Gestational Trophoblastic Neoplasias (GTN)Phase 2TROPHIMMUNNCT03135769

Avelumab in Chemo-resistant Gestational Trophoblastic Neoplasias

A Phase 2 study testing Avelumab administration at 10mg/kg in people with Gestational Trophoblastic Neoplasias (GTN), run by Hospices Civils de Lyon at 6 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Gestational Trophoblastic Neoplasias (GTN)
What is being tested?: Avelumab administration at 10mg/kg
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 6 sitesFrance
Study dates: 21 Feb 2017to 17 Mar 2021
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Woman older than 18 years - Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Patients with adequate bone marrow function :
Absolute neutrophil 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 :

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Calculated creatinine clearance >= 30 ml/min according to the Cockcroft-Gault formula (or local institutional standard method)
Patients with adequate hepatic function
Serum bilirubin ≤ 1.5 x UNL and AST/ALT ≤ 2.5 X UNL (≤ 5 X UNL for patients with liver metastases)
Patients must have a life expectancy ≥ 16 weeks
Confirmation of non-childbearing status for women of childbearing potential. An evolutive pregnancy can be ruled out in the following cases:
in case of a previous hysterectomy
if serum hCG level ≥ 2 000 IU/L and no intra or extra-uterine gestational sac is detected on pelvic ultrasound
if serum hCG level < 2 000 IU/L on a first measurement and serum hCG increases <100% on a second measurement performed 3 days later
Highly effective contraception if the risk of conception exists. (Note: The effects of the trial drug on the developing human fetus are unknown; thus, women of childbearing potential must agree to use 2 highly effective contraceptions, defined as methods with a failure rate of less than 1 % per year. Highly effective contraception is required at least 28 days prior, throughout and for at least 60 days after avelumab treatment.
Patients who gave their written informed consent to participate in the study
Patients affiliated to a social insurance regime
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Cohort A specific inclusion criteria :
Patients with gestational trophoblastic disease resistant to mono-chemotherapy (methotrexate and/or actinomycine-D
Cohort B specific inclusion criteria :
Patients with gestational trophoblastic disease resistant to polychemotherapy (such as EMA-CO; EMA-EP; BEP; … regimens) without limitation in the number of previous chemotherapy lines
Patients with limited risk of fast progression, according to "Centre de reference des maladies trophoblastiques". In the case where a validated therapeutic alternative is available (platinum salt-based chemotherapy in case of resistance to polychemotherapy without platinum salt), the patient must have been informed and the therapeutic alternative will be proposed in priority.

Who cannot join

Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti- CTLA 4 (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:
Brain metastases that have been treated locally and are clinically stable for at least 2 weeks prior to enrollment
No on-going 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)

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Subjects 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 1) with the exception of alopecia and sensory neuropathy ≤ grade 2, caused by previous cancer therapy.
Treatment with other investigational agents
Bowel occlusive syndrome, inflammatory bowel disease, immune colitis or other gastro-intestinal disorder that does not allow oral medication such as malabsorption.
Clinically significant (i.e active) cardiovascular disease : cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication
Patients with severe acute or chronic medical conditions including immune pneumonitis, inflammatory bowel disease, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partially controlled asthma Global Initiative for Asthma 2011).
Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness.
Active infection requiring systemic therapy.
Positive test for HBV surface antigen and / or confirmatory HCV RNA (if anti-HCV antibody tested positive)
Administration of a live vaccine within 4 weeks prior the first dose of avelumab.
Treatment with oral anticoagulant such Coumadin.
Current or prior use of immunosuppressive medication within 7 days prior to start of study treatment. The following are exceptions to this exclusion criterion:
Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection);
Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent;
Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).
Active autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible.
Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control
Resting ECG with QTc > 470msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.
Prior organ transplantation, including allogeneic stem cell transplantation (excluding autologous bone marrow transplant)
Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE Grade ≥ 3)
Patients under guardianship.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

France6 sites

Institut Bergonie
Bordeaux, 33000
Centre Francois Baclesse
Caen, 14000
Institut Paoli-Calmettes
Marseille, 13000
Aphp Hopital Tenon
Paris, 75020
Hospices Civils de Lyon - CHLS
Pierre-Bénite, 69495
Institut Universitaire Du Cancer de Toulouse - Oncopole
Toulouse, 31000

Other trials in France

About this study

Official title: A Phase II Trial of Avelumab in Chemo-resistant Gestational Trophoblastic Neoplasias (GTN)

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. GTN patients are commonly treated with single agent treatment (methotrexate or actinomycine-D) or polychemotherapy (first line treatment EMA-CO) according to the predicted risk of resistance to single agent treatment by FIGO score. GTN patients with resistance to these treatments are treated with another single agent drug or polychemotherapy regimens.

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 need for modern targeted agents with better benefit/toxicity profiles.

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 metastasic 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.
The case of complete and durable response to pembrolizumab was reported in a patient with multi chemo-resistant GTN.

Conditions: Gestational Trophoblastic Neoplasias (GTN)
Being tested: Avelumab administration at 10mg/kg
Keywords: avelumab, PDL1, Gestational Trophoblastic Neoplasias, GTN, Hydatiform mole, hCG

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Avelumab administration at 10mg/kgDrug
Avelumab administration at 10 mg/kg as a 1 hour IV infusion once every 14 days during 6 months (maximum).

Study groups in NCT03135769
Study group	Role	What they receive
Avelumab	Experimental	Avelumab administration at 10 mg/kg every 14 days during 6 months maximum Receives: Drug: Avelumab administration at 10mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

The rate of patients with successful normalization of hCG assays
Clinical efficacy of avelumab administration will be evaluated by the rate of patients with successful normalization of hCG assays allowing for treatment discontinuation (hCG normalization). Patients will continue on treatment until the hCG assays, measured weekly, reach the institutional normal threshold and then for 3 additional cycles.
Measured: up to 6 months

Secondary outcomes (9)

Resistance free survival
Number of patients alive free resistance (defined as a rise ≥ 20% rise over between two assays in three consecutive weekly hCG assays or plateau ≤ 10% decrease between two assays in four consecutive weekly hCG)
Measured: up to 6 months
Progression free survival
Number of patients alive progression free survival (defined as a rise ≥ 20% rise over between two assays in three consecutive weekly hCG assays or plateau ≤ 10% decrease between two assays in four consecutive weekly hCG)
Measured: up to 6 months
Overall survival
Number of patients alive 1 months after the end of treatment.
Measured: up to 6 months
Overall response rate according to RECIST
Radiological response to avelumab assessed by the overall response rate according to RECIST version 1.1 criteria and immune-related RECIST criteria assessed by imaging (TAP CT scanner and / or MRI if contraindication) after cycle 4, 8 and 12
Measured: up to 6 months
NCI CTCAE version 4.0
The safety of avelumab administration will be evaluated throughout the duration of treatment (6 months max) and until the end of patient follow up (1 month after treatment discontinuation) according to NCI CTCAE version 4.0
Measured: up to 7 months
Kinetics of hCG
Modeled hCGres parameter calculated with weekly values of hCG measured during treatment days after start of Avelumab treatment.
Measured: up to 7 months
PD-L1 expression in tumor samples
To predict the efficacy of anti-PD-L1 immunotherapy, we will quantify and characterize the intra and peritumoral immune infiltrate of GTN
Measured: up to 7 months
Phenotype of the intratumoral immune cell infiltrate
Immunohistochemistry with anti PD-L1, anti CD3, anti CD8, anti CD4, anti CD56 (uterine NK cells), anti FoxP3 primary antibodies will be performed on serial cuts of formalin fixed and paraffin embedded specimens from patients treated with avelumab.
Measured: up to 7 months
Phenotype of the peritumoral immune cell infiltrate
Immunohistochemistry with anti PD-L1, anti CD3, anti CD8, anti CD4, anti CD56 (uterine NK cells), anti FoxP3 primary antibodies will be performed on serial cuts of formalin fixed and paraffin embedded specimens from patients treated with avelumab.
Measured: up to 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Feb 201717 Mar 2021

First posted1 May 2017
Study start21 Feb 2017
Primary completion2 Dec 2020
Study completion17 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Gestational Trophoblastic Neoplasias (GTN)Studies of the same condition, open and under way.
More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03135769
Sponsor's protocol ID: 69HCL16_0123
Acronym: TROPHIMMUN
Status last verified: Dec 2025
First submitted: 6 Apr 2017
Last updated: 19 Dec 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

You B, Bolze PA, Lotz JP, Massardier J, Gladieff L, Joly F, Hajri T, Maucort-Boulch D, Bin S, Rousset P, Devouassoux-Shisheboran M, Roux A, Alves-Ferreira M, Grazziotin-Soares D, Langlois-Jacques C, Mercier C, Villeneuve L, Freyer G, Golfier F. Avelumab in Patients With Gestational Trophoblastic Tumors With Resistance to Single-Agent Chemotherapy: Cohort A of the TROPHIMMUN Phase II Trial. J Clin Oncol. 2020 Sep 20;38(27):3129-3137. doi: 10.1200/JCO.20.00803. Epub 2020 Jul 27.
PubMed 32716740
You B, Bolze PA, Lotz JP, Massardier J, Gladieff L, Floquet A, Hajri T, Descargues P, Langlois-Jacques C, Bin S, Villeneuve L, Roux A, Alves-Ferreira M, Grazziotin-Soares D, Dherret G, Gerentet C, Rousset P, Freyer G, Golfier F. Avelumab in patients with gestational trophoblastic tumors with resistance to polychemotherapy: Cohort B of the TROPHIMMUN phase 2 trial. Gynecol Oncol. 2023 Jan;168:62-67. doi: 10.1016/j.ygyno.2022.11.005. Epub 2022 Nov 16.
PubMed 36401942

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Clinicopathological Features , Outcomes and Prognostic Factors of High Risk Patients of Gestational Trophoblastic Neoplasia
Gestational Trophoblastic Neoplasias (GTN)
RecruitingObservational study
The Psychological Impact of GTN on Women Who Have Completed Chemotherapy Treatment
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Recruiting
Toripalimab Plus Actinomycin-D as Fist-Line Treatment for GTN With FIGO Score 5-6
Gestational Trophoblastic Neoplasia
RecruitingPhase 2
Toripalimab Plus Actinomycin-D As Fist-Line Treatment for GTN with FIGO Score 7
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RecruitingPhase 1/2
Avelumab and Methotrexate in in Low-risk Gestational Trophoblastic Neoplasias as First Line Treatment
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All Gestational Trophoblastic Neoplasias (GTN) trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Trial of Avelumab in Chemo-resistant Gestational Trophoblastic Neoplasias (GTN)
ClinicalTrials.gov ID: NCT03135769
Acronym / sponsor ID: TROPHIMMUN / 69HCL16_0123
Conditions: Gestational Trophoblastic Neoplasias (GTN)
Keywords: avelumab, PDL1, Gestational Trophoblastic Neoplasias, GTN, Hydatiform mole, hCG
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Hospices Civils de LyonUniversity, hospital or other
Study start: 21 Feb 2017 (actual)
Primary completion: 2 Dec 2020 (actual)
Study completion: 17 Mar 2021 (actual)
First posted: 1 May 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Spontaneous regressions of metastasic 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.
The case of complete and durable response to pembrolizumab was reported in a patient with multi chemo-resistant GTN.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Avelumab	Experimental	Drug: Avelumab administration at 10mg/kgAvelumab administration at 10 mg/kg every 14 days during 6 months maximum

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (23 listed)

Woman older than 18 years - Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Patients with adequate bone marrow function :
Patients with adequate renal function :
Patients with adequate hepatic function
Patients must have a life expectancy ≥ 16 weeks

Key exclusion criteria (29 listed)

Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti- CTLA 4 (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:
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Avelumab administration at 10mg/kgAvelumab administration at 10 mg/kg as a 1 hour IV infusion once every 14 days during 6 months (maximum).	Drug	Avelumab

Primary outcome

The rate of patients with successful normalization of hCG assays
Time frame: up to 6 months
Clinical efficacy of avelumab administration will be evaluated by the rate of patients with successful normalization of hCG assays allowing for treatment discontinuation (hCG normalization). Patients will continue on treatment until the hCG assays, measured weekly, reach the institutional normal threshold and then for 3 additional cycles.

9 secondary outcomes

Resistance free survival
Time frame: up to 6 months
Progression free survival
Time frame: up to 6 months
Overall survival
Time frame: up to 6 months
Overall response rate according to RECIST
Time frame: up to 6 months
NCI CTCAE version 4.0
Time frame: up to 7 months
Kinetics of hCG
Time frame: up to 7 months
PD-L1 expression in tumor samples
Time frame: up to 7 months
Phenotype of the intratumoral immune cell infiltrate
Time frame: up to 7 months
Phenotype of the peritumoral immune cell infiltrate
Time frame: up to 7 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
Results publication: PubMed 32716740You B, Bolze PA, Lotz JP, Massardier J, Gladieff L, Joly F, Hajri T, Maucort-Boulch D, Bin S, Rousset P, Devouassoux-Shisheboran M, Roux A, Alves-Ferreira M, Grazziotin-Soares D, Langlois-Jacques C, Mercier C, Villeneuve L, Freyer G, Golfier F. Avelumab in Patients With Gestational Trophoblastic Tumors With Resistance to Single-Agent Chemotherapy: Cohort A of the TROPHIMMUN Phase II Trial. J Clin Oncol. 2020 Sep 20;38(27):3129-3137. doi: 10.1200/JCO.20.00803. Epub 2020 Jul 27.
Results publication: PubMed 36401942You B, Bolze PA, Lotz JP, Massardier J, Gladieff L, Floquet A, Hajri T, Descargues P, Langlois-Jacques C, Bin S, Villeneuve L, Roux A, Alves-Ferreira M, Grazziotin-Soares D, Dherret G, Gerentet C, Rousset P, Freyer G, Golfier F. Avelumab in patients with gestational trophoblastic tumors with resistance to polychemotherapy: Cohort B of the TROPHIMMUN phase 2 trial. Gynecol Oncol. 2023 Jan;168:62-67. doi: 10.1016/j.ygyno.2022.11.005. Epub 2022 Nov 16.
Individual participant dataSharing planned: No

Related trials for Gestational Trophoblastic Neoplasias (GTN)

Not yet recruitingObservational study
Clinicopathological Features , Outcomes and Prognostic Factors of High Risk Patients of Gestational Trophoblastic Neoplasia
Gestational Trophoblastic Neoplasias (GTN)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Benoit YOU, MD principal investigator

Hospices Civils de Lyon - Centre Hospitalier Lyon Sud - Service d'Oncologie Médicale

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Avelumab administration at 10mg/kg in people with Gestational Trophoblastic Neoplasias (GTN), run by Hospices Civils de Lyon at 6 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of patients with successful normalization of hCG assays (time frame: up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03135769, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.