A Phase 3 interventional study of Nivolumab and Ipilimumab in Urothelial Cancer, sponsored by Bristol-Myers Squibb. Active, not recruiting at 174 sites in 30 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-06.
Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment
The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating participants with previously untreated inoperable or metastatic urothelial cancer.
Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Biological: Nivolumab · Biological: Ipilimumab
Drug: Gemcitabine · Drug: Cisplatin · Drug: Carboplatin
Biological: Nivolumab · Drug: Gemcitabine · Drug: Cisplatin
Drug: Gemcitabine · Drug: Cisplatin
Specified Dose on Specified Days
Also known as: BMS-936558, Opdivo
Specified Dose on Specified Days
Also known as: BMS-734016, Yervoy
Specified Dose on Specified Days
Specified Dose on Specified Days
Specified Dose on Specified Days
Overall Survival (OS) in Cisplatin-ineligible Randomized Participants for Primary Study
This measure looks at how long participants who cannot receive cisplatin (a type of chemotherapy) live after being placed into a treatment group in the primary study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand if the treatment can help people who are unable to receive cisplatin chemotherapy live longer.
Time frame: From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months)
Overall Survival (OS) in Programmed Death-Ligand 1 (PD-L1) Positive (≥ 1%) Randomized Participants by Immunohistochemistry (IHC) for Primary Study
This measure looks at how long participants with PD-L1 positive tumors (meaning their tumor cells have at least 1% PD-L1, as determined by a laboratory test called immunohistochemistry or IHC) live after being placed into a treatment group in the primary study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand whether the treatment can help people with PD-L1 positive tumors live longer.
Time frame: From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months)
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-study
This measure looks at how long people who can receive cisplatin chemotherapy live without their cancer getting worse after being assigned to a treatment group in the sub-study. Progression-Free Survival (PFS) is the time from when a participant is assigned to a group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment was given. These experts use standard rules (RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand if the treatment helps people eligible for cisplatin live longer without their cancer progressing.
Time frame: From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months)
Overall Survival (OS) in Cisplatin-eligible Participants for Sub-study
This measure looks at how long people who are able to receive cisplatin (a type of chemotherapy) live after being placed into a treatment group in the sub-study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand if the treatment can help people who are eligible for cisplatin chemotherapy live longer.
Time frame: From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months)
Overall Survival (OS) in All Randomized Participants for Primary Study
This measure looks at how long all participants live after being placed into a treatment group in the primary study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand whether the treatment can help all participants in the study live longer.
Time frame: From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months)
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Cisplatin-ineligible Randomized Participants for Primary Study
This measure looks at how long people who cannot receive cisplatin chemotherapy live without their cancer getting worse after being assigned to a treatment group in the primary study. Progression-Free Survival (PFS) is the time from when a participant is assigned to a group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment was given. These experts use standard rules (RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand if the treatment helps people unable to receive cisplatin live longer without their cancer progressing.
Time frame: From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months)
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Programmed Death-Ligand 1 (PD-L1) Positive (≥ 1%) Participants for Primary Study
This measure looks at how long people with PD-L1 positive tumors (meaning their tumor cells have at least 1% PD-L1, as determined by a lab test) live without their cancer getting worse after being assigned to a treatment group in the primary study. Progression-Free Survival (PFS) is the time from when a participant is assigned to a group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment was given. These experts use standard rules (RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand if the treatment helps people with PD-L1 positive tumors live longer without their cancer progressing.
Time frame: From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months)
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in All Randomized Participants for Primary Study
This measure looks at how long all participants in the primary study live without their cancer getting worse after being assigned to a treatment group. Progression-Free Survival (PFS) is defined as the time from when a participant is assigned to a treatment group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment the participant received. These experts use standard rules (called RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand whether the treatment can help participants live longer without their cancer progressing.
Time frame: From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months)
Change From Baseline in the European Organization for Research and Treatment of Care Quality-of-Life Questionnaire (EORTC QLQ-C30) Global Health Status Score in All Randomized Participants for Primary Study
The EORTC QLQ-C30 is a questionnaire used to assess the quality of life in cancer patients. It includes a global health status score, which is measured on a 4-point Likert scale: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much. Responses are combined and converted to scores ranging from 0 to 100. A high score for global health status or health-related quality of life (HRQoL) indicates a high overall HRQoL.
Time frame: At Baseline, Week 4, Week 10, Week 16, Week 20, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 108, Week 120, Week 144, Week 156, Week 168, Week 180 and Week 192
Change From Baseline in the European Organization for Research and Treatment of Care Quality-of-Life Questionnaire (EORTC QLQ-C30) Global Health Status Score for Sub-study
The EORTC QLQ-C30 is a questionnaire used to assess the quality of life in cancer patients. It includes a global health status score, which is measured on a 4-point Likert scale: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much. Responses are combined and converted to scores ranging from 0 to 100. A high score for global health status or health-related quality of life (HRQoL) indicates a high overall HRQoL.
Time frame: At Baseline, Week 4, Week 10, Week 16, Week 20, Week 24, Week 36, Week 48, Week 60, Week 72, Week 84, Week 96, Week 108, and Week 120
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] by Programmed Death-Ligand 1 (PD-L1) Expression at ≥1% Expression by Immunohistochemistry (IHC) for Sub-study
This measure looks at how long participants with PD-L1 positive tumors (meaning their tumor cells have at least 1% PD-L1, as determined by a lab test called immunohistochemistry or IHC) live without their cancer getting worse after being assigned to a treatment group in the sub-study. Progression-Free Survival (PFS) is the time from when a participant is assigned to a group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment was given. These experts use standard rules (RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check.
Time frame: From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months)
Overall Survival (OS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] by Programmed Death-Ligand 1 (PD-L1) Expression at ≥1% Expression by Immunohistochemistry (IHC) for Sub-study
This measure looks at how long participants with PD-L1 positive tumors (meaning their tumor cells have at least 1% PD-L1, as determined by a laboratory test called immunohistochemistry or IHC) live after being placed into a treatment group in the sub-study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand whether the treatment can help people with PD-L1 positive tumors live longer. The results are reviewed by independent experts who do not know which treatment each participant received, using standard criteria for measuring tumor response.
Time frame: From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months)
| Milestone | Treatment 1 | Treatment 2 | Treatment 3 | Treatment 4 |
|---|---|---|---|---|
| Started | 349 | 357 | 304 | 304 |
| Completed | 345 | 338 | 304 | 291 |
| Not completed | 4 | 19 | 0 | 13 |
| Withdrew: Other reasons | 1 | 2 | 0 | 5 |
| Withdrew: Participant no longer meets study criteria | 2 | 0 | 0 | 2 |
| Withdrew: Withdrawal by subject | 1 | 14 | 0 | 5 |
| Withdrew: Participant request to discontinue study treatment | 0 | 3 | 0 | 1 |
| Milestone | Treatment 1 | Treatment 2 | Treatment 3 | Treatment 4 |
|---|---|---|---|---|
| Started | 345 | 325 | 304 | 288 |
| Received different treatment than originally assigned | 0 | 13 | 0 | 3 |
| Completed | 46 | 149 | 29 | 157 |
| Not completed | 299 | 176 | 275 | 131 |
| Withdrew: Disease progression | 130 | 77 | 168 | 50 |
| Withdrew: Study drug toxicity | 95 | 45 | 26 | 22 |
| Withdrew: Death | 9 | 3 | 1 | 2 |
| Withdrew: Adverse event unrelated to study drug | 18 | 15 | 10 | 14 |
| Withdrew: Participant request to discontinue study treatment | 6 | 18 | 15 | 18 |
| Withdrew: Withdrawal by subject | 2 | 9 | 2 | 4 |
| Withdrew: Maximum clinical benefit | 6 | 1 | 6 | 10 |
| Withdrew: Poor/non compliance | 1 | 2 | 0 | 1 |
| Withdrew: Participant no longer meets study criteria | 0 | 1 | 1 | 1 |
| Withdrew: Administrative reason by sponsor | 1 | 0 | 2 | 1 |
| Withdrew: Other reasons | 31 | 5 | 21 | 8 |
| Withdrew: Ongoing treatment | 0 | 0 | 23 | 0 |
This measure looks at how long participants who cannot receive cisplatin (a type of chemotherapy) live after being placed into a treatment group in the primary study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand if the treatment can help people who are unable to receive cisplatin chemotherapy live longer.
| Months | Treatment 1 | Treatment 2 |
|---|---|---|
| Overall Survival (OS) in Cisplatin-ineligible Randomized Participants for Primary Study | 19.06 (13.47 to 22.60) | 13.21 (11.63 to 15.24) |
This measure looks at how long participants with PD-L1 positive tumors (meaning their tumor cells have at least 1% PD-L1, as determined by a laboratory test called immunohistochemistry or IHC) live after being placed into a treatment group in the primary study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand whether the treatment can help people with PD-L1 positive tumors live longer.
| Months | Treatment 1 | Treatment 2 |
|---|---|---|
| Overall Survival (OS) in Programmed Death-Ligand 1 (PD-L1) Positive (≥ 1%) Randomized Participants by Immunohistochemistry (IHC) for Primary Study | 16.30 (11.53 to 21.82) | 14.36 (10.48 to 17.64) |
This measure looks at how long all participants live after being placed into a treatment group in the primary study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand whether the treatment can help all participants in the study live longer.
| Months | Treatment 1 | Treatment 2 |
|---|---|---|
| Overall Survival (OS) in All Randomized Participants for Primary Study | 18.76 (15.05 to 21.82) | 14.32 (12.22 to 15.87) |
This measure looks at how long people who cannot receive cisplatin chemotherapy live without their cancer getting worse after being assigned to a treatment group in the primary study. Progression-Free Survival (PFS) is the time from when a participant is assigned to a group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment was given. These experts use standard rules (RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand if the treatment helps people unable to receive cisplatin live longer without their cancer progressing.
| Months | Treatment 1 | Treatment 2 |
|---|---|---|
| Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Cisplatin-ineligible Randomized Participants for Primary Study | 5.29 (3.78 to 5.95) | 5.88 (5.62 to 7.59) |
This measure looks at how long people with PD-L1 positive tumors (meaning their tumor cells have at least 1% PD-L1, as determined by a lab test) live without their cancer getting worse after being assigned to a treatment group in the primary study. Progression-Free Survival (PFS) is the time from when a participant is assigned to a group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment was given. These experts use standard rules (RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand if the treatment helps people with PD-L1 positive tumors live longer without their cancer progressing.
| Months | Treatment 1 | Treatment 2 |
|---|---|---|
| Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Programmed Death-Ligand 1 (PD-L1) Positive (≥ 1%) Participants for Primary Study | 5.39 (3.75 to 7.39) | 5.78 (4.80 to 6.93) |
This measure looks at how long all participants in the primary study live without their cancer getting worse after being assigned to a treatment group. Progression-Free Survival (PFS) is defined as the time from when a participant is assigned to a treatment group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment the participant received. These experts use standard rules (called RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand whether the treatment can help participants live longer without their cancer progressing.
| Months | Treatment 1 | Treatment 2 |
|---|---|---|
| Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in All Randomized Participants for Primary Study | 5.03 (3.94 to 5.98) | 6.01 (5.78 to 7.52) |
The EORTC QLQ-C30 is a questionnaire used to assess the quality of life in cancer patients. It includes a global health status score, which is measured on a 4-point Likert scale: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much. Responses are combined and converted to scores ranging from 0 to 100. A high score for global health status or health-related quality of life (HRQoL) indicates a high overall HRQoL.
| Score on a Scale | Treatment 1 | Treatment 2 |
|---|---|---|
| Global Health Status - Baseline | 63.4 ± 22.55 | 59.8 ± 25.05 |
| Global Health Status - Week 4 | -1.1 ± 18.28 | 2.7 ± 23.21 |
| Global Health Status - Week 10 | -0.5 ± 23.73 | 3.0 ± 23.55 |
| Global Health Status - Week 16 | 3.6 ± 22.59 | 3.1 ± 24.68 |
| Global Health Status - Week 20 | 2.6 ± 22.02 | 5.1 ± 24.44 |
| Global Health Status - Week 24 | 1.9 ± 25.78 | 2.5 ± 26.19 |
| Global Health Status - Week 36 | -0.9 ± 22.14 | -1.7 ± 28.81 |
| Global Health Status - Week 48 | 0.5 ± 19.72 | 2.8 ± 17.35 |
| Global Health Status - Week 60 | 7.6 ± 24.11 | — |
| Global Health Status - Week 72 | 2.7 ± 27.04 | — |
| Global Health Status - Week 84 | 8.1 ± 24.40 | — |
| Global Health Status - Week 96 | 3.2 ± 26.86 | — |
| Global Health Status - Week 108 | 4.7 ± 37.51 | — |
| Global Health Status - Week 120 | -20.8 ± 28.46 | — |
| Global Health Status - Week 144 | -16.7 ± NA | — |
| Global Health Status - Week 156 | -16.7 ± NA | — |
| Global Health Status - Week 168 | 0.0 ± NA | — |
| Global Health Status - Week 180 | -8.3 ± NA | — |
| Global Health Status - Week 192 | -16.7 ± NA | — |
This measure looks at how long people who can receive cisplatin chemotherapy live without their cancer getting worse after being assigned to a treatment group in the sub-study. Progression-Free Survival (PFS) is the time from when a participant is assigned to a group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment was given. These experts use standard rules (RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand if the treatment helps people eligible for cisplatin live longer without their cancer progressing.
| Months | Treatment 3 | Treatment 4 |
|---|---|---|
| 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-study | 7.92 (7.62 to 9.49) | 7.56 (6.05 to 7.75) |
This measure looks at how long people who are able to receive cisplatin (a type of chemotherapy) live after being placed into a treatment group in the sub-study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand if the treatment can help people who are eligible for cisplatin chemotherapy live longer.
| Months | Treatment 3 | Treatment 4 |
|---|---|---|
| Overall Survival (OS) in Cisplatin-eligible Participants for Sub-study | 21.72 (18.63 to 26.38) | 18.86 (14.72 to 22.44) |
The EORTC QLQ-C30 is a questionnaire used to assess the quality of life in cancer patients. It includes a global health status score, which is measured on a 4-point Likert scale: 1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much. Responses are combined and converted to scores ranging from 0 to 100. A high score for global health status or health-related quality of life (HRQoL) indicates a high overall HRQoL.
| Score on a Scale | Treatment 3 | Treatment 4 |
|---|---|---|
| Global Health Status - Baseline | 66.6 ± 22.7 | 66.8 ± 22.5 |
| Global Health Status - Week 4 | -0.2 ± 22.2 | 2.0 ± 17.8 |
| Global Health Status - Week 10 | 2.9 ± 24.2 | 1.1 ± 20.6 |
| Global Health Status - Week 16 | 1.8 ± 23.1 | -1.0 ± 23.7 |
| Global Health Status - Week 20 | 4.3 ± 24.6 | -0.5 ± 22.8 |
| Global Health Status - Week 24 | 4.0 ± 25.3 | -0.6 ± 13.0 |
| Global Health Status - Week 36 | 6.4 ± 25.1 | -3.7 ± 17.2 |
| Global Health Status - Week 48 | 7.1 ± 24.9 | -2.8 ± 12.7 |
| Global Health Status - Week 60 | 8.1 ± 25.0 | — |
| Global Health Status - Week 72 | 6.6 ± 26.5 | -8.3 ± NA |
| Global Health Status - Week 84 | 9.8 ± 26.7 | — |
| Global Health Status - Week 96 | 9.0 ± 18.2 | — |
| Global Health Status - Week 108 | 7.6 ± 13.7 | — |
| Global Health Status - Week 120 | 13.9 ± 25.5 | — |
This measure looks at how long participants with PD-L1 positive tumors (meaning their tumor cells have at least 1% PD-L1, as determined by a lab test called immunohistochemistry or IHC) live without their cancer getting worse after being assigned to a treatment group in the sub-study. Progression-Free Survival (PFS) is the time from when a participant is assigned to a group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment was given. These experts use standard rules (RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check.
| Months | Treatment 3 | Treatment 4 |
|---|---|---|
| Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] by Programmed Death-Ligand 1 (PD-L1) Expression at ≥1% Expression by Immunohistochemistry (IHC) for Sub-study | 8.08 (7.10 to 11.27) | 6.60 (5.78 to 7.59) |
This measure looks at how long participants with PD-L1 positive tumors (meaning their tumor cells have at least 1% PD-L1, as determined by a laboratory test called immunohistochemistry or IHC) live after being placed into a treatment group in the sub-study. Overall Survival (OS) is defined as the time between the date a participant is randomized (assigned to a treatment group) and the date of death from any cause. For participants without documentation of death, OS will be measured up to the last date the participant was known to be alive. If a participant was randomized but had no follow-up information, OS will be counted from the date of randomization. This helps to understand whether the treatment can help people with PD-L1 positive tumors live longer. The results are reviewed by independent experts who do not know which treatment each participant received, using standard criteria for measuring tumor response.
| Months | Treatment 3 | Treatment 4 |
|---|---|---|
| Overall Survival (OS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] by Programmed Death-Ligand 1 (PD-L1) Expression at ≥1% Expression by Immunohistochemistry (IHC) for Sub-study | 25.10 (17.28 to 35.55) | 15.34 (11.70 to 24.87) |
Collected over Participants were assessed for All-Cause Mortality from the date of randomization until primary study completion. SAEs and Other AEs were assessed from first dose of study medication until primary study completion (assessed up to approximately 89 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment 1 | 257/349 (73.6%) | 264/345 (76.5%) | 322/345 (93.3%) |
| Treatment 2 | 294/357 (82.4%) | 170/328 (51.8%) | 309/328 (94.2%) |
| Treatment 3 | 172/304 (56.6%) | 168/304 (55.3%) | 298/304 (98%) |
| Treatment 4 | 193/304 (63.5%) | 130/301 (43.2%) | 295/301 (98%) |
| Event | Treatment 1 | Treatment 2 | Treatment 3 | Treatment 4 |
|---|---|---|---|---|
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 51/345 | 38/328 | 47/304 | 22/301 |
| Urinary tract infectionInfections and infestations | 33/345 | 19/328 | 15/304 | 16/301 |
| DiarrhoeaGastrointestinal disorders | 19/345 | 2/328 | 1/304 | 1/301 |
| Acute kidney injuryRenal and urinary disorders | 19/345 | 4/328 | 13/304 | 5/301 |
| AnaemiaBlood and lymphatic system disorders | 6/345 | 18/328 | 9/304 | 8/301 |
| ColitisGastrointestinal disorders | 16/345 | 1/328 | 0/304 | 0/301 |
| PyrexiaGeneral disorders | 13/345 | 9/328 | 6/304 | 4/301 |
| Platelet count decreasedInvestigations | 0/345 | 12/328 | 7/304 | 1/301 |
| HepatotoxicityHepatobiliary disorders | 12/345 | 0/328 | 1/304 | 0/301 |
| SepsisInfections and infestations | 11/345 | 7/328 | 7/304 | 4/301 |
| Event | Treatment 1 | Treatment 2 | Treatment 3 | Treatment 4 |
|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 82/345 | 195/328 | 193/304 | 170/301 |
| NauseaGastrointestinal disorders | 74/345 | 122/328 | 159/304 | 161/301 |
| NeutropeniaBlood and lymphatic system disorders | 1/345 | 104/328 | 104/304 | 94/301 |
| DiarrhoeaGastrointestinal disorders | 113/345 | 46/328 | 59/304 | 46/301 |
| Decreased appetiteMetabolism and nutrition disorders | 79/345 | 66/328 | 94/304 | 61/301 |
| ConstipationGastrointestinal disorders | 53/345 | 90/328 | 92/304 | 86/301 |
| PruritusSkin and subcutaneous tissue disorders | 104/345 | 16/328 | 54/304 | 10/301 |
| FatigueGeneral disorders | 78/345 | 76/328 | 87/304 | 84/301 |
| Neutrophil count decreasedInvestigations | 3/345 | 90/328 | 78/304 | 61/301 |
| PyrexiaGeneral disorders | 81/345 | 55/328 | 40/304 | 39/301 |
| Age, Categorical(Participants) | Treatment 1 | Treatment 2 | Treatment 3 | Treatment 4 | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 120 | 127 | 150 | 148 | 545 |
| >=65 years | 229 | 230 | 154 | 156 | 769 |
| Sex: Female, Male(Participants) | Treatment 1 | Treatment 2 | Treatment 3 | Treatment 4 | Total |
|---|---|---|---|---|---|
| Female | 80 | 88 | 68 | 70 | 306 |
| Male | 269 | 269 | 236 | 234 | 1008 |
| Ethnicity (NIH/OMB)(Participants) | Treatment 1 | Treatment 2 | Treatment 3 | Treatment 4 | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 24 | 18 | 38 | 33 | 113 |
| Not Hispanic or Latino | 158 | 151 | 118 | 119 | 546 |
| Unknown or Not Reported | 167 | 188 | 148 | 152 | 655 |
| Race/Ethnicity, Customized(Participants) | Treatment 1 | Treatment 2 | Treatment 3 | Treatment 4 | Total |
|---|---|---|---|---|---|
| White | 253 | 232 | 211 | 225 | 921 |
| Black Or African American | 1 | 1 | 0 | 2 | 4 |
| American Indian Or Alaska Native | 2 | 2 | 1 | 1 | 6 |
| Asian | 79 | 105 | 75 | 63 | 322 |
| Other | 14 | 16 | 17 | 13 | 60 |
| Not Reported | 0 | 1 | 0 | 0 | 1 |
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Bristol-Myers Squibb