Pilot Study of Nivolumab w/Ipilimumab or Relatlimab in Surgically Resectable Melanoma Brain Metas… (NCT05704933) | Clinical Trial Compass
CompletedEarly Phase 1
Pilot Study of Nivolumab w/Ipilimumab or Relatlimab in Surgically Resectable Melanoma Brain Metastases
United States1 participantsStarted 2023-06-06
Plain-language summary
The purpose of this pilot study is to determine the safety and feasibility of giving a single dose of Nivolumab with Ipilimumab or Relatlimab in participants with brain metastases from melanoma who can undergo surgery for removal of their brain metastases 7- 10 days after receiving the study drug.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 years old or older on day of signing the informed consent.
* Histological confirmation of systemic cancer from melanoma.
* Surgery for metastatic brain lesions (i.e., MBM) is needed but not imminent. Imminent defined as requiring emergent intervention. A multidisciplinary team will determine the appropriateness for resection via craniotomy and level of urgency for surgery of the MBM.
* Resectable metastatic brain lesions (i.e., MBM) in whom surgical resection is a reasonable therapeutic option. A resectable metastatic brain lesion is defined as a lesion that is ≥10 mm in size of longest diameter and in a location outside of the brainstem. (Other target lesions, i.e. those that are not resected but are followed for response, can be ≥5 mm). A multidisciplinary team will determine the appropriateness for resection via craniotomy and level of urgency for surgery of the MBM.
* Patient is on ≤4 mg/day dexamethasone or equivalent/day over pre-op period.
* Patients treated with prior monotherapy with PD-1/PD-L1 are permitted.
* Treatment with BRAF MEK inhibitors (BRAF MEKi) (for example, dabrafenib / trametinib) is permitted as long as has been at least five half-lives or one week prior to study treatment, whichever is shorter.
* MRI with enhancing metastatic brain lesions (i.e., MBM) amenable to resection of contrast-enhancing tumor (determined by neurosurgeon). A multidisciplinary team will determine the appropriateness for resection via craniotomy and…
What they're measuring
1
Feasibility: Ability to recruit per treatment arm
Timeframe: At 30 months
2
Comparison of immune cell population per treatment arm
Timeframe: Up to 15 months
Trial details
NCT IDNCT05704933
SponsorH. Lee Moffitt Cancer Center and Research Institute