Pembrolizumab With Carboplatin/Paclitaxel in Patients With Metastatic Melanoma

NCT02617849 | Unknown Phase 2

• 1 other identifier: MK-3475-269
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Metastatic Malignant Melanoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate as assessed by RECIST 1.1 and immune-related Response Criteria

  56 months

Secondary Outcomes (4)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  56 months

• Overall Survival

  56 months

• Progression Free Survival

  56 months

• Melanoma-associated serological markers by multiplexed array will be generated

  56 months

Study Arms (1)

Pembrolizumab, Carboplatin, Paclitaxel

EXPERIMENTAL

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.

Drug: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel

Interventions

Pembrolizumab DRUG

200 mg IV every 3 weeks

Also known as: MK3475

Pembrolizumab, Carboplatin, Paclitaxel

Carboplatin DRUG

AUC=6, every 3 weeks x 4

Pembrolizumab, Carboplatin, Paclitaxel

Paclitaxel DRUG

175 mg/m2, every 3 weeks x 4

Pembrolizumab, Carboplatin, Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 1.1.
• 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 1.
• Demonstrate adequate organ function as below:
• Absolute neutrophil count (ANC) ≥1.5 x 109/L
• Platelets ≥100 x 109/L
• Hemoglobin ≥90 g/L (may be transfused)
• Serum creatinine OR CrCl ≤ 1.5 X upper limit of normal (ULN) OR ≥60 mL/min for subject with creatinine levels \> 1.5 X institutional ULN
• Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 ULN
• AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases

You may not qualify if:

• 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.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
• Has a known history of active TB (Bacillus Tuberculosis)
• Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.

Sponsors & Collaborators

• Wilson Miller: lead

Study Sites (2)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Hopital Notre-Dame

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Melanoma

Interventions

pembrolizumab; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Wilson Miller, MD, PhD

  Jewish General Hospital

  PRINCIPAL INVESTIGATOR

• Rahima Jamal, MD, PhD

  CHUM, Hopital Notre-Dame

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Oncologist

Study Record Dates

• First Submitted: November 3, 2015
• First Posted: December 1, 2015
• Study Start: May 19, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2025
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

CA (2)