An Investigational Immuno-Therapy Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma
CompletedPhase 2Results postedLast updated 29 June 2022
What this trial tests
Phase 2 trial testing Opdivo in Renal Cell Carcinoma in 104 participants. Completed in 15 June 2021.
18 and older, any sex, with Renal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Percentage of Participant With Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ) Within 2 Days After Any Dose in the Combination PeriodPrimary· From randomization to 2 days following any dose in the combination period (assessed up to November 24th, 2017, approximately 9 months)
The percentage of participants who experienced at least 1 adverse event in the MedDRA Anaphylactic Reaction broad scope SMQ with onset on the day of or within 2 days after any study therapy infusion during the combination period (Part 1).
Group
Value
95% CI
Arm A: Fixed Ratio Combination
11.5
4.4 – 23.4
Arm B: Sequential Combination
11.5
4.4 – 23.4
The Percentage of Participant With Adverse Events in the Narrow Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ) Occurring Within 2 Days After Any Dose in the Combination PeriodSecondary· From randomization to 2 days following any dose in the combination period (assessed up to November 24th, 2017, approximately 9 months)
The percentage of participants who experienced at least 1 adverse event in the MedDRA Anaphylactic Reaction narrow scope SMQ with onset on the day of or within 2 days after any study therapy infusion during the combination period (Part 1).
Group
Value
95% CI
Arm A: Fixed Ratio Combination
0
0.0 – 6.8
Arm B: Sequential Combination
0
0.0 – 6.8
The Percentage of Participants With Drug Related Grade 3-5 Adverse EventsSecondary· From first dose to 30 days after last dose of study therapy (up to approximately 48 months)
The percentage of participants who experienced at least 1 adverse event of Grade 3 or higher, judged to be related to study treatment by the investigator, with onset on or after the first dose of study treatment and within 30 days of the last dose of study treatment. Evaluated using Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 criteria.
Group
Value
95% CI
Arm A: Fixed Ratio Combination
48.1
34.0 – 62.4
Arm B: Sequential Combination
42.3
28.7 – 56.8
The Percentage of Participants With All Causality Grade 3-5 Adverse EventsSecondary· From first dose to 30 days after last dose of study therapy (up to approximately 48 months)
The percentage of participants who experienced at least 1 adverse event of Grade 3 or higher with onset on or after the first dose of study treatment and within 30 days of the last dose of study treatment. Evaluated using the NCI CTCAE version 4.0 criteria
Group
Value
95% CI
Arm A: Fixed Ratio Combination
73.1
59.0 – 84.4
Arm B: Sequential Combination
65.4
50.9 – 78.0
Objective Response Rate (ORR)Secondary· From randomization to the date of objectively documented progression or the date of first subsequent anti-cancer (up to approximately 52 months)
The percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). The BOR is defined as the best response designation, as determined by the investigator, recorded between the date of randomization and the date of objectively documented progression per RECIST 1.1 or the date of first subsequent anti-cancer therapy, whichever occurs first. For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR assessment. Complete Response is defined as the disappearance of all targe
Group
Value
95% CI
Arm A: Fixed Ratio Combination
50.0
35.8 – 64.2
Arm B: Sequential Combination
32.7
20.3 – 47.1
Progression Free Survival (PFS)Secondary· From randomization to the first date of documented progression or death due to any cause (up to approximately 52 months)
The time between the date of randomization and the first date of documented progression, or death due to any cause, whichever occurs first (per investigator). Participants who die without progression will be considered to have progressed on the date of their death. Participants who did not progress or die are censored on the date of their last evaluable tumor assessment. Participants with no on study tumor assessments and who did not die will be censored on their date of randomization. Participants who started anti-cancer therapy without a prior reported progression will be censored on the dat
Group
Value
95% CI
Arm A: Fixed Ratio Combination
12.06
9.92 – 18.23
Arm B: Sequential Combination
7.69
3.42 – 11.33
Geometric Mean Trough Concentrations of Nivolumab and IpilimumabSecondary· pre-dose on day 1 of cycle 2 and 4
Serum concentration-time data of nivolumab and ipilimumab administered as a fixed ratio combination to that of sequentially administered nivolumab and ipilimumab is summarized prior to the next dose (predose). 1 Cycle = 3 weeks
Ipilimumab - Cycle 2 Day 1
Group
Value
95% CI
Arm A: Fixed Ratio Combination
3.92
± 28.9
Arm B: Sequential Combination
3.43
± 43.1
Ipilimumab - Cycle 4 Day 1
Group
Value
95% CI
Arm A: Fixed Ratio Combination
5.90
± 37.8
Arm B: Sequential Combination
5.39
± 39.8
Nivolumab - Cycle 2 Day 1
Group
Value
95% CI
Arm A: Fixed Ratio Combination
16.2
± 29.1
Arm B: Sequential Combination
16.1
± 46.3
Nivolumab - Cycle 4 Day 1
Group
Value
95% CI
Arm A: Fixed Ratio Combination
28.5
± 35.3
Arm B: Sequential Combination
30.5
± 43.1
Geometric Mean End of Infusion (EOI) Concentrations of Nivolumab and IpilimumabSecondary· EOI on day 1 of cycle 1, 2, and 4
Serum concentration-time data of nivolumab and ipilimumab administered as a fixed ratio combination to that of sequentially administered nivolumab and ipilimumab is summarized at the end of infusion (EOI). 1 Cycle = 3 weeks
Ipilimumab - Cycle 1 Day 1
Group
Value
95% CI
Arm A: Fixed Ratio Combination
17.6
± 23.7
Arm B: Sequential Combination
13.4
± 61.1
Ipilimumab - Cycle 2 Day 1
Group
Value
95% CI
Arm A: Fixed Ratio Combination
21.4
± 24.8
Arm B: Sequential Combination
15.6
± 37.9
Ipilimumab - Cycle 4 Day 1
Group
Value
95% CI
Arm A: Fixed Ratio Combination
24.9
± 31.3
Arm B: Sequential Combination
19.5
± 38.5
Nivolumab - Cycle 1 Day 1
Group
Value
95% CI
Arm A: Fixed Ratio Combination
57.1
± 22.4
Arm B: Sequential Combination
60.7
± 23.0
Nivolumab - Cycle 2 Day 1
Group
Value
95% CI
Arm A: Fixed Ratio Combination
70.6
± 27.6
Arm B: Sequential Combination
79.5
± 71.9
Nivolumab - Cycle 4 Day 1
Group
Value
95% CI
Arm A: Fixed Ratio Combination
85.1
± 30.1
Arm B: Sequential Combination
88.9
± 55.1
Adverse events — posted to ClinicalTrials.gov
Time frame: From the date of first dose to 30 days after last dose of study therapy. (up to approximately 48 months) Participants were assessed for All Cause Mortality from their first dose until the study was completed (up to approximately 52 months).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Arm A: Fixed Ratio Combination
Serious: 27/52 (52%)
Deaths: 26/52
Arm B: Sequential Combination
Serious: 25/52 (48%)
Deaths: 29/52
Serious adverse events (62 terms)
Reaction
System
Arm A: Fixed Ratio Combina…
Arm B: Sequential Combinat…
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to evaluate safety and efficacy of different administration regimens of nivolumab plus ipilimumab in subjects with renal cell carcinoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 29 June 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03029780.