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자가면역 질환 및 진행성, 전이성 또는 절제 불가능한 암 환자를 치료하는 니볼루맙

2026년 10월 2일 업데이트: National Cancer Institute (NCI)

자가면역 질환 및 진행성 악성종양 환자를 대상으로 한 Nivolumab의 Ib상 연구(AIM-NIVO)

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

300

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Alabama
      • Birmingham, Alabama, 미국, 35233
        • 모집하지 않고 적극적으로
        • University of Alabama at Birmingham Cancer Center
    • California
      • Palo Alto, California, 미국, 94304
        • 모집하지 않고 적극적으로
        • Stanford Cancer Institute Palo Alto
      • Sacramento, California, 미국, 95817
        • 모병
        • University of California Davis Comprehensive Cancer Center
        • 연락하다:
          • Site Public Contact
          • 전화번호: 916-734-3089
        • 수석 연구원:
          • Surbhi Singhal
    • Connecticut
      • New Haven, Connecticut, 미국, 06520
        • 모병
        • Yale University
        • 연락하다:
        • 수석 연구원:
          • Patricia M. LoRusso
      • New Haven, Connecticut, 미국, 06510
        • 모병
        • Smilow Cancer Center/Yale-New Haven Hospital
        • 연락하다:
        • 수석 연구원:
          • Patricia M. LoRusso
    • District of Columbia
      • Washington D.C., District of Columbia, 미국, 20007
        • 모병
        • MedStar Georgetown University Hospital
        • 연락하다:
          • Site Public Contact
          • 전화번호: 202-444-2223
        • 수석 연구원:
          • Geoffrey T. Gibney
    • Georgia
      • Atlanta, Georgia, 미국, 30322
        • 모집하지 않고 적극적으로
        • Emory University Hospital/Winship Cancer Institute
    • Illinois
      • Chicago, Illinois, 미국, 60637
        • 모집하지 않고 적극적으로
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, 미국, 60611
        • 모집하지 않고 적극적으로
        • Northwestern University
    • Kansas
      • Fairway, Kansas, 미국, 66205
        • 모병
        • University of Kansas Clinical Research Center
        • 연락하다:
        • 수석 연구원:
          • Joaquina C. Baranda
      • Hays, Kansas, 미국, 67601
        • 모병
        • HaysMed
        • 연락하다:
          • Site Public Contact
          • 전화번호: 785-623-5774
        • 수석 연구원:
          • Joaquina C. Baranda
      • Kansas City, Kansas, 미국, 66160
        • 모병
        • University of Kansas Cancer Center
        • 연락하다:
        • 수석 연구원:
          • Joaquina C. Baranda
      • Lawrence, Kansas, 미국, 66044
        • 모병
        • Lawrence Memorial Hospital
        • 연락하다:
        • 수석 연구원:
          • Joaquina C. Baranda
      • Olathe, Kansas, 미국, 66061
        • 모병
        • The University of Kansas Cancer Center - Olathe
        • 수석 연구원:
          • Joaquina C. Baranda
        • 연락하다:
      • Overland Park, Kansas, 미국, 66211
        • 모병
        • University of Kansas Hospital-Indian Creek Campus
        • 연락하다:
        • 수석 연구원:
          • Joaquina C. Baranda
      • Overland Park, Kansas, 미국, 66210
        • 모병
        • University of Kansas Cancer Center-Overland Park
        • 연락하다:
        • 수석 연구원:
          • Joaquina C. Baranda
      • Pittsburg, Kansas, 미국, 66762
        • 정지된
        • Mercy Hospital Pittsburg
      • Salina, Kansas, 미국, 67401
        • 모병
        • Salina Regional Health Center
        • 연락하다:
        • 수석 연구원:
          • Joaquina C. Baranda
      • Topeka, Kansas, 미국, 66606
        • 모병
        • University of Kansas Health System Saint Francis Campus
        • 연락하다:
          • Site Public Contact
          • 전화번호: 785-295-8000
        • 수석 연구원:
          • Joaquina C. Baranda
      • Westwood, Kansas, 미국, 66205
        • 모병
        • University of Kansas Hospital-Westwood Cancer Center
        • 연락하다:
        • 수석 연구원:
          • Joaquina C. Baranda
    • Kentucky
      • Lexington, Kentucky, 미국, 40536
        • 모병
        • University of Kentucky/Markey Cancer Center
        • 연락하다:
          • Site Public Contact
          • 전화번호: 859-257-3379
        • 수석 연구원:
          • Susanne M. Arnold
    • Maryland
      • Baltimore, Maryland, 미국, 21287
        • 모병
        • Johns Hopkins University/Sidney Kimmel Cancer Center
        • 연락하다:
        • 수석 연구원:
          • Julie R. Brahmer
      • Bethesda, Maryland, 미국, 20892
        • 모병
        • National Cancer Institute Developmental Therapeutics Clinic
        • 연락하다:
          • Site Public Contact
          • 전화번호: 800-411-1222
        • 수석 연구원:
          • A P. Chen
      • Bethesda, Maryland, 미국, 20892
        • 모집하지 않고 적극적으로
        • National Institutes of Health Clinical Center
    • Massachusetts
      • Boston, Massachusetts, 미국, 02114
        • 모병
        • Massachusetts General Hospital Cancer Center
        • 연락하다:
          • Site Public Contact
          • 전화번호: 877-726-5130
        • 수석 연구원:
          • Patrick A. Ott
      • Boston, Massachusetts, 미국, 02215
        • 모병
        • Dana-Farber Cancer Institute
        • 연락하다:
          • Site Public Contact
          • 전화번호: 877-442-3324
        • 수석 연구원:
          • Patrick A. Ott
    • Michigan
      • Detroit, Michigan, 미국, 48201
        • 모집하지 않고 적극적으로
        • Wayne State University/Karmanos Cancer Institute
    • Missouri
      • City of Saint Peters, Missouri, 미국, 63376
        • 모병
        • Siteman Cancer Center at Saint Peters Hospital
        • 연락하다:
        • 수석 연구원:
          • Tanner M. Johanns
      • Creve Coeur, Missouri, 미국, 63141
        • 모병
        • Siteman Cancer Center at West County Hospital
        • 연락하다:
        • 수석 연구원:
          • Tanner M. Johanns
      • Kansas City, Missouri, 미국, 64154
        • 모병
        • University of Kansas Cancer Center - North
        • 연락하다:
        • 수석 연구원:
          • Joaquina C. Baranda
      • Kansas City, Missouri, 미국, 64108
        • 모병
        • University Health Truman Medical Center
        • 연락하다:
          • Site Public Contact
          • 전화번호: 816-404-4375
        • 수석 연구원:
          • Joaquina C. Baranda
      • Lee's Summit, Missouri, 미국, 64064
        • 모병
        • University of Kansas Cancer Center - Lee's Summit
        • 연락하다:
        • 수석 연구원:
          • Joaquina C. Baranda
      • North Kansas City, Missouri, 미국, 64116
        • 정지된
        • University of Kansas Cancer Center at North Kansas City Hospital
      • St Louis, Missouri, 미국, 63110
        • 모병
        • Washington University School of Medicine
        • 연락하다:
        • 수석 연구원:
          • Tanner M. Johanns
      • St Louis, Missouri, 미국, 63129
        • 모병
        • Siteman Cancer Center-South County
        • 연락하다:
        • 수석 연구원:
          • Tanner M. Johanns
      • St Louis, Missouri, 미국, 63136
        • 모병
        • Siteman Cancer Center at Christian Hospital
        • 연락하다:
        • 수석 연구원:
          • Tanner M. Johanns
    • New Jersey
      • New Brunswick, New Jersey, 미국, 08903
        • 모병
        • Rutgers Cancer Institute of New Jersey
        • 연락하다:
          • Site Public Contact
          • 전화번호: 732-235-7356
        • 수석 연구원:
          • Sarah A. Weiss
    • New York
      • Mineola, New York, 미국, 11501
        • 모병
        • NYU Langone Hospital - Long Island
        • 연락하다:
        • 수석 연구원:
          • Janice M. Mehnert
      • New York, New York, 미국, 10032
        • 모병
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
        • 수석 연구원:
          • Brian S. Henick
        • 연락하다:
      • New York, New York, 미국, 10016
        • 모병
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
        • 연락하다:
        • 수석 연구원:
          • Janice M. Mehnert
      • New York, New York, 미국, 10065
        • 모병
        • NYP/Weill Cornell Medical Center
        • 수석 연구원:
          • Ashish Saxena
        • 연락하다:
          • Site Public Contact
          • 전화번호: 212-746-1848
    • Ohio
      • Columbus, Ohio, 미국, 43210
        • 모병
        • Ohio State University Comprehensive Cancer Center
        • 연락하다:
        • 수석 연구원:
          • Yuanquan Yang
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19107
        • 모집하지 않고 적극적으로
        • Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, 미국, 15232
        • 모병
        • UPMC Hillman Cancer Center
        • 수석 연구원:
          • Yana Najjar
        • 연락하다:
          • Site Public Contact
          • 전화번호: 412-647-8073
    • Texas
      • Dallas, Texas, 미국, 75390
        • 모병
        • UT Southwestern/Simmons Cancer Center-Dallas
        • 연락하다:
        • 수석 연구원:
          • Hans Hammers
      • Dallas, Texas, 미국, 75237
        • 모병
        • UT Southwestern Simmons Cancer Center - RedBird
        • 수석 연구원:
          • Hans Hammers
        • 연락하다:
      • Fort Worth, Texas, 미국, 76104
        • 모병
        • UT Southwestern/Simmons Cancer Center-Fort Worth
        • 연락하다:
        • 수석 연구원:
          • Hans Hammers
      • Houston, Texas, 미국, 77030
        • 모병
        • UT MD Anderson Cancer Center
        • 연락하다:
        • 수석 연구원:
          • Ecaterina E. Ileana Dumbrava
      • Richardson, Texas, 미국, 75080
        • 모병
        • UT Southwestern Clinical Center at Richardson/Plano
        • 연락하다:
        • 수석 연구원:
          • Hans Hammers
    • Utah
      • Salt Lake City, Utah, 미국, 84112
        • 모집하지 않고 적극적으로
        • Huntsman Cancer Institute/University of Utah
    • Virginia
      • Richmond, Virginia, 미국, 23298
        • 모병
        • VCU Massey Comprehensive Cancer Center
        • 수석 연구원:
          • Andrew Poklepovic
        • 연락하다:
  • 캐나다
    • Ontario
      • Toronto, Ontario, 캐나다, M5G 2M9
        • 정지된
        • University Health Network-Princess Margaret Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • 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

  • If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load

  • 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 trial

  • 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 product

    • 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 contraception
    • 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/mL
    • 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 days
    • 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 pregnancy

  • Ability to understand and the willingness to sign a written informed consent document

  • 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)

  • 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 SSc

  • DM/SSc-SPECIFIC INCLUSION: Patients may be on any concurrent therapy for DM or SSc unless specifically excluded

  • DM/SSc-SPECIFIC INCLUSION: Patients must have a baseline computed tomography (CT) of the chest (within 6 months of study entry)

  • 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 RA

  • RA-SPECIFIC INCLUSION: Prednisone up to 10 mg/day will be allowed. Intraarticular steroids will be allowed for the treatment of new symptomatic joints

  • RA-SPECIFIC INCLUSION: Nonsteroidal anti-inflammatory drugs (NSAIDs) will be allowed

  • 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 mandatory

  • ULCERATIVE COLITIS (UC)-SPECIFIC INCLUSION: Diagnosis of UC must be made by endoscopy with biopsies

  • UC-SPECIFIC INCLUSION: Complete colonoscopy with biopsies during study screening, within 8 weeks before initial nivolumab administration, or within 4 weeks after initial nivolumab administration

  • 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 infections

  • 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 transplant

  • 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 cohort

  • 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, or other approved agent in this class), α4β7 integrin (vedolizumab or other approved agent in this class), selective JAK1 inhibitor (upadacitinib or other approved agent in this class), IL-23p19 inhibitors (risankizumab or other approved agent in this class), selective sphingosine 1-phosphate receptor (S1PR) inhibitors (ozanimod, etrasimod or other approved agent in this class), 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 cohort

  • 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 administration

  • 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 administration

  • CD-SPECIFIC INCLUSION: Deep enteroscopy techniques, such as double balloon enteroscopy, will not be required

  • 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 infections

  • 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 transplant

  • 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 cohort

  • 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, or other approved agent in this class), IL-12/23p40 (Ustekinumab or other approved agent in this class), α4β7 integrin (vedolizumab or other approved agent in this class), selective JAK1 inhibitor (upadacitinib or other approved agent in this class), selective sphingosine 1-phosphate receptor (S1PR) inhibitors (ozanimod, etrasimod or other approved agent in this class), 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 cohort

  • 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 question

  • 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 diagnosis

  • 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])

  • 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 equivalent

  • 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.)

  • 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 can resume concurrent MS therapy 2 weeks after Nivolumab initiation. Patients in the MS2 cohort may be receiving contemporary multiple sclerosis disease modifying therapies, including but not limited to anti CD20 agents (ocrelizumab, rituximab, ofatumumab, ublituximab), sphingosine 1 phosphate (S1P) modulators (fingolimod, siponimod, ozanimod, ponesimod), cladribine, or other FDA approved MS therapies

  • MS-SPECIFIC INCLUSION: Patients must have neurologic stability for at least 4 weeks prior to nivolumab initiation

  • 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 equivalent

  • 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)

  • 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 less

  • PSO/PSA-SPECIFIC INCLUSION: Patients may be on any concurrent therapy for PsO or PsA unless specifically excluded

Exclusion Criteria:

  • 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

  • Patients with thymoma concurrent with myasthenia gravis

  • UC-SPECIFIC EXCLUSION: Patients who have received ipilimumab treatment

  • UC-SPECIFIC EXCLUSION: Prior colectomy

  • UC-SPECIFIC EXCLUSION: Concurrent primary sclerosing cholangitis (PSC). Patients with PSC can be enrolled on the Other Autoimmune Diseases Cohorts

  • UC-SPECIFIC EXCLUSION: Patients on empiric immunosuppressive treatment without any clinical workup

  • CD-SPECIFIC EXCLUSION: Known untreated abscesses, untreated and symptomatic strictures, short gut physiology, or isolated jejunal disease

  • CD-SPECIFIC EXCLUSION: Patients who have received ipilimumab treatment

  • CD-SPECIFIC EXCLUSION: Patients on empiric immunosuppressive treatment without any clinical workup

  • MS-SPECIFIC EXCLUSION: Patients with MS cannot have medical contraindications to gadolinium-enhanced magnetic resonance imaging (MRI)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
생물학적: Nivolumab

Given IV

다른 이름들:
  • BMS-936558
  • MDX-1106
  • 니보
  • ONO-4538
  • 옵디보
  • CMAB819
  • 니볼루맙 바이오시밀러 CMAB819
  • MDX 1106
  • MDX1106
  • BMS 936558
  • ABP 206
  • 니볼루맙 바이오시밀러 ABP 206
  • BCD-263
  • 니볼루맙 바이오시밀러 BCD-263
  • BMS936558
  • 오노 4538
  • ONO4538
절차: Biospecimen Collection

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

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
실험적: 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.
생물학적: Ipilimumab

Given IV

다른 이름들:
  • 항세포독성 T-림프구 관련 항원-4 단클론항체
  • BMS-734016
  • 이필리무맙 바이오시밀러 CS1002
  • MDX-010
  • MDX-CTLA4
  • 여보이
  • MDX010
  • BMS734016
  • BMS 734016
  • MDX 010
생물학적: Nivolumab

Given IV

다른 이름들:
  • BMS-936558
  • MDX-1106
  • 니보
  • ONO-4538
  • 옵디보
  • CMAB819
  • 니볼루맙 바이오시밀러 CMAB819
  • MDX 1106
  • MDX1106
  • BMS 936558
  • ABP 206
  • 니볼루맙 바이오시밀러 ABP 206
  • BCD-263
  • 니볼루맙 바이오시밀러 BCD-263
  • BMS936558
  • 오노 4538
  • ONO4538
절차: Biospecimen Collection

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

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
실험적: 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.
생물학적: Nivolumab

Given IV

다른 이름들:
  • BMS-936558
  • MDX-1106
  • 니보
  • ONO-4538
  • 옵디보
  • CMAB819
  • 니볼루맙 바이오시밀러 CMAB819
  • MDX 1106
  • MDX1106
  • BMS 936558
  • ABP 206
  • 니볼루맙 바이오시밀러 ABP 206
  • BCD-263
  • 니볼루맙 바이오시밀러 BCD-263
  • BMS936558
  • 오노 4538
  • ONO4538
절차: Biospecimen Collection

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

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
의약품: Platinum Doublet

Given platinum doublet

다른 이름들:
  • 플래티넘 더블렛
  • 백금 기반 이중 화학요법
  • 백금 기반 화학요법 이중요법
  • 백금계 이중 항암화학요법 조합
  • 플래티넘 기반 이중제
  • 플래티넘 기반 이중요법
실험적: 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.
생물학적: Ipilimumab

Given IV

다른 이름들:
  • 항세포독성 T-림프구 관련 항원-4 단클론항체
  • BMS-734016
  • 이필리무맙 바이오시밀러 CS1002
  • MDX-010
  • MDX-CTLA4
  • 여보이
  • MDX010
  • BMS734016
  • BMS 734016
  • MDX 010
생물학적: Nivolumab

Given IV

다른 이름들:
  • BMS-936558
  • MDX-1106
  • 니보
  • ONO-4538
  • 옵디보
  • CMAB819
  • 니볼루맙 바이오시밀러 CMAB819
  • MDX 1106
  • MDX1106
  • BMS 936558
  • ABP 206
  • 니볼루맙 바이오시밀러 ABP 206
  • BCD-263
  • 니볼루맙 바이오시밀러 BCD-263
  • BMS936558
  • 오노 4538
  • ONO4538
절차: Biospecimen Collection

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

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
실험적: 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.
생물학적: Ipilimumab

Given IV

다른 이름들:
  • 항세포독성 T-림프구 관련 항원-4 단클론항체
  • BMS-734016
  • 이필리무맙 바이오시밀러 CS1002
  • MDX-010
  • MDX-CTLA4
  • 여보이
  • MDX010
  • BMS734016
  • BMS 734016
  • MDX 010
생물학적: Nivolumab

Given IV

다른 이름들:
  • BMS-936558
  • MDX-1106
  • 니보
  • ONO-4538
  • 옵디보
  • CMAB819
  • 니볼루맙 바이오시밀러 CMAB819
  • MDX 1106
  • MDX1106
  • BMS 936558
  • ABP 206
  • 니볼루맙 바이오시밀러 ABP 206
  • BCD-263
  • 니볼루맙 바이오시밀러 BCD-263
  • BMS936558
  • 오노 4538
  • ONO4538
절차: Biospecimen Collection

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

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
실험적: 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.
생물학적: Ipilimumab

Given IV

다른 이름들:
  • 항세포독성 T-림프구 관련 항원-4 단클론항체
  • BMS-734016
  • 이필리무맙 바이오시밀러 CS1002
  • MDX-010
  • MDX-CTLA4
  • 여보이
  • MDX010
  • BMS734016
  • BMS 734016
  • MDX 010
생물학적: Nivolumab

Given IV

다른 이름들:
  • BMS-936558
  • MDX-1106
  • 니보
  • ONO-4538
  • 옵디보
  • CMAB819
  • 니볼루맙 바이오시밀러 CMAB819
  • MDX 1106
  • MDX1106
  • BMS 936558
  • ABP 206
  • 니볼루맙 바이오시밀러 ABP 206
  • BCD-263
  • 니볼루맙 바이오시밀러 BCD-263
  • BMS936558
  • 오노 4538
  • ONO4538
절차: Biospecimen Collection

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

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
의약품: Platinum Doublet

Given platinum doublet

다른 이름들:
  • 플래티넘 더블렛
  • 백금 기반 이중 화학요법
  • 백금 기반 화학요법 이중요법
  • 백금계 이중 항암화학요법 조합
  • 플래티넘 기반 이중제
  • 플래티넘 기반 이중요법
실험적: 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.
생물학적: Ipilimumab

Given IV

다른 이름들:
  • 항세포독성 T-림프구 관련 항원-4 단클론항체
  • BMS-734016
  • 이필리무맙 바이오시밀러 CS1002
  • MDX-010
  • MDX-CTLA4
  • 여보이
  • MDX010
  • BMS734016
  • BMS 734016
  • MDX 010
생물학적: Nivolumab

Given IV

다른 이름들:
  • BMS-936558
  • MDX-1106
  • 니보
  • ONO-4538
  • 옵디보
  • CMAB819
  • 니볼루맙 바이오시밀러 CMAB819
  • MDX 1106
  • MDX1106
  • BMS 936558
  • ABP 206
  • 니볼루맙 바이오시밀러 ABP 206
  • BCD-263
  • 니볼루맙 바이오시밀러 BCD-263
  • BMS936558
  • 오노 4538
  • ONO4538
절차: Biospecimen Collection

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

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
실험적: 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.
생물학적: Ipilimumab

Given IV

다른 이름들:
  • 항세포독성 T-림프구 관련 항원-4 단클론항체
  • BMS-734016
  • 이필리무맙 바이오시밀러 CS1002
  • MDX-010
  • MDX-CTLA4
  • 여보이
  • MDX010
  • BMS734016
  • BMS 734016
  • MDX 010
생물학적: Nivolumab

Given IV

다른 이름들:
  • BMS-936558
  • MDX-1106
  • 니보
  • ONO-4538
  • 옵디보
  • CMAB819
  • 니볼루맙 바이오시밀러 CMAB819
  • MDX 1106
  • MDX1106
  • BMS 936558
  • ABP 206
  • 니볼루맙 바이오시밀러 ABP 206
  • BCD-263
  • 니볼루맙 바이오시밀러 BCD-263
  • BMS936558
  • 오노 4538
  • ONO4538
의약품: Cabozantinib

Given PO

절차: Biospecimen Collection

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

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
실험적: 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.
생물학적: Ipilimumab

Given IV

다른 이름들:
  • 항세포독성 T-림프구 관련 항원-4 단클론항체
  • BMS-734016
  • 이필리무맙 바이오시밀러 CS1002
  • MDX-010
  • MDX-CTLA4
  • 여보이
  • MDX010
  • BMS734016
  • BMS 734016
  • MDX 010
생물학적: Nivolumab

Given IV

다른 이름들:
  • BMS-936558
  • MDX-1106
  • 니보
  • ONO-4538
  • 옵디보
  • CMAB819
  • 니볼루맙 바이오시밀러 CMAB819
  • MDX 1106
  • MDX1106
  • BMS 936558
  • ABP 206
  • 니볼루맙 바이오시밀러 ABP 206
  • BCD-263
  • 니볼루맙 바이오시밀러 BCD-263
  • BMS936558
  • 오노 4538
  • ONO4538
절차: Biospecimen Collection

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

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
실험적: 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.
생물학적: Ipilimumab

Given IV

다른 이름들:
  • 항세포독성 T-림프구 관련 항원-4 단클론항체
  • BMS-734016
  • 이필리무맙 바이오시밀러 CS1002
  • MDX-010
  • MDX-CTLA4
  • 여보이
  • MDX010
  • BMS734016
  • BMS 734016
  • MDX 010
생물학적: Nivolumab

Given IV

다른 이름들:
  • BMS-936558
  • MDX-1106
  • 니보
  • ONO-4538
  • 옵디보
  • CMAB819
  • 니볼루맙 바이오시밀러 CMAB819
  • MDX 1106
  • MDX1106
  • BMS 936558
  • ABP 206
  • 니볼루맙 바이오시밀러 ABP 206
  • BCD-263
  • 니볼루맙 바이오시밀러 BCD-263
  • BMS936558
  • 오노 4538
  • ONO4538
절차: Biospecimen Collection

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

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
의약품: Fluoropyrimidine

Given fluoropyrimidine

의약품: Platinum Compound

Given platinum containing chemotherapy

다른 이름들:
  • 플래티넘 에이전트
  • 백금 기반 화학요법제
실험적: 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.
생물학적: Nivolumab

Given IV

다른 이름들:
  • BMS-936558
  • MDX-1106
  • 니보
  • ONO-4538
  • 옵디보
  • CMAB819
  • 니볼루맙 바이오시밀러 CMAB819
  • MDX 1106
  • MDX1106
  • BMS 936558
  • ABP 206
  • 니볼루맙 바이오시밀러 ABP 206
  • BCD-263
  • 니볼루맙 바이오시밀러 BCD-263
  • BMS936558
  • 오노 4538
  • ONO4538
절차: Biospecimen Collection

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

다른 이름들:
  • 생물학적 샘플 수집
  • 생체 표본 수집
  • 표본 수집
  • 샘플 수집
의약품: Fluoropyrimidine

Given fluoropyrimidine

의약품: Platinum Compound

Given platinum containing chemotherapy

다른 이름들:
  • 플래티넘 에이전트
  • 백금 기반 화학요법제

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence of adverse events
기간: 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.
Up to 100 days after completion of study treatment
Change in disease assessments
기간: Baseline up to 100 days after completion of study treatment

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
기간: 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.
Up to 5 years after completion of study treatment
Changes in serum chemokines and circulating immune cells over time
기간: Baseline up to 100 days after completion of study treatment

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
기간: 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.
Up to 100 days after completion of study treatment
Clinical measures of interest
기간: 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.
Up to 100 days after completion of study treatment

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

National Cancer Institute (NCI)

수사관

  • 수석 연구원: Hussein A Tawbi, University of Texas MD Anderson Cancer Center LAO

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 7월 16일

기본 완료 (추정된)

2028년 3월 30일

연구 완료 (추정된)

2028년 3월 30일

연구 등록 날짜

최초 제출

2019년 1월 24일

QC 기준을 충족하는 최초 제출

2019년 1월 24일

처음 게시됨 (실제)

2019년 1월 25일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 2일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NCI-2019-00241
  • UM1CA186688 (미국 NIH 보조금/계약)
  • NCI-2019-00241 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
  • 10204 (기타 식별자: CTEP)
  • 10204 (기타 식별자: University of Texas MD Anderson Cancer Center LAO)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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