Actively Recruiting
Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Resectable Tumors
Led by IO Biotech · Updated on 2024-03-18
60
Participants Needed
15
Research Sites
158 weeks
Total Duration
On this page
Sponsors
I
IO Biotech
Lead Sponsor
T
Theradex
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Resectable Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed diagnosis of cutaneous stage III melanoma or stage III/IVA resectable squamous cell carcinoma of the head and neck (SCCHN)
- Measurable disease based on RECIST 1.1 criteria
- Candidate for surgical resection with curative intent
- Age 18 years or older at time of informed consent
- Provided archival or new tumor tissue sample not previously irradiated
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function based on recent laboratory tests
- Women of childbearing potential must have negative pregnancy test and agree to use contraception or abstain from heterosexual activity during the trial and for 120 days after last dose
- HIV-positive patients must be on stable anti-retroviral therapy with well-controlled infection
- Hepatitis B or C patients must have undetectable viral load and be on or have completed antiviral therapy as required
You will not qualify if you...
- History of uveal, mucosal, acral melanoma, or oligometastatic stage IV melanoma
- In-transit metastases within the last 6 months
- Prior therapies targeting BRAF and/or MEK for melanoma
- Nasopharyngeal cancer, unknown primary, nasal cavity, or paranasal sinus carcinoma for SCCHN
- Participation in another investigational trial or use of investigational agents within 4 weeks prior to study treatment
- Prior treatment for the tumor under study
- Prior treatment with certain immunotherapies resulting in severe immune-related adverse events
- Recent chemotherapy, targeted therapy, or radiation within 2 weeks before trial treatment
- Recent live or live-attenuated vaccines within 30 days before study treatment
- Immunodeficiency or systemic immunosuppressive therapy within 7 days prior to treatment
- Active malignancy requiring treatment, except some skin cancers and in situ cervical cancer treated curatively
- History of allogeneic tissue or organ transplant
- Active autoimmune disease requiring systemic treatment in past 2 years
- History of radiation pneumonitis or pneumonitis requiring steroids
- Active infections needing systemic therapy
- HIV patients with Kaposi sarcoma or Multicentric Castleman Disease
- Known active hepatitis B or C infection
- Conditions or treatments that could interfere with trial participation or safety
- Psychiatric or substance abuse disorders interfering with trial cooperation
- Severe hypersensitivity to pembrolizumab or its components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Yale
New Haven, Connecticut, United States, 06519
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Massey Cancer Center
Richmond, Virginia, United States, 23219
Actively Recruiting
4
Melanoma Institute Australia The Uiniversity of Sydney, and Royal North Shore Hospital
Sydney, New South Wales, Australia, Sydney 2060
Actively Recruiting
5
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3VIC 3000
Actively Recruiting
6
Aarhus University Hospital
Aarhus, Denmark, 8200 Aarhus
Actively Recruiting
7
Copenhagen University Hospital Herlev
Copenhagen, Denmark, 9 DK-2730
Actively Recruiting
8
CHRU Lille
Lille, France, 59037 Lille
Actively Recruiting
9
Hôpital Ambroise-Paré
Paris, France, 92104 Boulogne
Actively Recruiting
10
Institut Gustave Roussy
Paris, France, 94805 Villejuif
Actively Recruiting
11
Universitätsklinikum Essen & Research Alliance Ruhr
Essen, Germany, D-45147 Essen
Actively Recruiting
12
Universität Heidelberg, Medizinische Fakultät
Heidelberg, Germany, 69120 Heidelberg
Actively Recruiting
13
Hospital Universitario Quirón Dexeus
Barcelona, Spain, 08028 Barcelona
Actively Recruiting
14
Hospital Universitario Ramón y Cajal
Madrid, Spain, Madrid 28034
Actively Recruiting
15
Hospital Clínico Universitario de Valencia -INCLIVA
Valencia, Spain, 46010 Valencia
Actively Recruiting
Research Team
D
Diane McDowell SVP, Clinical Development and Medical Affairs, MD
CONTACT
S
Shane O'Neill Clinical Program Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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