Ca224-104 A Phase 2 Randomized Double-Blind Study Of Relatlimab Plus Nivolumab In Combination With Chemotherapy Vs. Nivolumab In Combination With Chemotherapy As First Line Treatment For Participants With Stage Iv Or Recurrent Non-Small Cell Lung Cancer (
Posted Date: Jul 6, 2021
- Investigator: Muhammad Riaz
- Specialties: Cancer, Oncology, Pulmonary Diseases
- Type of Study: Drug
The primary purpose of this study is to assess the safety profile of nivolumab plus relatlimab in combination with platinum doublet chemotherapy and to determine if nivolumab plus relatlimab in combination with Platinum Doublet Chemotherapy (PDCT) improves progression free survival when compared to nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small cell lung cancer. Efficacy will be measured by Treatment-related adverse events leading to discontinuation within 12 weeks after the first dose and Progression-free survival per Response Evaluation Criteria in Solid Tumors. Patients in Part 1 Arm A will receive Nivolumab + Relatlimab Dose 1 + PDCT. Patients in Part 1 Arm B will receive Nivolumab + Relatlimab Dose 2 + PDCT. Patients in Part 2 Arm C will receive Nivolumab + Relatlimab Dose 1 or Dose 2 + PDCT. Patients in Part 2 Arm D will receive Nivolumab + Placebo + PDCT.
Criteria:
Ecog Performance Status Of Less Than Or Equal To 1 At Screening And Confirmed Prior To Randomization. Histologically Confirmed Metastatic Non-Small Cell Lung Cancer (Nsclc) Of Squamous (Sq) Or Non-Squamous (Nsq) Histology With Stage Iv A/B. Measurable Disease By Computed Tomography (Ct) Or Magnetic Resonance Resources (Mri) Per Response Evaluation Criteria In Solid Tumor Version 1.1 Criteria. No Participants With Egfr, Alk, Ros-1, Or Known B-Rapidly Accelerated Fibrosarcoma Proto-Oncogene (Braf V600e) Mutations That Are Sensitive To Available Targeted Therapy. No Untreated Cns Metastases. No Leptomeningeal Metastases. No Concurrent Malignancy Requiring Treatment Or History Of Prior Malignancy Active Within 2 Years Prior To Randomization. No Prior Treatment With An Anti-Programmed Cell Death Protein 1, Anti-Programmed Death-Ligand 1 (Pd-L1), Anti-Programmed Death-Ligand 2, Or Anti-Cytotoxic T-Lymphocyte-Associated Protein 4 Antibody, Or Any Other Antibody Or Drug Specifically Targeting T-Cell Co-Stimulation Or Checkpoint Pathways.
Keywords:
Lung, Cancer
For More Information:
Uc Cancer Center
5135847698
cancer@uchealth.com