Neoadjuvant ipilimumab + nivolumab for Stage III Malignant Melanoma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Stage III Malignant MelanomaNeoadjuvant ipilimumab + nivolumab - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new treatment for stage III melanoma that involves two drugs given before surgery, followed by more of one of the drugs or a different drug after surgery.

Eligible Conditions
  • Stage III Malignant Melanoma

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Analysis will be performed after 132 events, though not later than after 2 years follow-up of all patients.

Year 2
Comparison of event-free survival (EFS) in the neoadjuvant and adjuvant group.
Year 5
Description of surgical morbidity
Description of type of immune-related adverse events
Neoplasm Metastasis
Duration of immune-related adverse events
Upper arm
Health technology assessments, consisting of a cost-effectiveness analysis comparing the neoadjuvant arm with the standard adjuvant arm
Overall survival (OS)
Pathologic response rate in the neoadjuvant arm and evaluation of association between pathologic response rate and RFS, DMFS and OS.
Rate of immune-related adverse events
Recurrence free survival (RFS)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

B: Adjuvant
1 of 2
A: Neoadjuvant
1 of 2

Active Control

Experimental Treatment

420 Total Participants · 2 Treatment Groups

Primary Treatment: Neoadjuvant ipilimumab + nivolumab · No Placebo Group · Phase 3

A: Neoadjuvant
Drug
Experimental Group · 1 Intervention: Neoadjuvant ipilimumab + nivolumab · Intervention Types: Drug
B: Adjuvant
Drug
ActiveComparator Group · 1 Intervention: Adjuvant nivolumab · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: analysis will be performed after 132 events, though not later than after 2 years follow-up of all patients.

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor
2,499 Previous Clinical Trials
3,931,362 Total Patients Enrolled
2 Trials studying Stage III Malignant Melanoma
246 Patients Enrolled for Stage III Malignant Melanoma
The Netherlands Cancer InstituteLead Sponsor
257 Previous Clinical Trials
165,891 Total Patients Enrolled
2 Trials studying Stage III Malignant Melanoma
230 Patients Enrolled for Stage III Malignant Melanoma
Georgina Long, ProfStudy ChairMedical oncologist/researcher
Christian Blank, ProfStudy ChairMedical oncologist/researcher

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have no prior targeted therapy targeting BRAF and/or MEK.
You are a woman of childbearing potential (WOCP) and must use appropriate method(s) of contraception, i.e.