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New treatment option for Melanoma (Skin)
Official title Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases
ClinicalTrials.gov ID: NCT05704647
What this study is testing
What is BMS-986213 (Relatlimab-Nivolumab FDC)?
BMS-986213 (Relatlimab-Nivolumab FDC) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for melanoma (skin).
Also referred to as Relatlimab, BMS-986016.
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
- To learn if giving nivolumab in combination with relatlimab can help to control melanoma that has spread to the brain (melanoma with brain metastases). The safety and side effects of the study drug combination will also be studied.
- Phase 2: a mid-size study of how well it works
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
- Age ≥ 18 years old.
- Life Expectancy \> 12 weeks.
- people must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This...
- people must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.
- Histologically confirmed malignant melanoma with measurable metastases in the brain (≥ 0.5 cm).
You likely can't join if
- History of known leptomeningeal involvement (lumbar puncture not required).
- Previous stereotactic or highly conformal radiotherapy within 1 weeks before the start of dosing for this study. NOTE: The stereotactic radiotherapy...
- people previously treated with SRT \> 5 lesions in the brain. Prior whole brain radiation is not allowed.
- Brain lesion size \> 3 cm.
- Prior checkpoint inhibitor therapy in the metastatic setting
- Patients who received ipilimumab and/or anti-PD1 as adjuvant or neoadjuvant therapy must have a 6-month washout before receiving any dosing on this...
See the full eligibility criteria
Who can join
- Age ≥ 18 years old.
- Life Expectancy \> 12 weeks.
- people must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related...
- people must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.
- Histologically confirmed malignant melanoma with measurable metastases in the brain (≥ 0.5 cm).
- At least one measurable intracranial target lesion, which previously was not treated with local therapy (no prior SRS to this lesion).
- Largest diameter of ≥ 0.5cm, but ≤ 3cm as determined by contrast-enhanced MRI.
- Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks are preferred) OR at least 4 unstained slides, with an associated pathology report, for testing of tumor PD-L1 expression:
- Tumor tissue should be of good quality based on total and viable tumor content.
- Patients who do not have tissue specimens may undergo a biopsy during the screening period. Acceptable samples include core-needle biopsies for deep tumor tissue or excisional, incisional, punch, or forceps biopsies for...
- Tumor tissue from bone metastases is not evaluable for PD-L1 expression and is therefore not acceptable.
- However, if repeat biopsy is not feasible, and no archival tissue available patient still may be enrolled.
- Prior SRT and prior excision of up to 5 MBM is permitted if there has been complete recovery, with no neurologic sequelae, and measurable non irradiated lesions remain.
- Growth or change in a lesion previously irradiated will not be considered measurable. Regrowth in cavity of previously excised lesion will not be considered measurable.
- Any prior SRT to brain lesions or prior excision must have occurred ≥ 1 weeks before the start of dosing for this study.
- Radiation to NON-CNS lesions. Prior radiation to NON-CNS is allowed and does not require a washout period for treatment initiation.
- people must be free of neurologic signs and symptoms related to metastatic brain lesions and must not have required or received systemic corticosteroid therapy in the 5 days prior to beginning protocol therapy.
- ECOG performance status ≤1.
- Adequate organ function as described below.
- Women of child-bearing potential (WOCBP) must not be breastfeeding and must have a negative pregnancy test within 3 days prior to initiation of dosing. She must agree to use an acceptable method of birth control from...
- All associated toxicity from previous or concurrent cancer therapy must be resolved (to ≤ grade 1 or baseline) prior to study treatment administration. This excludes non-serious toxicities. However, stable...
- Steroids for physiological replacement are allowed.
What rules you out
- History of known leptomeningeal involvement (lumbar puncture not required).
- Previous stereotactic or highly conformal radiotherapy within 1 weeks before the start of dosing for this study. NOTE: The stereotactic radiotherapy field must not have included the brain index lesion(s).
- people previously treated with SRT \> 5 lesions in the brain. Prior whole brain radiation is not allowed.
- Brain lesion size \> 3 cm.
- Prior checkpoint inhibitor therapy in the metastatic setting
- Patients who received ipilimumab and/or anti-PD1 as adjuvant or neoadjuvant therapy must have a 6-month washout before receiving any dosing on this study.
- people with an active, known or suspected autoimmune disease. people with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not...
- people with major medical, neurologic or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolled.
- Subject has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. Note: The time requirement does not apply to participants who underwent...
- Has a known history of or is positive for hepatitis B (hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (hepatitis C virus [HCV] RNA [qualitative] is detected). a. NOTE: Without known history, testing needs...
- Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority.
- The use of corticosteroids is not allowed for 10 days prior to initiation of therapy (based upon 5 times the expected half-life of dexamethasone) except patients who are taking steroids for physiological replacement. If...
- people with a condition requiring systemic treatment with either corticosteroids (≤ 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study initiation. Inhaled or topical...
- Major surgical procedure, open biopsy (excluding skin cancer resection), or significant traumatic injury within 14 days of initiating study drug (unless the wound has healed) or anticipation of the need for major...
- Non-healing wound, ulcer, or bone fracture.
- Women who are breast-feeding or pregnant.
- Uncontrolled intercurrent illness (i.e., active infection ≥ grade 2) or concurrent condition that, in the opinion of the Investigator, would interfere with the study endpoints or the subject's ability to participate.
- History of clinically significant cardiac disease or congestive heart failure \> New York Heart Association (NYHA) class 2. people must not have unstable angina (anginal symptoms at rest) or new-onset angina within the...
- Troponin T (TnT) or I (TnI) \> 2 × institutional ULN. Participants with TnT or TnI levels between \> 1 to 2 × ULN will be permitted if repeat levels within 24 hours are ≤ 1 ULN. If TnT or TnI levels are between \>1 to 2...
- Investigational drug use within 14 days (or 5 half-lives, whichever is longer) of the first dose of nivolumab and relatlimab.
- With a history of non-infectious pneumonitis that required steroids or current pneumonitis.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
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 Houston, Texas, United States. 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.