TROPHIMMUN, a phase II trial of avelumab in chemo-resistant gestational trophoblastic neoplasias (GTN) - TROPHIMM

Hospices Civils de Lyon0 sitesDecember 16, 2016

ConditionsGestational trophoblastic neoplasias MedDRA version: 19.0Level: PTClassification code 10061988Term: Gestational trophoblastic tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Gestational trophoblastic neoplasias
Sponsor: Hospices Civils de Lyon
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 16, 2016

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

Hospices Civils de Lyon

Eligibility Criteria

Inclusion Criteria

•\-Woman older than 18 years
•\-Patients with gestational trophoblastic disease resistant to mono\-chemotherapy (methotrexate and/or actinomycine\-D) or polychemotherapy (such as EMA\-CO; EMA\-EP; BEP; … regimens).
•\-No limitation in the number of previous chemotherapy lines
•\-Patients with Eastern Cooperative Oncology Group (ECOG) performance status \= 2
•\-Archival tumor tissue available and assessable for planned analyses, or tumor lesion biopsy feasible
•\-Patients with adequate bone marrow function measured within 28 days prior to administration of study treatment as defined below
•\*Absolute granulocyte count \= 1\.5 x 10 9 /L
•\*Platelet count \= 100 x 10 9 /L
•\* Haemoglobin \= 9\.0 g/dL (may have been blood transfused)
•\-Patients with adequate renal function :

Exclusion Criteria

•\-Prior therapy with an anti\-PD\-1, anti\-PD\-L1, anti\-PD\-L2, anti\-CD137, or anti\-cytotoxicT lymphocyte\-associated antigen 4 (CTLA 4\) antibody (including ipilimumab, tremelimumab or any other antibody or drug specifically targeting T\-cell co\-stimulation or immune checkpoint pathways).
•\-Illness, incompatible with avelumab, such as congestive heart failure; respiratory distress; liver failure; allergy.
•\-Patients with second primary cancer, except: adequately treated non\-melanoma skin cancer, curatively treated in\-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for \= 5 years.
•\-All subjects with brain metastases, except those meeting the following criteria:
•oBrain metastases that have been treated locally and are clinically stable for at least 2 weeks prior to enrollment,
•oNo ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable).
•oSubjects with brain metastases must be either off steroids except a stable or decreasing dose of \<10mg daily prednisone (or equivalent).
•\-Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons), within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used). The patient can receive a stable dose of bisphosphonates for bone metastases, before and during the study as long as these were started at least 4 weeks prior to treatment with study drug.
•\-Persistent toxicities (\>\=CTCAE grade 2\) with the exception of alopecia and sensory neuropathy, caused by previous cancer therapy.
•\-Treatment with other investigational agents.