NCT03563729RecruitingPhase 2
Melanoma Metastasized to the Brain and Steroids
Efficacy of Immunotherapy in Melanoma Patients With Brain Metastases Treated With Steroids
Source: ClinicalTrials.gov · Last updated 13 Jul 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This clinical trial is to clarify whether treatment with a checkpoint inhibitor alone (pembrolizumab) or two in combination (ipilimumab and nivolumab), results in clinical benefit for MM patients with brain metastases and in need of steroid treatment. Patients will be treated in four arms depending on steroid dose level at inclusion (\> 10 \< 25 mg prednisolone or \> 25 mg prednisolone) and treatment (pembrolizumab alone or the combination of ipilimumab and nivolumab).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 6 Jun 2018
- Start date
- 6 Jun 2018
- Primary completion date
- 1 Jun 2024
- Lead sponsor
- Inge Marie Svane
- Diseases
- Melanoma
- NCT number
- NCT03563729
- EU CT number
- 2024-516585-11-00
- EudraCT number
- 2018-000875-34
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 80
- From 6 Jun 2018 to the primary completion date, 1 Jun 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Another malignancy or concurrent malignancy unless disease-free for 3 years
- Neurological symptoms from brain metastases present at baseline despite steroid treatment, unless symptoms are related to prior surgery
- Prior treatment with anti-PD-1/PD-L1/PD-L2/CTLA-4 antibodies in the metastatic setting
- Prior systemic treatment with anti-PD-1/PD-L1/PD-L2/CTLA-4 antibodies in the adjuvant setting, unless completed more than 6 months before enrolment in this study
- Simultaneous treatment with other experimental drugs or other anti-cancer drugs
- For arm E specifically: Prior treatment with BRAF/MEK inhibitors.
Other illness
- Known hypersensitivity to one of the active drugs or excipients
- Acute or chronic infections with HIV or hepatitis
- Any medical condition that will interfere with patient compliance or safety
Other
- Ocular melanoma
- Pregnant or breastfeeding females.
Who the study is looking for
- Histologically confirmed metastatic melanoma with radiologically verified brain metastasis
- Need for systemic steroid treatment (prednisolone \> 10 mg daily; dexamethasone \> 1.6 mg daily, hydrocortisone \> 40 mg daily or equivalent) due to brain metastasis
- At least one measurable lesion according to RECIST version 1.1 guidelines
- Evaluable intracranial disease
- 18 years of age or older
- Performance status 0-2
- Able to undergo MRI with gadolinium contrast agent
- Adequate hematological and organ function
- No significant toxicity from previous cancer treatments (CTC\<1)
- Women of childbearing potential: Negative serum pregnancy test and must use effective contraception. This applies from screening and until 6 months after treatment. Birth control pills, spiral, depot injection with gestagen, subdermal implantation, hormonal vaginal ring and transdermal depot patch are all considered effective contraceptives
- Men with female partner of childbearing potential must use effective contraception from screening and until 6 months after treatment. Effective contraceptives are as described above for the female partner. In addition documented vasectomy and sterility or double barrier contraception are considered effective contraceptives
- Signed statement of consent after receiving oral and written study information.
- Willingness to participate in the planned treatment and follow-up and capable of handling toxicities.
- For arm E specifically: Tumor cells must harbor BRAF mutation.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus Universitet Coordinator of this site? Confirm its status | Aarhus N | Denmark | Completed |
| Region Hovedstaden Coordinator of this site? Confirm its status | Herlev | Denmark | Completed |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense C | Denmark | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.