Renal Cell CarcinomaPhase 2NCT04088500
A Study of Combination Nivolumab and Ipilimumab Retreatment in Patients With Advanced Renal Cell Carcinoma
A Phase 2 study testing Nivolumab and Ipilimumab in people with Renal Cell Carcinoma, run by Bristol-Myers Squibb at 12 sites in 2 countries.
Trial summary
The purpose of the study is to assess the effectiveness of re-induction with Nivolumab combined with ipilimumab. 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?
- Nivolumab and Ipilimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 3 Sep 2020to 15 Nov 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
- -Participants and Target Disease Characteristics- -
- Confirmed disease progression by RECIST 1.1 criteria on nivolumab maintenance after induction with ipilimumab and nivolumab
- Progress of maintenance treatment of nivolumab by RECIST. Pathology report must be submitted for embedded tissue block or tumor tissue.
- Age and Reproduction Sexually active males with WOCBP must agree to instructions for contraception and fetal protection.
- WOCBP need to use contraception throughout the study and for 5 months post treatment.
Who cannot join
- Active central nervous system metastases
- Participants with an active autoimmune disease, diabetes mellitus, skin disorders, hyperthyroidism requiring hormone treatments are permitted to enroll.
- Any major surgery 28 days before 1st treatment Concomitant Therapy
- participants that have received a live vaccine within 30 days of treatment.
- use of investigational agent or device with in 28 days before first dosage study treatment.
- Physical and Laboratory Test Findings Allergies and Adverse Drug Reaction Age and Reproduction
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Canada11 sites
Local Institution
Calgary, Alberta, T3B 3L1
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Atlantic Clinical Cancer Research Unit
Halifax, Nova Scotia, B3H 1V7
Hamilton Health Sciences (HHS) - Juravinski Cancer Centre (JCC)
Hamilton, Ontario, L8V 5C2
Local Institution
Montreal, Quebec, H2X 3E4
Local Institution - 0005
Montreal, Quebec, H3T 1E2
Local Institution
Québec, Quebec, G2L 2Z3
Local Institution - 0006
Sherbrooke, Quebec, J1H 5N4
Toronto Sunnybrook Regional Cancer Ctr
Toronto, Ontario, M4N 3M5
Local Institution
Toronto, Ontario, M5G 2M9
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, V5Z 4E6
United States1 site
Washington University School of Medicine in St. Louis WUSTL
St Louis, Missouri, 63108
About this study
Official title: A Phase 2, Single-arm Open-label Study of Combination Nivolumab and Ipilimumab Retreatment in Advanced Renal Cell Carcinoma Patients Progressing on Nivolumab Maintenance Therapy After Nivolumab and Ipilimumab Induction
The purpose of the study is to assess the effectiveness of re-induction with Nivolumab combined with ipilimumab.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Nivolumab, Ipilimumab
- 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.
NivolumabBiological
Also called Opdivo
Specific dose on specific days
IpilimumabBiological
Specific dose on specific days
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab + Ipilimumab (combination) | Experimental | Nivolumab + Ipilimumab (combination) Q3W for 4 doses Receives: Biological: Nivolumab; Biological: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate (DCR)
Disease Control Rate (DCR) is defined as the percentage of participants who achieve a confirmed best response of complete response (CR), partial response (PR), or stable disease (SD) for at least 6 months after first treatment dose per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
Measured: From first dose up to approximately 14 months
Secondary outcomes (6)
Overall Survival (OS)
Overall Survival (OS) is defined as the time from first dose to the date of death from any cause. For participants that are alive, their survival time will be censored at the date of last contact ("last known alive date"). OS will be censored for participants at the date of first dose if they were treated but had no follow-up.
Measured: From first dose to the date of death from any cause (up to approximately 14 months)
Overall Response Rate (ORR)
Overall Response Rate (ORR) is defined as the percentage of participants who achieve a best response of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From first dose and the date of objectively documented progression criteria or the date of subsequent therapy, whichever occurs first (up to approximately 14 months)
Duration of Response (DOR)
Duration of Response (DOR) is defined as the time between the date of first documented response (complete response (CR) or partial response (PR)) to the date of the first documented progression, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, or death due to any cause, whichever occurs first.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From first dose to the date of the first documented progression or death due to any cause, whichever occurs first (up to approximately 14 months)
Progression Free Survival (PFS)
Progression Free Survival (PFS) is defined as the time between the date of first dose and the first date of documented progression, as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, or death due to any cause, whichever occurs first. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, 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 first dose to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 14 months)
Time to Objective Response (TTR)
Time to Objective Response (TTR) is defined as the time between the date of the first dose and the first confirmed documented response (complete response (CR) or partial response (PR)) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: From first dose to the first confirmed documented response (up to approximately 14 months)
The Number of Participants Experiencing Adverse Events (AEs)
The number of participants with any grade adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Measured: From first dose and 100 days after lost dose (up to approximately 14 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start3 Sep 2020
- Primary completion15 Nov 2021
- Study completion15 Nov 2021
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088500
- Sponsor's protocol ID
- CA209-73M
- Status last verified
- Dec 2022
- First submitted
- 10 Sep 2019
- Last updated
- 10 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single-arm Open-label Study of Combination Nivolumab and Ipilimumab Retreatment in Advanced Renal Cell Carcinoma Patients Progressing on Nivolumab Maintenance Therapy After Nivolumab and Ipilimumab Induction
- ClinicalTrials.gov ID
- NCT04088500
- Acronym / sponsor ID
- CA209-73M
- Conditions
- Renal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 12 Sep 2019 (actual)
- Results
- Posted 10 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the effectiveness of re-induction with Nivolumab combined with ipilimumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nivolumab + Ipilimumab (combination) | Experimental | Biological: Nivolumab, Biological: IpilimumabNivolumab + Ipilimumab (combination) Q3W for 4 doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- -Participants and Target Disease Characteristics- -
- Confirmed disease progression by RECIST 1.1 criteria on nivolumab maintenance after induction with ipilimumab and nivolumab
- Progress of maintenance treatment of nivolumab by RECIST. Pathology report must be submitted for embedded tissue block or tumor tissue.
- Age and Reproduction Sexually active males with WOCBP must agree to instructions for contraception and fetal protection.
- WOCBP need to use contraception throughout the study and for 5 months post treatment.
Key exclusion criteria (6 listed)
- Active central nervous system metastases
- Participants with an active autoimmune disease, diabetes mellitus, skin disorders, hyperthyroidism requiring hormone treatments are permitted to enroll.
- Any major surgery 28 days before 1st treatment Concomitant Therapy
- participants that have received a live vaccine within 30 days of treatment.
- use of investigational agent or device with in 28 days before first dosage study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: OpdivoSpecific dose on specific days | Biological | Nivolumab + Ipilimumab (combination) |
| IpilimumabSpecific dose on specific days | Biological | Nivolumab + Ipilimumab (combination) |
Primary outcome
Disease Control Rate (DCR)
Time frame: From first dose up to approximately 14 months
Disease Control Rate (DCR) is defined as the percentage of participants who achieve a confirmed best response of complete response (CR), partial response (PR), or stable disease (SD) for at least 6 months after first treatment dose per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.
6 secondary outcomes
Overall Survival (OS)
Time frame: From first dose to the date of death from any cause (up to approximately 14 months)
Overall Response Rate (ORR)
Time frame: From first dose and the date of objectively documented progression criteria or the date of subsequent therapy, whichever occurs first (up to approximately 14 months)
Duration of Response (DOR)
Time frame: From first dose to the date of the first documented progression or death due to any cause, whichever occurs first (up to approximately 14 months)
Progression Free Survival (PFS)
Time frame: From first dose to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 14 months)
Time to Objective Response (TTR)
Time frame: From first dose to the first confirmed documented response (up to approximately 14 months)
The Number of Participants Experiencing Adverse Events (AEs)
Time frame: From first dose and 100 days after lost dose (up to approximately 14 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
Related trials for Renal Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab and Ipilimumab in people with Renal Cell Carcinoma, run by Bristol-Myers Squibb at 12 sites in 2 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada, United States. 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 10 Jan 2023). 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?
Disease Control Rate (DCR) (time frame: From first dose up to approximately 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jan 2023.