A phase II trial of nivolumab in combination with ipilimumab to evaluate efficacy and safety in relapsed lung cancer and to evaluate biomarkers predictive for response to immune checkpoint inhibition

niversity of Cologne0 sites90 target enrollmentNovember 15, 2016

ConditionsPatients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) and patients with Small cell lung cancer (SCLC) after failure of platinum-based first-line therapy.MedDRA version: 21.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10041068Term: Small cell lung cancer extensive stageSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10029515Term: Non-small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10041070Term: Small cell lung cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: PTClassification code 10059514Term: Small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsOPDIVO Yervoy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) and patients with Small cell lung cancer (SCLC) after failure of platinum-based first-line therapy.
Sponsor: niversity of Cologne
Enrollment: 90
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 15, 2016

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

niversity of Cologne

Eligibility Criteria

Inclusion Criteria

•Note: Cohort 1 is closed for enrollment. Subjects who started screening for cohort 1 prior to stop of recruitment initiated by Coordinating PI on April 25 2019 will continue to receive treatment.
•Cohort 1: Subjects with histologically or cytologically confirmed advanced non\-squamous non\-small cell lung cancer who present with stage IIIB/IV disease after failure of platinum\-based first\-line therapy (second line). Subjects who received adjuvant/neoadjuvant therapy or definitive chemoradiation and develop recurrence or progression, with evidence of stage IIIB\-IV disease within 6 months after completion of therapy, are eligible.
•Cohort 2a: Subjects with histologically or cytologically confirmed limited\-stage or extensive\-stage small cell lung cancer after failure of platinum\-based first\-line therapy with or without anti\-PD\-1/PD\-L1 treatment.(TMB non\-discrimated SCLC patients).
•Note: Cohort 2a is closed for enrollment.
•Cohort 2b: Subjects with histologically or cytologically confirmed limited\-stage or extensive\-stage TMB high small cell lung cancer after failure of platinum\-based first\-line therapy with or without anti\-PD\-1/PD\-L1 treatment.Inclusion after 2nd line Topotecan\-Therapy is allowed. Only TMB high SCLC patients are included, as tested on tumor material during routine biopsies for first diagnosis (whole exome sequencing on FFPE tissue). For definition of TMB high, please refer to chapter 5\.5\.1\.2
•The following inclusion criteria apply for Cohort 1, 2a and 2b:
•Signed and dated IRB/IEC\-approved written informed consent form must be obtained before the performance of any study\-specific procedure
•Male or female patients over 18 years of age
•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\-1
•Subjects must be willing to undergo at baseline screening biopsy.

Exclusion Criteria

•Subjects with squamous cell NSCLC
•For Cohort 1 only: EGFR activating mutation or ALK translocation
•More than one prior line of chemotherapy for treatment of advanced disease
•Medical conditions associated with significantly increased risk for bleeding complications caused by biopsy procedures (e.g. known coagulopathies, therapeutic anticoagulation)
•Active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for 4 weeks after treatment has been completed and within 28 days prior to the first dose of study drug administration. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (\> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration.
•Presence or history of any other primary malignancy other than non\-squamous NSCLC for Cohort 1 and SCLC for Cohort 2a/2b within 5 years prior to enrolment into the trial, except for adequately treated basal or squamous cell carcinoma of the skin or any adequately treated in situ carcinoma.
•Subjects with active, known or suspected autoimmune disease. Subjects are permitted to enrol if they have 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
•Positive test for hepatitis B virus surface antigen (HBV sAg or HBV\-DNA) or hepatitis C virus ribonucleic acid (HCV\-RNA) indicating acute or chronic infection
•Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
•Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first dose of study drug administration. Inhaled or topical steroids and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease