TROPHIMMUN
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.
Overview
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.
- 53.3 out of 100 people reached this endpoint with Avelumab 10 mg/kg every 2 weeks.
- 93 out of 100 people reached this endpoint with Avelumab 10 mg/kg every 2 weeks.
- There was no comparison group, so this number cannot tell you how much of the effect is due to the treatment.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: 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. People in a different situation may not see the same effect.
- The trial selected people by a biomarker (PD-L1); the result should not be assumed for people whose cancer does not have it.
- Only 24 people took part, so the numbers are less certain than in a large trial.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
24 enrolled.
8 of 15 after a median of 9 cycles; no relapse at a median follow-up of 25 months
SourceFatigue 33.3%, nausea or vomiting 33.3%, infusion reaction 26.7%
SourceSimilar pages
not linked directly; found by shared links- TrialNCI9673
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- TrialPOD1UM-303/InterAACT-2
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- TrialCONTINUUM
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- Key paperTROPHIMMUN cohort A: avelumab in gestational trophoblastic tumours resistant to single-agent chemotherapy
Shares Low-risk gestational trophoblastic neoplasia (FIGO score 0 to 6), Avelumab.
- TrialAvelumab Program Rollover Study
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- TrialA Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)
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- TrialJAVELIN Bladder 100
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- TrialPhase Ib/II of TG4001 and Avelumab in HPV16 Positive R/M Cancers
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