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New treatment option for Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic...
Official title Window of Opportunity in Preserving Laryngeal Function Trial
ClinicalTrials.gov ID: NCT07423078
What this study is testing
What is Toripalimab?
Toripalimab is an investigational medicine, being studied as a potential treatment for head and neck squamous cell carcinoma (hnscc) - recurrent/metastatic (r/m).
Also referred to as Loqtorzi.
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 trial will study the safety and tolerability and disease survival rates in adult patients with recurrent/metastatic (R/M) HNSCC when treated with carboplatin or cisplatin, paclitaxel, and toripalimab.
- Phase 2: a mid-size study of how well it works
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 confirmed and previously untreated squamous cell carcinoma of the larynx or hypopharynx
- AJCC 8th Edition Stage III - IV disease (T1-T2/N1-N3, T3-T4/N0-N3)
- Disease (primary \& nodal) must be potentially surgically resectable and curable with conventional surgery and CRT
- ECOG PS 0 - 2
- Sexually active fertile people and their partners must agree to use highly effective method of contraception prior to study entry, during the course...
You likely can't join if
- Prior treatment for head and neck cancer
- Unresectable laryngeal or hypopharyngeal squamous cell carcinoma
- Distant metastatic disease
- Has an active autoimmune disease requiring systemic treatment within the past 3 months, or a syndrome that requires ongoing systemic steroids or...
- Has a history of non-infectious pneumonitis that required steroids, evidence of interstitial lung disease, or currently active non-infectious...
- Known allergy or hypersensitivity to carboplatin or cisplatin, toripalimab, or paclitaxel.
See the full eligibility criteria
- Pathologically confirmed and previously untreated squamous cell carcinoma of the larynx or hypopharynx
- AJCC 8th Edition Stage III - IV disease (T1-T2/N1-N3, T3-T4/N0-N3)
- Disease (primary \& nodal) must be potentially surgically resectable and curable with conventional surgery and CRT
- ECOG PS 0 - 2
- Sexually active fertile people and their partners must agree to use highly effective method of contraception prior to study entry, during the course of the study, and for 1 year after the last dose of treatment...
- Female people of childbearing potential must not be pregnant or breastfeeding at screening. Female people are considered to be of childbearing potential unless one of the following criteria is met: Permanent...
- Must have normal organ and marrow function as defined below:
- Hemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count ≥ 1,500/mcL
- Platelet count ≥ 100,000/mcL
- Total bilirubin ≤ 1.5 X the institutional upper limit of normal (ULN)
- AST (SGOT) ≤ 2.5 X institutional upper limit of normal (ULN)
- ALT (SGPT) ≤ 2.5 X institutional ULN
- Creatinine clearance ≥ 40 mL/min/1.73 m2 for patients with a creatinine level above institutional normal
- Must have the ability to understand and the willingness to sign a written informed consent document.
- Prior treatment for head and neck cancer
- Unresectable laryngeal or hypopharyngeal squamous cell carcinoma
- Distant metastatic disease
- Has an active autoimmune disease requiring systemic treatment within the past 3 months, or a syndrome that requires ongoing systemic steroids or immunosuppressive agents. people with vitiligo, Grave's disease, or...
- Has a history of non-infectious pneumonitis that required steroids, evidence of interstitial lung disease, or currently active non-infectious pneumonitis.
- Known allergy or hypersensitivity to carboplatin or cisplatin, toripalimab, or paclitaxel.
- Prior malignancy within 2 years that in the investigator's opinion would be likely to affect the outcomes for the patient.
- Peripheral sensory neuropathy \> grade 2 by CTCAE v5.0
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is...
- Has acute or chronic active hepatitis B and C virus infection or known history of untreated hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (HCV) (defined as HCV...
- Note: No testing for Hepatitis B, Hepatitis C, or HIV is required unless mandated by local health authority or clinically indicated.
- Note: Participants with a history of HIV infection are considered eligible if CD4+ T cell counts are ≥350 cells/µL and the patient has had no opportunistic infections in the last 12 months.
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 Pittsburgh, Pennsylvania, United States. 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.