Patient Observation for Advanced Melanoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Advanced Melanoma+10 MorePatient Observation - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing if doctors can safely shorten the use of anti-PD1 therapy for melanoma by using biomarkers seen on PET/CT imaging and tumor biopsy.

Eligible Conditions
  • Advanced Melanoma
  • Clinical Stage III Cutaneous Melanoma
  • Unresectable Acral Lentiginous Melanoma
  • Unresectable Melanoma
  • Stage IIIB Cutaneous Melanoma
  • Melanoma of Unknown Primary
  • Stage IV Cutaneous Melanoma
  • Unresectable Mucosal Melanoma
  • Pathologic Stage III Cutaneous Melanoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 5 years

Month 24
Metabolic response on serial FDG-PET/CT
Month 12
Rates of pathologic response (Arm B)
At 12 months
Event free survival (EFS) rate (Arm A)
At 24 months
EFS
Overall survival
Up to 5 years
Tumor Markers
Determine FDG-PET/CT positivity between the local site read and central review
Therapeutic procedure
Therapeutic procedure

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Arm B (nivolumab, pembrolizumab, ipilimumab)
1 of 2
Arm A (active surveillance)
1 of 2

Active Control

Experimental Treatment

150 Total Participants · 2 Treatment Groups

Primary Treatment: Patient Observation · No Placebo Group · Phase 2

Arm A (active surveillance)
Other
Experimental Group · 1 Intervention: Patient Observation · Intervention Types: Other
Arm B (nivolumab, pembrolizumab, ipilimumab)ActiveComparator Group · 2 Interventions: Pembrolizumab, Nivolumab · Intervention Types: Biological, Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,072 Previous Clinical Trials
41,128,768 Total Patients Enrolled
6 Trials studying Advanced Melanoma
568 Patients Enrolled for Advanced Melanoma
ECOG-ACRIN Cancer Research GroupLead Sponsor
103 Previous Clinical Trials
171,885 Total Patients Enrolled
Geoffrey T GibneyPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have melanoma originating from a primary site other than the skin, eyelid, or mucous membrane
Patient must have had measurable disease by imRECIST prior to start of initial anti-PD-1 therapy.
You have active advanced melanoma, defined as unresectable stage IIIB-IV by AJCC 8th edition.
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.