# TROPHIMMUN

Source: https://onco.cc/trials/trophimmun/  
OnCo record `trophimmun` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

TROPHIMMUN was the first immunotherapy trial in gestational trophoblastic disease, a rare tumour that arises from a pregnancy; the PD-L1 antibody avelumab cured about half of the women whose disease had stopped responding to single-drug chemotherapy, with mild side effects and a healthy pregnancy afterwards in one patient.

## Summary

TROPHIMMUN was a French single-arm phase 2 trial at the Hospices Civils de Lyon in women with gestational trophoblastic neoplasia resistant to chemotherapy, treated with avelumab every two weeks until hCG normalised and for three cycles beyond. Cohort A enrolled 15 women resistant to single-agent methotrexate or actinomycin D; cohort B enrolled women resistant to combination chemotherapy. The primary endpoint was the rate of hCG normalisation.

In cohort A, eight of 15 women (53 percent) reached normal hCG after a median of nine cycles and none relapsed, with grade 1 to 2 fatigue, nausea and infusion reactions the main toxicities and one patient going on to a healthy pregnancy; those who did not respond were cured with actinomycin D or combination chemotherapy and surgery. Cohort B, reported in 2023, showed little activity after combination chemotherapy failure. The corpus's low-risk gestational trophoblastic neoplasia page cites TROPHIMMUN for avelumab as a chemotherapy-sparing option.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-22
- Also known as: 69HCL16_0123
- Tags: soc-trials
- Registry id: NCT03135769
- Phase: 2
- Setting: Gestational trophoblastic neoplasia resistant to chemotherapy: the PD-L1 antibody avelumab 10 mg/kg every two weeks in two cohorts, after single-agent methotrexate or actinomycin D failure (cohort A) and after combination chemotherapy failure (cohort B), with normalisation of hCG as the primary endpoint
- Sponsor: Hospices Civils de Lyon
- Enrolled: 24
- Result: hCG normalisation in 8 of 15 women (53 percent) with single-agent chemotherapy-resistant disease, none of whom relapsed; grade 1 to 2 adverse events in 93 percent and no treatment-related grade 3 events.
- Outcomes: hCG normalisation, cohort A (resistance to single-agent chemotherapy): Avelumab 10 mg/kg every 2 weeks 53.3%; Treatment-related grade 1 to 2 adverse events, cohort A: Avelumab 10 mg/kg every 2 weeks 93%

## Sources

- ClinicalTrials.gov NCT03135769: https://clinicaltrials.gov/study/NCT03135769

## Connected records

- cancers: [Gestational trophoblastic neoplasia](https://onco.cc/cancers/gestational-trophoblastic/), [Low-risk gestational trophoblastic neoplasia (FIGO score 0 to 6)](https://onco.cc/cancers/low-risk-gtn/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Avelumab](https://onco.cc/drugs/avelumab/)
- key papers: [TROPHIMMUN cohort A: avelumab in gestational trophoblastic tumours resistant to single-agent chemotherapy](https://onco.cc/key-papers/paper-trophimmun-avelumab-chemoresistant-gtn-you-jco-2020/)

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