Melanoma study: IO102-IO103 vs Pembrolizumab KEYTRUDA®
Official title Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Resectable Tumors
ClinicalTrials.gov ID: NCT05280314
What this study is testing
What is IO102-IO103?
an investigational peptide vaccine being studied as a potential treatment for melanoma (and other cancers) in combination with pembrolizumab. is designed to stimulate the immune system to recognize and attack cells expressing IDO1 and PD-L1.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether the new drug IO102-IO103 plus KEYTRUDA can fight cancer before and after surgery. It also looks at how safe the combo is and how it affects the immune system.
- Who it's for
- You may be able to join if you have a resectable melanoma or squamous cell cancer of the head or neck and meet the study’s health criteria.
- What's involved
- You will receive the new drug and KEYTRUDA before surgery, then again after surgery. You will have regular visits for blood tests, scans, and doctor check‑ins.
- Time commitment
- The study lasts about 6 months, with visits before surgery, after surgery, and at follow‑up appointments.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Melanoma-specific
- Primary cutaneous melanoma with clinically apparent regional lymph node metastases
- Clinically detected recurrent melanoma at the proximal regional lymph node(s) basin
- Clinically detected primary cutaneous melanoma involving multiple regional nodal groups
- Clinically detected nodal melanoma (if single site) arising from an unknown primary
You likely can't join if
- Current or prior history of uveal, mucosal, or acral melanoma
- Oligometastatic stage IV melanoma
- History of in-transit metastases within the last 6 months
- Currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks of the...
- Any prior treatment for the tumor under study
- Prior therapy for another tumor with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory...
See the full eligibility criteria
Who can join
- Melanoma-specific
- Primary cutaneous melanoma with clinically apparent regional lymph node metastases
- Clinically detected recurrent melanoma at the proximal regional lymph node(s) basin
- Clinically detected primary cutaneous melanoma involving multiple regional nodal groups
- Clinically detected nodal melanoma (if single site) arising from an unknown primary
- Relapsed resectable stage III melanoma SCCHN-specific
- Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
- Candidate for surgical resection with curative intent
- The patient (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Age ≥18 years on the day of signing the informed consent form
- Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides.
- Eastern Cooperative Oncology Group (ECOG) performance score status of 0 or 1
- Absolute neutrophil count (ANC) ≥1500/µL
- Platelets ≥100 000/µL
- Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L (Note: Criterion must be met without packed red blood cell transfusion within the prior 2 weeks. Patients can be on stable dose of erythropoietin [≥ approximately 3 months].)
- Creatinine or measured or calculated creatinine clearance (glomerular filtration rate can also be used in place of creatinine or creatinine clearance) ≤1.5 × upper limit of normal (ULN) or ≥30 mL/min for patient with...
- Serum total bilirubin ≤1.5 × ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels \>1.5 × ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN
- International normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN unless the patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within the therapeutic range of...
- Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless the patient is receiving anticoagulant therapy as long as PT or PTT is within the therapeutic range of intended use of anticoagulants
- Women of childbearing potential: Negative urine or serum pregnancy within 72 hours prior to receiving the first dose of trial medication.
- Women of childbearing potential: Willing to use highly effective contraception or abstain from heterosexual activity for the duration of the trial and for at least 120 days after the last dose of trial medication
- Known history of HBV infection
- Known history of HCV infection
- Mandated by local health authority. Melanoma-specific
What rules you out
- Current or prior history of uveal, mucosal, or acral melanoma
- Oligometastatic stage IV melanoma
- History of in-transit metastases within the last 6 months
- Currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks of the first dose of trial treatment Note: Patients who have entered the...
- Any prior treatment for the tumor under study
- Prior therapy for another tumor with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137), and discontinued from...
- Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of trial treatment
- Note: Patients must have recovered from all adverse events (AEs) due to previous therapies (i.e., grade ≤1 at baseline). Patients with grade ≤2 neuropathy are eligible for the trial.
- Note: If the patient has had major surgery, the patient must have recovered adequately from the procedure and/or complications from the surgery prior to starting trial treatment.
- Live or live-attenuated vaccine within 30 days prior to the first dose of trial treatment. Note: Administration of inactivated vaccines, mRNA-based vaccines [e.g., COVID-19] and vector-based vaccines are allowed.
- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- Additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially...
- History of an allogeneic tissue/solid organ transplant.
- Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Patients with type I diabetes mellitus
- History of radiation pneumonitis
- History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Active infection requiring systemic therapy
- HIV-infected patients with a history of Kaposi sarcoma and/or Multicentric Castleman Disease
- Has known active hepatitis B virus (HBV; defined as hepatitis B surface antigen [HBsAg] reactive and/or detectable HBV DNA) or known active hepatitis C virus (HCV) (defined as anti HCV Ab positive and detectable HCV...
- Known history of HBV or HCV infection
- Mandated by local health authority. Patients with a history of hepatitis will be screened using serology to confirm status.
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in...
- Psychiatric or substance abuse disorders that would interfere with the patient's ability to cooperate with the trial requirements
- Severe hypersensitivity (grade ≥3) to pembrolizumab and/or any of its excipients
The study team makes the final eligibility decision.
Where it is enrolling
- New Haven, Connecticut, United States
- Boston, Massachusetts, United States
- Richmond, Virginia, United States
- Sydney, New South Wales, Australia
- Melbourne, Victoria, Australia
- Aarhus, Denmark
- Copenhagen, Denmark
- Lille, France
- Paris, France
- Essen, Germany
- Heidelberg, Germany
- Barcelona, Spain
- Madrid, Spain
- Valencia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at New Haven, Connecticut, United States; Boston, Massachusetts, United States; Richmond, Virginia, United States; Sydney, New South Wales, Australia; Melbourne, Victoria, Australia; Aarhus, Denmark and 8 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.