Actively Recruiting
Window of Opportunity in Preserving Laryngeal Function Trial
Led by Matthew Spector · Updated on 2026-04-13
87
Participants Needed
1
Research Sites
264 weeks
Total Duration
On this page
Sponsors
M
Matthew Spector
Lead Sponsor
C
Coherus Oncology, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Window of Opportunity in Preserving Laryngeal Function Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 chemoradiotherapy
- ECOG performance status 0 - 2
- Sexually active fertile subjects and their partners must agree to use highly effective contraception during the study and for 1 year after last treatment; men must agree not to donate sperm and women must agree not to donate eggs during these periods
- Female subjects of childbearing potential must not be pregnant or breastfeeding at screening; permanent sterilization or documented postmenopausal status is acceptable
- Must have normal organ and marrow function, including hemoglobin ≥ 9.0 g/dL, neutrophils ≥ 1500/mcL, platelets ≥ 100,000/mcL, bilirubin ≤ 1.5x ULN, AST/ALT ≤ 2.5x ULN, creatinine clearance ≥ 40 mL/min/1.73 m2 if creatinine elevated
- Must be able to understand and willing to sign informed consent
You will not qualify if you...
- Prior treatment for head and neck cancer
- Unresectable laryngeal or hypopharyngeal squamous cell carcinoma
- Distant metastatic disease
- Active autoimmune disease requiring systemic treatment within past 3 months or ongoing systemic steroids/immunosuppressive therapy (exceptions: vitiligo, Grave's disease, psoriasis without systemic therapy, resolved childhood asthma/atopy)
- History of non-infectious pneumonitis requiring steroids, interstitial lung disease, or active non-infectious pneumonitis
- Known allergy or hypersensitivity to carboplatin, cisplatin, toripalimab, or paclitaxel
- Prior malignancy within 2 years likely to affect study outcomes
- Peripheral sensory neuropathy greater than grade 2 by CTCAE v5.0
- Any condition or abnormality that may interfere with study participation or results, as judged by investigator
- Acute or chronic active hepatitis B or C infection, untreated hepatitis B, active hepatitis C, or HIV infection (except HIV with CD4+ ≥350 cells/μL and no recent opportunistic infections)
AI-Screening
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Trial Site Locations
Total: 1 location
1
UPMC Hillman Cancer
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
J
Jennifer Ruth, RN, BSN, CCRP
CONTACT
M
Mel J Mendez, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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