PROMO: A phase II study of Pembrolizumab in patients with Relapsed Or Metastatic Osteosarcoma not eligible for curative surgery - PROMO

OSLO UNIVERSITETSSYKEHUS HF0 sites25 target enrollmentFebruary 27, 2018

DrugsKEYTRUDA - 50 MG- POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE- USO ENDOVENOSO- FLACONCINO (VETRO) 1 FLACONCINO

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: OSLO UNIVERSITETSSYKEHUS HF
Enrollment: 25
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 27, 2018

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

OSLO UNIVERSITETSSYKEHUS HF

Eligibility Criteria

Inclusion Criteria

•1\. Histologically confirmed osteosarcoma.
•2\. Disease relapse or progression after at least one line of systemic treatment.
•3\. Surgical resection with curative intent not possible.
•4\. Be willing and able to provide written informed consent/assent for the trial.
•5\. Be 18 years of age on day of signing informed consent.
•6\. Have measurable disease based on RECIST, version 1\.1\.
•7\. Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion.
•8\. Have a performance status of 0 or 1 on the ECOG Performance Scale.
•9\. Demonstrate adequate organ function as defined in Table 1\.
•Are the trial subjects under 18? no

Exclusion Criteria

•1\. Is currently participating and receiving study therapy 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 a known history of active TB (Bacillus Tuberculosis)
•4\. Has a history of (non\-infectious) pneumonitis that required steroids or current pneumonitis.Hypersensitivity to pembrolizumab or any of its excipients.
•5\. Hypersensitivity to pembrolizumab or any of its excipients.
•6\. 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 agents administered more than 4 weeks earlier.
•7\. 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.
•8\. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
•9\. Has known active central nervous system (CNS) metastases and/or sarcomatous meningitis.
•10\. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).