Safety and Efficacy of MBG453 as Single Agent and in Combination With PDR001 in Patients With Advanced Malignancies.



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:10/4/2018
Start Date:November 23, 2015
End Date:March 8, 2019
Contact:Novartis Pharmaceuticals
Email:Novartis.email@novartis.com
Phone:1-888-669-6682

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Phase I-Ib/II Open-label Multi-center Study of the Safety and Efficacy of MBG453 as Single Agent and in Combination With PDR001 in Adult Patients With Advanced Malignancies

The purpose of this first-in-human study of MBG453 is to characterize the safety,
tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MBG453
administered i.v. as a single agent or in combination with PDR001 in adult patients with
advanced solid tumors


Inclusion Criteria:

- Histologically documented advanced or metastatic solid tumors.

- Phase I-Ib part (including dose ranging part): Patients with advanced/metastatic solid
tumors, with measurable or non-measurable disease as determined by RECIST v1.1, who
have progressed despite standard therapy or are intolerant of standard therapy, or for
whom no standard therapy exists and who did not receive prior anti-PD-1/PD-L1
treatment.

- Phase II part (MBG453 single agent): Patients with advanced/metastatic solid tumors in
the indication in which at least one confirmed PR or CR was seen during the dose
escalation phase I part. Patients must have measurable disease as determined by RECIST
v1.1, have progressed despite standard therapy or be intolerant to standard therapy.

- Phase II part (MBG453 in combination PDR001): Patients with advanced/metastatic tumors
in the below selected indications, with at least one measurable lesion as determined
by RECIST v1.1, who have received standard therapy and are intolerant of standard
therapy or have progressed following their last prior therapy.:

- Melanoma (anti-PD-1/PD-L1 therapy naïve or pre-treated)

- Non small cell lung cancer (anti-PD-1/PD-L1 therapy naïve or pre-treated)

- Renal Cell Carcinoma (anti-PD-1/PD-L1 therapy naïve or pre-treated)

- Must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy
according to the treating institution's guidelines. Patient must be willing to undergo
a new tumor biopsy at screening/baseline, and during therapy on the study.

Exclusion Criteria:

- Presence of symptomatic central nervous system metastases.

- History of severe hypersensitivity reactions to other monoclonal antibodies.

- Human Immunodeficiency Virus, Hepatitis B Virus or Hepatitis C Virus infection.

- Active autoimmune disease or a documented history of autoimmune disease, including
ulcerative colitis and Crohn's disease or any condition that requires systemic
steroids.

- Systemic steroid therapy or any immunosuppressive therapy (≥10mg/day prednisone or
equivalent).

- Use of any vaccines against infectious diseases (e.g. varicella, pneumococcus) within
4 weeks of initiation of study treatment.

- Pre-treatment with anti-CTLA4 antibodies in combination with any other antibody or
drug specifically targeting T-cell co-stimulation or checkpoint pathway.

- Participation in an interventional, investigational non-immunotherapy study within 2
weeks of the first dose of study treatment.

- Prior participation in an interventional, investigational cancer vaccine or
immunotherapy study except for an anti-PD-1/PD-L1 study.

Other inclusion/exclusion criteria may apply.
We found this trial at
5
sites
San Antonio, Texas 78207
Principal Investigator: John Sarantopoulos
Phone: 210-450-3838
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Baltimore, Maryland 21287
Principal Investigator: Patrick Forde
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Boston, Massachusetts 02118
Principal Investigator: F Stephen Hodi
Phone: 617-582-7116
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Houston, Texas 77030
Principal Investigator: Aung Naing
Phone: 713-563-9033
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Toronto, Ontario
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