Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020
Avelumab in Patients With Gestational Trophoblastic Tumors With Resistance to Single-Agent Chemotherapy: Cohort A of the TROPHIMMUN Phase II Trial.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03135769 (A Phase II Trial of Avelumab in Chemo-resistant Gestational Trophoblastic Neoplasias), which is not on this map. Cited by 54 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase II Trial of Avelumab in Chemo-resistant Gestational Trophoblastic Neoplasias (GTN)
Who cites it
54 citing papers in PubMed, 4 syntheses or guidelines pooled it, 100 citations in OpenAlex.
- Pembrolizumab in gestational trophoblastic neoplasia: Systematic review and meta-analysis with sub-group analysis of potential prognostic factors.Clinics (Sao Paulo, Brazil) · 2025Pooled it
- Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of gynecologic cancer.Journal for immunotherapy of cancer · 2023Guideline
- Immunotherapy in the treatment of chemoresistant gestational trophoblastic neoplasia - systematic review with a presentation of the first 4 Brazilian cases.Clinics (Sao Paulo, Brazil) · 2023Pooled it
- Harnessing the Gut Microbiome in Cancer Immunotherapy: Mechanisms, Challenges, and Routes to Personalized Medicine-A Systematic Review.Technology in cancer research & treatmentPooled it
- A Phase II Basket Trial of Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors (DART SWOG 1609 Cohort 47) in Patients with Gestational Trophoblastic Neoplasia.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024Trial
- Immunotherapy in Gynecologic Cancers: Current Evidence, Biomarker-Driven Practice, and Future Directions.Cancers · 2026Review
- Refractory ultra-high-risk Choriocarcinoma achieving complete response to intensive multi-agent and intrathecal chemotherapy and anti-PD-L1 therapy.Gynecologic oncology reports · 2026Article
- Gut microbiota and cancer immunotherapy: from dysbiosis to personalized immune checkpoint blockade optimization.Folia microbiologica · 2026Review
- Precision, prevention and progress: charting two decades of change in gynaecological oncology-a narrative review.Translational cancer research · 2026Review
- Treatment Selection Based on Dominant Tumor Biology in Endometrial Carcinoma with Choriocarcinomatous Differentiation: A Case-Based Review.Current oncology (Toronto, Ont.) · 2026Review
- Checkpoint Inhibition in Gestational Trophoblastic Neoplasia: A Narrative Review on the Reawakening of Antitumor Immunity.Advances in therapy · 2026Review
- Stage I placental site trophoblastic tumor with complete response after pembrolizumab.Gynecologic oncology reports · 2026Article
- Primary cervical choriocarcinoma: a case report.Frontiers in oncology · 2026Article
- Choriocarcinoma at an Abdominal Wall Cesarean Scar: Recurrence After Multi-Line Chemotherapy and Exploration of Salvage Therapy.International journal of women's health · 2026Article
- Gestational Trophoblastic Disease: Diagnostic and Therapeutic Updates in Light of Recent Evidence: A Literature Review.Medicina (Kaunas, Lithuania) · 2025Review
- Immune checkpoint inhibitors in gynecologic oncology: Current status and perspectives.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2025Review
- Immune Checkpoint Inhibitors (ICI) in Urological Cancers: A New Modern Era, but Not Generally Applied.International journal of molecular sciences · 2025Review
- Fertility Sparing Medical Management Options in Gynecologic Cancers.Current treatment options in oncology · 2025Review
- Gestational trophoblastic neoplasm: Patient outcomes and clinical pearls from a multidisciplinary referral center.Gynecologic oncology · 2025Article
- Immunotherapy in gestational trophoblastic neoplasia: advances and future directions.Frontiers in immunology · 2025Review
Corrections and comments
- Commented on by
- Commented on by
Authors and funding
19 authors at 6 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeWomen with gestational trophoblastic tumors (GTT) resistant to single-agent chemotherapy receive alternative chemotherapy regimens, which, although effective, cause considerable toxicity. All GTT subtypes express programmed death-ligand 1 (PD-L1), and natural killer (NK) cells are involved in trophoblast immunosurveillance. Avelumab (anti-PD-L1) induces NK cell-mediated cytotoxicity. The TROPHIMMUN trial assessed avelumab in women with chemotherapy-resistant GTT.
methodsIn this phase II multicenter trial (ClinicalTrials.gov identifier: NCT03135769), women with GTT who experienced disease progression after single-agent chemotherapy received avelumab 10 mg/kg intravenously every 2 weeks until human chorionic gonadotropin (hCG) normalization, followed by 3 consolidation cycles. Rate of hCG normalization was the primary endpoint (2-step Simon design).
resultsBetween December 2016 and September 2018, 15 patients were treated. Median age was 34 years; disease stage was I or III in 53.3% and 46.7% of women, respectively; and International Federation of Gynecology and Obstetrics (FIGO) score was 0-4 in 33.3%, 5-6 in 46.7%, and ≥ 7 in 20% of patients. Prior treatment included methotrexate (100%) and actinomycin D (7%). Median follow-up was 25 months, and median number of avelumab cycles was 8 (range, 2-11). Grade 1-2 treatment-related adverse events occurred in 93% of patients, most commonly (≥ 25%) fatigue (33.3%), nausea/vomiting (33.3%), and infusion-related reaction (26.7%). One patient had grade 3 uterine bleeding (treatment unrelated). Eight patients (53.3%) had hCG normalization after a median of 9 avelumab cycles; none subsequently relapsed. Probability of normalization was not associated with disease stage, FIGO score, or baseline hCG. One patient subsequently had a healthy pregnancy. In avelumab-resistant patients (46.7%), hCG was normalized with actinomycin D (42.3%) or combination chemotherapy/surgery (57.1%).
conclusionIn patients with single-agent chemotherapy-resistant GTT, avelumab had a favorable safety profile and cured approximately 50% of patients. Avelumab could be a new therapeutic option, particularly in patients who would otherwise receive combination chemotherapy.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.