TheranosticTrials.org

Clinical Trial · NCT03325816

Nivolumab and 177Lu-DOTA0-Tyr3-Octreotate for Patients With Extensive-Stage Small Cell Lung Cancer

Overview

This research study is being done to assess the safety and tolerability of study drugs, 177Lu-DOTA0-Tyr3-Octreotate (Lutathera) and nivolumab in subjects with small cell lung cancer or advanced or inoperable neuroendocrine tumor of the lung that has overexpressed somatostatin receptors (SSRT). Lutathera is an investigational radioactive agent that targets tumor cells that express SSRT. Nivolumab is an investigational agent that targets and inhibits a pathway that prevents your immune system from effectively fighting your cancer. The combination of these 2 study drugs is investigational. The term "Investigational" in this context means that the drugs have not been approved for clinical use by the US Food and Drug Administration (FDA). Giving Lutathera and nivolumab together may increase the effectiveness of this therapy. We first need to find out the highest dose of Lutathera that can be given safely together with nivolumab. This study will be the first study to test giving Lutathera together with nivolumab. Once we have found the highest dose of Lutathera that can be given with nivolumab, we will treat more patients with this combination to determine how effective it is. The purposes of this study are: To find the highest doses of Lutathera that can be given with nivolumab without causing severe side effects. To find out the side effects seen by giving Lutathera at different dose levels with nivolumab. To determine if the amount of something in your tumor called PD-L1 makes you more likely to have a response to the combination of Lutathera and nivolumab.

Sponsor

Western University

Phase

Phase 1/2

Contacts

Chul Kim, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03325816

Drug / Compound

DOTA0-Tyr3-Octreotate

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

Eligibility

Inclusion

Inclusion criteria not yet provided.

Exclusion

  • Cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), or unstable angina.
  • Phase ISubjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.Patients with human immunodeficiency virus (HIV) infection, or active hepatitis B or C virus infection will be excluded.Patients who received prior anti-tumoral radionuclide therapy (with unsealed sources) are not eligible for the study.Prior major surgery within 12 weeks or prior major surgery from which the patient has not sufficiently recovered yet.Untreated and uncontrolled second tumor in the past 2 years.Logistical or psychological hindrance to participation in clinical research.Uncontrolled or significant cardiovascular disease, including any of the following:
  • Cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), or unstable angina.
  • Phase IISubjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.Patients with human immunodeficiency virus (HIV) infection, or active hepatitis B or C virus infection will be excluded.Patients who received prior anti-tumoral radionuclide therapy (with unsealed sources) are not eligible for the study.Prior major surgery within 12 weeks or prior major surgery from which the patient has not sufficiently recovered yet.Untreated and uncontrolled second tumor in the past 2 years.Logistical or psychological hindrance to participation in clinical research.Uncontrolled or significant cardiovascular disease, including any of the following:
  • Symptomatic congestive heart failure (New York Heart Association Classification Class II).
  • Uncontrolled hypertension or uncontrolled cardiac arrhythmia.Any other medical condition that in the Investigator's opinion would not make the patient a good candidate for the study.
  • Symptomatic congestive heart failure (New York Heart Association Classification Class II).
  • Uncontrolled hypertension or uncontrolled cardiac arrhythmia.Any other medical condition that in the Investigator's opinion would not make the patient a good candidate for the study.