A Study of Experimental Therapy With Nivolumab For Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: autoimmune disease, cancer with autoimmune disease, non-small cell lung cancer, Rheumatoid arthritis, ulcerative colitis, crohn's disease, Sjogrens, Systemic lupus erythroderma, Dermatomyositis, multiple sclerosis
Type: Drug study, Phase 1
Target:
10 Participants
Investigator:
Description
This study is being done to answer the following question:

Can we safely and effectively treat your cancer with nivolumab given any of the following auto-immune diseases?
-Rheumatoid arthritis
-Polymyalgia rheumatica
-Sjogrens
-Ulcerative colitis
-Crohn's disease
-Systemic lupus erythroderma
-Dermatomyositis
-Multiple sclerosis

Nivolumab is an antibody that can block signals that some types of tumors may use to suppress the immune system.

We are doing this study because we want to find out if this approach is better or worse than the usual approach for your cancer and your auto-immune disease. The usual approach is defined as care most people get for their cancer while having an auto-immune disease. Treatment with nivolumab is considered experimental. It is not currently approved by the FDA for cancer in people with auto-immune diseases.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

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):
  10. For rheumatoid arthritis: DAS28 < 5.1
  11. For polymyalgia rheumatica: PMR-AS < 17
  12. For Sjogrens: ESSDAI < 14
  13. For ulcerative colitis: SSCAI < 5
  14. For Crohn's disease: CDAI < 450
  15. For systemic lupus erythroderma: SLEDAI-2K < 20
  16. For multiple sclerosis: EDSS < 5.5
  17. Adequate organ and marrow function as defined by:
  18. absolute neutrophil count ≥ 1,500/mcL
  19. platelets ≥ 100,000/mcL
  20. total bilirubin ≤ 2.5 × institutional upper limit of normal
  21. AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional upper limit of normal, OR
  22. AST(SGOT)/ALT(SGPT ) ≤5 × institutional upper limit of normal if liver metastases are present
  23. Creatinine within normal institutional limits OR
  24. Creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
  25. Non-pregnant and non-nursing.
  26. 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.
  27. 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
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
If you decide to take part in this study, you will receive the study drug for up to 2 years. After you finish your treatment, your doctor and study team will watch you for side effects even if you are placed on other anti-cancer drugs. They will check you every 3 months for 2 years after treatment. After that, they will check you every 6 months for 3 years. This means you will keep seeing your doctor for 5 years after treatment
Recruitment period
From Sept. 26, 2019
Location
UC Davis Comprehensive Cancer Center
4501 X Street
Sacramento, CA 95817
Contact
Corinne Turrell
Research Topic
Conditions:
  • Autoimmune Diseases
  • Non-small Cell Lung Cancer
  • Rheumatoid Arthritis
  • Psoriasis
  • Giant Cell Arteritis
  • Polymyalgia Rheumatica
  • Systemic Lupus Erythematosus
  • Crohn Disease
  • Multiple Sclerosis
  • Ulcerative Colitis

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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