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DRUG:

Opdualag (nivolumab/relatlimab-rmbw)

i
Other names: BMS-986213, BMS-936558/BMS-986016, BMS986213, BMS 986213, BMS936558/BMS986016, BMS 936558/BMS 986016
Company:
BMS, Ono Pharma
Drug class:
PD1 inhibitor, LAG-3 inhibitor
Related drugs:
1d
Trial completion
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Opdivo (nivolumab) • Opdualag (nivolumab/relatlimab-rmbw)
15d
Neo ReNi II: A Phase 2 Clinical Trial of Neoadjuvant Relatlimab and Nivolumab in High Risk, Clinical Stage II Cutaneous Melanoma (clinicaltrials.gov)
P2, N=20, Active, not recruiting, Melanoma Institute Australia | Recruiting --> Active, not recruiting
Enrollment closed
|
BRAF (B-raf proto-oncogene)
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BRAF mutation • NRAS mutation • NRAS wild-type
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Opdualag (nivolumab/relatlimab-rmbw)
17d
A Study of IO102/IO103, Nivolumab, and Relatlimab in People With Melanoma (clinicaltrials.gov)
P2, N=43, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting
Enrollment closed
|
BRAF (B-raf proto-oncogene)
|
Opdivo (nivolumab) • Cylembio (imsapepimut and etimupepimut, adjuvanted) • Opdualag (nivolumab/relatlimab-rmbw)
1m
PERIO-01: Intrahepatic Delivery of SD-101 by Pressure-Enabled Regional Immuno-oncology (PERIO), With Checkpoint Blockade in Adults With Metastatic Uveal Melanoma (clinicaltrials.gov)
P1, N=67, Terminated, TriSalus Life Sciences, Inc. | Active, not recruiting --> Terminated; The decision was made to terminate the study after the completion of Phase 1 enrollment and not proceed with Phase 2. Trial termination was not due to patient safety or data concerns.
Trial termination • Checkpoint inhibition
|
Yervoy (ipilimumab) • Opdualag (nivolumab/relatlimab-rmbw) • nelitolimod (SD-101) • relatlimab (BMS-986016)
2ms
Adjuvant nivolumab and relatlimab in stage III/IV melanoma: the randomized phase 3 RELATIVITY-098 trial. (PubMed, Nat Med)
The absence of macroscopic tumor and reduced peripheral LAG-3+ T cells may explain the lack of added benefit of nivolumab plus relatlimab over nivolumab in resected versus metastatic melanoma. ClinicalTrials.gov identifier: NCT05002569 .
P3 data • Journal
|
LAG3 (Lymphocyte Activating 3)
|
Opdivo (nivolumab) • Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
2ms
Patient preferences for stages II-IV melanoma treatments in the UK: results from a cross-sectional study. (PubMed, Melanoma Manag)
Based on the hypothetical drug profile presented in the DCE, the fixed dose combination of nivolumab and relatlimab was the preferred regimen in the metastatic disease setting while either pembrolizumab or nivolumab were preferred in the adjuvant setting.Our study highlights the importance of considering patients' prioritization of treatment efficacy as the primary factor when making decisions about melanoma care, both in the adjuvant and metastatic settings. Although efficacy and safety were attributed to have relatively similar importance for treatment preference in the adjuvant setting, patients with more advanced disease or those carrying the BRAF mutation placed heightened emphasis on treatment efficacy.
Observational data • Journal • PD(L)-1 Biomarker • IO biomarker
|
BRAF (B-raf proto-oncogene)
|
BRAF mutation
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • Opdualag (nivolumab/relatlimab-rmbw)
2ms
Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases (clinicaltrials.gov)
P2, N=30, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2026 --> Jul 2028 | Trial primary completion date: Jul 2025 --> Jul 2028
Trial completion date • Trial primary completion date
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Opdivo (nivolumab) • Opdualag (nivolumab/relatlimab-rmbw)
3ms
Analysis of treatment-free survival of patients with advanced melanoma receiving nivolumab as monotherapy or in combination with relatlimab in RELATIVITY-047. (PubMed, J Immunother Cancer)
This analysis demonstrated TFS benefit during the 48 months since initiating nivolumab plus relatlimab compared with nivolumab alone in patients with advanced melanoma. A direct comparison between nivolumab plus relatlimab and nivolumab plus ipilimumab is needed to determine the differences between the regimens in TFS and those in traditional endpoints.
Journal • PD(L)-1 Biomarker • IO biomarker
|
PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene)
|
PD-L1 expression • BRAF mutation • BRAF wild-type
|
Opdivo (nivolumab) • Yervoy (ipilimumab) • Opdualag (nivolumab/relatlimab-rmbw)
3ms
Enrollment open
|
Yervoy (ipilimumab) • Opdualag (nivolumab/relatlimab-rmbw)
3ms
CA209-1451: Neoadjuvant Opdualag Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma (clinicaltrials.gov)
P2, N=30, Recruiting, University of California, San Diego | Not yet recruiting --> Recruiting
Enrollment open
|
Opdualag (nivolumab/relatlimab-rmbw) • relatlimab (BMS-986016)
4ms
Trial completion date • IO biomarker
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • cisplatin • carboplatin • pemetrexed • Opdualag (nivolumab/relatlimab-rmbw)
4ms
RELATIVITY-123: A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal Cancer (clinicaltrials.gov)
P3, N=770, Terminated, Bristol-Myers Squibb | Active, not recruiting --> Terminated; Inability to meet protocol objectives
Trial termination
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression • RAS wild-type
|
Opdivo (nivolumab) • Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil) • Opdualag (nivolumab/relatlimab-rmbw)