Therapy Detail

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Therapy Name Nivolumab + Relatlimab
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Nivolumab Opdivo MDX-1106|BMS-936558 Immune Checkpoint Inhibitor 155 PD-L1/PD-1 antibody 105 Opdivo (nivolumab) is an antibody that targets PD-1 (PDCD1), which results in increased T-cell activation and enhanced anti-tumor immune response (PMID: 28891423). Opdivo (nivolumab) is FDA approved for use as a monotherapy in patients with non-small cell lung cancer (NSCLC) progressed on prior therapies, Hodgkin's lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, esophageal squamous cell carcinoma, resected esophageal or gastroesophageal junction (GEJ) cancer, as a monotherapy or in combination with Yervoy (ipilimumab) in patients with melanoma, renal cell carcinoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (including patients 12 years or older), and hepatocellular carcinoma, in combination with Yervoy (ipilimumab) as first-line therapy in patients with PD-L1-positive (>=1%) metastatic NSCLC without EGFR or ALK alterations, in combination with Yervoy (ipilimumab) and platinum-based chemotherapy as first-line therapy in patients with metastatic or recurrent NSCLC without EGFR or ALK alterations, in combination with platinum doublet chemotherapy as neoadjuvant treatment for patients with resectable NSCLC, in combination with Cabometyx (cabozantinib) in patients with advanced renal cell carcinoma, and in combination with fluoropyrimidine- and platinum-containing chemotherapy in patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma (FDA.gov).
Relatlimab BMS-986016 Immune Checkpoint Inhibitor 155 LAG3 Antibody 18 Relatlimab (BMS-986016) is a monoclonal antibody that targets LAG3 and inhibits binding of MHC II molecules to increase cytokine production by T-cells and prevent tumor growth (Journal of Clinical Oncology 35, no. 15_suppl (May 20 2017) 9520-9520).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02658981 Phase I Relatlimab Urelumab Nivolumab + Urelumab Nivolumab + Relatlimab Anti-LAG-3 Alone & in Combination w/ Nivolumab Treating Patients w/ Recurrent GBM (Anti-CD137 Arm Closed 10/16/18) Active, not recruiting USA 0
NCT02465060 Phase II Nivolumab + Relatlimab Dabrafenib + Trametinib Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Active, not recruiting USA 2
NCT02061761 Phase Ib/II Nivolumab + Relatlimab Relatlimab Safety Study of Anti-LAG-3 in Relapsed or Refractory Hematologic Malignancies Completed USA | CAN 0
NCT05629546 Phase I Nivolumab + Relatlimab Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors Not yet recruiting USA 0
NCT03493932 Phase I Nivolumab + Relatlimab Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade Active, not recruiting USA 0
NCT05625399 Phase III Nivolumab + Relatlimab A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma (RELATIVITY-127) Recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT 12
NCT03607890 Phase II Nivolumab + Relatlimab Study of Nivolumab and Relatlimab in Advanced Mismatch Repair Deficient Cancers Resistant to Prior PD-(L)1 Inhibitor Recruiting USA 0
NCT01968109 Phase I Nivolumab + Relatlimab Relatlimab Safety Study of Anti-LAG-3 With and Without Anti-PD-1 in the Treatment of Solid Tumors Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | AUT 8
NCT03743766 Phase II Relatlimab Nivolumab + Relatlimab Nivolumab Nivolumab, BMS-936558 in Combination With Relatlimab, BMS-986016 in Patients With Metastatic Melanoma Naïve to Prior Immunotherapy in the Metastatic Setting Recruiting USA 0
NCT04567615 Phase II Nivolumab Nivolumab + Relatlimab A Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Liver Cancer Who Have Never Been Treated With Immuno-oncology Therapy After Prior Treatment With Tyrosine Kinase Inhibitors Active, not recruiting FRA | ESP 15
NCT04658147 Phase I Nivolumab + Relatlimab Nivolumab Feasibility and Efficacy of Perioperative Nivolumab With or Without Neoadjuvant Relatlimab for Patients With Potentially Resectable Hepatocellular Carcinoma (HCC) Recruiting USA 0
NCT05255601 Phase Ib/II Nivolumab + Relatlimab A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adults With Hodgkin and Non-Hodgkin Lymphoma (RELATIVITY-069) Recruiting USA | ITA | FRA | ESP | DEU 3
NCT02996110 Phase II Nivolumab + Relatlimab Ipilimumab + Nivolumab A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma (FRACTION-RCC) Completed USA | ITA | CAN | AUT 2
NCT05002569 Phase III Nivolumab + Relatlimab Nivolumab A Study to Assess Adjuvant Immunotherapy With Relatlimab and Nivolumab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma (RELATIVITY-098) Recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT 17
NCT04080804 Phase II Nivolumab Nivolumab + Relatlimab Ipilimumab + Nivolumab Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer Recruiting USA 0
NCT05148546 Phase II Ipilimumab + Nivolumab Nivolumab Nivolumab + Relatlimab Neoadjuvant Study With Combination Immuno-oncology for Primary Clear Cell Renal Cell Cancer (NESCIO) Recruiting 2
NCT03335540 Phase I BMS-986205 + Nivolumab Nivolumab + Relatlimab Cabiralizumab + Nivolumab Lirilumab + Nivolumab BMS-986156 + Nivolumab Ipilimumab + Nivolumab Nivolumab An Adaptive Study to Match Patients With Solid Tumors to Various Immunotherapy Combinations Based Upon a Broad Biomarker Assessment Completed USA 0
NCT03867799 Phase II Nivolumab + Relatlimab iSCORE: Immunotherapy Sequencing in COlon and REctal Cancer Active, not recruiting 1
NCT02750514 Phase II Dasatinib + Nivolumab Nivolumab + Relatlimab Nivolumab BMS-986205 + Nivolumab An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer (FRACTION-Lung) Terminated USA | ITA | FRA | ESP | CAN | AUT 2
NCT04204837 Phase II Nivolumab + Relatlimab Nivolumab Nivolumab for Treatment of Squamous Cell Carcinoma of the Skin Recruiting AUT 0
NCT02935634 Phase II Nivolumab + Relatlimab Ipilimumab + Nivolumab A Study to Test Combination Treatments in Patients With Advanced Gastric Cancer (FRACTION-GC) Active, not recruiting USA | ITA | DEU | CAN 5
NCT04095208 Phase II Nivolumab + Relatlimab Nivolumab Combination of Nivolumab Plus Relatlimab in Patients With Advanced or Metastatic Soft-tissue Sarcoma: a Proof-of-concept Randomized Phase II Study (CONGRATS) Recruiting FRA 0
NCT04326257 Phase II Nivolumab + Relatlimab Ipilimumab + Nivolumab Personalized Immunotherapy in Patients With Recurrent /Metastatic SCCHN That Have Progressed on Prior Immunotherapy Recruiting USA 0
NCT03470922 Phase II Nivolumab + Relatlimab Nivolumab A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT 17
NCT03724968 Phase II Nivolumab + Relatlimab Ipilimumab + Nivolumab Nivolumab Plus Relatlimab or Ipilimumab in Metastatic Melanoma Stratified by MHC-II Expression Terminated USA 0
NCT05347212 Phase II Nivolumab + Relatlimab Phase II Trial of Immunotherapy in Patients With Carcinomas Arising From the Renal Medulla Recruiting USA 0
NCT03610711 Phase Ib/II Nivolumab + Relatlimab Nivolumab REACTION (Radiation Enhanced Assessment of Combination Therapies in Immuno-ONcology) - Nivolumab or Nivolumab in Combination With Other Immuno-oncology (IO) Agents After Targeted Systemic Radiation in Patients With Advanced Esophagogastric Cancer (REACTION) Recruiting USA 0
NCT03704077 Phase II Nivolumab Paclitaxel + Ramucirumab Nivolumab + Paclitaxel Nivolumab + Paclitaxel + Relatlimab Nivolumab + Relatlimab An Investigational Immuno-therapy Study of Relatlimab Plus Nivolumab Compared to Various Standard-of-Care Trherapies in Previously Treated Participants With Recurrent, Advanced or Metastatic Gastric Cance or Gastroesophageal Junction Adenocarcinoma Withdrawn USA | ITA | ESP | DEU | CAN 9
NCT03623854 Phase II Nivolumab + Relatlimab Nivolumab and Relatlimab in Treating Participants With Advanced Chordoma Active, not recruiting USA 0
NCT03642067 Phase II Nivolumab + Relatlimab Study of Nivolumab and Relatlimab in Patients With Microsatellite Stable (MSS) Advanced Colorectal Cancer Recruiting USA 0
NCT04552223 Phase II Nivolumab + Relatlimab Nivolumab Plus Relatlimab in Patients With Metastatic Uveal Melanoma Active, not recruiting USA 0
NCT04205552 Phase II Nivolumab + Relatlimab Nivolumab Neoadjuvant Nivolumab Combination Treatment in Resectable Non-small Cell Lung Cancer Patients (NEOpredict) Recruiting DEU | BEL 1
NCT04062656 Phase II Nivolumab + Relatlimab Nivolumab Docetaxel + Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin Perioperative Immunotherapy vs. Chemo-immunotherapy in Patients With Advanced GC and AEG (IMAGINE) Active, not recruiting DEU 0


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