Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre
Safety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease
What it found
The trial ended early for another reason (see below).
Reason given: low accrual
This trial finished 5 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Nivolumab
Programmed cell death protein 1 inhibitor
What it measured
Main measures
Dose-Limiting Toxicity (DLT)
48 Months
Safety
Other measures (3)
Overall Response Rate
48 Months
Progression-Free Survival
48 Months
Overall Survival
48 Months
Who could take part
MS (type not specified) · 18 and over
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Background
Anderson J, Caplan L, Yazdany J, Robbins ML, Neogi T, Michaud K, Saag KG, O'Dell JR, Kazi S. Rheumatoid arthritis disease activity measures: American College of Rheumatology recommendations for use in clinical practice. Arthritis Care Res (Hoboken). 2012 May;64(5):640-7. doi: 10.1002/acr.21649.Background
Prevoo ML, van 't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum. 1995 Jan;38(1):44-8. doi: 10.1002/art.1780380107.Background
van der Heijde DM, van Leeuwen MA, van Riel PL, Koster AM, van 't Hof MA, van Rijswijk MH, van de Putte LB. Biannual radiographic assessments of hands and feet in a three-year prospective followup of patients with early rheumatoid arthritis. Arthritis Rheum. 1992 Jan;35(1):26-34. doi: 10.1002/art.1780350105.Background
Wijnands MJ, van't Hof MA, van Leeuwen MA, van Rijswijk MH, van de Putte LB, van Riel PL. Long-term second-line treatment: a prospective drug survival study. Br J Rheumatol. 1992 Apr;31(4):253-8. doi: 10.1093/rheumatology/31.4.253.Background
Fransen J, van Riel PL. The Disease Activity Score and the EULAR response criteria. Clin Exp Rheumatol. 2005 Sep-Oct;23(5 Suppl 39):S93-9.Background
Leeb BF, Bird HA. A disease activity score for polymyalgia rheumatica. Ann Rheum Dis. 2004 Oct;63(10):1279-83. doi: 10.1136/ard.2003.011379.Background
Leeb BF, Bird HA, Nesher G, Andel I, Hueber W, Logar D, Montecucco CM, Rovensky J, Sautner J, Sonnenblick M. EULAR response criteria for polymyalgia rheumatica: results of an initiative of the European Collaborating Polymyalgia Rheumatica Group (subcommittee of ESCISIT). Ann Rheum Dis. 2003 Dec;62(12):1189-94. doi: 10.1136/ard.2002.002618.Background
Leeb BF, Rintelen B, Sautner J, Fassl C, Bird HA. The polymyalgia rheumatica activity score in daily use: proposal for a definition of remission. Arthritis Rheum. 2007 Jun 15;57(5):810-5. doi: 10.1002/art.22771.Background
Seror R, Theander E, Brun JG, Ramos-Casals M, Valim V, Dorner T, Bootsma H, Tzioufas A, Solans-Laque R, Mandl T, Gottenberg JE, Hachulla E, Sivils KL, Ng WF, Fauchais AL, Bombardieri S, Valesini G, Bartoloni E, Saraux A, Tomsic M, Sumida T, Nishiyama S, Caporali R, Kruize AA, Vollenweider C, Ravaud P, Vitali C, Mariette X, Bowman SJ; EULAR Sjogren's Task Force. Validation of EULAR primary Sjogren'Background
Puzenat E, Bronsard V, Prey S, Gourraud PA, Aractingi S, Bagot M, Cribier B, Joly P, Jullien D, Le Maitre M, Paul C, Richard-Lallemand MA, Ortonne JP, Aubin F. What are the best outcome measures for assessing plaque psoriasis severity? A systematic review of the literature. J Eur Acad Dermatol Venereol. 2010 Apr;24 Suppl 2:10-6. doi: 10.1111/j.1468-3083.2009.03562.x.
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History
Started
Jun 2019
Main results due
Mar 2021
Finished
Mar 2021