MelanomaPhase 2NCT05496192
A Study of Nivolumab Intravenous (IV) to Subcutaneous (SC) Switch in Adjuvant Melanoma and Bladder Cancer
A Phase 2 study testing Nivolumab/rHuPH20 and Nivolumab in people with Melanoma and Urothelial Carcinoma, run by Bristol-Myers Squibb at 3 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the switch from Nivolumab Intravenous (IV) infusions to Nivolumab Subcutaneous (SC) administration in participants with resected Stage IIIA/B/C/D or Stage IV melanoma or resected invasive Urothelial Carcinoma (UC) originating in the bladder who have high risk of recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Urothelial Carcinoma
- What is being tested?
- Nivolumab/rHuPH20 and Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 31 May 2023to 24 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Participant must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Participants must be eligible for adjuvant therapy for melanoma or muscle-invasive Urothelial Carcinoma (UC) originating from the bladder.
- All participants must have disease-free status (DFS) documented by a complete physical examination and imaging studies within 4 weeks prior to treatment assignment.
Who cannot join
- History of ocular or uveal or mucosal melanoma.
- Upper tract UC (ureter, renal pelvis), non-muscle-invasive UC.
- Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment.
- Untreated/unresected Central Nervous System (CNS) or leptomeningeal metastases.
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Germany2 sites
Local Institution - 0001
Berlin, 10117
Local Institution - 0020
Essen, North Rhine-Westphalia, 45136
About this study
Official title: A Phase II Study of Adjuvant Nivolumab Switch From Intravenous (IV) to Subcutaneous (SC) Use in Participants With Resected Stage III or Stage IV Melanoma or High Risk Invasive Urothelial Carcinoma Originating in the Bladder
The purpose of this study is to evaluate the switch from Nivolumab Intravenous (IV) infusions to Nivolumab Subcutaneous (SC) administration in participants with resected Stage IIIA/B/C/D or Stage IV melanoma or resected invasive Urothelial Carcinoma (UC) originating in the bladder who have high risk of recurrence.
- Conditions
- Melanoma, Urothelial Carcinoma
- Being tested
- Nivolumab/rHuPH20, Nivolumab
- Keywords
- Resected Invasive Urothelial Carcinoma, Nivolumab, Bladder, Melanoma, Adjuvant, Subcutaneous
- Medical subject headings
- Melanoma, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab/rHuPH20Drug
Also called Opdivo, BMS-986298
Specified dose on specified days
NivolumabDrug
Also called Opdivo, BMS-936558
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab IV followed by Nivolumab SC | Experimental | Not described Receives: Drug: Nivolumab/rHuPH20; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants That Prefer Nivolumab SC at the First Assessment of Patient Preference Using Patient Experience and Preference Questionnaire (PEPQ) (Question 1)
Measured: Up to 24 hours after first full dose at Cycle 4, Day 1 (98 Days)
Secondary outcomes (2)
Number of Participants with Adverse Events (AEs)
Measured: Up to 100 days following last dose of nivolumab (Up to Day 465)
Proportion of Participants That Prefer Nivolumab SC at the Second Assessment of Patient Preference Using PEPQ (Question 1)
Measured: Up to 24 hours after fourth full dose at Cycle 5, Day 15 (140 Days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start31 May 2023 (estimated)
- Primary completion24 Jun 2024 (estimated)
- Study completion24 Jun 2026 (estimated)
Why it stopped: Replaced it with another clinical trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT05496192
- Sponsor's protocol ID
- CA209-6L6
- Other IDs
- 2022-000294-67, U1111-1273-4725
- Status last verified
- Apr 2023
- First submitted
- 9 Aug 2022
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and research/disclosurecommitment.html
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Adjuvant Nivolumab Switch From Intravenous (IV) to Subcutaneous (SC) Use in Participants With Resected Stage III or Stage IV Melanoma or High Risk Invasive Urothelial Carcinoma Originating in the Bladder
- ClinicalTrials.gov ID
- NCT05496192
- Acronym / sponsor ID
- CA209-6L6
- Conditions
- Melanoma, Urothelial Carcinoma
- Keywords
- Resected Invasive Urothelial Carcinoma, Nivolumab, Bladder, Melanoma, Adjuvant, Subcutaneous
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Replaced it with another clinical trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 31 May 2023 (estimated)
- Primary completion
- 24 Jun 2024 (estimated)
- Study completion
- 24 Jun 2026 (estimated)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
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 this study is to evaluate the switch from Nivolumab Intravenous (IV) infusions to Nivolumab Subcutaneous (SC) administration in participants with resected Stage IIIA/B/C/D or Stage IV melanoma or resected invasive Urothelial Carcinoma (UC) originating in the bladder who have high risk of recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nivolumab IV followed by Nivolumab SC | Experimental | Drug: Nivolumab/rHuPH20, Drug: Nivolumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Participants must be eligible for adjuvant therapy for melanoma or muscle-invasive Urothelial Carcinoma (UC) originating from the bladder.
- All participants must have disease-free status (DFS) documented by a complete physical examination and imaging studies within 4 weeks prior to treatment assignment.
Key exclusion criteria (5 listed)
- History of ocular or uveal or mucosal melanoma.
- Upper tract UC (ureter, renal pelvis), non-muscle-invasive UC.
- Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment.
- Untreated/unresected Central Nervous System (CNS) or leptomeningeal metastases.
- Other protocol-defined inclusion/exclusion criteria apply
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 |
|---|---|---|
| Nivolumab/rHuPH20Also: Opdivo, BMS-986298Specified dose on specified days | Drug | Nivolumab IV followed by Nivolumab SC |
| NivolumabAlso: Opdivo, BMS-936558Specified dose on specified days | Drug | Nivolumab IV followed by Nivolumab SC |
Primary outcome
Proportion of Participants That Prefer Nivolumab SC at the First Assessment of Patient Preference Using Patient Experience and Preference Questionnaire (PEPQ) (Question 1)
Time frame: Up to 24 hours after first full dose at Cycle 4, Day 1 (98 Days)
2 secondary outcomes
Number of Participants with Adverse Events (AEs)
Time frame: Up to 100 days following last dose of nivolumab (Up to Day 465)
Proportion of Participants That Prefer Nivolumab SC at the Second Assessment of Patient Preference Using PEPQ (Question 1)
Time frame: Up to 24 hours after fourth full dose at Cycle 5, Day 15 (140 Days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and research/disclosurecommitment.html
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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
3 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/rHuPH20 and Nivolumab in people with Melanoma and Urothelial Carcinoma, run by Bristol-Myers Squibb at 3 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 3 inclusion and 5 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: withdrawn, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Spain. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Proportion of Participants That Prefer Nivolumab SC at the First Assessment of Patient Preference Using Patient Experience and Preference Questionnaire (PEPQ) (Question 1) (time frame: Up to 24 hours after first full dose at Cycle 4, Day 1 (98 Days)). 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 14 Apr 2023.