Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease
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ClinicalTrials.gov Identifier: NCT03656627 |
Recruitment Status :
Active, not recruiting
First Posted : September 4, 2018
Last Update Posted : June 18, 2021
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The purpose of this study is to explore the safety, tolerability and activity of Nivolumab, a PD-1 inhibitor, in cohorts of patients with autoimmune disease. Two cohorts of patients will be enrolled, based on autoimmune disease type.
Patients will be screened within 28 days prior to the start of dosing. Eligible patients will be enrolled in either of the two cohorts. Patients will receive treatment every two weeks, in an outpatient setting. One cycle is a 28-day period, with Nivolumab given on days 1 and 15 of a 28-day cycle. Subjects will be permitted to continue treatment beyond initial RECIST 1.1.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Autoimmune Diseases Non-small Cell Lung Cancer Rheumatoid Arthritis Psoriasis Giant Cell Arteritis Polymyalgia Rheumatica Systemic Lupus Erythematosus Crohn Disease Multiple Sclerosis Ulcerative Colitis | Drug: Nivolumab | Phase 1 |
The purpose of this study is to explore the safety, tolerability and activity of Nivolumab, a PD-1 inhibitor, in cohorts of patients with autoimmune disease. Two cohorts of patients will be enrolled, based on autoimmune disease type as outlined below. Entry into cohorts 1 and 2 will start simultaneously and enroll independently.
Cohort 1: Rheumatoid arthritis, psoriasis, giant cell arteritis/polymyalgia rheumatica, systemic lupus erythematosis Cohort 2: Other autoimmune diseases (ulcerative colitis, Crohn's disease, multiple sclerosis). Patients must be discussed with PI prior to enrollment.
Patients will be screened within 28 days prior to the start of dosing. Eligible patients will be enrolled in either of the two cohorts. Patients will receive treatment every two weeks, in an outpatient setting. One cycle is a 28-day period, with Nivolumab given on days 1 and 15 of a 28-day cycle. Subjects will be permitted to continue treatment beyond initial RECIST 1.1. For each cohort, all patients will be dosed at 240 mg IV. There will be no dose de-escalation or escalation from this dose level.
Participants will be followed with telephone follow up for two years after removal from protocol therapy or until death, whichever occurs first. Phone calls will be placed every six months and survival follow up obtained. Participants removed from protocol therapy for unacceptable adverse event(s) will be followed until resolution or stabilization of the adverse event, in addition to the follow up for two years after removal from protocol therapy or until death, whichever occurs first.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 7 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Safety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease |
Actual Study Start Date : | June 27, 2019 |
Estimated Primary Completion Date : | October 31, 2022 |
Estimated Study Completion Date : | October 31, 2022 |

Arm | Intervention/treatment |
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Experimental: Nivolumab: Autoimmune Diseases Cohort 1
Arms determined by autoimmune type. First cohort consists of patients with: Rheumatoid arthritis, psoriasis, giant cell arteritis/polymyalgia rheumatica, systemic lupus erythematosis If a patient has more than one autoimmune condition, if all the conditions are within either cohort 1 or 2 above, the patient will be assigned to that cohort. If the patient has conditions from both cohort 1 and 2, the patient will be grouped in cohort 2. |
Drug: Nivolumab
Nivolumab will be given as an IV infusion every two weeks, in an outpatient setting. One cycle is a 28-day period, with Nivolumab given on days 1 and 15 of a 28-day cycle. For each cohort, all patients will be dosed at 240 mg IV. There will be no dose de-escalation or escalation from this dose level. |
Experimental: Nivolumab: Autoimmune Diseases Cohort 2
Arms determined by autoimmune type. Second cohort consists of patients with: Other autoimmune diseases (ulcerative colitis, Crohn's disease, multiple sclerosis). Patients must be discussed with PI prior to enrollment. If a patient has more than one autoimmune condition, if all the conditions are within either cohort 1 or 2 above, the patient will be assigned to that cohort. If the patient has conditions from both cohort 1 and 2, the patient will be grouped in cohort 2. |
Drug: Nivolumab
Nivolumab will be given as an IV infusion every two weeks, in an outpatient setting. One cycle is a 28-day period, with Nivolumab given on days 1 and 15 of a 28-day cycle. For each cohort, all patients will be dosed at 240 mg IV. There will be no dose de-escalation or escalation from this dose level. |
- Dose-Limiting Toxicity (DLT) [ Time Frame: 48 Months ]The DLT determination period is the first six weeks after cycle 1 day 1. Dose limiting toxicities are further defined in the trial protocol.
- Overall Response Rate [ Time Frame: 48 Months ]Overall response rate is defined to be the best objective status recorded from the start of the treatment until disease progression/recurrence
- Progression-Free Survival [ Time Frame: 48 Months ]Progression-free survival will be evaluated for each cohort using Kaplan-Meier estimator.
- Overall Survival [ Time Frame: 48 Months ]Overall survival will be evaluated for each cohort using Kaplan-Meier estimator.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age > 18
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Metastatic, locally advanced or recurrent NSCLC, not amenable to curative therapy.
- Patients should have received at least one platinum-based chemotherapy regimen for recurrent or metastatic disease or have received platinum-based chemotherapy as part of adjuvant or neoadjuvant therapy and experienced progression of disease within 6 months of completing therapy.
- Patients with tumor genetic alterations such as EGFR, ALK, ROS1 or BRAF V600E alterations for which there is FDA-approved targeted therapy must have been treated with the appropriate targeted inhibitors in prior therapy
- No limit on number of prior therapies
- Ability to provide written, informed consent
- Patients must be on a stable regimen of treatment for their autoimmune condition without need for addition of new medications or escalating doses of preexisting medications in the previous 12 weeks prior to study entry
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In addition, patients with the following autoimmune diseases must have baseline disease activity scores as follows (please see Appendix A):
- For rheumatoid arthritis: DAS28 < 5.1
- For polymyalgia rheumatica: PMR-AS < 17
- For Sjogrens: ESSDAI < 14
- For ulcerative colitis: SSCAI < 5
- For Crohn's disease: CDAI < 450
- For systemic lupus erythroderma: SLEDAI-2K < 20
- For multiple sclerosis: EDSS < 5.5
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Adequate organ and marrow function as defined by:
- absolute neutrophil count ≥ 1,500/mcL
- platelets ≥ 100,000/mcL
- total bilirubin ≤ 2.5 × institutional upper limit of normal
- AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional upper limit of normal, OR
- AST(SGOT)/ALT(SGPT ) ≤5 × institutional upper limit of normal if liver metastases are present
- Creatinine within normal institutional limits OR
- Creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
- Non-pregnant and non-nursing.
- Women of childbearing potential (WOCBP) must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 5 months after the last dose of study medication. Patients of childbearing potential are those who have not been surgically sterilized or have not been free of menses > 1 year.
- Male patients must agree to use an adequate method of contraception starting with the first dose of study therapy through 7 months after the last dose of study therapy.
Exclusion Criteria:
- No chemotherapy or radiotherapy within two weeks of study entry. Prior targeted therapy is allowed as long as at least 5 half-lives have elapsed since last dose.
- All adverse events (other than alopecia) from prior therapy must be resolved to Grade 1 or less.
- Patients who are known to be HIV positive are excluded due to the known immunologic alterations associated with the disease. HIV testing is not required.
- No uncontrolled intercurrent illness such as active infection, or psychiatric illness or social situation that in the judgment of the investigator would limit compliance with study requirements
- No active interstitial lung disease (ILD) or pneumonitis, or a history of ILD or pneumonitis requiring treatment with corticosteroids
- No live vaccine within 30 days of start of study treatment
- No carcinomatous meningitis or untreated CNS metastases
- No history of significant cardiac disease or presence of an abnormality in electrocardiograms that, in the investigator's opinion, is medically exclusionary or clinically meaningful
- No other active malignancy
- No known history of or positivity for active hepatitis B or C. HBV DNA and/or HCV RNA must be undetectable and HBsAg must be negative at the time of screening
- No active unstable angina and/or congestive heart failure, or myocardial infarction within 6 months prior to protocol participation

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656627
United States, Illinois | |
University of Chicago Medical Center | |
Chicago, Illinois, United States, 60637 | |
United States, Maryland | |
Marlene and Stewart Greenebaum Comprehensive Cancer Center/University of Maryland School of Medicine | |
Baltimore, Maryland, United States, 21201 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, Michigan | |
St. Joseph Mercy Hospital | |
Ann Arbor, Michigan, United States, 48106 | |
United States, Minnesota | |
Metro Minnesota Community Oncology Research Consortium | |
Saint Louis Park, Minnesota, United States, 55416 | |
United States, New Hampshire | |
Dartmouth Hitchcock Norris Cotton Cancer Center | |
Lebanon, New Hampshire, United States, 03756 | |
United States, New Jersey | |
Atlantic Health System/Morristown Medical Center | |
Morristown, New Jersey, United States, 07962 | |
United States, Ohio | |
The Ohio State University Wexner Medical Center - Thoracic Oncology Clinic | |
Columbus, Ohio, United States, 43210 | |
United States, Oregon | |
Providence Cancer Institute Franz Clinic | |
Portland, Oregon, United States, 97213 | |
United States, Pennsylvania | |
UPMC Hillman Cancer Center | |
Pittsburgh, Pennsylvania, United States, 15232 | |
United States, Wisconsin | |
University of Wisconsin Clinical Science Center | |
Madison, Wisconsin, United States, 53792 |
Responsible Party: | Alliance Foundation Trials, LLC. |
ClinicalTrials.gov Identifier: | NCT03656627 |
Other Study ID Numbers: |
AFT-42 |
First Posted: | September 4, 2018 Key Record Dates |
Last Update Posted: | June 18, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Autoimmune Diseases Non-small Cell Lung Cancer Ulcerative Colitis Multiple Sclerosis Crohn Disease Systemic Lupus Erythematosus |
Polymyalgia Rheumatica Giant Cell Arteritis Psoriasis Rheumatoid Arthritis Nivolumab Opdivo |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Arthritis Arthritis, Rheumatoid Polymyalgia Rheumatica Crohn Disease Colitis Colitis, Ulcerative Multiple Sclerosis Giant Cell Arteritis Arteritis Psoriasis Lupus Erythematosus, Systemic Autoimmune Diseases Sclerosis |
Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Joint Diseases Musculoskeletal Diseases Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases |