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Protocol Details

A phase 1b Study of Nivolumab in Patients with Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required


Population Exclusion(s)



Checkpoint Inhibitor;

Recruitment Keyword(s)



Solid Tumors;

Investigational Drug(s)


Investigational Device(s)



Biological/Vaccine: Nivolumab

Supporting Site

National Cancer Institute


Autoimmune disorders are diseases in which a person s immune system attacks healthy cells. Immunotherapy targets a person s immune system to treat cancer. The side effects of immunotherapy drugs are caused by the immune system becoming overactive and attacking normal tissue. Because of this, people who have autoimmune disorders have not been included in immunotherapy clinical trials. Researchers want to see if an anticancer drug may work for people with these disorders.


To test the safety of nivolumab in people with autoimmune disorders.


Adults age 18 and older who have a metastatic, unresectable solid tumor and an autoimmune disorder, such as lupus erythematosus, systemic sclerosis, dermatomyositis, multiple sclerosis, rheumatoid arthritis, or Sjogren s syndrome


Participants will be screened with

-Physical exam

-Medical history

-Medicine review

-Blood tests

-Eye exam

-EKG (to test their heart)

-Tumor measurements.

Participants will get nivolumab through a vein in the arm once every 4 weeks. Each 4-week period is called a cycle. They will get the study drug on the first day of each cycle. The study has 24 cycles.

Participants will repeat the screening tests during the study. They will fill out questionnaires. They will also have

-Tumor biopsies

-Thyroid tests

-Assessments of their illness

-CT or MRI scans.

Based on autoimmune disorder, participants may have

-Saliva and/or urine samples taken

-Lung function tests


-Body fluid taken from the joints, lung, spinal cord, or pericardium

-Neurological exams

-Skin biopsies.

Participants will get the study drug for up to 2 years. They will be monitored for 16 weeks after treatment ends.

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-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. 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 FDA-approved for the treatment of melanoma, NSCLC, merkel cell cancer, bladder cancer, RCC, gastric cancer, HCC, cervical cancer, head and neck cancer, Hodgkin lymphoma (HL), metastatic SCLC, and any solid tumor with 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 PI. Patients enrolling on the trial for adjuvant use will be restricted to those2 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 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 greater than or equal to 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 greater than or equal to 60).

-Life expectancy of greater than 12 weeks.

-Patients must have normal organ and marrow function as defined below:

--leukocytes greater than or equal to 1,000/mcL

--absolute neutrophil count greater than or equal to 500/mcL

--platelets greater than or equal to 50,000/mcL

--total bilirubin less than or equalto 2.0(SqrRoot) institutional upper limit of normal (ULN)

--AST(SGOT)/ALT(SGPT) less than or equal to 5 (SqrRoot) institutional ULN or <8(SqrRoot) institutional ULN for patients with liver metastases or an autoimmune disease that is contributing to the elevation of these values

--creatinine ULN


--glomerular filtration rate (GFR) greater than or equal to 30 mL/min (if using the Cockcroft-Gault formula below):

--Female creatinine clearance (CrCl) = ((140 - age in years) x weight in kg x 0.85) divided by

72 x serum creatinine in mg/dL

--Male CrCl = ((140 - age in years) x weight in kg x 1.00) divided by 72 x serum creatinine in mg/dL

-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 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 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. 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.


-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 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:

1. Repeat imaging demonstrates no new sites of bone metastases.

2. 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.

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Alice P. Chen, M.D.
National Cancer Institute (NCI)
(240) 781-3320

Nancy Moore, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 8D53
10 Center Drive
Bethesda, Maryland 20892
(240) 760-6045

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


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