Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO

NCT03816345 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: NCI-2019-0024110204UM1CA186688
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 52

Brief Summary

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.

Conditions

Sjogren Syndrome; Systemic Scleroderma; Ulcerative Colitis; Multiple Sclerosis; Autoimmune Disease; Crohn Disease; Dermatomyositis; Hematopoietic and Lymphoid Cell Neoplasm; Inflammatory Bowel Disease; Rheumatoid Arthritis; Systemic Lupus Erythematosus; Malignant Solid Neoplasm; Psoriasis; Psoriatic Arthritis

Outcome Measures

Primary Outcomes (6)

• Incidence of adverse events

  Will be reported overall and by severity, and dose limiting toxicities will be summarized for all patients and by disease severity cohort.

  Up to 100 days after completion of study treatment

• Change in disease assessments

  Will be summarized at each time point for each disease severity cohort.

  Baseline up to 100 days after completion of study treatment

• Overall response rate

  Will be computed along with its associated exact 95% confidence interval for all patients and by disease severity cohort.

  Up to 5 years after completion of study treatment

• Changes in serum chemokines and circulating immune cells over time

  Will be summarized and assessed using generalized linear mixed modeling.

  Baseline up to 100 days after completion of study treatment

• Gene expression in normal tissues

  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.

  Up to 100 days after completion of study treatment

• Clinical measures of interest

  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.

  Up to 100 days after completion of study treatment

Study Arms (11)

Arm I (nivolumab)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Biological: Nivolumab

Arm II (nivolumab, ipilimumab)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Biological: Ipilimumab; Biological: Nivolumab

Arm III (nivolumab, platinum doublet)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Biological: Nivolumab; Drug: Platinum Doublet

Arm IV (nivolumab, ipilimumab)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Biological: Ipilimumab; Biological: Nivolumab

Arm IX (nivolumab, ipilimumab)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Biological: Ipilimumab; Biological: Nivolumab

Arm V (nivolumab, ipilimumab, platinum doublet therapy)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Biological: Ipilimumab; Biological: Nivolumab; Drug: Platinum Doublet

Arm VI (nivolumab, ipilimumab)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Biological: Ipilimumab; Biological: Nivolumab

Arm VII (nivolumab, ipilimumab, cabozantinib)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Drug: Cabozantinib; Biological: Ipilimumab; Biological: Nivolumab

Arm VIII (nivolumab, ipilimumab)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Biological: Ipilimumab; Biological: Nivolumab

Arm X (nivolumab, fluoropyrimidine, platinum, ipilimumab)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Drug: Fluoropyrimidine; Biological: Ipilimumab; Biological: Nivolumab; Drug: Platinum Compound

Arm XI (nivolumab, fluoropyrimidine, platinum)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Drug: Fluoropyrimidine; Biological: Nivolumab; Drug: Platinum Compound

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood, CSF, tissue, stool and urine samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (nivolumab); Arm II (nivolumab, ipilimumab); Arm III (nivolumab, platinum doublet); Arm IV (nivolumab, ipilimumab); Arm IX (nivolumab, ipilimumab); Arm V (nivolumab, ipilimumab, platinum doublet therapy); Arm VI (nivolumab, ipilimumab); Arm VII (nivolumab, ipilimumab, cabozantinib); Arm VIII (nivolumab, ipilimumab); Arm X (nivolumab, fluoropyrimidine, platinum, ipilimumab); Arm XI (nivolumab, fluoropyrimidine, platinum)

Nivolumab BIOLOGICAL

Given IV

Also known as: ABP 206, BCD-263, BMS 936558, BMS-936558, BMS936558, CMAB819, MDX 1106, MDX-1106, MDX1106, NIVO, Nivolumab Biosimilar ABP 206, Nivolumab Biosimilar BCD-263, Nivolumab Biosimilar CMAB819, ONO 4538, ONO-4538, ONO4538, Opdivo

Arm I (nivolumab); Arm II (nivolumab, ipilimumab); Arm III (nivolumab, platinum doublet); Arm IV (nivolumab, ipilimumab); Arm IX (nivolumab, ipilimumab); Arm V (nivolumab, ipilimumab, platinum doublet therapy); Arm VI (nivolumab, ipilimumab); Arm VII (nivolumab, ipilimumab, cabozantinib); Arm VIII (nivolumab, ipilimumab); Arm X (nivolumab, fluoropyrimidine, platinum, ipilimumab); Arm XI (nivolumab, fluoropyrimidine, platinum)

Cabozantinib DRUG

Given PO

Arm VII (nivolumab, ipilimumab, cabozantinib)

Fluoropyrimidine DRUG

Given fluoropyrimidine

Arm X (nivolumab, fluoropyrimidine, platinum, ipilimumab); Arm XI (nivolumab, fluoropyrimidine, platinum)

Ipilimumab BIOLOGICAL

Given IV

Also known as: Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS 734016, BMS-734016, BMS734016, Ipilimumab Biosimilar CS1002, MDX 010, MDX-010, MDX-CTLA4, MDX010, Yervoy

Arm II (nivolumab, ipilimumab); Arm IV (nivolumab, ipilimumab); Arm IX (nivolumab, ipilimumab); Arm V (nivolumab, ipilimumab, platinum doublet therapy); Arm VI (nivolumab, ipilimumab); Arm VII (nivolumab, ipilimumab, cabozantinib); Arm VIII (nivolumab, ipilimumab); Arm X (nivolumab, fluoropyrimidine, platinum, ipilimumab)

Platinum Compound DRUG

Given platinum containing chemotherapy

Also known as: Platinum Agents, Platinum-Based Chemotherapeutic Agent

Arm X (nivolumab, fluoropyrimidine, platinum, ipilimumab); Arm XI (nivolumab, fluoropyrimidine, platinum)

Platinum Doublet DRUG

Given platinum doublet

Also known as: Platinum Doublets, Platinum-based Chemotherapy Doublet, Platinum-based Chemotherapy Doublets, Platinum-based Double Chemotherapy Combination, Platinum-based Doublet, Platinum-based Doublets

Arm III (nivolumab, platinum doublet); Arm V (nivolumab, ipilimumab, platinum doublet therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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 cancer
• 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 chemotherapy
• 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 weeks
• Age \>= 18 years; children are excluded from this study but may be eligible for future pediatric phase 1 combination trials
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Karnofsky \>= 60)
• Life expectancy of greater than 12 weeks
• Leukocytes \>= 1,000/mcL
• Absolute neutrophil count \>= 500/mcL
• Platelets \>= 50,000/mcL
• Total bilirubin =\< 2 x institutional upper limit of normal (ULN)
• 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 values
• Creatinine ULN OR glomerular filtration rate (GFR) \>= 30 mL/min (if using the Cockcroft-Gault formula)
• Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial
• If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated

You may not qualify if:

• 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:
• Repeat imaging demonstrates no new sites of bone metastases
• The lesion being considered for palliative radiation is not a target lesion
• Patients with prior therapy with an anti-PD-1 or anti-PD-L1
• Patients with prior allogeneic hematologic transplant
• Patients who are receiving any other anticancer investigational agents
• 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 requirements

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (52)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

ACTIVE NOT RECRUITING

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States

ACTIVE NOT RECRUITING

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

RECRUITING

Smilow Cancer Center/Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

RECRUITING

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

ACTIVE NOT RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

ACTIVE NOT RECRUITING

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

ACTIVE NOT RECRUITING

University of Kansas Clinical Research Center

Fairway, Kansas, 66205, United States

RECRUITING

HaysMed

Hays, Kansas, 67601, United States

RECRUITING

University of Kansas Cancer Center

Kansas City, Kansas, 66160, United States

RECRUITING

Lawrence Memorial Hospital

Lawrence, Kansas, 66044, United States

RECRUITING

The University of Kansas Cancer Center - Olathe

Olathe, Kansas, 66061, United States

RECRUITING

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, 66210, United States

RECRUITING

University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, 66211, United States

RECRUITING

Mercy Hospital Pittsburg

Pittsburg, Kansas, 66762, United States

SUSPENDED

Salina Regional Health Center

Salina, Kansas, 67401, United States

RECRUITING

University of Kansas Health System Saint Francis Campus

Topeka, Kansas, 66606, United States

RECRUITING

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205, United States

RECRUITING

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States

RECRUITING

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

RECRUITING

National Cancer Institute Developmental Therapeutics Clinic

Bethesda, Maryland, 20892, United States

RECRUITING

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

ACTIVE NOT RECRUITING

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

ACTIVE NOT RECRUITING

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, 63376, United States

RECRUITING

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141, United States

RECRUITING

University Health Truman Medical Center

Kansas City, Missouri, 64108, United States

RECRUITING

University of Kansas Cancer Center - North

Kansas City, Missouri, 64154, United States

RECRUITING

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064, United States

RECRUITING

University of Kansas Cancer Center at North Kansas City Hospital

North Kansas City, Missouri, 64116, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Siteman Cancer Center-South County

St Louis, Missouri, 63129, United States

RECRUITING

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, 63136, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

RECRUITING

NYU Langone Hospital - Long Island

Mineola, New York, 11501, United States

RECRUITING

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, 10016, United States

RECRUITING

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

RECRUITING

NYP/Weill Cornell Medical Center

New York, New York, 10065, United States

RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

ACTIVE NOT RECRUITING

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

UT Southwestern Simmons Cancer Center - RedBird

Dallas, Texas, 75237, United States

RECRUITING

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States

RECRUITING

UT Southwestern/Simmons Cancer Center-Fort Worth

Fort Worth, Texas, 76104, United States

RECRUITING

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

UT Southwestern Clinical Center at Richardson/Plano

Richardson, Texas, 75080, United States

RECRUITING

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

ACTIVE NOT RECRUITING

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States

RECRUITING

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

SUSPENDED

Related Publications (1)

• Vaziri H, Turshudzhyan A, Vecchio E. Immunotherapy-induced Colitis: A Comprehensive Review of Epidemiology, Clinical Presentation, Diagnostic Workup, and Management Plan. J Clin Gastroenterol. 2022 Aug 1;56(7):555-564. doi: 10.1097/MCG.0000000000001705. Epub 2022 Apr 21.

  PMID: 35470301 DERIVED

MeSH Terms

Conditions

Autoimmune Diseases; Crohn Disease; Dermatomyositis; Hematologic Neoplasms; Inflammatory Bowel Diseases; Multiple Sclerosis; Psoriasis; Arthritis, Psoriatic; Arthritis, Rheumatoid; Sjogren's Syndrome; Lupus Erythematosus, Systemic; Scleroderma, Systemic; Colitis, Ulcerative

Interventions

Specimen Handling; cabozantinib; Ipilimumab; CTLA-4 Antigen; Nivolumab; Platinum Compounds

Condition Hierarchy (Ancestors)

Immune System Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Polymyositis; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Skin Diseases, Papulosquamous; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Immune Checkpoint Proteins; Costimulatory and Inhibitory T-Cell Receptors; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Antigens, Differentiation, T-Lymphocyte; Antigens, Differentiation; Antigens, Surface; Antigens; Biological Factors; Biomarkers; Inorganic Chemicals

Study Officials

• Hussein A Tawbi

  University of Texas MD Anderson Cancer Center LAO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 25, 2019
• Study Start: July 16, 2019
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): March 30, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CA (1); US (51)