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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: 22 February 2021
Main ID:  NCT03656627
Date of registration: 31/08/2018
Prospective Registration: Yes
Primary sponsor: Alliance Foundation Trials, LLC.
Public title: Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease
Scientific title: Safety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease
Date of first enrolment: June 27, 2019
Target sample size: 72
Recruitment status: Recruiting
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1
Countries of recruitment
United States
Name:     Director of Project Management
Telephone: 617-732-8727
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age > 18

2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

3. Metastatic, locally advanced or recurrent NSCLC, not amenable to curative therapy.

4. 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.

5. 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

6. No limit on number of prior therapies

7. Ability to provide written, informed consent

8. 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

9. 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

10. 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.

11. Non-pregnant and non-nursing.

12. 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.

13. 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:

1. 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.

2. All adverse events (other than alopecia) from prior therapy must be resolved to Grade
1 or less.

3. 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.

4. 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

5. No active interstitial lung disease (ILD) or pneumonitis, or a history of ILD or
pneumonitis requiring treatment with corticosteroids

6. No live vaccine within 30 days of start of study treatment

7. No carcinomatous meningitis or untreated CNS metastases

8. 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

9. No other active malignancy

10. 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

11. No active unstable angina and/or congestive heart failure, or myocardial infarction
within 6 months prior to protocol participation

Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Autoimmune Diseases
Crohn Disease
Giant Cell Arteritis
Multiple Sclerosis
Non-small Cell Lung Cancer
Polymyalgia Rheumatica
Rheumatoid Arthritis
Systemic Lupus Erythematosus
Ulcerative Colitis
Drug: Nivolumab
Primary Outcome(s)
Dose-Limiting Toxicity (DLT) [Time Frame: 48 Months]
Secondary Outcome(s)
Overall Response Rate [Time Frame: 48 Months]
Overall Survival [Time Frame: 48 Months]
Progression-Free Survival [Time Frame: 48 Months]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Bristol-Myers Squibb
Ethics review
Results available:
Date Posted:
Date Completed:
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