IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or mUBC

Part of paid clinical trials in Duarte, California.

Sponsor
IO Biotech
Study ID
NCT05077709
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • IO102-IO103 in combination with pembrolizumab — DRUG
    The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides

Study Details

A Phase II Multi-Arm (basket) Trial Investigating the Safety and Efficacy of IO102-IO103 in Combination with pembrolizumab, as First-line Treatment for Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC), Squamous Cell Carcinoma of Head or Neck (SCCHN), or Metastatic Urothelial Bladder Cancer (mUBC)

Key Dates

Start date
Apr 11, 2022
Status verified
Mar 2026
Primary completion
Nov 30, 2025
Completion
Feb 8, 2026

Study Design

Enrollment
63 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (NSCLC)
    NSCLC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W
  • Experimental: Arm B (SCCHN)
    SCCHN patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W
  • Experimental: Arm C (mUBC)
    mUBC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W

Primary Outcome Measure

ORR [ Time Frame: From date of informed consent until disease progression, death or withdrawal of consent whichever came first, assessed for up to 3 years. ]

Locations (9)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
UC Davis Cancer CenterSacramentoCalifornia95817-
University of California San DiegoSan DiegoCalifornia92093-
Mid Florida Hematology and Oncology CenterOrange CityFlorida32763-
Montefiore Medical CenterThe BronxNew York10467-
University of Toledo Medical CenterToledoOhio43614-
Oregon Health & Science UniversityPortlandOregon97239-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Virginia Cancer SpecialistsFairfaxVirginia22031-

Related coverage on Hipa.ai

Find similar trials in Duarte, CA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
City of Hope· Duarte, CAUC Davis Cancer Center· Sacramento, CAUniversity of California San Diego· San Diego, CAMid Florida Hematology and Oncology Center· Orange City, FLMontefiore Medical Center· The Bronx, NYUniversity of Toledo Medical Center· Toledo, OH

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