BridgeMD
New treatment option for Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma...
Official title Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
ClinicalTrials.gov ID: NCT07195734
What this study is testing
What is Carboplatin?
Carboplatin is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for clinical stage ii hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8.
Also referred to as Blastocarb, Carboplat.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial tests the addition of chemotherapy, with carboplatin and paclitaxel, or chemo-immunotherapy, with carboplatin, paclitaxel and cemiplimab to standard salvage surgery followed by post operative radiation therapy and cisplatin for high risk patients, for the treatment of patients with PD-L1 positive head and neck squamous cell carcinoma that has come back and spread to nearby tissue or lymph nodes after a period of improvement (locally recurrent) or is persistent. Carboplatin is in a class of medications known as platinum-containing compounds.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Pathologically (histologically or cytologically) proven diagnosis of locally recurrent or persistent squamous cell carcinoma of head and neck (SCCHN)...
- PD-L1 combined positive score (CPS) ≥ 1 using a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory
- Verify insurance (or other payment) coverage for neoadjuvant chemotherapy
- Measurable disease as defined by RECIST 1.1
- Patients must have locally recurrent or persistent SCCHN arising within the oral cavity, oropharynx, larynx, or hypopharynx (American Joint Committee...
See the full eligibility criteria
- Pathologically (histologically or cytologically) proven diagnosis of locally recurrent or persistent squamous cell carcinoma of head and neck (SCCHN) arising within the oral cavity, oropharynx, larynx, or hypopharynx
- PD-L1 combined positive score (CPS) ≥ 1 using a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory
- Verify insurance (or other payment) coverage for neoadjuvant chemotherapy
- Measurable disease as defined by RECIST 1.1
- Patients must have locally recurrent or persistent SCCHN arising within the oral cavity, oropharynx, larynx, or hypopharynx (American Joint Committee on Cancer [AJCC] Cancer Staging Manual, 8th Edition) AND are deemed...
- P16 positive oropharynx patients with T2, T3, T4, N0, N1, N2 and all other patients with T2, T3, T4a, N0, N1, N2a, N2b, N2c, N3a are eligible.
- Patients must be deemed surgically resectable without gross residual disease.
- For patients with oral cavity SCCHN, only those with recurrent or persistent disease after prior surgery are eligible.
- Patients who are candidates for salvage laryngectomy to treat recurrent laryngeal cancer and who are having salvage surgery for curative intent are eligible.
- Patients with resectable lymph node-only recurrence are eligible.
- No major vascular involvement (\> 180° involvement of the common carotid or internal carotid artery), jugular foramen involvement, or prevertebral, paraspinous muscle involvement precluding a curative resection
- No evidence of distant metastatic disease
- The following minimum diagnostic workup is required:
- General history and physical examination.
- Diagnostic-quality neck CT and PET/CT of neck (PET with attenuation-correction CT of neck, chest, and abdomen)
- Age ≥ 18
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Negative urine or serum pregnancy test (in persons of childbearing potential) within 30 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone...
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
- Platelets ≥ 100,000 cells/mm\^3
- Hemoglobin ≥ 8.0 g/dL (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] ≥ 8.0 g/dL is acceptable)
- Adequate renal function defined as creatinine clearance (CrCL) \> 50 mL/min by the Cockcroft-Gault formula
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (Not applicable to patients with known Gilbert's syndrome)
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x institutional ULN
- Only patients who received prior radiation therapy in the definitive or post-operative setting (limited to one course) are eligible.
- Prior radiation therapy must have been completed at least 6 months prior to registration with the majority of the index persistent/recurrent cancer volume (\> 50%) irradiated to ≥ 40 Gy at the time
- Prior systemic therapy including immunotherapy with anti-PD1 or anti-PDL1 within the definitive setting (neo-adjuvant, or adjuvant) is permitted and must have been completed at least 4 months prior to registration
- Prior systemic therapy including immunotherapy for treatment of recurrent or metastatic SCCHN is not permitted
- No investigational anti-cancer agents received within 4 weeks prior to registration
- No New York Heart Association Functional Classification III or IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk...
- No active infection requiring IV antibiotics, IV antiviral, or IV antifungal treatments
- No peripheral neuropathy grade 3 or 4
- No history of interstitial lung disease
- No active, noninfectious pneumonitis requiring immunosuppressive therapy
- No history of a solid organ transplant (other than corneal transplant)
- No active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease-modifying agents, corticosteroids [\> 10 mg prednisone/day or equivalent] or immunosuppressive drugs)
- NOTE: Patients meeting the following criteria are not considered immunosuppressed and are eligible to enroll:
- Patients who require a brief course of steroids (e.g., prophylaxis for imaging assessments due to hypersensitivity to contrast agents) are not excluded
- Patients with type I diabetes mellitus, and endocrinopathies (including hypothyroidism due to autoimmune thyroiditis) only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not...
- Physiologic replacement doses ≤ 10 mg prednisone/day or equivalent are allowed. Inhaled or topical steroids are permitted
- No history of allergic reaction to the study agent, compounds of similar chemical or biologic composition to the study agent, and immune checkpoint inhibitors (or any of its excipients)
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- DeKalb, Illinois, United States
- Geneva, Illinois, United States
- Glenview, Illinois, United States
- Grayslake, Illinois, United States
- Lake Forest, Illinois, United States
- Lisle, Illinois, United States
- Oak Brook, Illinois, United States
- Orland Park, Illinois, United States
- Shiloh, Illinois, United States
- Warrenville, Illinois, United States
- Ankeny, Iowa, United States
- Clive, Iowa, United States
- Council Bluffs, Iowa, United States
- Des Moines, Iowa, United States
- Waukee, Iowa, United States
+ 55 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Los Angeles, California, United States; Sacramento, California, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States; DeKalb, Illinois, United States and 69 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.