Phase II, multi‑cohort trial of neoadjuvant and post‑surgery IO102‑IO103 and pembrolizumab in patients with selected resectable tumors

Conditions

Melanoma and squamous cell carcinoma of the head and neck

Brief summary

MPR, defined as pCR (0% residual viable tumor) or near pCR (≤10% residual viable tumor) at surgery (central assessment)

Detailed description

pCR (0% residual viable tumor) at surgery (central assessment), Pathological response rate (% of patients with pPR, near pCR or pCR) (central assessment), ORR, determined by RECIST 1.1, at the end of neoadjuvant treatment (investigator assessment), EFS from the start of neoadjuvant treatment (investigator assessment), DFS from the date of surgery (investigator assessment), Safety endpoints • Incidence of adverse events (AEs) • Incidence of serious adverse events (SAEs) • Incidence of treatment-related AEs • Incidence of treatment-related SAEs • Incidence of AEs leading to discontinuation of trial treatment

Georgina V. Long, Robert I. Haddad, Caroline Robert, Laurent Mortier, Dirk Schadendorf et al. (17 authors)

Journal of Clinical Oncology2024-06-013 citations

10.1200/jco.2024.42.16_suppl.tps2701

Interventions

DRUGIO102-IO103

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
MPR, defined as pCR (0% residual viable tumor) or near pCR (≤10% residual viable tumor) at surgery (central assessment)	—

Secondary

Measure	Time frame
pCR (0% residual viable tumor) at surgery (central assessment), Pathological response rate (% of patients with pPR, near pCR or pCR) (central assessment), ORR, determined by RECIST 1.1, at the end of neoadjuvant treatment (investigator assessment), EFS from the start of neoadjuvant treatment (investigator assessment), DFS from the date of surgery (investigator assessment), Safety endpoints • Incidence of adverse events (AEs) • Incidence of serious adverse events (SAEs) • Incidence of treatment-related AEs • Incidence of treatment-related SAEs • Incidence of AEs leading to discontinuation of trial treatment	—

Measure

Time frame

pCR (0% residual viable tumor) at surgery (central assessment), Pathological response rate (% of patients with pPR, near pCR or pCR) (central assessment), ORR, determined by RECIST 1.1, at the end of neoadjuvant treatment (investigator assessment), EFS from the start of neoadjuvant treatment (investigator assessment), DFS from the date of surgery (investigator assessment), Safety endpoints • Incidence of adverse events (AEs) • Incidence of serious adverse events (SAEs) • Incidence of treatment-related AEs • Incidence of treatment-related SAEs • Incidence of AEs leading to discontinuation of trial treatment

—

Countries

Denmark, France, Germany, Spain

Outcome results

None listed