these medications in combination with any of the medications listed in the Mild cohortRegistry-derived · unreviewed
- UC-SPECIFIC INCLUSION: Severe Disease Cohort (A or B): Patients must either be A) in clinical remission, defined as a MCS of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 on a biologic therapy targeting tumor necrosis alpha (TNF-α) (infliximab, adalimumab, golimumab), α4β7 integrin (vedolizumab), or one of these biologic therapies in combination with any of the medications listed in the Mild or Moderate cohort, or B) have mild active disease defined as a MCS of 3-5 and no subscore higher than 2, and an endoscopic subscore of \< 2 on one of the medications or combination of medications defined for the Moderate or Mild cohortRegistry-derived · unreviewed
- CROHN'S DISEASE (CD)-SPECIFIC INCLUSION: Complete colonoscopy with biopsies during study screening, within 8 weeks before initial nivolumab administration, or within 4 weeks after initial nivolumab administrationRegistry-derived · unreviewed
- CD-SPECIFIC INCLUSION: If patients have prior known disease in the stomach or small intestines, appropriate endoscopic evaluation (esophagogastroduodenoscopy/video capsule endoscopy) and/or imaging (computed tomography or magnetic resonance enterography) must also be current within 4 weeks prior to nivolumab administrationRegistry-derived · unreviewed
- CD-SPECIFIC INCLUSION: Patients must test negative for hepatitis B (sAg negative, cAb negative, sAb positive or negative) and M. tuberculosis (PPD or ELISpot or T-spot) or be on appropriate anti-microbial treatment for these infectionsRegistry-derived · unreviewed
- CD-SPECIFIC INCLUSION: Mild Disease Cohort: Patients must be in clinical remission as defined by a Crohn's Disease Activity Index (CDAI) \< 150 either without treatment or on a 5-ASA derivative, probiotic, antibiotics, or following fecal transplantRegistry-derived · unreviewed
- CD-SPECIFIC INCLUSION: Moderate Disease Cohort: Patients must be in clinical remission as defined by a CDAI \< 150 on 6-mercaptopurine, azathioprine, methotrexate, rectal hydrocortisone, budesonide, or one of these medications in combination with any of the medications listed in the Mild cohortRegistry-derived · unreviewed
- CD-SPECIFIC INCLUSION: Severe Disease Cohort (A or B): Patients must either A) be in clinical remission as defined by a CDAI \< 150 on biologic therapy targeting TNF-α (infliximab, adalimumab, certolizumab pegol), IL-12/23p40 (ustekinumab), α4β7 integrin (vedolizumab), or one of these biologic therapies in combination with any of the medications listed in the Mild or Moderate cohort, or B) have mild active disease as defined by a CDAI of 150 to 220 on one of medications or combination of medications defined for the Moderate or Mild cohortRegistry-derived · unreviewed
- OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For other autoimmune diseases that cannot be classified, the eligibility criteria will be determined by the managing rheumatologist or other autoimmune disease specialist, based on the clinical judgement and current American College of Radiology (ACR) classification guidelines or other relevant guidelines, as per the disease category in questionRegistry-derived · unreviewed
- OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For giant cell arteritis (GCA), patients must have had positive temporal artery biopsy for GCA and abnormal erythrocyte sedimentation rate (ESR) at time of diagnosisRegistry-derived · unreviewed
- OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For polymyalgia rheumatica (PMR), patients must have clinical diagnosis in addition to elevated inflammatory markers including (ESR, C reactive protein \[CRP\])Registry-derived · unreviewed
- OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: Patients can be in remission (with no glucocorticoids or immunosuppressive medications) or have low-moderate activity, which is defined as being on prednisone ≤ 10 mg or equivalentRegistry-derived · unreviewed
- MS-SPECIFIC INCLUSION: Patients must meet 2017 McDonald criteria for the diagnosis of MS (Thompson AJ, et al. Diagnosis of multiple sclerosis: 2017 revision of the McDonald criteria. Lancet Neurol. 17(2):162-173.)Registry-derived · unreviewed
- MS-SPECIFIC INCLUSION: Patients with MS can be in remission and can have a history of being on immunomodulatory agents, but at the time of entry into the clinical trial, patients should be off any concurrent MS therapy for at least 2 weeks. Patients receiving concomitant interferon gamma (IFN-γ treatment) will be permitted in the studyRegistry-derived · unreviewed
- SJS-SPECIFIC INCLUSION: SjS diagnosed by a rheumatologist or oral medicine provider. The patient should meet the American-European Consensus Criteria for Sjögren's Syndrome (Vitali, et al., 2002). If on treatment, the patient may only be on hydroxychloroquine and prednisone ≤ 10 mg or equivalentRegistry-derived · unreviewed
- PSO/PSA-SPECIFIC INCLUSION: Patients with known PsO as diagnosed by a dermatologist or PsA by a rheumatologist and/or by Classification for Psoriatic Arthritis (CASPAR) criteria (Tillett et al., 2012)Registry-derived · unreviewed
- PSO/PSA-SPECIFIC INCLUSION: Patients must have stable disease as determined by the investigator with no change in systemic therapy and/or biologic therapy for at least 3 months, except for those on tumor necrosis factor (TNF) inhibitors. In the case of TNF inhibition, patients may have transitioned to an alternative biologic therapy with stable disease for at least 4 weeks. For PsA, no change in corticosteroid therapy for at least 1 month prior to baseline and dose must be 10 mg or lessRegistry-derived · unreviewed
Exclusion criteria (7)
- Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (AEs) due to agents administered more than 4 weeks earlier have not resolved or stabilized. Palliative (limited-field) radiation therapy (RT) is permitted (2 week washout from start of treatment), if all of the following criteria are met:Registry-derived · unreviewed
- Repeat imaging demonstrates no new sites of bone metastasesRegistry-derived · unreviewed
- The lesion being considered for palliative radiation is not a target lesionRegistry-derived · unreviewed
- Patients with prior therapy with an anti-PD-1 or anti-PD-L1Registry-derived · unreviewed
- Patients with prior allogeneic hematologic transplantRegistry-derived · unreviewed
- Patients who are receiving any other anticancer investigational agentsRegistry-derived · unreviewed
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirementsRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Incidence of adverse events
Time frame: Up to 100 days after completion of study treatment
Will be reported overall and by severity, and dose limiting toxicities will be summarized for all patients and by disease severity cohort.
Primary outcome
Change in disease assessments
Time frame: Baseline up to 100 days after completion of study treatment
Will be summarized at each time point for each disease severity cohort.
Primary outcome
Overall response rate
Time frame: Up to 5 years after completion of study treatment
Will be computed along with its associated exact 95% confidence interval for all patients and by disease severity cohort.
Primary outcome
Changes in serum chemokines and circulating immune cells over time
Time frame: Baseline up to 100 days after completion of study treatment
Will be summarized and assessed using generalized linear mixed modeling.
Primary outcome
Gene expression in normal tissues
Time frame: Up to 100 days after completion of study treatment
Will be compared with gene expression in malignant tissues based on two-sample t-test and Wilcoxon rank sum test. False discovery rate, if appropriate, will be used to control for multiple testing.
Primary outcome
Clinical measures of interest
Time frame: Up to 100 days after completion of study treatment
The association between demographic and clinical measures of interest with overall response rate and toxicity will be evaluated using logistic regression modeling to identify potential predictors of outcomes.
Recruiting locations in the United States
University of California Davis Comprehensive Cancer Center
RecruitingSacramento, California, 95817, United States
Site Public Contact916-734-3089
Surbhi Singhal
Smilow Cancer Center/Yale-New Haven Hospital
RecruitingNew Haven, Connecticut, 06510, United States
Site Public Contact203-785-5702canceranswers@yale.edu
Patricia M. LoRusso
Yale University
RecruitingNew Haven, Connecticut, 06520, United States
Site Public Contact203-785-5702canceranswers@yale.edu
Patricia M. LoRusso
MedStar Georgetown University Hospital
RecruitingWashington D.C., District of Columbia, 20007, United States
Site Public Contact202-444-2223
Geoffrey T. Gibney
University of Kansas Clinical Research Center
RecruitingFairway, Kansas, 66205, United States
Site Public Contact913-588-3671KUCC_Navigation@kumc.edu
Joaquina C. Baranda
HaysMed
RecruitingHays, Kansas, 67601, United States
Site Public Contact785-623-5774
Joaquina C. Baranda
University of Kansas Cancer Center
RecruitingKansas City, Kansas, 66160, United States
Site Public Contact913-588-3671KUCC_Navigation@kumc.edu
Joaquina C. Baranda
Lawrence Memorial Hospital
RecruitingLawrence, Kansas, 66044, United States
Site Public Contact785-505-2800Stephanie.Norris@LMH.ORG
Joaquina C. Baranda
The University of Kansas Cancer Center - Olathe
RecruitingOlathe, Kansas, 66061, United States
Site Public Contact913-588-1569OlatheCCResearch@kumc.edu
Joaquina C. Baranda
University of Kansas Cancer Center-Overland Park
RecruitingOverland Park, Kansas, 66210, United States
Site Public Contact913-588-3671KUCC_Navigation@kumc.edu
Joaquina C. Baranda
University of Kansas Hospital-Indian Creek Campus
RecruitingOverland Park, Kansas, 66211, United States
Site Public Contact913-588-3671KUCC_Navigation@kumc.edu
Joaquina C. Baranda
Salina Regional Health Center
RecruitingSalina, Kansas, 67401, United States
Site Public Contact785-452-7038mleepers@srhc.com
Joaquina C. Baranda
University of Kansas Health System Saint Francis Campus
RecruitingTopeka, Kansas, 66606, United States
Site Public Contact785-295-8000
Joaquina C. Baranda
University of Kansas Hospital-Westwood Cancer Center
RecruitingWestwood, Kansas, 66205, United States
Site Public Contact913-588-3671KUCC_Navigation@kumc.edu
Joaquina C. Baranda
University of Kentucky/Markey Cancer Center
RecruitingLexington, Kentucky, 40536, United States
Site Public Contact859-257-3379
Susanne M. Arnold
Johns Hopkins University/Sidney Kimmel Cancer Center
RecruitingBaltimore, Maryland, 21287, United States
Site Public Contact410-955-8804jhcccro@jhmi.edu
Julie R. Brahmer
National Cancer Institute Developmental Therapeutics Clinic
RecruitingBethesda, Maryland, 20892, United States
Site Public Contact800-411-1222
A P. Chen
Dana-Farber Cancer Institute
RecruitingBoston, Massachusetts, 02215, United States
Site Public Contact877-442-3324
Patrick A. Ott
Massachusetts General Hospital Cancer Center
RecruitingBoston, Massachusetts, 02114, United States
Site Public Contact877-726-5130
Patrick A. Ott
Siteman Cancer Center at Saint Peters Hospital
RecruitingCity of Saint Peters, Missouri, 63376, United States
Site Public Contact800-600-3606info@siteman.wustl.edu
Tanner M. Johanns
Siteman Cancer Center at West County Hospital
RecruitingCreve Coeur, Missouri, 63141, United States
Site Public Contact800-600-3606info@siteman.wustl.edu
Tanner M. Johanns
University Health Truman Medical Center
RecruitingKansas City, Missouri, 64108, United States
Site Public Contact816-404-4375
Joaquina C. Baranda
University of Kansas Cancer Center - North
RecruitingKansas City, Missouri, 64154, United States
Site Public Contact913-588-3671KUCC_Navigation@kumc.edu
Joaquina C. Baranda
University of Kansas Cancer Center - Lee's Summit
RecruitingLee's Summit, Missouri, 64064, United States
Site Public Contact913-588-3671KUCC_Navigation@kumc.edu
Joaquina C. Baranda
University of Kansas Cancer Center at North Kansas City Hospital
RecruitingNorth Kansas City, Missouri, 64116, United States
Site Public Contact913-588-3671KUCC_Navigation@kumc.edu
Joaquina C. Baranda
Siteman Cancer Center at Christian Hospital
RecruitingSt Louis, Missouri, 63136, United States
Site Public Contact800-600-3606info@siteman.wustl.edu
Tanner M. Johanns
Siteman Cancer Center-South County
RecruitingSt Louis, Missouri, 63129, United States
Site Public Contact800-600-3606info@siteman.wustl.edu
Tanner M. Johanns
Washington University School of Medicine
RecruitingSt Louis, Missouri, 63110, United States
Site Public Contact800-600-3606info@siteman.wustl.edu
Tanner M. Johanns
Rutgers Cancer Institute of New Jersey
RecruitingNew Brunswick, New Jersey, 08903, United States
Site Public Contact732-235-7356
Sarah A. Weiss
NYU Langone Hospital - Long Island
RecruitingMineola, New York, 11501, United States
Site Public Contact212-263-4432cancertrials@nyulangone.org
Janice M. Mehnert
Laura and Isaac Perlmutter Cancer Center at NYU Langone
RecruitingNew York, New York, 10016, United States
Site Public ContactCancerTrials@nyulangone.org
Janice M. Mehnert
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
RecruitingNew York, New York, 10032, United States
Site Public Contact212-342-5162cancerclinicaltrials@cumc.columbia.edu
Brian S. Henick
NYP/Weill Cornell Medical Center
RecruitingNew York, New York, 10065, United States
Site Public Contact212-746-1848
Ashish Saxena
Ohio State University Comprehensive Cancer Center
RecruitingColumbus, Ohio, 43210, United States
Site Public Contact800-293-5066Jamesline@osumc.edu
Yuanquan Yang
UPMC Hillman Cancer Center
RecruitingPittsburgh, Pennsylvania, 15232, United States
Site Public Contact412-647-8073
Yana Najjar
UT Southwestern/Simmons Cancer Center-Dallas
RecruitingDallas, Texas, 75390, United States
Site Public Contact214-648-7097canceranswerline@UTSouthwestern.edu
Hans Hammers
UT Southwestern Simmons Cancer Center - RedBird
RecruitingDallas, Texas, 75237, United States
Site Public Contact214-648-7097canceranswerline@utsouthwestern.edu
Hans Hammers
UT Southwestern/Simmons Cancer Center-Fort Worth
RecruitingFort Worth, Texas, 76104, United States
Site Public Contact214-648-7097canceranswerline@UTSouthwestern.edu
Hans Hammers
UT MD Anderson Cancer Center
RecruitingHouston, Texas, 77030, United States
Site Public Contact866-632-6789askmdanderson@mdanderson.org
Ecaterina E. Ileana Dumbrava
UT Southwestern Clinical Center at Richardson/Plano
RecruitingRichardson, Texas, 75080, United States
Site Public Contact972-669-7044Suzanne.cole@utsouthwestern.edu
Hans Hammers
VCU Massey Comprehensive Cancer Center
RecruitingRichmond, Virginia, 23298, United States
Site Public Contact804-628-6430CTOclinops@vcu.edu
Andrew Poklepovic
This study also lists 1 location outside the United States. It is not shown here.
Registry dates
- First posted
- Jan 25, 2019
- Primary completion
- Mar 30, 2028
- Overall completion
- Mar 30, 2028
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.