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Pembrolizumab With Carboplatin/Paclitaxel in Patients With Metastatic Melanoma | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Pembrolizumab With Carboplatin/Paclitaxel in Patients With Metastatic Melanoma

A Phase II Study of Pembrolizumab With Carboplatin/Paclitaxel in Patients With Metastatic Melanoma

NCT02617849•Wilson Miller

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The subject must:
•1. Be willing and able to provide written informed consent for the trial.
•2. Be ≥ 18 years of age on day of signing informed consent.
•3. Have histologically confirmed diagnosis of unresectable Stage III or metastatic melanoma.
•* Patients may not have a diagnosis of uveal melanoma.
•4. Have measurable disease based on RECIST 1.1.
•5. Have a tumor sample (FFPE archival or newly obtained biopsy) of a metastatic site that is available for biomarker analysis.
•6. Have an ECOG of 0 or 1.
•7. Demonstrate adequate organ function as below:
•* Absolute neutrophil count (ANC) ≥1.5 x 109/L
+12 more criteria

Exclusion Criteria

•The subject must be excluded from participating in the trial if the subject:
•1. 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.
•2. Has received prior therapy with an anti-CTLA4, anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
•3. Has evidence of symptomatic CNS lesions as determined by the investigator. Patients with asymptomatic lesions or previously irradiated or surgically resected are eligible.
•4. Has a known additional malignancy that is progressing or requires active treatment.
•5. 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.
•6. Has ≥ Grade 2 peripheral neuropathy.
•7. 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.
•8. Has an active infection requiring systemic therapy.
•9. 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.
+4 more criteria

Locations (2)

Jewish General Hospital

Montreal, Quebec, Canada

Hopital Notre-Dame

Montreal, Quebec, Canada

Key Dates

Start Date

May 19, 2016

Primary Completion Date

December 1, 2021

Completion Date

December 1, 2025

Last Updated

February 18, 2021

Enrollment

ACTUAL participants

Conditions

Metastatic Malignant Melanoma

Interventions

Pembrolizumab

DRUG

Carboplatin

DRUG

Paclitaxel

DRUG

A Study of IMC-1121B (Ramucirumab) With or Without Dacarbazine in Metastatic Malignant Melanoma

NCT00533702

Metastatic Malignant Melanoma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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