Nivolumab Monotherapy Active in Recurrent Metastatic Urothelial Carcinoma

Share this content:

Single-agent nivolumab induced durable clinical responses with a manageable safety profile in previously treated patients with locally advanced or metastatic urothelial carcinoma, according to a study published in the journal The Lancet Oncology.1

Because limited treatment options exist for patients with advanced urothelial carcinoma who have progressed after platinum-based chemotherapy, researchers sought to evaluate the activity and tolerability of nivolumab, which has demonstrated activity in a variety of cancer types, in patients with locally advanced or metastatic urothelial carcinoma.

For the international, open-label, phase 1/2 trial ( Identifier: NCT01928394), investigators enrolled 86 patients with metastatic urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra. All patients received nivolumab monotherapy every 2 weeks until disease progression or unacceptable toxicity.

At a median follow-up of 15.2 months, results showed that 24.4% (95% CI, 15.2-35.4) of 78 evaluable patients achieved a response per investigator assessment.

Researchers found that 22% experienced grade 3 to 4 treatment-related adverse events, with the most common being elevated lipase, fatigue, maculopapular rash, dyspnea, lymphopenia, and neutropenia.

In total, 10% experienced serious treatment-related adverse events and 3% discontinued nivolumab therapy and subsequently died due to treatment-related grade 4 pneumonitis and grade 4 thrombocytopenia.

The encouraging findings ultimately support the further investigation of single-agent nivolumab in this patient population.


1. Sharma P, Callahan MK, Bono P, et al. Nivolumab monotherapy in recurrent metastatic urothelial carcinoma (CheckMate 032): a multicentre, open-label, two-stage, multi-arm, phase 1/2 trial. Lancet Oncol. 2016 Oct 9. doi: 10.1016/S1470-2045(16)30496-X. [Epub ahead of print]

You must be a registered member of ONA to post a comment.

Sign Up for Free e-newsletters

Regimen and Drug Listings


Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Genitourinary Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Rare Cancers Regimens
Skin Cancer Regimens Drugs