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

NCT05077709 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: IOB-022KEYNOTE-D38
• Study Type: interventional
• Target: 63
• Locations: 3 countries
• Sites: 21

Brief Summary

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)

Conditions

Head and Neck Squamous Cell Carcinoma; Urothelial Carcinoma Bladder; Lung Cancer Non Small Cell

Keywords

NSCLC; SCCHN; mUCB

Outcome Measures

Primary Outcomes (1)

• ORR

  Confirmed Objective Response Rate according to RECIST v1.1

  From date of informed consent until disease progression, death or withdrawal of consent whichever came first, assessed for up to 3 years.

Secondary Outcomes (6)

• Progression Free Survival (PFS)

  Every 9 weeks during the first year of treatment and then every 12 weeks for the second year of treatment until disease progression, death or withdrawal consent, whichever comes first, for up to 3 years.

• Duration of Response (DoR)

  Every 9 weeks during the first year of treatment and then every 12 weeks for the second year of treatment until disease progression, death or withdrawal consent, whichever comes first, for up to 3 years.

• Complete Response Rate (CRR)

  Every 9 weeks during the first year of treatment and then every 12 weeks for the second year of treatment until disease progression, death or withdrawal consent, whichever comes first, for up to 3 years.

• Disease Control Rate (DCR)

  Every 9 weeks during the first year of treatment and then every 12 weeks for the second year of treatment until disease progression, death or withdrawal consent, whichever comes first, for up to 3 years.

• Overall Survival (OS)

  From inform consent until death of any cause or withdrawal consent, whichever comes first, for up to 3 years.

Study Arms (3)

Arm A (NSCLC)

EXPERIMENTAL

NSCLC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W

Drug: IO102-IO103 in combination with pembrolizumab

Arm B (SCCHN)

EXPERIMENTAL

SCCHN patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W

Drug: IO102-IO103 in combination with pembrolizumab

Arm C (mUBC)

EXPERIMENTAL

mUBC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W

Drug: IO102-IO103 in combination with pembrolizumab

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

Arm A (NSCLC); Arm B (SCCHN); Arm C (mUBC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically or cytologically confirmed:
• Metastatic NSCLC (Arm A), who have not received prior systemic treatment for their metastatic disease and who have:
• no known sensitizing EGFR or ALK mutations.
• Metastatic SCCHN (Arm B) with no prior therapy and who have:
• Histologically- or cytologically-confirmed recurrent or metastatic SCCHN considered incurable by local therapies. Tumors of nasopharyngeal origin (any histology) are excluded
• Documented results of HPV status for oropharyngeal cancer.
• Metastatic UBC (Arm C) with no prior therapy and not eligible for any cisplatin therapy:
• Advanced/unresectable (inoperable) or metastatic urothelial cancer of the renal pelvis, ureter, bladder or urethra (transitional cell and mixed transitional/non transitional cell histologies permitted but transitional cell histology must be the dominant histology)
• All solitary metastases must be biopsied to confirm diagnosis of metastases from primary indication
• PD-L1 tumor expression or PD-L1 CPS (as confirmed prior to enrolment using the DAKO 22C3 assay, using local/central services):
• Arm A (NSCLC): PD-L1 TPS ≥ 50%
• Arm B (SCCHN): PD-L1 CPS ≥ 20; HPV +/-
• Arm C (mUBC): PD-L1 CPS ≥ 10
• A male participant able to father a child must agree to use contraception starting with the screening visit and through 120 days after last dose of pembrolizumab or 180 days after last dose of treatment with IO102-IO103.
• A female participant is eligible to participate if she is not pregnant not breastfeeding, and at least one of the following conditions applies:

You may not qualify if:

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• A WOCBP who has a positive urine pregnancy test (e.g., within 72 hours) prior to treatment. If at any time, a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
• Has received prior therapy 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 (eg, CTLA-4, OX 40, CD137) other than for adjuvant or neoadjuvant treatment AND was discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE).
• Has received prior systemic anti-cancer therapy in the first line setting for the participant's metastatic disease (treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as completed at least 6 months prior to diagnosis of metastatic disease).
• Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy are eligible.
• Has received prior radiotherapy to the lung \>30 Gy within 6 months of start of trial treatment and have recovered from all radiation-related adverse events, not have require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
• Have a life expectancy of \< 3 months and/or rapidly progressing disease.
• Have received a live or live attenuated vaccine within 30 days prior to the first dose of trial treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
• Participation in or has participated in a trial of an investigational agent within 30 days prior to study entry or has used an investigational device within 6 months prior to the first dose of trial treatment. Note: Participants who have entered the follow-up phase of an investigational trial may participate as long as it has been 6 months after the last dose of the previous investigational agent.
• Has a diagnosis of immunodeficiency10. Received any of the following medications or procedures within 2 weeks prior to time of treatment initiation: Systemic or topical corticosteroids at immunosuppressive doses \> 10 mg/day of hydrocortisone or \> 5mg/day of prednisone equivalent.
• Has a known additional malignancy that is progressing or has required active treatment within the past 2 years.
• Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
• Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during trial screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of trial treatment.
• Has severe hypersensitivity (≥Grade 3) to IO102 or IO103, pembrolizumab and/or any of their excipients.
• Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.

Sponsors & Collaborators

• IO Biotech: lead
• Theradex: collaborator
• Almac: collaborator
• NeoGenomics: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (21)

City of Hope

Duarte, California, 91010, United States

Location

UC Davis Cancer Center

Sacramento, California, 95817, United States

Location

University of California San Diego

San Diego, California, 92093, United States

Location

Mid Florida Hematology and Oncology Center

Orange City, Florida, 32763, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

University of Toledo Medical Center

Toledo, Ohio, 43614, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Hospital Universitario Virgen Macarena

Seville, Sevilla, 41009, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, Valencia, Spain

Location

Hospital Clínico Lozano Blesa

Zaragoza, Zaragoza, 50009, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Institut Català d'Oncologia (ICO) Badalona (Catalan Institute of Oncology)

Barcelona, 08916, Spain

Location

Hospital Universitari de Girona Doctor Josep Trueta

Girona, 17007, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

Velindre Cancer Center

Cardiff, CF14 2TL, United Kingdom

Location

Guys and St Thomas Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Squamous Cell Carcinoma of Head and Neck

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms

Results Point of Contact

• Title: Mai-Britt Zocca
• Organization: IO Biotech

mb@iobiotech.com

+45 21947856

Study Officials

• Jonathan W Riess, MD, MSc

  Division of Hematology/Oncology, UC Davis Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants receive IO102-IO103 for three different indications.

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: October 14, 2021
• Study Start: April 11, 2022
• Primary Completion: November 30, 2025
• Study Completion: February 8, 2026
• Last Updated: April 8, 2026
• Results First Posted: April 8, 2026

Record last verified: 2026-03

Locations

US (9); ES (10); GB (2)