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Checkpoint Inhibitor

Nivolumab for Skin Cancer

Phase 1
Waitlist Available
Led By Nikhil Khushalani, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up start of study treatment until withdrawal of consent for follow-up or death - up to 6 years
Awards & highlights

Study Summary

This trial is testing the side effects of a new vaccine for melanoma and investigating if it is effective in boosting the immune system and preventing the cancer from returning.

Eligible Conditions
  • Skin Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start of study treatment until withdrawal of consent for follow-up or death - up to 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and start of study treatment until withdrawal of consent for follow-up or death - up to 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to Relapse
Secondary outcome measures
Overall Survival (OS)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Nivolumab and Peptide VaccineExperimental Treatment5 Interventions
Cohorts 1 through 3: Participants will receive nivolumab with the peptide vaccine within 8 days after their first apheresis procedure. Vaccine Combining Multiple Class I Peptides and Montanide ISA 51 VG with Escalating Doses of Anti-PD-1 Antibody Nivolumab (BMS-936558). Level 1: 1 mg/kg Nivolumab + peptide vaccine. Level 2: 3 mg/kg Nivolumab + peptide vaccine. Level 3: 10 mg/kg Nivolumab + peptide vaccine.
Group II: Nivolumab and IpilimumabExperimental Treatment2 Interventions
Cohorts 4 and 5. Participants will receive their first dose of nivolumab with ipilimumab within 28 days after screening blood draws. Both drugs will be given. Cohort 4: nivolumab 1mg/kg plus ipilimumab 3mg/kg. Cohort 5: nivolumab 3mg/kg plus ipilimumab 1mg/kg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Montanide ISA 51 vegetable grade (VG)
2010
Completed Phase 1
~80
NY-ESO-1 157-165 (165V)
2010
Completed Phase 1
~80
Nivolumab
2014
Completed Phase 3
~4750
Apheresis Procedure
2010
Completed Phase 2
~100
Ipilimumab
2014
Completed Phase 3
~2620
gp100:280-288 (288V)
2010
Completed Phase 1
~80

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,419 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,661 Previous Clinical Trials
40,924,371 Total Patients Enrolled
MedarexIndustry Sponsor
15 Previous Clinical Trials
1,993 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Vaccine Combining Multiple Class I Peptides and Montanide ISA 51VG With Escalating Doses of Anti-PD-1 Antibody Nivolumab or Ipilimumab With Nivolumab For Patients With Resected Stages IIIC/ IV Melanoma
2010. "Vaccine Combining Multiple Class I Peptides and Montanide ISA 51VG With Escalating Doses of Anti-PD-1 Antibody Nivolumab or Ipilimumab With Nivolumab For Patients With Resected Stages IIIC/ IV Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01176474.
~5 spots leftby Apr 2025
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