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Clinical Trials/NL-OMON42782
NL-OMON42782
Completed
Phase 2

An open-label, single-arm, phase II, multicenter study to evaluate the efficacy of nivolumab in metastatic melanoma patients with symptomatic brain metastases. - Nivolumab in symptomatic brain metastases of melanoma origin

niversitair Medisch Centrum Groningen0 sites70 target enrollmentTBD
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Conditionsadvanced melanomaMetastatic melanoma10027476

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
advanced melanoma
Sponsor
niversitair Medisch Centrum Groningen
Enrollment
70
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Subjects must sign informed consent prior to inclusion in this trial.
  • •2\.Subjects must be \*18 years of age and competent to give informed consent.
  • •3\.Subjects must have a histologically confirmed diagnosis of stage IV melanoma.
  • •4\.Subjects must have clinical symptoms that are relatable to the intracranial lesions as assessed by a neurologist.
  • •5\.At least one new cerebral lesion on MRI, measurable by RANO\-BM criteria (longest diameter \* 10 mm and perpendicular diameter \* 5 mm), must be present. Lesions with prior local treatment (i.e., SRT or surgical resection) are considered measurable if progression since the time of local treatment has been demonstrated. Leptomeningeal metastases are allowed, but will not be labeled target lesions.
  • •6\.Treatment with BRAF\-inhibitors during a maximum of eight weeks is allowed for patients with a positive BRAF\-mutational status.
  • •7\.Subjects must be treatment\-naive to nivolumab.
  • •8\.Subjects must score 0 \* 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
  • •9\.Subjects must have adequate organ function as defined by the following laboratory values (determined within 28 days prior to randomization and registration):
  • •\*White blood cells (WBC) \* 2000 /µL

Exclusion Criteria

  • •1\.Subjects who have been treated with an anti\-PD\-1, anti\-PD\-L1, anti\-PD\-L2 antibody previously.
  • •2\.Subjects who have not recovered to Common Terminology Criteria for Adverse Events (CTCAE) v4\.0 grade 1 or better from adverse events due to previous cancer therapy.
  • •3\.Evidence for an active autoimmune disease, known or suspected. Potential subjects diagnosed with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • •4\.Subjects treated with corticosteroids in an increasing dosage 7 days prior to the first administration of nivolumab. (A stable or decreasing dosage of \* 4 mg dexamethasone or equivalent is allowed. In addition, inhaled or topical steroids and adrenal replacement doses are permitted in the absence of active autoimmune disease.)
  • •5\.Known history of other (non\-melanoma) malignancies, with the exception of non\-melanoma skin cancers, in situ bladder cancer, gastric or colon cancers andcervical cancers/dysplasia or breast carcinoma in situ or patients in whom a complete remission was achieved at least 1 year prior to study entry and no additional therapy is required nor anticipated during the study period.
  • •6\.Known history of severe hypersensitivity reaction to treatment with monoclonal antibodies, or known hypersensitivity to study drug components.
  • •7\.Acute or chronic hepatitis B or C infection, indicated by a positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody).
  • •8\.Known history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
  • •9\.Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or impairs the ability of the patient to receive protocol therapy.
  • •10\.A known psychiatric or substance abuse disorder that could interfere with cancer therapy.

Outcomes

Primary Outcomes

Not specified

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