Actively Recruiting
Avelumab and Methotrexate in in Low-risk Gestational Trophoblastic Neoplasias as First Line Treatment
Led by Hospices Civils de Lyon · Updated on 2024-02-29
26
Participants Needed
9
Research Sites
452 weeks
Total Duration
On this page
Sponsors
H
Hospices Civils de Lyon
Lead Sponsor
M
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Collaborating Sponsor
AI-Summary
What this Trial Is About
Gestational trophoblastic neoplasias (GTN) are characterized by the persistence of elevated hCG titers after complete uterine evacuation of a partial hydatidiform mole (PHM) or a complete hydatidiform mole. Low-risk GTN patients (FIGO score ≤ 6) are commonly treated with single agent treatment (methotrexate or actinomycin-D) The cure rate, assessed by hCG normalization, is obtained in 65 to 75% of patients with these agents GTN patients with resistance to these treatments are treated with another single agent drug or polychemotherapy regimens, such as EMA-CO or BEP regimen. Chemotherapy standard regimens are old and toxic for these young lady patients, with potential long term effects detrimental for further maternity and quality of life There is a strong rational for investigating the anti-PDL1 monoclonal antibody avelumab in chemoresistant GTN patients. Several elements suggest that the normal pregnancy immune tolerance is "hijacked" by GTN cell for proliferating : * Spontaneous regressions of metastastic GTN are regularly observed, thereby the role of immune system for rejecting GTN cells. * Strong and constant overexpression of PDL1 and NK cells has been found in all subtypes and settings of GTN tumors from French reference gestational trophoblastic center. * Complete and durable responses to pembrolizumab were reported in 3 patients with multi-chemoresistant GTN in United Kingdom. * Three cases of hCG normalization with avelumab in 6 patients with chemo-resistant GTN enrolled in TROPHIMMUN cohort A (resistant to a mono-chemotherapy). * Cytotoxicity of avelumab is mediated through antibody dependent cell cytotoxicity (ADCC) by NK cells.
CONDITIONS
Official Title
Avelumab and Methotrexate in in Low-risk Gestational Trophoblastic Neoplasias as First Line Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Woman older than 18 years
- Low-risk gestational trophoblastic neoplasia with FIGO score 6 or less requiring methotrexate as first-line treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Adequate bone marrow function: granulocyte count at least 1.5 x 10^9/L, platelet count at least 100 x 10^9/L, hemoglobin at least 9.0 g/dL (blood transfusion allowed)
- Adequate renal function with creatinine clearance at least 30 ml/min
- Adequate liver function: serum bilirubin no more than 1.5 times normal, AST/ALT no more than 2.5 times normal (up to 5 times if liver metastases present)
- Life expectancy of at least 16 weeks
- Confirmation of non-childbearing status or effective contraception if of childbearing potential
- Written informed consent to participate
- Affiliation to a social insurance regime
- Willingness and ability to follow the treatment protocol
You will not qualify if you...
- Prior treatment with immune checkpoint inhibitors targeting PD-1, PD-L1, PD-L2, CD137, or CTLA-4
- Serious illnesses incompatible with avelumab such as heart failure, respiratory distress, liver failure, uncontrolled epilepsy, or allergy
- Known allergy to methotrexate or its ingredients
- Second primary cancer except certain treated skin or cervical cancers or solid tumors with no disease for 5 years
- Brain metastases unless treated, stable for at least 2 weeks, and off steroids or on low stable steroid dose
- Recent systemic chemotherapy or radiotherapy within 2 weeks before study treatment
- Persistent moderate or worse toxicities from previous cancer therapy
- Treatment with other investigational agents
- Gastrointestinal disorders preventing oral medication
- Active oral ulcers or gastrointestinal ulcers
- Severe cardiovascular disease or abnormalities
- Immune pneumonitis or pulmonary fibrosis
- Severe allergic reactions to monoclonal antibodies, history of anaphylaxis, or uncontrolled asthma
- HIV/AIDS or active infection requiring systemic therapy
- Positive hepatitis B or C tests
- Live vaccine within 30 days before study
- Use of immunosuppressive medication within 7 days prior to study treatment with some exceptions
- Active autoimmune disease that worsens with immunostimulatory agents
- Pregnancy, lactation, or not using effective birth control if of childbearing potential
- Use of oral anticoagulants like Coumadin
- Alcoholism
- Certain heart rhythm abnormalities or serious cardiac history
- Prior organ transplantation including allogeneic stem cell transplant
- Patients under legal guardianship
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Centre Hospitalier Lyon Sud
Pierre-Bénite, Pierre Bénite, France, 69495
Actively Recruiting
2
Institut Bergonié
Bordeaux, France, 33000
Actively Recruiting
3
Centre François Baclesse
Caen, France, 14000
Not Yet Recruiting
4
Centre Oscar Lambret
Lille, France, 59000
Not Yet Recruiting
5
Institut Paoli-Calmettes
Marseille, France, 13000
Not Yet Recruiting
6
Centre Antoine Lacassagne
Nice, France, 06000
Actively Recruiting
7
Assistance Publique Hôpitaux de Paris
Paris, France
Actively Recruiting
8
Centre Eugène Marquis
Rennes, France, 35000
Actively Recruiting
9
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, France, 31000
Actively Recruiting
Research Team
B
Benoit YOU, MD
CONTACT
L
Laurent VILLENEUVE
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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