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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 1 March 2021
Main ID:  NCT03816345
Date of registration: 24/01/2019
Prospective Registration: Yes
Primary sponsor: National Cancer Institute (NCI)
Public title: Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer
Scientific title: A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)
Date of first enrolment: April 4, 2019
Target sample size: 312
Recruitment status: Recruiting
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
United States
Name:     Hussein A Tawbi
Affiliation:  University of Texas MD Anderson Cancer Center LAO
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients must have histologically confirmed malignancy that is radiologically
evaluable and metastatic or unresectable. 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 is Food and Drug Administration
(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 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

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Karnofsky >=

- Life expectancy of greater than 12 weeks

- Leukocytes >= 2,000/mcL

- Absolute neutrophil count >= 1,500/mcL

- Platelets >= 100,000/mcL

- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)

- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< 2.5 x institutional ULN unless the patient has dermatomyositis and in the opinion
of the investigator the elevation is due to diabetes mellitus (DM)

- 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 treated brain metastases are eligible if there is no evidence of
progression for at least 4 weeks after central nervous system (CNS)-directed
treatment, as ascertained by clinical examination and brain imaging (magnetic
resonance imaging [MRI] or computed tomography [CT] scan) during the screening period.
Patients with new or progressive brain metastases (active brain metastases) or
leptomeningeal disease are eligible if the treating physician determines that
immediate 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) 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

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

Exclusion Criteria:

- Patients who have had chemotherapy or radiotherapy within 4 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, 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 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 who have had evidence of active or acute diverticulitis, intra-abdominal
abscess, gastrointestinal (GI) bleeding, obstruction, and abdominal carcinomatosis
which are known risk factors for bowel perforation should be evaluated for the

Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Advanced Malignant Solid Neoplasm
Autoimmune Disease
Crohn Disease
Hematopoietic and Lymphoid Cell Neoplasm
Inflammatory Bowel Disease
Metastatic Malignant Solid Neoplasm
Multiple Sclerosis
Rheumatoid Arthritis
Sjogren Syndrome
Systemic Lupus Erythematosus
Systemic Scleroderma
Ulcerative Colitis
Unresectable Malignant Solid Neoplasm
Biological: Nivolumab
Primary Outcome(s)
Change in disease assessments [Time Frame: Baseline up to 100 days]
Changes in serum chemokines and circulating immune cells over time [Time Frame: Baseline up to 100 days]
Clinical measures of interest [Time Frame: Up to 100 days]
Gene expression in normal tissues [Time Frame: Up to 100 days]
Incidence of adverse events [Time Frame: Up to 100 days]
Overall response rate [Time Frame: Up to 100 days]
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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