Natera (NTRA) and BMS (BMY) Initiate Clinical Trial for Urothelial Carcinoma Using Opdivo and Relatlimab with ctDNA
Introduction of Precision Residual Disease Diagnosis Based on ctDNA
This MODERN (Alliance A032103) clinical trial aims to revolutionize the detection of microscopic residual cancer after surgery. It utilizes Natera's (NTRA) Signatera, a personalized tumor-derived circulating tumor DNA (ctDNA) assay platform, to assess the presence of molecular minimal residual disease (MRD) in patients. This approach overcomes the limitations of conventional imaging and enables earlier detection of recurrence, paving the way for personalized precision medicine. The diagnostics industry anticipates that Natera (NTRA), which achieved $2.31 billion in annual revenue in 2025, will further solidify its position as the standard of care in the liquid biopsy diagnostics market through this large-scale clinical trial.
Personalized Treatment Intensity Adjustment Strategy
Previously, high-risk urothelial carcinoma (Urothelial Carcinoma) patients who underwent radical resection received systemic, potent immunotherapy, despite high recurrence rates, and had to accept the risk of adverse effects. The Phase 2/3 MODERN trial applies a treatment de-escalation strategy by closely monitoring ctDNA-negative patients without administering immunotherapy. Conversely, patients with ctDNA-positive results, who are at high risk of recurrence, will receive a more intensive combination therapy. This approach aims to reduce unnecessary drug toxicity, improve patients' quality of life, and maximize the efficiency of national health insurance and healthcare costs, marking a significant milestone.
Maximizing the Value of BMS's Immune Checkpoint Inhibitor Pipeline
This trial actively validates the combination therapy of Opdivo (nivolumab), Bristol Myers Squibb's (BMY) anti-PD-1 immunotherapy, and relatlimab, an anti-LAG-3 monoclonal antibody. Opdivo has already been approved by the FDA in August 2021 as adjuvant therapy for urothelial carcinoma and achieved blockbuster status with $10 billion in annual revenue in 2025. By adding relatlimab, a key component of Opdualag, a melanoma treatment, BMS (BMY) aims to create synergy in immune checkpoint inhibitors and establish a new standard of care, reflecting its long-term strategy for revenue expansion. If the clinical trial demonstrates the synergistic effect of the two drugs, the market dominance of the Opdualag line, which exceeded $1 billion in annual revenue in 2025, will be significantly expanded into the urothelial carcinoma area.
Intensifying Competition in the Adjuvant Urothelial Carcinoma Market
The global urothelial carcinoma treatment market is estimated at $3.1 billion to $6.9 billion in 2026, and the adjuvant therapy segment is considered the most profitable. Roche is also conducting the IMvigor011 trial, using the same Signatera ctDNA platform to evaluate the efficacy of its immune checkpoint inhibitor, Tecentriq (atezolizumab), creating a highly competitive landscape. Furthermore, with Merck's (MRK) Keytruda threatening the market through the AMBASSADOR trial, this trial will be a turning point for BMS to outpace its competitors and secure a clear lead. This trial, which officially began in February 2024 and is scheduled to be completed in September 2030, with 1,000 participants, will be a key battleground that will determine the future of non-invasive precision oncology.
This trial, set in the global urothelial carcinoma market valued at up to $6.9 billion in 2026, will establish the standard for ctDNA-based precision adjuvant therapy, driving structural growth in the companion diagnostics market. Natera (NTRA) will demonstrate the clinical value of Signatera, which achieved $2.31 billion in revenue in 2025, through Phase 2/3 and Phase 3 large-scale studies, allowing it to secure a dominant position in the liquid biopsy market against competitors such as Roche (IMvigor011). For Bristol Myers Squibb (BMY), the successful acquisition of clinical significance for the combination therapy of Opdivo, with $10 billion in annual revenue, and relatlimab, with $1 billion in annual revenue, will ensure long-term patent and revenue defense in the urothelial carcinoma field. From the perspective of researchers and clinicians, the availability of data on treatment de-escalation, which reduces unnecessary administration of immunotherapy and lowers toxicity, will lead to a paradigm shift in cancer treatment towards true patient-centered precision medicine after the completion of the trial in September 2030.
Source: ClinicalTrials.gov (api_ct)