Phase II study evaluating peptide-based immunotherapies as monotherapy for 3 weeks prior to standard treatment for head and neck cancer.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Cliniques Universitaires Saint-Luc

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Otorhinolaryngologic Diseases [C09]

Trial duration

completed 20 Mar 2025

Decision date (initial)

2024-09-18

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

IO Biotech ApS

External identifiers

EU CT number

2024-513447-82-00

EudraCT number

2020-000120-19

ClinicalTrials.gov

NCT04445064

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety, Efficacy

To evaluate a T-cell peptide specific response in the blood.

Secondary objectives 12

1. Arm A (IO102 vaccine): 1) To assess the safety and tolerability of IO102.
2. Arm A (IO102 vaccine) : 2) To state the reduction of immune suppression induced by IDO-positive cells.
3. Arm A (IO102 vaccine) : 3) To evaluate the anti tumor effect of IO102.
4. Arm A (IO102 vaccine) : 4) To evaluate the activity of peptide vaccine
5. Arm C (IO103 vaccine) : 1) To assess the safety and tolerability of IO103.
6. Arm C (IO103 vaccine) : 2) To state the reduction of immune suppression induced by IDO-positive cells.
7. Arm C (IO103 vaccine) : 3) To evaluate the anti tumor effect of IO103.
8. Arm C (IO103 vaccine) : 4) To evaluate the activity of peptide vaccine
9. Arm D (IO102+IO103 vaccines) : 1) To assess the safety and tolerability of IO102+IO103.
10. Arm D (IO102+IO103 vaccines) : 2) To state the reduction of immune suppression induced by PDL1 & IDO-positive cells.
11. Arm D (IO102+IO103 vaccines) : 3) To evaluate the anti tumor effect of IO102+IO103.
12. Arm D (IO102+IO103 vaccines) : 4) To evaluate the activity of peptide vaccine

Conditions and MedDRA coding

squamous cell carcinoma of the head and neck

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. Men and women ≥ 18 years of age on day of signing informed consent.
2. Histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx.
3. Patients selected for a curative treatment.
4. No distant metastases.
5. Measurable disease as per RECIST 1.1.
6. No active second malignancy during the last 3 years except non melanomatous skin cancer or carcinoma in situ of the cervix.
7. The participant provides written signed informed consent for the trial in accordance with ICH-GCP and local legislation prior to admission to the trial.
8. ECOG performance status 0-1 and Karnofsky score > or = 70.
9. Neutrophil count > 1,500/mm3, platelet count > 75,000/mm3, WBC> or = 3.0/109 L, bilirubin or creatinine < 2 times ULN, ALT or AST < 5 times ULN, Hemoglobin ≥ 9 g/dL.
10. A male participant able to father a child must agree to use contraception starting with the screening visit and throughout the duration of the trial.
11. A female participant is eligible to participate if she is not pregnant not breastfeeding, and at least one of the following conditions applies: a. Not a woman of childbearing potential (WOCBP). b. A WOCBP who agrees to follow contraceptive guidance starting with the screening and throughout the duration of the trial. WOCBP are allowed in the trial if they are using proper contraception (follow guidelines from the European Union Heads of Medicines Agency (CTFG, 2014 - see Appendix H).

Exclusion criteria 14

1. Nasopharynx cancer, unknown primary and nasal cavity and paranasal sinuses carcinomas.
2. Previous exposure to immunotherapy.
3. Known diagnosis of immune deficiency or a positive serology of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
4. Active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected) or pre-existing liver cirrhosis.
5. Other uncontrolled active illnesses or nonmalignant systemic disease (examples include, but are not limited to, active infections requiring antibiotics, bleeding disorders, uncontrolled diabetes, uncon-trolled ventricular arrhythmia, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome).
6. Has received a live vaccine within 30 days prior to the first dose of trial treatment
7. 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 insuffi-ciency) is not considered a form of systemic treatment and is allowed.
8. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing ex-ceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of trial treatment.
9. Any psychiatric, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
10. Any malignancy (other than SCCHN, non-melanoma skin cancer or localized cervical cancer or localized and presumed cured prostatic cancer or basal cell carcinoma of the skin and carcinoma in situ of the cervix or bladder) within the last 3 years prior to registration.
11. Women of Child Bearing Potential (WOCBP) who has a positive urine pregnancy test (e.g., within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum preg-nancy test will be required.
12. Pregnant woman and women who are expecting to conceive.
13. Breastfeeding women.
14. Patients expected to father children within the projected duration of the trial.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. ELISpot responses will be considered positive when the numbers of IFN-γ secreting cells will be at least two-fold greater than the mean value of the baseline with a minimum of 50 spots (per 2-5 × 105 PBMC) detected

Secondary endpoints 12

1. Arm A (IO102 vaccine) : 1) Safety, tolerability of IO102, as assessed by AEs, clinical laboratory tests, physical examination results using CTC-NCIv5.0.
2. Arm A (IO102 vaccine) : 2) Evaluation of the increased tumoral infiltration by CD3+ and CD8+ T-lymphocytes and by measuring the serum levels of kynurenin, tryptophan and kynurenin/tryptophan ratio.
3. Arm A (IO102 vaccine) : 3) Objective response rate (ORR), Overall survival (OS), Disease Free-Survival (DFS), Disease Specific Survival (DSS)
4. Arm A (IO102 vaccine) : 4) To investigate the efficacy of IO102 in monotherapy using MRI and DWI-MRI to visualize possible significant tumor modifications
5. Arm C (IO103 vaccine) : 1) Safety, tolerability of IO103, as assessed by AEs, clinical laboratory tests, physical examination results using CTC-NCIv5.0
6. Arm C (IO103 vaccine) : 2) Evaluation of the increased tumoral infiltration by CD3+ and CD8+ T-lymphocytes
7. Arm C (IO103 vaccine) : 3) Objective response rate (ORR), Overall survival (OS), Disease Free-Survival (DFS), Disease Specific Survival (DSS)
8. Arm C (IO103 vaccine) : 4) To investigate the efficacy of IO103 in monotherapy using MRI and DWI-MRI to visualize possible significant tumor modifications
9. Arm D (IO102+IO103 vaccines) : 1) Safety, tolerability of IO102+IO103, as assessed by AEs, clinical laboratory tests, physical examination results using CTC-NCIv5.0.
10. Arm D (IO102+IO103 vaccines) : 2) Evaluation of the increased tumoral infiltration by CD3+ and CD8+ T-lymphocytes by measuring the serum levels of kynurenin, tryptophan and kynurenin/tryptophan ratio.
11. Arm D (IO102+IO103 vaccines) : 3) Objective response rate (ORR), Overall survival (OS), Disease Free-Survival (DFS), Disease Specific Survival (DSS)
12. Arm D (IO102+IO103 vaccines) : 4) To investigate the efficacy of IO102+IO103 in monotherapy using MRI and DWI-MRI to visualize possible significant tumor modifications

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Cliniques Universitaires Saint-Luc

Sponsor organisation

Cliniques Universitaires Saint-Luc

Address

Hippokrateslaan 10, Batiment 54 Batiment 54

City

Sint-Lambrechts-Woluwe

Postcode

1200

Country

Belgium

Scientific contact point

Organisation

Cliniques Universitaires Saint-Luc

Contact name

Jean-Pascal Machiels

Public contact point

Organisation

Cliniques Universitaires Saint-Luc

Contact name

Jean-Pascal Machiels

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications