Nivolumab With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients Wit… (NCT02910700) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Nivolumab With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma
United States52 participantsStarted 2016-12-09
Plain-language summary
This phase II trial studies the side effects and how well nivolumab with trametinib and dabrafenib, or encorafenib and binimetinib work in treating patients with BRAF-mutated stage III-IV melanoma that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Trametinib, dabrafenib, encorafenib, and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known if nivolumab with trametinib and dabrafenib, or encorafenib and binimetinib may work better in treating patients with BRAF-mutated melanoma.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed metastatic melanoma (stage IV) or unresectable Stage III that have progressed on or after receiving prior PD-1 directed therapy; only patients with BRAF V600 mutated melanoma are eligible; please note that patients with brain metastasis are not required to have prior PD-1
* Prior therapies for metastatic melanoma are allowed, including chemo-, cytokine-, immuno, biological and vaccine-therapy as long as they did not include BRAFi, MEKi; patients who have progressed on or after receiving anti-PD-1therapy in the adjuvant setting are also allowed; prior ipilimumab and/or PD-1 directed therapy will be allowed with a washout period of 2 weeks and if all autoimmune adverse events have resolved to grade 1 (except endocrine abnormalities that require continuous replacement)
* Evidence of evaluable disease
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Patients with melanoma brain metastases are allowed regardless of prior PD-1 exposure. Subjects with brain metastases are eligible if:
* Metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for 2 weeks after treatment is complete and within 14 days of the first dose of nivolumab administration; or
* If they are untreated but asymptomatic; or
* If they are untreated and symptomatic but symptoms are controlled on stable or decreasing doses of steroids for 14 days prior to drug administration; or
* If they h…
What they're measuring
1
Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors version 1.1 on both arms
Timeframe: From the time of initial response until documented tumor progression, assessed up to 3 years