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Renal Cell CarcinomaPhase 2CheckMate 800NCT03029780

An Investigational Immuno-Therapy Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma

A Phase 2 study testing Opdivo and Yervoy in people with Renal Cell Carcinoma, run by Bristol-Myers Squibb at 11 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Renal Cell Carcinoma
What is being tested?
Opdivo and Yervoy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
11 sitesin 3 countries
Study dates
16 Feb 2017to 15 Jun 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Advanced Renal Cell Carcinoma
  • Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
  • Must have at least 1 lesion with measurable disease

Who cannot join

  • Subjects with active central nervous system metastases
  • Subjects who received prior therapy with checkpoint inhibitor
  • Subjects with active, known or suspected autoimmune disease
  • Other protocol defined inclusion/exclusion criteria could apply

Trial locations and contacts

11 sites in 3 countries.

11 sites in 3 countries

Australia5 sites

  • Local Institution

    Elizabeth Vale, South Australia, 5112

  • Local Institution

    Herston, Queensland, 4029

  • Local Institution

    Malvern, Victoria, 3144

  • Local Institution

    Waratah, New South Wales, 2298

  • Local Institution

    Westmead, New South Wales, 2145

Other trials in Australia

United States4 sites

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

  • University Of Iowa Hospitals And Clinics

    Iowa City, Iowa, 52242

  • Cancer Specialists of North FL

    Jacksonville, Florida, 32256

  • Local Institution

    Pittsburgh, Pennsylvania, 15212-0000

Other trials in United States

Chile2 sites

  • Centro Internacional de Estudios Clinicos

    Recoleta, Santiago de Chile

  • Fundacion Arturo Lopez Perez

    Santiago, Santiago Metropolitan, 7500921

Other trials in Chile

About this study

Official title: Phase II, Randomized, Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma

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.

Being tested
Opdivo, Yervoy
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OpdivoBiological

    Also called Nivolumab

    Specified dose on specified days

  • YervoyBiological

    Also called Ipilimumab

    Specified dose on specified days

Study groups in NCT03029780
Study groupRoleWhat they receive
Co-AdministrationExperimentalNivolumab and Ipilimumab Co-Administration
Receives: Biological: Opdivo; Biological: Yervoy
Sequential AdministrationExperimentalNivolumab and Ipilimumab Sequential Administration
Receives: Biological: Opdivo; Biological: Yervoy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 Period

    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).

    Measured: From randomization to 2 days following any dose in the combination period (assessed up to November 24th, 2017, approximately 9 months)

Secondary outcomes (7)

  1. 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 Period

    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).

    Measured: From randomization to 2 days following any dose in the combination period (assessed up to November 24th, 2017, approximately 9 months)

  2. The Percentage of Participants With Drug Related Grade 3-5 Adverse Events

    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.

    Measured: From first dose to 30 days after last dose of study therapy (up to approximately 48 months)

  3. The Percentage of Participants With All Causality Grade 3-5 Adverse Events

    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

    Measured: From first dose to 30 days after last dose of study therapy (up to approximately 48 months)

  4. Objective Response Rate (ORR)

    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 target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10mm. Partial Response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: From randomization to the date of objectively documented progression or the date of first subsequent anti-cancer (up to approximately 52 months)

  5. Progression Free Survival (PFS)

    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 date of their last evaluable tumor assessment prior to the first subsequent anti-cancer therapy. Progression is defined as at least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression)

    Measured: From randomization to the first date of documented progression or death due to any cause (up to approximately 52 months)

  6. Geometric Mean Trough Concentrations of Nivolumab and Ipilimumab

    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

    Measured: pre-dose on day 1 of cycle 2 and 4

  7. Geometric Mean End of Infusion (EOI) Concentrations of Nivolumab and Ipilimumab

    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

    Measured: EOI on day 1 of cycle 1, 2, and 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2017 (estimated)
  2. Study start16 Feb 2017
  3. Primary completion27 Nov 2017
  4. Study completion15 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03029780
Sponsor's protocol ID
CA209-800
Acronym
CheckMate 800
Status last verified
Jun 2022
First submitted
20 Jan 2017
Last updated
29 Jun 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Menzies AM, Salman P, Frontera OA, Pook D, Hocking CM, Zakharia Y, Gurney H, Gedye C, Goh JC, Telivala B, Grob JJ, Lebbe C, de la Cruz Merino L, Machet L, Neidhardt EM, Qureshi A, Hosein F, Hamuro L, Simsek B, Amin A. Administration of nivolumab plus ipilimumab: Infusion of the fixed-ratio combination versus sequential infusions in two randomized controlled trials of metastatic melanoma (CheckMate 742) and renal cell carcinoma (CheckMate 800). Cancer. 2025 Jul 15;131(14):e35962. doi: 10.1002/cncr.35962.

    PubMed 40614118

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Opdivo and Yervoy in people with Renal Cell Carcinoma, run by Bristol-Myers Squibb at 11 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Australia, United States, Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 Period (time frame: From randomization to 2 days following any dose in the combination period (assessed up to November 24th, 2017, approximately 9 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03029780, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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