MelanomaPhase 2NCT05280314
Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Resectable Tumors
A Phase 2 study testing IO102-IO103 and Pembrolizumab KEYTRUDA® in people with Melanoma and Squamous Cell Carcinoma of Head and Neck, run by IO Biotech at 15 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- IO102-IO103 and Pembrolizumab KEYTRUDA®
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 15 sitesin 6 countries
- Study dates
- 21 Dec 2023to Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- In addition to the indication-specific inclusion criteria, a patient must meet all the following general criteria to be eligible for participation in this trial:
- Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
- Candidate for surgical resection with curative intent
- The patient (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Age ≥18 years on the day of signing the informed consent form
- Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides.
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- Eastern Cooperative Oncology Group (ECOG) performance score status of 0 or 1
- Adequate organ function as defined below performed on screening labs obtained within 4 weeks before first dose:
- Absolute neutrophil count (ANC) ≥1500/µL
- Platelets ≥100 000/µL
- Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L (Note: Criterion must be met without packed red blood cell transfusion within the prior 2 weeks. Patients can be on stable dose of erythropoietin [≥ approximately 3 months].)
- Creatinine or measured or calculated creatinine clearance (glomerular filtration rate can also be used in place of creatinine or creatinine clearance) ≤1.5 × upper limit of normal (ULN) or ≥30 mL/min for patient with creatinine levels >1.5 × institutional ULN
- Serum total bilirubin ≤1.5 × ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels >1.5 × ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN
- International normalized ratio (INR) or prothrombin time (PT) ≤1.5 × ULN unless the patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within the therapeutic range of intended use of anticoagulants
- Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless the patient is receiving anticoagulant therapy as long as PT or PTT is within the therapeutic range of intended use of anticoagulants
- Women of childbearing potential: Negative urine or serum pregnancy within 72 hours prior to receiving the first dose of trial medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Women of childbearing potential: Willing to use highly effective contraception or abstain from heterosexual activity for the duration of the trial and for at least 120 days after the last dose of trial medication
- HIV-infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease defined as:
- a Patients on ART must have a CD4+ T-cell count >350 cells/mm3 at time of screening b Patients on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 copies/mL or the lower limit of qualification (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks prior to first dose of trial medication (Day 1) c Patients on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks prior to first dose of trial medication (Day 1) 11. Patients who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to start of trial intervention.
- Note: Patients should remain on anti-viral therapy throughout trial intervention and follow local guidelines for HBV anti-viral therapy after completion of trial intervention.
- Hepatitis B screening tests are not required unless:
- Known history of HBV infection
- Mandated by local health authority. 12. Patients with a history of hepatitis C (HCV) infection are eligible if HCV viral load is undetectable at screening.
- Note: Patients must have completed curative antiviral therapy at least 4 weeks prior to start of trial intervention.
- Hepatitis C screening tests are not required unless:
- Known history of HCV infection
- Mandated by local health authority.
- Melanoma-specific exclusion criteria:
- Current or prior history of uveal, mucosal, or acral melanoma
- Oligometastatic stage IV melanoma
- History of in-transit metastases within the last 6 months
- Prior therapy targeting BRAF and/or MEK
- SCCHN-specific exclusion criteria:
- Nasopharyngeal cancer, unknown primary, nasal cavity or paranasal sinus carcinoma
Who cannot join
- In addition, patients meeting any of the following criteria must be excluded:
- Currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks of the first dose of trial treatment Note: Patients who have entered the follow-up phase of an investigational trial may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- Any prior treatment for the tumor under study
- Prior therapy for another tumor 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 (e.g., CTLA-4, OX40, CD137), and discontinued from that treatment due to a grade 3 or higher immune-related adverse event (irAE)
- Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of trial treatment
- Note: Patients must have recovered from all adverse events (AEs) due to previous therapies (i.e., grade ≤1 at baseline). Patients with grade ≤2 neuropathy are eligible for the trial. Patients with endocrine-related AEs grade ≤2 requiring treatment or hormone replacement are also eligible.
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- Note: If the patient has had major surgery, the patient must have recovered adequately from the procedure and/or complications from the surgery prior to starting trial treatment.
- Live or live-attenuated vaccine within 30 days prior to the first dose of trial treatment. Note: Administration of inactivated vaccines, mRNA-based vaccines [e.g., COVID-19] and vector-based vaccines are allowed.
- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Patients who are currently receiving steroids at a dose equivalent to <5 mg/day of prednisone do not need to discontinue steroids prior to enrollment. Patients who require topical, ophthalmologic and inhalational steroids will not be excluded from the trial. Patients with hypothyroidism stable on hormone replacement or Sjögren's syndrome will not be excluded from the trial.
- Additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
- History of an allogeneic tissue/solid organ transplant.
- Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Patients with type I diabetes mellitus; hypothyroidism only requiring hormone replacement; skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment; or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- History of radiation pneumonitis
- History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Active infection requiring systemic therapy
- HIV-infected patients with a history of Kaposi sarcoma and/or Multicentric Castleman Disease
- Has known active hepatitis B virus (HBV; defined as hepatitis B surface antigen [HBsAg] reactive and/or detectable HBV DNA) or known active hepatitis C virus (HCV) (defined as anti HCV Ab positive and detectable HCV ribonucleic acid [RNA] [qualitative]) infection.
- Note: Testing for hepatitis B and hepatitis C is not required unless
- Known history of HBV or HCV infection
- Mandated by local health authority. Patients with a history of hepatitis will be screened using serology to confirm status.
- 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
- Psychiatric or substance abuse disorders that would interfere with the patient's ability to cooperate with the trial requirements
- Severe hypersensitivity (grade ≥3) to pembrolizumab and/or any of its excipients
Trial locations and contacts
15 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
Diane McDowell SVP, Clinical Development and Medical Affairs, MD contact
15 sites in 6 countries
United States3 sites, 3 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Barry Anderson, banderson@theradex.com
Kartik Sehgal, Kartik_Sehgal@DFCI.HARVARD.EDU
- Recruiting
Yale
New Haven, Connecticut, 06519
Stacy Severin, stacy.severin@yale.edu
Barbara Burtness
- Recruiting
Massey Cancer Center
Richmond, Virginia, 23219
Carrie Donovan, cdonovan2@vcu.edu
Erin Alesi, MD
France3 sites, 3 recruiting
- Recruiting
CHRU Lille
Lille, 59037 Lille
Sylvie Brice, sylvie.brice@chu-lille.fr
Laurent Mortier, MD
- Recruiting
Hôpital Ambroise-Paré
Paris, 92104 Boulogne
Veronique Clerisse, veronique.clerisse@aphp.fr
Philippe Saiag, MD
- Recruiting
Institut Gustave Roussy
Paris, 94805 Villejuif
Myriam Maalej-Chaari, myriam.maalej-chaari@gustaveroussy.fr
Caroline Robert, MD
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitario Quirón Dexeus
Barcelona, 08028 Barcelona
Carlos Esparre, Carlos Esparre <cesparre@oncorosell.com>
Alba Silvestre, asilvestre@oncorosell.com
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, Madrid 28034
Lucia Castillon, lcastillon@salud.madrid.org
Pardo de Vera, bpardo@salud.madrid.org
- Recruiting
Hospital Clínico Universitario de Valencia -INCLIVA
Valencia, 46010 Valencia
Inma Blasco, Inma Blasco <iblasco@incliva.es>
Silvia Moreno, smoreno@incliva.es
Australia2 sites, 2 recruiting
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3VIC 3000
Maria Vassiliou, Dr, (03)85595000, Maria.Vassiliou@petermac.org
Caroline Suhr, (03)85595000, caroline.suhr@petermac.org <Caroline.Suhr@petermac.org>
- Recruiting
Melanoma Institute Australia The Uiniversity of Sydney, and Royal North Shore Hospital
Sydney, New South Wales, Sydney 2060
Karen Bush, ealong@melanoma.org.au
Georgina Long, MD
Denmark2 sites, 2 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8200 Aarhus
Mona Kjaer, mona.kjaer@rm.dk
Tina Kusk, tinakk@auh.rm.dk
- Recruiting
Copenhagen University Hospital Herlev
Copenhagen, 9 DK-2730
Signe Reinhold, signe.rud.reinhold@regionh.dk
Inge Marie Svane, Dr
Germany2 sites, 2 recruiting
- Recruiting
Universitätsklinikum Essen & Research Alliance Ruhr
Essen, D-45147 Essen
Katharina Metz, Katharina.Metz@uk-essen.de
Dirk Schadendorf, MD
- Recruiting
Universität Heidelberg, Medizinische Fakultät
Heidelberg, 69120 Heidelberg
Melanie Leieren, Melanie.Leierer@med.uni-heidelberg.de
Jessica Hassell, MD
About this study
Official title: Phase II, Multi-cohort Trial of Neoadjuvant and Post-surgery IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Selected Resectable Tumors
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.
Read the detailed description
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. Approximately 60 patients with melanoma or SCCHN will be included (approximately 15 for each indication).During the neoadjuvant period, patients in cohort A, cohort B and Cohort C (Arm A) will receive IO102-IO103 and pembrolizumab KEYTRUDA® Q3W. Patients in Cohort C (Arm B) will receive pembrolizumab KEYTRUDA® Patients with melanoma will receive 3 doses of neoadjuvant treatment. Patients with SCCHN will receive 2 or 3 doses of neoadjuvant treatment, at the investigator's discretion. Surgical resection will be performed 1 to 3 weeks after the last dose of neoadjuvant treatment. All patients in cohort A,B and Cohort C (Arm A)will receive post-surgery treatment with IO102-IO103 and pembrolizumab KEYTRUDA® for a total of 15 cycles (up to 45 weeks). Patients in Cohort C (Arm B) will receive post-surgery treatment with pembrolizumab KEYTRUDA® for a total of 15 cycles (up to 45 weeks).
Patients with melanoma and patients with SCCHN who do not require SOC RT ± cisplatin will start post-surgery treatment after adequate recovery from surgery (approximately 1 to 2 months; no more than 12 weeks).Patients with SCCHN who require postoperative SOC therapy after surgery will start post-surgery IO102-IO103 and pembrolizumab KEYTRUDA® after adequate recovery from SOC therapy (approximately 1 to 2 months; no more than 12 weeks).
Objective response will be based on imaging; pathologic tumor response of the surgical specimens will be assessed at the time of surgery. Safety will be assessed by recording adverse events. The primary endpoint will be the percentage of patients with major pathologic response (MPR) in the resected tumor tissue after neoadjuvant treatment. Secondary endpoints include disease-free survival (DFS) at 2 years after surgery. All patients will have an end-of-treatment visit approximately 4 weeks after their last dose of trial treatment. Follow-up visits will be conducted at 6 and 12 months after the end-of-treatment visit. Following completion of the 12-month follow-up period, long-term follow-up for overall survival (OS) will be conducted every 6 months for at least a further 12 month.
- Conditions
- Melanoma, Squamous Cell Carcinoma of Head and Neck
- Being tested
- IO102-IO103, Pembrolizumab KEYTRUDA®
- Medical subject headings
- Melanoma, 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-IO103Drug
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 group | Role | What they receive |
|---|---|---|
| Cohort A - Melanoma | Experimental | 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. Receives: Drug: IO102-IO103; Drug: Pembrolizumab KEYTRUDA® |
| Cohort B - SCCHN | Experimental | 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. Receives: Drug: IO102-IO103; Drug: Pembrolizumab KEYTRUDA® |
| Cohort C | Experimental | 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) Receives: Drug: IO102-IO103; Drug: Pembrolizumab KEYTRUDA® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathologic response
Major pathologic response, defined as pathologic complete response (pCR) (0% residual viable tumor) or near pCR (≤10% residual viable tumor)
Measured: Observed in the resected tumor tissue after neoadjuvant treatment at surgery
Secondary outcomes (6)
Pathologic complete response
Pathologic complete response (pCR) (0% residual viable tumor)
Measured: Observed in the resected tumor tissue after neoadjuvant treatment at surgery
Pathologic tumor response
Pathologic tumor response (≤ 49% residual viable tumor) at surgery
Measured: Pathologic tumor response of the surgical specimens will be assessed at the time of surgery.
Objective response rate
Objective response rate (ORR), determined by RECIST 1.1
Measured: Determined after 9 weeks of treatment
Disease-free survival
Disease-free survival (DFS) from the date of surgery
Measured: at 2 years after surgery
Event-free survival
Event-free-survival (EFS)
Measured: Determined after 9 weeks of treatment
Event-free survival
Event-free-survival (EFS)
Measured: at 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start21 Dec 2023
- Primary completion30 Apr 2025 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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
- Multicenter, Multi-arm, Two indications, One Cohort SCCHN 2 Cohorts melanoma (1 cohort randomized and one cohort not randomized)
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IO Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Theradex, Almac, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Barbara Burtness, MD, Prof, Principal investigator, Yale New Haven Hospital - Yale Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280314
- Sponsor's protocol ID
- IO102-IO103-032/IOB-032
- Other IDs
- MK-3475-E40
- Status last verified
- Mar 2024
- First submitted
- 22 Feb 2022
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Multi-cohort Trial of Neoadjuvant and Post-surgery IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Selected Resectable Tumors
- ClinicalTrials.gov ID
- NCT05280314
- Acronym / sponsor ID
- IO102-IO103-032/IOB-032
- Conditions
- Melanoma, Squamous Cell Carcinoma of Head and Neck
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IO BiotechIndustry (pharma, biotech, devices)
- Collaborators
- Theradex, Almac, Merck Sharp & Dohme LLC
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Approximately 60 patients with melanoma or SCCHN will be included (approximately 15 for each indication).During the neoadjuvant period, patients in cohort A, cohort B and Cohort C (Arm A) will receive IO102-IO103 and pembrolizumab KEYTRUDA® Q3W. Patients in Cohort C (Arm B) will receive pembrolizumab KEYTRUDA® Patients with melanoma will receive 3 doses of neoadjuvant treatment. Patients with SCCHN will receive 2 or 3 doses of neoadjuvant treatment, at the investigator's discretion. Surgical resection will be performed 1 to 3 weeks after the last dose of neoadjuvant treatment. All patients in cohort A,B and Cohort C (Arm A)will receive post-surgery treatment with IO102-IO103 and pembrolizumab KEYTRUDA® for a total of 15 cycles (up to 45 weeks). Patients in Cohort C (Arm B) will receive post-surgery treatment with pembrolizumab KEYTRUDA® for a total of 15 cycles (up to 45 weeks).
Patients with melanoma and patients with SCCHN who do not require SOC RT ± cisplatin will start post-surgery treatment after adequate recovery from surgery (approximately 1 to 2 months; no more than 12 weeks).Patients with SCCHN who require postoperative SOC therapy after surgery will start post-surgery IO102-IO103 and pembrolizumab KEYTRUDA® after adequate recovery from SOC therapy (approximately 1 to 2 months; no more than 12 weeks).
Objective response will be based on imaging; pathologic tumor response of the surgical specimens will be assessed at the time of surgery. Safety will be assessed by recording adverse events. The primary endpoint will be the percentage of patients with major pathologic response (MPR) in the resected tumor tissue after neoadjuvant treatment. Secondary endpoints include disease-free survival (DFS) at 2 years after surgery. All patients will have an end-of-treatment visit approximately 4 weeks after their last dose of trial treatment. Follow-up visits will be conducted at 6 and 12 months after the end-of-treatment visit. Following completion of the 12-month follow-up period, long-term follow-up for overall survival (OS) will be conducted every 6 months for at least a further 12 month.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Multicenter, Multi-arm, Two indications, One Cohort SCCHN 2 Cohorts melanoma (1 cohort randomized and one cohort not randomized)
| Arm | Type | Receives |
|---|---|---|
| Cohort A - Melanoma | Experimental | Drug: IO102-IO103, Drug: Pembrolizumab KEYTRUDA®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. |
| Cohort B - SCCHN | Experimental | Drug: IO102-IO103, Drug: Pembrolizumab KEYTRUDA®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. |
| Cohort C | Experimental | Drug: IO102-IO103, Drug: Pembrolizumab KEYTRUDA®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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (35 listed)
- In addition to the indication-specific inclusion criteria, a patient must meet all the following general criteria to be eligible for participation in this trial:
- Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
- Candidate for surgical resection with curative intent
- The patient (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Age ≥18 years on the day of signing the informed consent form
Key exclusion criteria (23 listed)
- Currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks of the first dose of trial treatment Note: Patients who have entered the follow-up phase of an investigational trial may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- Any prior treatment for the tumor under study
- Prior therapy for another tumor 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 (e.g., CTLA-4, OX40, CD137), and discontinued from that treatment due to a grade 3 or higher immune-related adverse event (irAE)
- Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of trial treatment
- Live or live-attenuated vaccine within 30 days prior to the first dose of trial treatment. Note: Administration of inactivated vaccines, mRNA-based vaccines [e.g., COVID-19] and vector-based vaccines are allowed.
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-IO103IO102-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). | Drug | Cohort A - Melanoma, Cohort B - SCCHN, Cohort C |
| Pembrolizumab KEYTRUDA®Pembrolizumab KEYTRUDA® administered intravenously | Drug | Cohort A - Melanoma, Cohort B - SCCHN, Cohort C |
Primary outcome
Major pathologic response
Time frame: Observed in the resected tumor tissue after neoadjuvant treatment at surgery
Major pathologic response, defined as pathologic complete response (pCR) (0% residual viable tumor) or near pCR (≤10% residual viable tumor)
6 secondary outcomes
Pathologic complete response
Time frame: Observed in the resected tumor tissue after neoadjuvant treatment at surgery
Pathologic tumor response
Time frame: Pathologic tumor response of the surgical specimens will be assessed at the time of surgery.
Objective response rate
Time frame: Determined after 9 weeks of treatment
Disease-free survival
Time frame: at 2 years after surgery
Event-free survival
Time frame: Determined after 9 weeks of treatment
Event-free survival
Time frame: at 2 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
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A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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.
Diane McDowell SVP, Clinical Development and Medical Affairs, MD contact
Barbara Burtness, MD, Prof principal investigator
Yale New Haven Hospital - Yale Cancer Center
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IO102-IO103 and Pembrolizumab KEYTRUDA® in people with Melanoma and Squamous Cell Carcinoma of Head and Neck, run by IO Biotech at 15 sites in 6 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 35 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, France, Spain, Australia, Denmark and 1 more country. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diane McDowell SVP, Clinical Development and Medical Affairs, MD (+1 267 252 7296, dmd@iobiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathologic response (time frame: Observed in the resected tumor tissue after neoadjuvant treatment at surgery). 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 18 Mar 2024.