Trials Sponsors Conditions Drugs Pricing

Conditions

Metastatic Adult Soft Tissue Sarcoma Recurrent Adult Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

overall survival (OS)
up to 57 months from randomization

Secondary Outcomes (6)

AEs / SAEs and Treatment Emergent Adverse Events according to CTCAE 4.03
up to 18 months from randomization
Objective Response Rate (ORR) according to RECIST 1.1 criteria
up to 57months from randomization
OS mile stone rate at 24 months
up to 24 months from randomization
Duration of response
up to 57 months from randomization
progression-free survival (PFS)
up to 57 months from randomization
+1 more secondary outcomes

Study Arms (2)

Durvalumab and Tremelimumab

EXPERIMENTAL

Cycles/courses 1-3: Durvalumab 1.5g q4wks Tremelimumab 75 mg q4wks Cycles/courses ≥4: Durvalumab 1.5g q4wks Tremelimumab 75 mg q12wks

Biological: Durvalumab and Tremelimumab

Doxorubicin

ACTIVE COMPARATOR

Doxorubicin 75 mg/qm q3wks for 6 courses

Drug: Doxorubicin

Interventions

Durvalumab and TremelimumabBiological

immun checkpoint inhibitor

Durvalumab and Tremelimumab

DoxorubicinDrug

Anthracycline

Doxorubicin

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Durvalumab and Tremelimumab
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Fibrosarcoma
Pleomorphic high grade sarcoma ("malignant fibrous histiocytoma")

Sponsors & Collaborators

AIO-Studien-gGmbH
Otherlead
AstraZeneca
Industrycollaborator

Study Sites (1)

Medizinische Hochschule Hannover

Hanover, 30625, Germany

MeSH Terms

Conditions

Sarcoma

Interventions

durvalumabtremelimumabDoxorubicin

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

Viktor Grünwald, Dr.
Universitätsklinikum Essen
PRINCIPAL INVESTIGATOR

Enrollment

103 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

October 18, 2017

First Posted

October 23, 2017

Study Start

December 15, 2017

Actual (reported)

You may not qualify if:

\. Patients who are suitable for anthracycline-based combination therapies 2. Cardiac events such as arrhythmias, myocardial infarction, CHF, apoplexy, lung embolism within 6 months prior to study treatment 3. Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Fredericia's correction 4. Uncontrolled severe hypertension (failure of diastolic blood pressure to fall below 100 mmHg and systolic blood pressure \>160 mmHg) 5. Previous malignancy (other than STS) which either progresses or requires active treatment.
Exceptions are: basal cell cancer of the skin, pre-invasive cancer of the cervix, T1a or T1b prostate carcinoma, or superficial bladder tumor \[Ta, Tis and T1\].
\. History or clinical evidence of CNS metastases
Exceptions are: Subjects who have completed local therapy and who meet both of the following criteria:
are asymptomatic and
have no requirement for steroids 6 weeks prior to start of study treament. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS metastases 7. Active or prior documented autoimmune disease within the past 2 years. NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
\. Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) 9. History of primary immunodeficiency 10. History of allogeneic organ transplant 11. History of hypersensitivity to durvalumab, tremelimumab (alone or in combination), doxorubicin or any of the constituents of the products 12. Medication that is known to interfere with any of the agents applied in the trial.
\. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent.
\. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study medication. Note: Local surgery of isolated lesions for palliative intent is acceptable.
Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Coordinating Investigator.
Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab (if applicable) may be included only after consultation with the Coordinating Investigator.
\. Previous enrollment or randomization in the present study (does not include screening failure).
\. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities (§ 40 Abs. 1 S. 3 Nr. 4 AMG).
\. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts \[§ 40 Abs. 1 S. 3 Nr. 3a AMG\].

Durvalumab and Tremelimumab Compared to Doxorubicin in Patients With Advanced or Metastatic Soft Tissue Sarcoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Durvalumab and Tremelimumab

Doxorubicin

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

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

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Durvalumab and Tremelimumab

Doxorubicin

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

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