Last updated on January 2020

MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Solid Tumors
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Ability to understand the purpose of the study, provide signed and dated informed consent, and able to comply with all procedures
  • In Japan, if a subject is < 20 years, the written informed consent from his/her parent or guardian will be required in addition to the subject's written consent
  • Male or female subjects aged greater than or equal to (>=) 18 years
  • Life expectancy >= 12 weeks as judged by the Investigator
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry
  • Disease must be measurable with at least 1 uni dimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Adequate hematological, hepatic and renal function as defined in the protocol
  • Effective contraception for both male and female subjects if the risk of conception exists

Other protocol-defined inclusion criteria could apply.

Exclusion Criteria:

  • Concurrent treatment with non-permitted drugs and other interventions
  • Anticancer treatment within 28 days before the start of trial treatment, for example cyto reductive therapy, radiotherapy (with the exception of palliative radiotherapy delivered in a normal organ-spearing technique), immune therapy, or cytokine therapy
  • Major surgery within 28 days before the start of trial treatment (prior diagnostic biopsy is permitted)
  • Systemic therapy with immunosuppressive agents within 7 days before the start of trial treatment; or use of any investigational drug within 28 days before the start of trial treatment
  • Previous malignant disease (other than the target malignancy to be investigated in this trial) within the last 3 years. Subjects with history of cervical carcinoma in situ, superficial or non invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent are NOT excluded. Subjects with other localized malignancies treated with curative intent need to be discussed with the Medical Monitor.
  • Rapidly progressive disease which, in the opinion of the Investigator, may predispose to inability to tolerate treatment or trial procedures
  • Subjects with active central nervous system (CNS) metastases causing clinical symptoms or metastases that require therapeutic intervention are excluded
  • Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (eg, corneal transplant, hair transplant)

Other protocol-defined exclusion criteria could apply

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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