Logo image
Back
Long-term follow-up from the OMNIVORE trial: response-adaptive nivolumab and ipilimumab in advanced renal cell carcinoma
Journal article   Open access   Peer reviewed

Long-term follow-up from the OMNIVORE trial: response-adaptive nivolumab and ipilimumab in advanced renal cell carcinoma

Rana R McKay, Michael Serzan, Wanling Xie, Bradley A McGregor, David Braun, Xiao Wei, Christos Kyriakopoulos, Yousef Zakharia, Benjamin L Maughan, Tracy Rose, …
Journal for immunotherapy of cancer, Vol.14(7), e01550
07/01/2026
DOI: 10.1136/jitc-2026-015501
PMID: 42386345
url
https://doi.org/10.1136/jitc-2026-015501View
Published (Version of record) Open Access

Abstract

Immune checkpoint inhibitor-based combinations represent the standard of care for advanced renal cell carcinoma. The OMNIVORE trial investigated a response-adaptive strategy, including treatment discontinuation in early nivolumab responders (Arm A) and salvage ipilimumab addition in non-responders (Arm B). Here we report outcomes with extended follow-up. OMNIVORE was a phase II response-adaptive trial in which patients received induction nivolumab monotherapy. Patients achieving a confirmed complete or partial response discontinued nivolumab and entered observation (Arm A), while patients with stable disease or progressive disease received two doses of ipilimumab added to ongoing nivolumab (Arm B). This analysis characterizes long-term overall survival across the full study cohort and durability of response among patients who discontinued nivolumab following an early objective response. Of 83 patients who initiated treatment, 12 (14%) were allocated to Arm A and 57 (69%) to Arm B, with a median follow-up among living patients of 59.4 months (range 29.1-85.4 months) in Arm A and 31.4 months (range 4.6-62.6 months) in Arm B. The 3-year overall survival rate from nivolumab initiation was 64% (95% CI 51% to 74%) in the overall cohort, 83% (95% CI 48% to 96%) in Arm A, and 63% (95% CI 47% to 76%) in Arm B. Of the 12 Arm A patients, 6 (50%) remained off nivolumab at 1 year following treatment discontinuation, of whom 5 maintained responses beyond 43 months off therapy, with all remaining alive at last known follow-up, with overall survival ranging from 48.8 to 85.4 months from nivolumab initiation. Of the six patients who resumed treatment, only one achieved a durable complete response remaining on treatment at 83.2 months from nivolumab initiation. All 57 Arm B patients discontinued treatment with a median treatment duration of 3.7 months (range 1-24.8 months) and a median progression-free survival from nivolumab plus ipilimumab initiation of 4.6 months (95% CI 2.7 to 6.5 months). With extended follow-up, a meaningful subset of patients achieving an early objective response to nivolumab maintained prolonged treatment-free survival following a short course of treatment. Salvage ipilimumab in nivolumab non-responders demonstrated limited benefit, reinforcing that upfront concurrent dual checkpoint blockade remains the preferred approach. NCT03203473.
 Adult Aged Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - pharmacology Antineoplastic Combined Chemotherapy Protocols - therapeutic use Carcinoma, Renal Cell - drug therapy Carcinoma, Renal Cell - mortality Carcinoma, Renal Cell - pathology Female Follow-Up Studies Humans Ipilimumab - pharmacology Ipilimumab - therapeutic use Kidney Neoplasms - drug therapy Kidney Neoplasms - mortality Kidney Neoplasms - pathology Male Middle Aged Nivolumab - pharmacology Nivolumab - therapeutic use

Details

Metrics

1 Record Views
Logo image