Relativity - 1093 Trial Information | BMS Clinical Trials

RELATIVITY-1093 is a randomized, open-label Phase 3 clinical trial that is testing an investigational drug called relatlimab. This clinical trial aims to see if the addition of relatlimab with nivolumab is effective at treating patients with non-squamous stage IV or recurrent NSCLC and a PD-L1 Expression ≥1%. Participants will receive either relatlimab in combination with nivolumab and chemotherapy or pembrolizumab in combination with chemotherapy.

Pembrolizumab and nivolumab are monoclonal antibodies (mAb) targeting programmed cell death. By blocking the interaction between PD-1 and its ligands, the drugs remove PD-1-mediated suppression of T-cell proliferation and cytokine production, potentially enhancing the immune response against cancer.
Relatlimab, nivolumab, and chemotherapy work in different ways to fight cancer, which means they could complement each other when used together. Since immunotherapy and chemotherapy have minimal overlapping side effects, this combination may be easier for patients to tolerate. This combination is currently being evaluated in a Phase 3 Clinical Trial of NSCLC.

two overlapping squares with the overlapping section filled in and the non-overlapping portions empty

Key Inclusion Criteria

Males and females ≥ 18 years of age or local age of majority.
Histologically confirmed Stage IV or recurrent NSCLC (as defined by the 8th International Association for the Study of Lung Cancer Classification) of NSQ histology with no prior systemic anti-cancer therapy (including targeted treatment, for EGFR, ALK, ROS-1 and if previously identified, BRAF-1, RET or NTRK gene fusions) given as primary therapy for advanced or metastatic disease.
Tumor cell PD-L1 expression ≥ 1% - participants must have measurable PD-L1 ≥ 1% Tumor Cell (TC) score by the investigational PD-L1 immunohistochemistry (IHC) assay VENTANA PD-L1 (SP263) CDx Assay conducted by central laboratory during the screening period prior to randomization.
Measurable disease by computed tomography or magnetic resonance imaging per Response Evaluation Criteria in Solid Tumors v1.1 criteria; radiographic tumor assessment performed within 32 days before randomization.
ECOG Performance Status of ≤ 1 at screening and confirmed prior to randomization.
Participants must have a life expectancy of at least 3 months at the time of randomization.

two overlapping squares with the overlapping section empty and the non-overlapping portions filled in

Key Exclusion Criteria

Individuals who are pregnant and/or breastfeeding.
Participants with EGFR, ALK, or ROS-1 mutations that are sensitive to available targeted inhibitor therapy. All participants must have been tested for EGFR, ALK, or ROS-1 mutation status. Participants with unknown EGFR, ALK, or ROS-1 status are excluded.
Participants with known BRAFV600E mutations, that are sensitive to available targeted inhibitor therapy; participants with known activating RET mutations or NTRK fusion gene alterations are excluded. Participants with unknown or indeterminate BRAF mutation, activating RET mutations or NTRK fusion gene alterations are eligible.
Participants with uncontrolled and untreated central nervous system metastases.
Participants with leptomeningeal metastases (carcinomatous meningitis).
Concurrent malignancy requiring treatment.
Participants with active autoimmune disease.
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting the T-cell co-stimulation or checkpoint pathways.
Participants with history of myocarditis.
Participants who have history of interstitial lung disease (ILD) or pneumonitis that required oral or intravenous (IV) glucocorticoids to assist with management.

*Other protocol-defined inclusion-exclusion criteria may apply

What are the endpoints?

The primary endpoint is Overall Survival. The secondary endpoints include Progression-Free Survival per RECIST 1.1 by BICR evaluation and Investigator evaluation, Objective Response Rate per RECIST 1.1 by BICR evaluation and Investigator evaluation, Duration of Response per RECIST 1.1 by BICR evaluation and Investigator evaluation, Safety Characterization, and Time Until Definitive Deterioration Based on NSCLC-SAQ Total Score.

What is the timeline of the study?

Screening Period: Eligibility will be established according to the key eligibility criteria found in section below. For additional information on screening procedures, please ask the study staff.
Study treatment period: The initial treatment of I/O therapy plus chemotherapy is intended for 12 weeks. However treatment can continue with I/O therapy for up to a maximum of 2 years.
Post-treatment follow-up period: Participants will be followed for a period of time post-treatment.

What biomarkers are important for this study?

To be eligible for the RELATIVITY-1093 study, the patient must have been diagnosed with non-squamous stage IV or recurrent NSCLC and have a PD-L1 Expression ≥1%.