A Phase IIIb/IV Safety Trial of Flat Dose Nivolumab in Combination with Ipilimumab in Participants with Non-Small Cell Lung Cancer

Phase 3

Completed

Conditions: Non-small cell lung cancer
10038666

Registration Number: NL-OMON47686

Lead Sponsor: Bristol-Myers Squibb

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 22

Inclusion Criteria

D4. Main inclusion criteria
- Male and female patients over the age of 18 with ECOG status of 0-2 -
Participants with histologically confirmed Stage IV (1st line NCSLC) or IIIB/IV
(2nd line NSCLC) or recurrent, progressive NSCLC squamous or non-squamous
histology, with no prior systemic anticancer therapy (including EGFR and ALK
inhibitors) given as primary therapy for advanced or metastatic disease (1st
line NSCLC) or with recurrent or progressive disease following multimodal
therapy or platinum-doublet chemotherapy (2nd line NSCLC).
Patients with untreated brain metastases, a controlled HIV infection, hepatic
or renal impairment, or with a ECOG PS 2- Measurable disease by CT or MRI per
RECIST 1.1.
Participants must have tissue submitted for PD-L1 IHC testing prior to the
treatment assignment. If PD-L1 IHC testing has already been conducted during
screening for another BMS study, it does not need to be repeated for CA209-817.
Women of childbearing potential must not be breastfeeding and must have a
negative serum or urine pregnancy test within 24 hours prior to start of study
treatment. This test will be repeated every 6 weeks during the study. Patients
must follow the contraception requirements while enrolled in the study.

Exclusion Criteria

-Patients previously treated with drugs targeting T-cell co-stimulation or
checkpoint pathways.
Patients with known EGFR mutations or ALK translocations sensitive to available
targeted inhibitor therapy.
Patients with an active, known or suspected autoimmune disease.
Patients with type I diabetes mellitus, hypothyroidism only requiring hormone
replacement, skin disorders (such as vitiligo, psoriasis or alopecia) not
requiring systemic treatment, or conditions not expected to recur in the
absence of an external trigger are permitted to enrol.
Patients with a condition requiring systemic treatment with either
corticosteroids (> 10mg daily prednisone equivalent) or other immunosuppressive
medications within 14 days of treatment assignment.. Patients with interstitial
lung disease or, who are incarcerated or temporarily detained for psychiatric
or physical illness.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of the study will be assessed by summarizing the number<br /><br>and percentage of participants who experience high grade (Grade 3-4 and Grade<br /><br>5) treatment-related select and immune-mediated adverse events.<br /><br><br /><br>The select adverse events of interest are the following:<br /><br>- pneumonitis<br /><br>- interstitial nephritis<br /><br>- diarrhea/colitis<br /><br>- hepatitis<br /><br>- rash<br /><br>- endocrinopathies<br /><br>- hypersensitivity/infusion reaction events</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Progression-free survival (PFS)<br /><br>- Objective Response Rate (ORR)<br /><br>- Overall survival (OS)<br /><br>- Duration of Response (DOR) *<br /><br>- Participant reported outcomes (PROs): assessment of changes in<br /><br>disease-related symptoms </p><br>