Neoadjuvant Immunotherapy of Operable Metastatic Melanoma in Real Life (GCC)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Besancon

About this trial

This study aims to evaluate efficacy and tolerance of real life neoadjuvant immunotherapy in advanced yet operable melanoma.

The complete histological response will be assessed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with operable metastatic melanoma (stage III or IV of American Joint Committee on Cancer [AJCC] Stages CLassification) treated with neoadjuvant immunotherapy (anti-PD1 or anti-PD1 + anti-CTLA-4), even if surgery cancelled due to disease progression or complete response or patient's refusal to be operated.

Efficacy of the neoadjuvant immunotherapy histologically of radiologically assessed

Disqualifiers

Uveal melanoma

Trial population

Patients with operable metastatic melanoma (stade III or IV of AJCC) treated with neoadjuvant immunotherapy (anti-PD1 or anti-PD1 + anti-CTLA-4)

Trial design

Design model

Case-only

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

77 Participants
are grouped into 1 trial group
Group A: Operable metastatic melanoma

Trial outcomes

Primary outcomes

1

Complete histological response

Histological response rate on histological analysis of the resected specimen

Time frame
Day 1

Secondary outcomes

1

Objectival response rate

Objectival response rate on imaging

Time frame
Day 1
2

Event-free survival

An event is defined by progression of the disease or toxicity making surgery impossible, the impossibility of starting adjuvant treatment within 84 days following surgery, recurrence of melanoma after surgery or death.

Time frame
Month 12
3

Disease Free Survival after surgery

Time frame
Month 12
4

Overall survival

Time frame
Month 18

Other outcomes

Sponsors and contacts

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