Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Resectable Tumors

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
IO Biotech
Study ID
NCT05280314
Phase
PHASE2
Status
Recruiting
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Conditions

  • Melanoma
  • Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IO102-IO103 — DRUG
    IO102-IO103 is a combination of an indoleamine 2,3-dioxygenase 1 (IDO1) peptide (IO102) and a programmed death-ligand 1 (PD-L1) peptide (IO103), emulsified with an adjuvant (Montanide ISA 51 VG).
  • Pembrolizumab KEYTRUDA® — DRUG
    Pembrolizumab KEYTRUDA® administered intravenously

Study Details

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.

Key Dates

Start date
Dec 21, 2023
Status verified
Mar 2024
Primary completion
Apr 30, 2025
Completion
Jan 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A - Melanoma
    Cutaneous resectable Stage III melanoma. Neoadjuvant Treatment (3 cycles): Subcutaneous IO102-IO103 (IO102 85 μg and IO103 85 μg) and intravenous Pembrolizumab KEYTRUDA® 200mg Q3W. Post-surgery Treatment (15 cycles): Subcutaneous IO102-IO103 (IO102 85 μg and IO103 85 μg) and intravenous Pembrolizumab KEYTRUDA® 200mg Q3W.
  • Experimental: Cohort B - SCCHN
    Stage III or IVA resectable locoregionally advanced Squamous cell carcinoma of the head and neck (SCCHN) of the oral cavity, oropharynx (HPV-negative), hypopharynx, or larynx Neoadjuvant Treatment (2-3 cycles): Subcutaneous IO102-IO103 (IO102 85 μg and IO103 85 μg) and intravenous Pembrolizumab KEYTRUDA® 200mg Q3W Post-surgery Treatment (15 cycles): Subcutaneous IO102-IO103 (IO102 85 μg and IO103 85 μg) and intravenous Pembrolizumab KEYTRUDA® 200mg Q3W.
  • Experimental: Cohort C
    Cutaneous resectable Stage III melanoma. Neoadjuvant Treatment (3 cycles): Subcutaneous IO102-IO103 (IO102 85 μg and IO103 85 μg) and intravenous Pembrolizumab KEYTRUDA® 200mg Q3W (Arm A) versus intravenous Pembrolizumab KEYTRUDA® 200mg Q3W alone (Arm B) Post-surgery Treatment (15 cycles): Subcutaneous IO102-IO103 (IO102 85 μg and IO103 85 μg) and intravenous Pembrolizumab KEYTRUDA® 200mg Q3W (Arm A) versus Pembrolizumab KEYTRUDA® 200mg Q3W alone (Arm B)

Primary Outcome Measure

Major pathologic response [ Time Frame: Observed in the resected tumor tissue after neoadjuvant treatment at surgery ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
YaleNew HavenConnecticut06519
Stacy Severin
[email protected]
Barbara Burtness (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Barry Anderson
[email protected]
Kartik Sehgal
[email protected]
Robert Haddad (PRINCIPAL_INVESTIGATOR)
Massey Cancer CenterRichmondVirginia23219
Carrie Donovan
[email protected]
Erin Alesi, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Haven, CT

By condition
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By specialty
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By research site
Yale· New Haven, CTDana Farber Cancer Institute· Boston, MAMassey Cancer Center· Richmond, VA

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