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Immune Booster

BMS-936558 for Skin Cancer

Phase 1
Waitlist Available
Led By Nikhil I. 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 2 years, 6 months
Awards & highlights

Study Summary

This trial will test an investigational vaccine in combination with an immune booster, to see if it is safe and effective in treating patients with melanoma.

Eligible Conditions
  • Skin Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best Overall Response Rate (BORR)
Secondary outcome measures
Duration of Response
Time to Response

Side effects data

From 2020 Phase 3 trial • 405 Patients • NCT01721746
51%
Fatigue
42%
Nausea
30%
Anaemia
29%
Alopecia
24%
Neutropenia
24%
Vomiting
23%
Constipation
21%
Arthralgia
21%
Decreased appetite
18%
Malignant neoplasm progression
18%
Diarrhoea
14%
Dyspnoea
13%
Abdominal pain
13%
Pain in extremity
13%
Paraesthesia
11%
Thrombocytopenia
11%
Neuropathy peripheral
11%
Asthenia
11%
Headache
10%
Pyrexia
10%
Leukopenia
10%
Myalgia
9%
Infusion related reaction
9%
Platelet count decreased
9%
White blood cell count decreased
8%
Neutrophil count decreased
8%
Weight decreased
8%
Cough
6%
Aspartate aminotransferase increased
6%
Abdominal pain upper
6%
Depression
6%
Insomnia
6%
Rash
5%
Oedema peripheral
5%
Dizziness
4%
Urinary tract infection
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Alanine aminotransferase increased
4%
Dyspepsia
4%
Influenza like illness
4%
Pain
4%
Hypertension
3%
Dysgeusia
3%
Dry mouth
3%
Chills
3%
Blood alkaline phosphatase increased
3%
Hyperkalaemia
3%
Neck pain
3%
Dry skin
2%
Back pain
2%
Upper respiratory tract infection
2%
Acute kidney injury
2%
Febrile neutropenia
2%
Pleural effusion
2%
Blood creatinine increased
2%
Pruritus
2%
Rash maculo-papular
2%
Hyponatraemia
1%
Food poisoning
1%
Toxicity to various agents
1%
Cellulitis
1%
Muscle spasms
1%
Cancer pain
1%
Embolism arterial
1%
Small intestinal perforation
1%
Incoherent
1%
Transient ischaemic attack
1%
Febrile bone marrow aplasia
1%
Myocardial infarction
1%
Colitis
1%
Multiple organ dysfunction syndrome
1%
Erysipelas
1%
Febrile infection
1%
Localised infection
1%
Neutropenic sepsis
1%
Femur fracture
1%
Hypoglycaemia
1%
Flank pain
1%
Malignant melanoma
1%
Metastases to central nervous system
1%
Cerebrovascular accident
1%
Skin haemorrhage
1%
Hypotension
1%
Peripheral embolism
1%
Hyperglycaemia
1%
Hypoalbuminaemia
1%
Anxiety
1%
Vitiligo
1%
Skin neoplasm bleeding
1%
Tumour associated fever
1%
Neoplasm progression
1%
Hypokalaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
Nivolumab

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: A1 - Phase I Dose EscalationExperimental Treatment6 Interventions
Cohorts 1 through 5. Each treatment cycle is comprised of 6 doses of BMS-936558 and 6 peptide vaccines administered every 2 weeks for 12 weeks (cohort 6 has no peptides) (Cycle 1: Weeks 1, 3, 5, 7, 9, and 11; Cycle 2: Weeks 13, 15, 17, 19, 21, and 23) with tumor response assessments at the end of each cycle (during Weeks 12 and 24).
Group II: A2 - BMS-936558 Without Peptide VaccineActive Control1 Intervention
Cohort 6. Each treatment cycle is comprised of 6 doses of BMS-936558 administered every 2 weeks for 12 weeks (cohort 6 has no peptides) (Cycle 1: Weeks 1, 3, 5, 7, 9, and 11; Cycle 2: Weeks 13, 15, 17, 19, 21, and 23) with tumor response assessments at the end of each cycle (during Weeks 12 and 24).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MART-1
2010
Completed Phase 1
~130
NY-ESO-1
2010
Completed Phase 1
~130
Montanide ISA 51 VG
2008
Completed Phase 3
~610
BMS-936558
2012
Completed Phase 3
~640
gp100:209-217(210M)
1999
Completed Phase 2
~170
gp100:280-288(288V)
2010
Completed Phase 1
~130

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,365 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,540 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,387 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
Journal of Clinical OncologyJournal
Safety, Efficacy, and Biomarkers of Nivolumab with Vaccine in Ipilimumab-refractory or -naive Melanoma
Weber, Jeffrey S., Ragini Reiney Kudchadkar, Bin Yu, Donna Gallenstein, Christine E. Horak, H. David Inzunza, Xiuhua Zhao, et al.. 2013. “Safety, Efficacy, and Biomarkers of Nivolumab with Vaccine in Ipilimumab-refractory or -naive Melanoma”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2013.51.4802.
clinicaltrials.govStudy
Multiple Class I Peptides & Montanide ISA 51 VG w Escalating Doses of Anti-PD-1 ab BMS936558
2010. "Multiple Class I Peptides & Montanide ISA 51 VG w Escalating Doses of Anti-PD-1 ab BMS936558". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01176461.
~9 spots leftby Apr 2025
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