BridgeMD
Phase II, multi‑cohort trial of neoadjuvant and post‑surgery IO102‑IO103 and pembrolizumab in patients with selected resectable tumors
EU CTIS ID: 2022-502787-20-00
What this study is testing
To investigate the efficacy of neoadjuvant treatment with IO102‑IO103 in combination with pembrolizumab, in terms of major pathological response (MPR) in resected tumors.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
- HIV‑infected patients must be on anti‑retroviral therapy (ART) and have a well‑controlled HIV infection/disease defined as: a Patients on ART must have a CD4+ T‑cell count 350 cells/mm3 at time of screening b Patients on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 copies/mL or the lower limit of qualification (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks prior to first dose of trial medication (Day 1) c Patients on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks prior to first dose of trial medication (Day 1)
- Patients who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to start of trial intervention
- Patients with a history of hepatitis C (HCV) infection are eligible if HCV viral load is undetectable at screening
- Melanoma‑specific inclusion criteria: • Histologically or cytologically confirmed diagnosis of cutaneous stage III melanoma according to the American Joint Committee on Cancer (AJCC) 8th edition. Patients with resectable tumors are eligible for this trial either at presentation for primary melanoma with concurrent regional nodal metastasis or at the time of clinically detected nodal recurrence; they may belong to any of the following groups: o Primary cutaneous melanoma with clinically apparent regional lymph node metastases o Clinically detected recurrent melanoma at the proximal regional lymph node(s) basin o Clinically detected primary cutaneous melanoma involving multiple regional nodal groups o Clinically detected nodal melanoma (if single site) arising from an unknown primary o Relapsed resectable stage III melanoma
- SCCHN‑specific inclusion criteria: • Newly diagnosed and histologically confirmed SCCHN that presents as locoregionally advanced (stage III or IVA) resectable disease of the oral cavity, oropharynx (with known HPV‑negative or p16‑negative status assessed per institution standard), hypopharynx, or larynx
You likely can't join if
- 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
- 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 or known active hepatitis C virus (HCV) infection
See the full eligibility criteria
Who can join
- Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
- HIV‑infected patients must be on anti‑retroviral therapy (ART) and have a well‑controlled HIV infection/disease defined as: a Patients on ART must have a CD4+ T‑cell count 350 cells/mm3 at time of screening b Patients on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 copies/mL or the lower limit of qualification (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks prior to first dose of trial medication (Day 1) c Patients on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks prior to first dose of trial medication (Day 1)
- Patients who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to start of trial intervention
- Patients with a history of hepatitis C (HCV) infection are eligible if HCV viral load is undetectable at screening
- Melanoma‑specific inclusion criteria: • Histologically or cytologically confirmed diagnosis of cutaneous stage III melanoma according to the American Joint Committee on Cancer (AJCC) 8th edition. Patients with resectable tumors are eligible for this trial either at presentation for primary melanoma with concurrent regional nodal metastasis or at the time of clinically detected nodal recurrence; they may belong to any of the following groups: o Primary cutaneous melanoma with clinically apparent regional lymph node metastases o Clinically detected recurrent melanoma at the proximal regional lymph node(s) basin o Clinically detected primary cutaneous melanoma involving multiple regional nodal groups o Clinically detected nodal melanoma (if single site) arising from an unknown primary o Relapsed resectable stage III melanoma
- SCCHN‑specific inclusion criteria: • Newly diagnosed and histologically confirmed SCCHN that presents as locoregionally advanced (stage III or IVA) resectable disease of the oral cavity, oropharynx (with known HPV‑negative or p16‑negative status assessed per institution standard), hypopharynx, or larynx
- 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 (≤3 months old) or newly obtained core or excisional biopsy of a tumor lesion (primary tumor and/or lymph node) not previously irradiated.
- Eastern Cooperative Oncology Group (ECOG) performance score status of 0 or 1
- Adequate organ function
- 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
What rules you out
- 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
- 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 or known active hepatitis C virus (HCV) infection
- 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 the best interest of the patient to participate, in the opinion of the treating investigator
- 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
- Women of childbearing potential: Pregnant or breastfeeding, or expecting to conceive a child within the projected duration of the trial, from time of informed consent until at least 120 days after the last dose of trial treatment
- Melanoma‑specific exclusion criteria: • Current or prior history of uveal, mucosal, or acral melanoma • Oligometastatic stage IV melanoma • History of in‑transit or satellite metastases within the last 6 months • Prior therapy targeting BRAF and/or MEK
- Any prior systemic treatment for the tumor under study. Melanoma patients may have received prior non-immunotherapy adjuvant therapy if more than 6 months prior to the first dose of trial treatment.
- SCCHN‑specific exclusion criteria: • Nasopharyngeal cancer, unknown primary, nasal cavity or paranasal sinus carcinoma
- Prior therapy 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.
- Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of trial treatment
- Live or live‑attenuated vaccine within 30 days prior to the first dose of trial treatment
- 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. Patients who are currently receiving steroids at a dose equivalent to <5 mg/day of prednisone do not need to discontinue steroids prior to enrollment. Patients who require topical, ophthalmologic and inhalational steroids will not be excluded from the trial. Patients with hypothyroidism stable on hormone replacement or Sjögren’s syndrome will not be excluded from the trial
- 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 curative therapy
- History of an allogeneic tissue/solid organ transplant
- Active autoimmune disease that has required systemic treatment in past 2 years. Patients with type I diabetes mellitus; hypothyroidism only requiring hormone replacement; skin disorders not requiring systemic treatment; or conditions not expected to recur in the absence of an external trigger are permitted to enroll
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Australia
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 - 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.