Lung Cancer Non Small CellPhase 2NCT05077709
IO102-IO103 in Combination With Pembrolizumab as First-line Treatment for Patients With Metastatic NSCLC, SCCHN, or mUBC
A Phase 2 study testing IO102-IO103 in combination with pembrolizumab in people with Lung Cancer Non Small Cell and Head and Neck Squamous Cell Carcinoma, run by IO Biotech at 21 sites in 3 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer Non Small Cell, Head and Neck Squamous Cell Carcinoma, Urothelial Carcinoma Bladder
- What is being tested?
- IO102-IO103 in combination with pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 21 sitesin 3 countries
- Study dates
- 11 Apr 2022to 8 Feb 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- or
- 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
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- Documented results of HPV status for oropharyngeal cancer.
- or
- 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:
- Not a woman of childbearing potential (WOCBP)
- A WOCBP who agrees to follow contraceptive guidance starting with the screening visit and through 120 days after last dose of pembrolizumab or 180 days after last dose of chemotherapy.
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial in accordance with ICH-GCP and local legislation prior to admission to the trial.
- At least 18 years of age on day of signing informed consent
- Have measurable disease per RECIST 1.1 as assessed by local site investigator/radiologist. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Have provided a blood sample and archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded tissue blocks are preferred to slides.
- Have an ECOG performance status of 0 to 1.
- If participant received major surgery, they must have recovered adequately from the adverse events and/or complications from the intervention prior to starting trial treatment.
- Have adequate organ function as defined in the protocol. Specimens must be collected within 10 days prior to the start of trial treatment.Have adequate organ function as defined below. Specimens must be collected within 10 days prior to the start of trial treatment.
- Adequate organ function as defined by:
- Haematology:
- Absolute neutrophil count ≥ 1500/µL or ≥ 1.5 x 109/L Platelets ≥ 100,000/µL or ≥ 100 x 109/L Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L • Renal: Creatinine ≤ 1.5 x ULN, or Measured or calculated creatinine clearance (CrCl) ≥ 60 mL/min for patients with creatinine levels > 1.5 x institutional ULN; GFR can also be used in place of creatinine or CrCl • Hepatic: Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels ≤3 x ULN AST and ALT ≤ 2.5 x ULN (≤ 5xULN for patients with liver metastases) Alkaline Phosphatase ≤ 2.5 x ULN
- Endocrine: Thyroid stimulating hormone (TSH) within normal limits, or Total T3 is within normal limits, or Free T3 and free T4 are within the normal limits
- Coagulation:
- International normalised ratio, PT or aPTT ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
Who cannot join
- <!-- -->
- 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.
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- 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.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority.
- Known adrenal insufficiency function (that is basal cortisol level < 140nmol/L or < 5 μg/dL).
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (HCV) (defined as HCV ribonucleic acid [RNA] [qualitative] is detected) infection.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after last dose of trial treatment.
- Has had an allogenic tissue/solid organ transplant.
- Has progressive disease (PD) within six months of completion of curatively intended systemic treatment for locoregionally advanced SCCHN.
Trial locations and contacts
21 sites in 3 countries.
21 sites in 3 countries
Spain10 sites
Hospital Vall d'Hebron
Barcelona, 08035
Institut Català d'Oncologia (ICO) Badalona (Catalan Institute of Oncology)
Barcelona, 08916
Hospital Universitari de Girona Doctor Josep Trueta
Girona, 17007
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Hospital Universitario Virgen Macarena
Seville, Sevilla, 41009
Hospital Clínico Universitario de Valencia
Valencia, Valencia
Hospital Clínico Lozano Blesa
Zaragoza, Zaragoza, 50009
United States9 sites
City of Hope
Duarte, California, 91010
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University
Portland, Oregon, 97239
UC Davis Cancer Center
Sacramento, California, 95817
University of California San Diego
San Diego, California, 92093
Montefiore Medical Center
The Bronx, New York, 10467
University of Toledo Medical Center
Toledo, Ohio, 43614
United Kingdom2 sites
Velindre Cancer Center
Cardiff, CF14 2TL
Guys and St Thomas Hospital
London
About this study
Official title: 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 NSCLC, SCCHN, or Metastatic mUBC
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)
Read the detailed description
Naturally occurring IDO/PD-L1 specific T-cells recognize MHC-bound IDO/PD-L1 peptides, and are able to eliminate IDO expressing or PD-L1 expressing immune regulatory cells and cancer cells. Activation of IDO or PD-L1 specific T-cells through vaccination with the IDO and PD-L1 peptides (IO102-IO103) will boost natural killing of cancer cells and counteract immune regulatory mechanisms in the tumor microenvironment. Thus, IDO/PD-L1 specific T-cells may both directly support anti-cancer immunity by killing target T-cells but also indirectly by releasing pro-inflammatory cytokines in the microenvironment to boost additional anti-cancer immunity.
This is a non comparative, open label, unblinded, multi-arm (basket) trial of IO102-IO103 in combination with pembrolizumab in three indications: NSCLC, SCCHN or mUBC. The primary objective of the trial is to investigate the efficacy of IO102-IO103 in combination with pembrolizumab in the frontline treatment in each of the different metastatic solid tumour indications with the intent to expand a specific arm if a clinically meaningful signal is observed based on primary endpoint (dual target of either ORR or PFS by investigator assessment according to RECIST v.1.1).
Approximately 90 patients will be enrolled and treated; approximately 30 patients in each arm. All eligible patients will receive treatment for up to 2 years with IO102-IO103 (IO102 85μg and IO103 185μg) SC Q3W in combination with pembrolizumab IV 200mg Q3W.
- Conditions
- Lung Cancer Non Small Cell, Head and Neck Squamous Cell Carcinoma, Urothelial Carcinoma Bladder
- Being tested
- IO102-IO103 in combination with pembrolizumab
- Keywords
- NSCLC, SCCHN, mUCB
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IO102-IO103 in combination with pembrolizumabDrug
The experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides
| Study group | Role | What they receive |
|---|---|---|
| Arm A (NSCLC) | Experimental | NSCLC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W Receives: 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 Receives: 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 Receives: Drug: IO102-IO103 in combination with pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Confirmed Objective Response Rate according to RECIST v1.1
Measured: 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)
PFS is defined as the time from first treatment with IMP to the first documented disease progression (based on disease evaluation done locally for all patients in accordance with RECIST v.1.1) or death from any cause. If a patient is not known to have progressed or died then they will be censored at the date of the last disease assessment. If a patient progresses after they have 2 or more missed disease assessment visits then they will be censored at the date of the last non missing disease assessment.
Measured: 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)
DoR will be measured from the date of first observed objective response until disease progression or death (whichever is earlier). Date of progression and censoring will be handled in the same way as for PFS (evaluation done locally for all patients in accordance with RECIST v.1.1). The time of the initial response will be defined as the latest of the dates contributing towards the first visit response of PR or CR. If a patient does not progress following a response, then their duration of response will use the PFS censoring time.
Measured: 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)
CRR is defined as the number (%) of patients with a visit response of CR. Evaluation of response will be done locally for all patients in accordance with RECIST v.1.1.
Measured: 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)
DCR is defined as the number (%) of patients with a visit response of PR or CR or SD. Evaluation of response will be done locally for all patients in accordance with RECIST v.1.1.
Measured: 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)
Overall survival is defined as the time from first dose of IMP until death from any cause. Patients not known to have died will be censored at the date last known to be alive. After disease progression, all patients are expected to be followed every 12 weeks to confirm their survival status. These follow-up visits/contacts continue until the last planned overall survival analysis.
Measured: From inform consent until death of any cause or withdrawal consent, whichever comes first, for up to 3 years.
Time to Response (TTR)
In the subset of responding patients, TTR is defined as the time from first dose of IMP until the date of the first observed partial or complete response. Evaluation of response will be done locally for all patients in accordance with RECIST v.1.1.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start11 Apr 2022
- Primary completion30 Nov 2025
- Study completion8 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung Cancer Non Small CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All participants receive IO102-IO103 for three different indications.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- IO Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Theradex, Almac, NeoGenomics, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Jonathan W Riess, MD, MSc, Principal investigator, Division of Hematology/Oncology, UC Davis Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077709
- Sponsor's protocol ID
- IOB-022
- Other IDs
- KEYNOTE-D38
- Status last verified
- Mar 2026
- First submitted
- 9 Sep 2021
- Last updated
- 8 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 NSCLC, SCCHN, or Metastatic mUBC
- ClinicalTrials.gov ID
- NCT05077709
- Acronym / sponsor ID
- IOB-022
- Conditions
- Lung Cancer Non Small Cell, Head and Neck Squamous Cell Carcinoma, Urothelial Carcinoma Bladder
- Keywords
- NSCLC, SCCHN, mUCB
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- IO BiotechIndustry (pharma, biotech, devices)
- Collaborators
- Theradex, Almac, NeoGenomics, Merck Sharp & Dohme LLC
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 8 Feb 2026 (actual)
- First posted
- 14 Oct 2021 (actual)
- Results
- Posted 8 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
Naturally occurring IDO/PD-L1 specific T-cells recognize MHC-bound IDO/PD-L1 peptides, and are able to eliminate IDO expressing or PD-L1 expressing immune regulatory cells and cancer cells. Activation of IDO or PD-L1 specific T-cells through vaccination with the IDO and PD-L1 peptides (IO102-IO103) will boost natural killing of cancer cells and counteract immune regulatory mechanisms in the tumor microenvironment. Thus, IDO/PD-L1 specific T-cells may both directly support anti-cancer immunity by killing target T-cells but also indirectly by releasing pro-inflammatory cytokines in the microenvironment to boost additional anti-cancer immunity.
This is a non comparative, open label, unblinded, multi-arm (basket) trial of IO102-IO103 in combination with pembrolizumab in three indications: NSCLC, SCCHN or mUBC. The primary objective of the trial is to investigate the efficacy of IO102-IO103 in combination with pembrolizumab in the frontline treatment in each of the different metastatic solid tumour indications with the intent to expand a specific arm if a clinically meaningful signal is observed based on primary endpoint (dual target of either ORR or PFS by investigator assessment according to RECIST v.1.1).
Approximately 90 patients will be enrolled and treated; approximately 30 patients in each arm. All eligible patients will receive treatment for up to 2 years with IO102-IO103 (IO102 85μg and IO103 185μg) SC Q3W in combination with pembrolizumab IV 200mg Q3W.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All participants receive IO102-IO103 for three different indications.
| Arm | Type | Receives |
|---|---|---|
| Arm A (NSCLC) | Experimental | Drug: IO102-IO103 in combination with pembrolizumabNSCLC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W |
| Arm B (SCCHN) | Experimental | Drug: IO102-IO103 in combination with pembrolizumabSCCHN patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W |
| Arm C (mUBC) | Experimental | Drug: IO102-IO103 in combination with pembrolizumabmUBC patients (metastatic stage IV) treated with IO102-IO103 SC Q3W in combination with pembrolizumab IV 200mg Q3W |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Patients with histologically or cytologically confirmed:
- Metastatic NSCLC (Arm A), who have not received prior systemic treatment for their metastatic disease and who have:
- or
- or
- All solitary metastases must be biopsied to confirm diagnosis of metastases from primary indication
Key exclusion criteria (25 listed)
- <!-- -->
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IO102-IO103 in combination with pembrolizumabThe experimental drug IO102-IO103 is for SC injection and consist of IDO and PD-L1 peptides | Drug | Arm A (NSCLC), Arm B (SCCHN), Arm C (mUBC) |
Primary outcome
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.
Confirmed Objective Response Rate according to RECIST v1.1
6 secondary outcomes
Progression Free Survival (PFS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: From inform consent until death of any cause or withdrawal consent, whichever comes first, for up to 3 years.
Time to Response (TTR)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan W Riess, MD, MSc principal investigator
Division of Hematology/Oncology, UC Davis Comprehensive Cancer Center
21 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IO102-IO103 in combination with pembrolizumab in people with Lung Cancer Non Small Cell and Head and Neck Squamous Cell Carcinoma, run by IO Biotech at 21 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Spain, United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.