Breaking Down the CheckMate 901 Trial Data for Metastatic Bladder Cancer

Investigators evaluated treatment with Opdivo (nivolumab) plus Yervoy (ipilimumab) versus gemcitabine-carboplatin chemotherapy for previously untreated unresectable or metastatic urothelial carcinoma, according to Dr. Guru Sonpavde.

Final results from the cisplatin-ineligible patient population evaluated in the CheckMate 901 trial were shared at the 2025 ASCO Annual Meeting.

Notably, the Food and Drug Administration (FDA) has approved Opdivo in combination with chemotherapy for the first-line treatment of patients with unresectable or metastatic urothelial carcinoma in March 2024. This regulatory approval was generated by data from the CheckMate 901 trial.

To further discuss this topic, Sonpavde sat down for an interview with CURE live on site at the meeting to discuss how the results of the CheckMate 901 trial may influence discussions around starting immunotherapy versus standard chemotherapy in the treatment of patients with metastatic or unresectable urothelial cancer who cannot receive cisplatin.

Sonpavde serves as the medical director of genitourinary oncology, and is an assistant director of the Clinical Research Unit and the Christopher K. Glanz Chair for Bladder Cancer Research at the AdventHealth Cancer Institute, located in Orlando, Florida.

Trancript:

At the moment … we really cannot institute Opdivo plus Yervoy, since it's not going to be approved based on these data. Of course, being a negative trial for the Opdivo plus Yervoy comparison, I think it does provide some momentum to the strategy of combined PD-1 and CTLA-4 therapy for at least a subset of patients. Remember, the PD-1/CTLA-4 strategy is also being looked at in metastatic disease.

We are still awaiting a trial called the NILE trial, which is looking at platinum-based chemotherapy plus Imfinzi (durvalumab) and Imjudo (tremelimumab) for advanced disease. That trial also has a (gemcitabine)-platinum plus Imfinzi comparison with (gemcitabine)-platinum as the standard. Also, we have a potentially even more exciting neoadjuvant trial, which is looking at Imfinzi and Imjudo plus Padcev (enfortumab vedotin-ejfv).

So, I think there's still some scope for a PD-1 plus CTLA-4 inhibition combination coming into the clinic. We'll have to wait and see what the results of NILE and the neoadjuvant trial — that's the VOLGA trial — look like. Perhaps there's still some scope for that kind of double immune checkpoint inhibitor combination.

Transcript has been edited for clarity and conciseness.

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