A Phase II Study of Pembrolizumab With Carboplatin/Paclitaxel in Patients With Metastatic Melanoma
Overview
- Phase
- Phase 2
- Intervention
- Pembrolizumab
- Conditions
- Metastatic Malignant Melanoma
- Sponsor
- Wilson Miller
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Overall Response Rate as assessed by RECIST 1.1 and immune-related Response Criteria
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
This is a multi-center, open-label, Phase II clinical trial evaluating pembrolizumab in combination with carboplatin/paclitaxel as a treatment in unresectable locally advanced or metastatic melanoma.
Investigators
Wilson Miller
Medical Oncologist
Jewish General Hospital
Eligibility Criteria
Inclusion Criteria
- •The subject must:
- •Be willing and able to provide written informed consent for the trial.
- •Be ≥ 18 years of age on day of signing informed consent.
- •Have histologically confirmed diagnosis of unresectable Stage III or metastatic melanoma.
- •Patients may not have a diagnosis of uveal melanoma.
- •Have measurable disease based on RECIST 1.
- •Have a tumor sample (FFPE archival or newly obtained biopsy) of a metastatic site that is available for biomarker analysis.
- •Have an ECOG of 0 or
- •Demonstrate adequate organ function as below:
- •Absolute neutrophil count (ANC) ≥1.5 x 109/L
Exclusion Criteria
- •The subject must be excluded from participating in the trial if the subject:
- •Has had prior treatment for advanced unresectable or metastatic melanoma. Prior treatment with BRAF and MEK inhibitors is permitted in this setting. A washout of at least 5-half-lives (median terminal half-life) prior to the first dose of trial treatment must have elapsed.
- •Has received prior therapy with an anti-CTLA4, anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
- •Has evidence of symptomatic CNS lesions as determined by the investigator. Patients with asymptomatic lesions or previously irradiated or surgically resected are eligible.
- •Has a known additional malignancy that is progressing or requires active treatment.
- •Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (\>10 mg daily prednisone equivalents) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Inhaled or topical steroids, and adrenal replacement doses ≤ 10 mg prednisone equivalents are permitted.
- •Has ≥ Grade 2 peripheral neuropathy.
- •Patients with an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo or resolved childhood asthma/atopy is an exception to this rule. Patients that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Patients with hypothyroidism stable on hormone replacement will not be excluded from the study.
- •Has an active infection requiring systemic therapy.
- •Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Arms & Interventions
Pembrolizumab, Carboplatin, Paclitaxel
Carboplatin will be administered at AUC = 6, IV over 60 minutes every 3 weeks for up to 4 doses. Paclitaxel will be administered at 175mg/m2, IV over 3 hours every 3 weeks for up to 4 doses. Pembrolizumab will be administered at 200 mg, IV over 30 minutes every 3 weeks.
Intervention: Pembrolizumab
Pembrolizumab, Carboplatin, Paclitaxel
Carboplatin will be administered at AUC = 6, IV over 60 minutes every 3 weeks for up to 4 doses. Paclitaxel will be administered at 175mg/m2, IV over 3 hours every 3 weeks for up to 4 doses. Pembrolizumab will be administered at 200 mg, IV over 30 minutes every 3 weeks.
Intervention: Carboplatin
Pembrolizumab, Carboplatin, Paclitaxel
Carboplatin will be administered at AUC = 6, IV over 60 minutes every 3 weeks for up to 4 doses. Paclitaxel will be administered at 175mg/m2, IV over 3 hours every 3 weeks for up to 4 doses. Pembrolizumab will be administered at 200 mg, IV over 30 minutes every 3 weeks.
Intervention: Paclitaxel
Outcomes
Primary Outcomes
Overall Response Rate as assessed by RECIST 1.1 and immune-related Response Criteria
Time Frame: 56 months
Secondary Outcomes
- Overall Survival(56 months)
- Progression Free Survival(56 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(56 months)
- Melanoma-associated serological markers by multiplexed array will be generated(56 months)