Trials Sponsors Conditions Drugs Pricing

Conditions

Metastatic Adult Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (2)

progression free survival rate at 6 months - PFSR6
The primary efficacy endpoint of the trial is the progression-free survival rate after 6 months (PFSR6), assessed by applying RECIST 1.1.
after 6 months of treatment
safety, as measured by: - Incidence of adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation, and deaths - Incidence of clinical laboratory test abnormalities
The primary safety endpoint is to assess the feasibility of combined treatment with trabectedin and nivolumab in patients with metastatic or inoperable soft tissue sarcomas as determined by the safety and tolerability of the combination treatment.
through study completion, an average of 24 months

Secondary Outcomes (5)

overall response rate (ORR)
through study completion, an average of 24 months
overall survival (OS)
through study completion, an average of 24 months
progression-free survival (PFS)
through study completion, an average of 24 months
duration of disease stabilization (DoDS)
through study completion, an average of 24 months
PDL-1 expression
through study completion, an average of 24 months

Study Arms (2)

Group A - L-sarcoma

EXPERIMENTAL

Patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen will receive drug treatment with trabectedin (1 cycle mono-therapy) followed by trabectedin/nivolumab combination (up to 15 additional cycles); 16 cycles in total

Drug: TrabectedinDrug: Nivolumab

Group B - non-L-sarcoma

EXPERIMENTAL

Patients with unresectable or metastatic soft tissue sarcoma other than liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen (GIST excluded) will receive drug treatment with trabectedin (1 cycle mono-therapy) followed by trabectedin/nivolumab combination (up to 15 additional cycles); 16 cycles in total

Drug: TrabectedinDrug: Nivolumab

Interventions

TrabectedinDrug

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

Also known as: Yondelis

Group A - L-sarcomaGroup B - non-L-sarcoma

NivolumabDrug

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Group A:
Patients must have histologically confirmed liposarcoma or leiomyosarcoma

Sponsors & Collaborators

University Medicine Greifswald
Otherlead
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Othercollaborator

Study Sites (9)

Helios Klinikum Bad Saarow, Klinik für Hämatologie, Onkologie und Palliativmedizin, Sarkomzentrum Berlin-Brandenburg

Bad Saarow, 15526, Germany

Helios Klinikum Berlin Buch, Klinik für interdisziplinäre Onkologie, Sarkomzentrum Berlin-Brandenburg

Berlin, 13125, Germany

Charité Universitätsmedizin Berlin, Campus Virchow Klinikum Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie (CC14)

Berlin, 13353, Germany

Medizinische Fakultät "Carl Gustav Carus" der TU Dresden, Medizinische Klinik I

Dresden, 01307, Germany

Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere Medizin C, Hämatologie und Onkologie

Greifswald, 17475, Germany

Universitätsklinikum Medizinische Fakultät Mannheim der Universität Heidelberg, Interdisziplinäres Tumorzentrum Mannheim (ITM)

MeSH Terms

Conditions

Sarcoma

Interventions

TrabectedinNivolumab

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

DioxolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-Ring

Study Officials

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

Enrollment

92 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 21, 2018

First Posted

July 18, 2018

Study Start

June 8, 2018

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Study Arms (2)

Group A - L-sarcoma

Group B - non-L-sarcoma

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Study Arms (2)

Group A - L-sarcoma

Group B - non-L-sarcoma

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations