Phase II Trial of IO102-IO103 and Pembrolizumab KEYTRUDA® for Resectable Melanoma and Head and Neck Squamous Cell Carcinoma
This study is testing a combination of two drugs, IO102-IO103 and Pembrolizumab KEYTRUDA®, for people with resectable (surgically removable) melanoma or squamous cell carcinoma of the head and neck. IO102-IO103 is a combination of peptides (small proteins) designed to work with your immune system. Pembrolizumab KEYTRUDA® is an immunotherapy drug. You would receive these treatments before surgery (neoadjuvant) and continue them after surgery (adjuvant). The main goal is to see how much the tumors shrink or disappear after the pre-surgery treatment. About 60 people will join this study. The current status of this trial is unclear.
- Study design
- This is a multi-center study involving approximately 60 participants with melanoma or head and neck squamous cell carcinoma. It is an interventional study, meaning participants will receive specific treatments.
- What's involved
- You would receive treatment before surgery for 2-3 cycles, followed by surgery. After surgery, you would continue treatment for up to 15 cycles (about 45 weeks).
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint, major pathologic response, is measured in the resected tumor tissue after neoadjuvant treatment at surgery.
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NCT05280314
Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Resectable Tumors
Recruiting
PHASE2Ages 18+InterventionalTreatmentIO Biotech
~60 participants
Updated 2024-03-18 on ClinicalTrials.gov
What's tested:IO102-IO103Pembrolizumab KEYTRUDA®
At a glance
Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Major pathologic response
Measured over Observed in the resected tumor tissue after neoadjuvant treatment at surgery
Conditions
Where it's being run
15 sites across 9 statesFrance3
Spain3
Denmark2
Germany2
Connecticut1
Massachusetts1
Virginia1
New South Wales1
Study leadership
- Barbara Burtness, MD, Prof · PRINCIPAL_INVESTIGATOR · Yale New Haven Hospital - Yale Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Primary cutaneous melanoma with clinically apparent regional lymph node metastases
Clinically detected recurrent melanoma at the proximal regional lymph node(s) basin
Clinically detected primary cutaneous melanoma involving multiple regional nodal groups
Clinically detected nodal melanoma (if single site) arising from an unknown primary
Relapsed resectable stage III melanoma
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 8. 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. 9. 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 10. HIV-infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease defined as:
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.
Known history of HCV infection
Mandated by local health authority.
Exclusion
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
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.
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. 5. 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. 6. 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. 7. 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. 8. History of an allogeneic tissue/solid organ transplant. 9. 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. 10. History of radiation pneumonitis 11. History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease 12. Active infection requiring systemic therapy 13. HIV-infected patients with a history of Kaposi sarcoma and/or Multicentric Castleman Disease 14. 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.
What this trial measures
- Major pathologic responseObserved 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)