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Monoclonal Antibodies

IO102-IO103 + Pembrolizumab for Advanced Melanoma

Phase 3
Waitlist Available
Led By Inge Marie Svane, MD, Prof
Research Sponsored by IO Biotech
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed stage III (unresectable) or stage IV melanoma, as per American Joint Committee on Cancer 8th edition guidelines not amenable to local therapy
At least 1 measurable lesion according to response evaluation criteria for solid tumors (RECIST v1.1) and confirmed by IRC
Must not have
Patients with BRAFV600-positive disease who are experiencing rapidly progressing disease and/or have received standard first-line therapy with BRAF and/or MEK inhibitor for unresectable or metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 5.5 years
Awards & highlights

Summary

This trial tests a new treatment (IO102-IO103) combined with an existing drug (pembrolizumab) for patients with advanced melanoma that hasn't been treated and can't be surgically removed. The treatment works by boosting the immune system to attack cancer cells more effectively. Pembrolizumab is a standard treatment for advanced melanoma and has been shown to improve survival rates.

Who is the study for?
This trial is for adults with advanced melanoma that hasn't been treated before. It's open to those with a specific BRAFV600 mutation, provided they haven't had rapid disease progression or prior systemic cancer treatment for their condition. They must have at least one measurable tumor and can't have central nervous system metastases as the only active disease site.
What is being tested?
The study compares IO102-IO103 combined with pembrolizumab against pembrolizumab alone in first-line treatment of unresectable or metastatic melanoma. Patients will receive treatments every three weeks, up to two years, aiming to see if the combination improves survival without disease progression.
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation in various organs, infusion-related symptoms like fever or chills, fatigue, skin issues, and possibly an increased risk of infections due to immune system changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My melanoma is at an advanced stage and cannot be removed with surgery.
Select...
I have at least one tumor that can be measured.
Select...
I have not received any treatment for my advanced melanoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer has a BRAFV600 mutation and is worsening quickly after standard treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 5.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 5.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival (PFS)
Secondary study objectives
Complete response rate (CRR)
Disease control rate (DCR)
Durable Objective response rate (DRR)
+6 more

Side effects data

From 2022 Phase 1 & 2 trial • 35 Patients • NCT03003468
40%
FATIGUE
37%
INFUSION RELATED REACTION
37%
NAUSEA
23%
DIARRHEA
23%
BACK PAIN
23%
ABDOMINAL PAIN
23%
ANOREXIA
20%
ARTHRALGIA
20%
COUGH
20%
NON-CARDIAC CHEST PAIN
17%
DYSPNEA
17%
CONSTIPATION
17%
CHILLS
17%
MYALGIA
13%
DIZZINESS
13%
HEADACHE
13%
PRURITUS
13%
RASH MACULO-PAPULAR
10%
ANEMIA
10%
URTICARIA
10%
SINUS TACHYCARDIA
10%
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
10%
EDEMA LIMBS
10%
ALLERGIC REACTION
10%
ANXIETY
10%
LUNG INFECTION
10%
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
7%
TUMOR PAIN
7%
EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY
7%
HYPERGLYCEMIA
7%
PAIN
7%
PELVIC PAIN
7%
PRODUCTIVE COUGH
7%
PLEURAL EFFUSION
7%
VOICE ALTERATION
7%
VOMITING
7%
FEVER
7%
FLATULENCE
7%
CREATININE INCREASED
7%
HYPERTHYROIDISM
7%
NECK PAIN
7%
DEPRESSION
7%
FLU LIKE SYMPTOMS
7%
LYMPHOCYTE COUNT DECREASED
7%
DYSPEPSIA
7%
FLUSHING
7%
HYPONATREMIA
7%
HYPOTHYROIDISM
7%
URINARY TRACT INFECTION
3%
MUSCLE WEAKNESS LOWER LIMB
3%
ALKALINE PHOSPHATASE INCREASED
3%
DYSPHAGIA
3%
ESOPHAGITIS
3%
GASTROESOPHAGEAL REFLUX DISEASE
3%
OSTEONECROSIS OF JAW
3%
BRONCHOSPASM
3%
PNEUMONITIS
3%
BLURRED VISION
3%
GAIT DISTURBANCE
3%
HEMORRHOIDS
3%
POSTNASAL DRIP
3%
PRESYNCOPE
3%
SORE THROAT
3%
ACUTE KIDNEY INJURY
3%
PERIPHERAL MOTOR NEUROPATHY
3%
DRY SKIN
3%
FLASHING LIGHTS
3%
HYPOMAGNESEMIA
3%
HYPERTENSION
3%
HYPOTENSION
3%
SINUSITIS
3%
SYNCOPE
3%
HEARING IMPAIRED
3%
RASH ACNEIFORM
3%
SOMNOLENCE
3%
COLITIS
3%
HOT FLASHES
3%
RESPIRATORY FAILURE
3%
CONJUNCTIVITIS
3%
MOVEMENTS INVOLUNTARY
3%
NASAL CONGESTION
3%
PARESTHESIA
3%
VAGINAL INFECTION
3%
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
3%
NEUTROPHIL COUNT DECREASED
3%
ALLERGIC RHINITIS
3%
PAIN IN EXTREMITY
3%
SEPSIS
3%
BLOATING
3%
DEHYDRATION
3%
DRY MOUTH
3%
INSOMNIA
3%
MALAISE
3%
PAIN OF SKIN
3%
THROMBOEMBOLIC EVENT
3%
TREMOR
3%
WEIGHT GAIN
100%
80%
60%
40%
20%
0%
Study treatment Arm
Imprime PGG 4 mg/kg
Imprime PGG 2 mg/kg

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: IO102-IO103 + pembrolizumabExperimental Treatment2 Interventions
IO102-IO103 subcutaneous injections (85µg) every 3 weeks for a maximum 35 cycles (up to 2 years treatment). Additional dose given during the induction period on Day 8 of cycles 1 and 2. Each patient can be treated for a maximum of 37 administrations in total (up to 2 years treatment). Pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles.
Group II: pembrolizumabActive Control1 Intervention
Pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles (up to 2 years treatment).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2070

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for melanoma, such as IO102-IO103 and pembrolizumab, work by enhancing the body's immune response against cancer cells. IO102-IO103 is a dual-antigen immunotherapy that targets specific melanoma antigens, boosting the immune system's ability to recognize and destroy melanoma cells. Pembrolizumab, a PD-1 inhibitor, blocks the PD-1 pathway, preventing cancer cells from evading immune detection and allowing the immune system to attack the tumor more effectively. These mechanisms are vital for melanoma patients as they harness the body's natural defenses to combat cancer, potentially improving treatment outcomes and survival rates.
Rhabdomyolysis during high dose interleukin-2 treatment of metastatic melanoma after sequential immunotherapies: a case report.

Find a Location

Who is running the clinical trial?

IO BiotechLead Sponsor
8 Previous Clinical Trials
345 Total Patients Enrolled
2 Trials studying Melanoma
103 Patients Enrolled for Melanoma
Syneos HealthOTHER
174 Previous Clinical Trials
67,819 Total Patients Enrolled
3 Trials studying Melanoma
103 Patients Enrolled for Melanoma
Merck Sharp & Dohme LLCIndustry Sponsor
3,950 Previous Clinical Trials
5,174,576 Total Patients Enrolled
121 Trials studying Melanoma
21,716 Patients Enrolled for Melanoma

Media Library

IO102-IO103 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05155254 — Phase 3
Melanoma Research Study Groups: IO102-IO103 + pembrolizumab, pembrolizumab
Melanoma Clinical Trial 2023: IO102-IO103 Highlights & Side Effects. Trial Name: NCT05155254 — Phase 3
IO102-IO103 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05155254 — Phase 3
~99 spots leftby Jul 2025
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