A Phase I/II Study of Pembrolizumab (MK-3475) in Children with advanced melanoma or a PD-L1 positive advanced, relapsed or refractory solid tumor or lymphoma (KEYNOTE-051) - A Phase I/II trial of MK-3475 (pembrolizumab) in children’s solid tumors and lymphoma

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites311 target enrollmentFebruary 27, 2015

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Enrollment: 311
Status: Active, not recruiting
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 27, 2015

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Be willing and able to provide written informed consent/assent for the trial. The subject may also provide consent/assent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
•2\. Be between 6 months and less than 18 years of age on day of signing informed consent/assent.
•3\. Have histologically or cytologically\-documented, locally\-advanced, or metastatic solid malignancy that is incurable and has either (a) failed prior standard therapy, (b) for which no standard therapy exists, or (c) standard therapy is not considered appropriate by the patient and treating physician. There is no limit to the number of prior treatment regimens.
•4\. Be able to provide tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated (tumors progressing in a prior site of radiation are allowed for characterization, other exceptions may be considered after Sponsor consultation).
•5\. Have either advanced melanoma or a PD\-L1 positive advanced, relapsed or refractory solid tumor or lymphoma as determined by IHC in archival formal fixed paraffin embedded tumor (FFPET) or newly obtained biopsy. (Subjects with PD\-L1 negative tumors may be enolled in Part II of the trial in selet tumor types where preliminary response is observed)
•6\. Have measurable disease based on RECIST 1\.1\. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. During Part I of the trial, subjects with neuroblastoma may be enrolled with evaluable disease.
•7\. Have a performance status as defined below:
•Lansky Play Scale \=70 for children up to and including 16 years of age;
•Karnofsky score \=70 for children \> 16 years of age
•8\. Demonstrate adequate organ function

Exclusion Criteria

•1\. Is currently participating and receiving study therapy in,or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
•2\. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
•3\. Has had a prior anti\-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., \= Grade 1 or at baseline) from adverse events due to mAbs administered more than 4 weeks earlier.
•4\. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., \= Grade 1 or at baseline) from adverse events due to a previously administered agent.
•5\. Has a known additional malignancy that is progressing or requires active treatment with limited exceptions.
•6\. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging \[using the same imaging techniques for diagnosis and follow\-up] for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability. Patients with primary CNS tumors or metastases of primary CNS tumors are not excluded but must be neurologically stable (e.g. without a progression of neurologic symptoms or requiring systemic steroid therapy within last 2 weeks).
•7\. Has an active autoimmune disease that has required systemic treatment in past 2 years
•8\. Has evidence of interstitial lung disease.
•9\. Has an active infection requiring systemic therapy.
•10\. 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.