OncoMatch/Clinical Trials/NCT05280314
Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Resectable Tumors
Is NCT05280314 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including IO102-IO103 and Pembrolizumab KEYTRUDA® for melanoma.
Treatment: IO102-IO103 · Pembrolizumab KEYTRUDA® — This is a multicenter, multi-arm trial evaluating anti-tumor activity, safety, and immune infiltration of IO102-IO103 in combination with pembrolizumab KEYTRUDA® as neoadjuvant and post-surgery treatment. This proof-of-concept trial will include patients with resectable tumors in at least 2 indications.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: HPV negative
oropharynx (with known HPV-negative or p16-negative status assessed per institution standard or centrally)
Disease stage
Required: Stage III, IVA (AJCC 8th edition)
Excluded: Stage OLIGOMETASTATIC STAGE IV MELANOMA
cutaneous stage III melanoma according to the American Joint Committee on Cancer (AJCC) 8th edition; Stage III or IVA resectable locoregionally advanced SCCHN
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: BRAF inhibitor
Prior therapy targeting BRAF
Cannot have received: MEK inhibitor
Prior therapy targeting MEK
Cannot have received: any prior treatment for the tumor under study
Any prior treatment for the tumor under study
Cannot have received: anti-PD-1 therapy
Exception: if discontinued due to grade 3 or higher immune-related adverse event
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 that treatment due to a grade 3 or higher immune-related adverse event (irAE)
Cannot have received: chemotherapy
Exception: within 2 weeks prior to first dose of trial treatment
Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of trial treatment
Cannot have received: targeted small molecule therapy
Exception: within 2 weeks prior to first dose of trial treatment
Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of trial treatment
Cannot have received: radiation therapy
Exception: within 2 weeks prior to first dose of trial treatment
Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of trial treatment
Lab requirements
Blood counts
ANC ≥1500/µL; Platelets ≥100,000/µL; Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L (without packed red blood cell transfusion within prior 2 weeks; stable erythropoietin allowed)
Kidney function
Creatinine or measured or calculated creatinine clearance ≤1.5 × ULN or ≥30 mL/min for patient with creatinine levels >1.5 × institutional ULN
Liver function
Serum total bilirubin ≤1.5 × ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels >1.5 × ULN; AST and ALT ≤2.5 × ULN
Adequate organ function as defined below performed on screening labs obtained within 4 weeks before first dose: ANC ≥1500/µL; Platelets ≥100,000/µL; Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L (without packed red blood cell transfusion within prior 2 weeks; stable erythropoietin allowed); Creatinine or measured or calculated creatinine clearance ≤1.5 × ULN or ≥30 mL/min for patient with creatinine levels >1.5 × institutional ULN; Serum total bilirubin ≤1.5 × ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels >1.5 × ULN; AST and ALT ≤2.5 × ULN; INR or PT ≤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; 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Yale · New Haven, Connecticut
- Dana Farber Cancer Institute · Boston, Massachusetts
- Massey Cancer Center · Richmond, Virginia
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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