Treatment for melanoma that has spread to the brain using immune therapy and steroids
Efficacy of Immunotherapy in Melanoma Patients With Brain Metastases Treated With Steroids
PHASE2 · Herlev Hospital · NCT03563729
This study is testing if a combination of immune therapies can help patients with melanoma that has spread to the brain while they are also taking steroids.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Herlev Hospital (other) |
| Drugs / interventions | pembrolizumab, ipilimumab, nivolumab, immunotherapy |
| Locations | 3 sites (Herlev, Capital Region and 2 other locations) |
| Trial ID | NCT03563729 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of checkpoint inhibitors, specifically pembrolizumab alone or in combination with ipilimumab and nivolumab, in patients with malignant melanoma that has metastasized to the brain and requires steroid treatment. Participants will be assigned to one of four treatment arms based on their steroid dosage and treatment type. The study aims to determine if these therapies can provide clinical benefits despite the use of steroids, which are typically thought to inhibit immune response. The trial addresses a significant unmet need for patients who are often excluded from immunotherapy due to their steroid use.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed metastatic melanoma and brain metastases requiring systemic steroid treatment.
Not a fit: Patients who do not have brain metastases or those who do not require steroid treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for melanoma patients with brain metastases who currently have limited therapeutic choices.
How similar studies have performed: While small phase II studies have shown promise for checkpoint inhibitors in similar patient populations, this approach remains largely untested in larger cohorts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Another malignancy or concurrent malignancy unless disease-free for 3 years * Ocular melanoma * Neurological symptoms from brain metastases present at baseline despite steroid treatment, unless symptoms are related to prior surgery * 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 * 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 * Pregnant or breastfeeding females. * For arm E specifically: Prior treatment with BRAF/MEK inhibitors.
Where this trial is running
Herlev, Capital Region and 2 other locations
- Herlev Universityhospital — Herlev, Capital Region, Denmark (RECRUITING)
- Aarhus Universityhospital — Aarhus, Midt, Denmark (NOT_YET_RECRUITING)
- Odense Universityhospital — Odense, Syd, Denmark (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Troels H Borch, PhD — Center for Cancer Immune Therapy, Department of Hematology and Department of Oncology
- Study coordinator: Inge M Svane, Professor
- Email: inge.marie.svane@regionh.dk
- Phone: 004538683868
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Malignant Melanoma, Immune therapy, checkpoint inhibitor, pembrolizumab, ipilimumab, nivolumab, steroid, brain metastasis