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Combination of Nivolumab Plus Relatlimab in Patients With Advanced or Metastatic Soft-tissue Sarcoma: a Proof-of-concept Randomized Phase II Study

2019-09-24 05:27:28 | BioPortfolio

Summary

This is a multicenter study assessing the efficacy of nivolumab in association with relatlimab.

Description

This multicenter, prospective, open-labeled 2-arm, randomized non-comparative phase II trial. This phase II trial is based on a 2-stage Simon's optimal design. Randomization 1:1 with 1 patient randomized in experimental arm A (association of nivolumab plus relatlimab) and 1 patient randomized in arm B (treatment by nivolumab alone).

Study Design

Conditions

Soft Tissue Sarcoma Adult

Intervention

Association of Nivolumab + Relatlimab, Nivolumab

Location

Institut Bergonié
Bordeaux
France
33000

Status

Not yet recruiting

Source

Institut Bergonié

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-24T05:27:28-0400

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Medical and Biotech [MESH] Definitions

Injuries of tissue other than bone. The concept is usually general and does not customarily refer to internal organs or viscera. It is meaningful with reference to regions or organs where soft tissue (muscle, fat, skin) should be differentiated from bones or bone tissue, as "soft tissue injuries of the hand".

The assessment, treatment, and management of soft tissue injury or dysfunction. Therapy is designed to reduce tension and irritation in affected tissues and may include MASSAGE; muscle stretching, or direct pressure on muscles, connective tissue, and TRIGGER POINTS.

The most commonly diagnosed soft tissue sarcoma. It is a neoplasm with a fibrohistiocytic appearance found chiefly in later adult life, with peak incidence in the 7th decade.

Infections of non-skeletal tissue, i.e., exclusive of bone, ligaments, cartilage, and fibrous tissue. The concept is usually referred to as skin and soft tissue infections and usually subcutaneous and muscle tissue are involved. The predisposing factors in anaerobic infections are trauma, ischemia, and surgery. The organisms often derive from the fecal or oral flora, particularly in wounds associated with intestinal surgery, decubitus ulcer, and human bites. (From Cecil Textbook of Medicine, 19th ed, p1688)

Neoplasms developing from some structure of the connective and subcutaneous tissue. The concept does not refer to neoplasms located in connective or soft tissue.

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