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

First listed
Mar 15, 2022
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
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Yale· New Haven, CTDana Farber Cancer Institute· Boston, MAMassey Cancer Center· Richmond, VA

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