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New treatment option for Melanoma Stage IV
Official title Safe Stop Ipilimumab-nivolumab (IPI-NIVO) Trial
ClinicalTrials.gov ID: NCT05652673
What this study is testing
What is nivolumab?
nivolumab is an investigational medicine, being studied as a potential treatment for melanoma stage iv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Safe Stop IPI-NIVO Trial: Early discontinuation of nivolumab upon achieving a (confirmed) complete or partial response in patients with irresectable stage III or metastatic melanoma treated with first-line ipilimumab-nivolumab
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 18 years of age or older
- Irresectable stage III or metastatic melanoma
- Treated with at least one dose of first-line ipilimumab-nivolumab and considered to be a candidate for maintenance treatment with nivolumab:
- previous systemic treatment, including immune-checkpoint inhibitors, in (neo)adjuvant setting for resectable melanoma is allowed
- in this protocol, nivolumab maintenance is interchangeable with pembrolizumab maintenance therapy.
You likely can't join if
- Patients with SD/PD according to RECIST v1.1
- Malignant disease other than being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated...
- Presence of symptomatic brain metastases:
- prior to first-line treatment with ipilimumab-nivolumab, or;
- when defined as new or progressive brain metastases at the time of study entry;
- brain metastases with need for steroid treatment in the last 8 weeks prior to study entry Note: An incidental epileptic seizure caused by a brain...
See the full eligibility criteria
- 18 years of age or older
- Irresectable stage III or metastatic melanoma
- Treated with at least one dose of first-line ipilimumab-nivolumab and considered to be a candidate for maintenance treatment with nivolumab:
- previous systemic treatment, including immune-checkpoint inhibitors, in (neo)adjuvant setting for resectable melanoma is allowed
- in this protocol, nivolumab maintenance is interchangeable with pembrolizumab maintenance therapy.
- Response evaluation according to RECIST v1.1 30 using a diagnostic CT documenting target lesions every 12 (-2/+6) weeks from the start of ipilimumab-nivolumab:
- for patients with CR on a diagnostic CT at response evaluation, a low-dose CT (which is usually part of 18FDG-PET/CT) is allowed at baseline
- for patients with PR on a diagnostic CT at response evaluation, a low-dose CT (which is usually part of 18FDG-PET/CT) is allowed if sufficient target lesions are measurable for response evaluation according to RECIST...
- in case of asymptomatic brain metastases prior to start of first-line ipilimumab-nivolumab, intracerebral tumor response should be confirmed using an MRI for response evaluation prior to inclusion in this study.
- Patients should be included after first CR/PR or first confirmed CR/PR according to RECIST v1.1 30:
- inclusion should take place no later than 5 weeks after first confirmed CR/PR
- in case of SD at first response evaluation, confirmed CR/PR is required for inclusion
- planned and willing to discontinue nivolumab within 4(+1) weeks after inclusion, i.e. first CR/PR or first confirmed CR/PR
- no later than 9 months after start of treatment with ipilimumab-nivolumab
- Presence of MRI brain for the screening of brain metastases (prior to discontinuation of ipilimumab-nivolumab)
- Participants with previously locally treated brain metastases may participate in case they meet the following criteria:
- completely asymptomatic brain metastases at inclusion
- MRI of brain at baseline and for response evaluation during treatment
- Signed and dated informed consent form
- Patients with SD/PD according to RECIST v1.1
- Malignant disease other than being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to start of study...
- Presence of symptomatic brain metastases:
- prior to first-line treatment with ipilimumab-nivolumab, or;
- when defined as new or progressive brain metastases at the time of study entry;
- brain metastases with need for steroid treatment in the last 8 weeks prior to study entry Note: An incidental epileptic seizure caused by a brain lesion is not considered an exclusion criterion. (provided that the other...
- Presence of leptomeningeal metastases;
- Systemic chronic steroid therapy (\>10mg/day prednisone or equivalent) at inclusion or patients who need or needed any other second-line immunosuppressive therapy (e.g. infliximab, mycophenolate mofetil) for the...
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before...
The study team makes the final eligibility decision.
Where it's taking place
- Rotterdam, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rotterdam, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.