trialsTrialActive

Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer

A phase 3 trial of Nivolumab, Ipilimumab, Gemcitabine, Cisplatin and Carboplatin in bladder & urothelial cancer, run by Bristol-Myers Squibb, active and no longer recruiting.

Also called: CheckMate901

Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer is a phase 3 interventional study registered as NCT03036098 by Bristol-Myers Squibb, with 1314 participants enrolled, started 2017-03-24 and due to reach its primary completion in 2024-08-30. Interventions recorded: Nivolumab, Ipilimumab, Gemcitabine, Cisplatin and Carboplatin. Results have been posted on the registry.

Setting

A Phase 3, Open-label, Randomized Study of Nivolumab Combined With Ipilimumab, or With Standard of Care Chemotherapy, Versus Standard of Care Chemotherapy in Participants With Previously Untreated Unresectable or Metastatic Urothelial Cancer

Phase

Phase 3

Sponsor

Bristol-Myers Squibb

Registry

Started

2017-03-24

Reported

2025

Enrolled

1,314 enrolled

Outcomes

In plain words

What these results mean for people, not percentages

1,314 enrolled

Overall Survival (OS) in Cisplatin-ineligible Randomized Participants for Primary Studyprimarysurvival endpoint

Median 19.1 vs 13.2 months with Treatment 1 compared with Treatment 2; about 5.8 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Put another way, the treated group had about 21 percent lower chance of the event at any given time (hazard ratio 0.79, likely range 0.64 to 0.97).

Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.

Overall Survival (OS) in Programmed Death-Ligand 1 (PD-L1) Positive (≥ 1%) Randomized Participants by Immunohistochemistry (IHC) for Primary Studyprimarysurvival endpoint

Median 16.3 vs 14.4 months with Treatment 1 compared with Treatment 2; about 1.9 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.

Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.

Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Cisplatin-eligible Participants for Sub-studyprimarysurrogate endpoint

Median 7.9 vs 7.6 months with Treatment 3 compared with Treatment 4; about 0.4 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Put another way, the treated group had about 28 percent lower chance of the event at any given time (hazard ratio 0.72, likely range 0.59 to 0.88).

This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.

Caveats

These results apply to the people the trial enrolled: A Phase 3, Open-label, Randomized Study of Nivolumab Combined With Ipilimumab, or With Standard of Care Chemotherapy, Versus Standard of Care Chemotherapy in Participants With Previously Untreated Unresectable or Metastatic Urothelial Cancer. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

1,314 enrolled.

Overall Survival (OS) in Cisplatin-ineligible Randomized Participants for Primary Studyprimary

HR 0.79 (0.64 to 0.97) · p = 0.0032

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95% CI 13.47 to 22.60; Figures from the ClinicalTrials.gov results section (first posted 2025-09-18), not from a publication · 95% CI 11.63 to 15.24

Overall Survival (OS) in Programmed Death-Ligand 1 (PD-L1) Positive (≥ 1%) Randomized Participants by Immunohistochemistry (IHC) for Primary Studyprimary

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95% CI 11.53 to 21.82; Figures from the ClinicalTrials.gov results section (first posted 2025-09-18), not from a publication · 95% CI 10.48 to 17.64

Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Cisplatin-eligible Participants for Sub-studyprimary

HR 0.72 (0.59 to 0.88) · p = 0.0018

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95% CI 7.62 to 9.49; Figures from the ClinicalTrials.gov results section (first posted 2025-09-18), not from a publication · 95% CI 6.05 to 7.75

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Overall Survival (OS) in Cisplatin-ineligible Randomized Participants for Primary Studyprimary	Treatment 1	221	19.06 months	0.79 (0.64 to 0.97)	0.0032	link
	Treatment 2	224	13.21 months	0.79 (0.64 to 0.97)	0.0032	link
Overall Survival (OS) in Programmed Death-Ligand 1 (PD-L1) Positive (≥ 1%) Randomized Participants by Immunohistochemistry (IHC) for Primary Studyprimary	Treatment 1	123	16.3 months	-	-	link
	Treatment 2	127	14.36 months	-	-	link
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Cisplatin-eligible Participants for Sub-studyprimary	Treatment 3	304	7.92 months	0.72 (0.59 to 0.88)	0.0018	link
	Treatment 4	304	7.56 months	0.72 (0.59 to 0.88)	0.0018	link

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cancers

Bladder & urothelial cancer Muscle-invasive and advanced bladder cancer

technologies

Immune checkpoint inhibitors

drugs

ApprovedCytotoxic chemotherapy (platinum)

ApprovedCytotoxic chemotherapy (platinum)

Cisplatin · Platinol (generic)

ApprovedNucleoside analogue (deoxycytidine)

Gemcitabine · Gemzar / Infugem

ApprovedMonoclonal antibody (anti-CTLA-4)

Ipilimumab · Yervoy

ApprovedMonoclonal antibody (anti-PD-1)

Nivolumab · Opdivo / Opdivo Qvantig (SC)

companies

Bristol Myers Squibb Deciphera Pharmaceuticals (Ono)