← Back to Search

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 5.5 years
Awards & highlights

Study Summary

This trial is investigating the safety and efficacy of IO102-IO103 in combination with pembrolizumab as first-line treatment for patients with previously untreated unresectable or metastatic (advanced) melanoma.

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.Check my eligibility
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.See study design
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 had targeted or immune therapy over 6 months ago and didn't relapse during or within 6 months after treatment.
Select...
I can provide a recent biopsy sample and blood for testing.
Select...
My melanoma has a BRAFV600 mutation and I haven't received treatment for it yet.
Select...
I have not received any treatment for my advanced melanoma.

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

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

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

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
~1950

Find a Location

Who is running the clinical trial?

IO BiotechLead Sponsor
8 Previous Clinical Trials
342 Total Patients Enrolled
2 Trials studying Melanoma
73 Patients Enrolled for Melanoma
Syneos HealthOTHER
172 Previous Clinical Trials
68,059 Total Patients Enrolled
3 Trials studying Melanoma
103 Patients Enrolled for Melanoma
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,293 Total Patients Enrolled
120 Trials studying Melanoma
21,235 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any precedent for this combination of drugs?

"At this moment, there are 1000 ongoing clinical trials for IO102-IO103 with 122 of them being in Phase 3. However, many of the trials for IO102-IO103 are based in Houston, Texas, there are 35962 locations running studies for IO102-IO103."

Answered by AI

Has the FDA cleared IO102-IO103 for prescription use?

"There is already some efficacy data available for IO102-IO103, as well as multiple rounds of data attesting to its safety. Consequently, we have given it a score of 3."

Answered by AI

For what therapeutic purposes is IO102-IO103 often prescribed?

"IO102-IO103 has demonstrated efficacy in the treatment of malignant neoplasms, unresectable melanoma, and microsatellite instability high."

Answered by AI
~165 spots leftby Jul 2025