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Combined Treatment With Nivolumab and Trabectedin in Patients With Metastatic or Inoperable Soft Tissue Sarcomas

NCT03590210 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2022-11-08

No results posted yet for this study

Summary

The "NiTraSarc" trial evaluates the efficacy and feasibility (as determined by the safety and tolerability) of combined treatment with trabectedin and nivolumab in patients with metastatic or inoperable soft tissue sarcomas

Conditions

  • Metastatic Adult Soft Tissue Sarcoma

Interventions

DRUG

Trabectedin

Cycle 1 to 16 1.5mg/m² IV over 24 hours, q3w

DRUG

Nivolumab

Cycle 2 to 16 240 mg IV over 30 minutes, q3w

Sponsors & Collaborators

  • Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

    collaborator OTHER

  • PharmaMar

    collaborator INDUSTRY

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • University Medicine Greifswald

    lead OTHER

Principal Investigators

  • Daniel Pink, MD · Klinik und Poliklinik für Innere Medizin C, Hämatologie und Onkologie, Transplantationszentrum, Universitätsmedizin Greifswald

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-08
Primary Completion
2022-02-12
Completion
2022-02-12

Countries

  • Germany

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03590210 on ClinicalTrials.gov