Pembrolizumab with nab-paclitaxel and cisplatin for locally advanced head and neck cancer

Induction Therapy With Nab-paclitaxel, Cisplatin and Pembrolizumab in Untreated Locally Advanced Head and Neck Squamous Cell Carcinoma

This trial tries adding pembrolizumab to nab-paclitaxel and cisplatin as initial treatment for adults with resectable, locally advanced head and neck squamous cell carcinoma to see if it increases tumor shrinkage and organ preservation.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Guangdong Provincial People's Hospital (Academic / other)
• Drugs / interventions: prednisone, Pembrolizumab
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05272696 on ClinicalTrials.gov

What this trial studies

This is a single-arm Phase II study giving two three-week cycles of induction therapy with nab-paclitaxel (260 mg/m² IV), cisplatin (75 mg/m² IV), and pembrolizumab (200 mg IV) to patients with resectable, locoregionally advanced head and neck squamous cell carcinoma. After induction, a multidisciplinary team (MDT) reviews response: patients with good shrinkage may receive chemoradiotherapy (CRT) while others proceed to surgery, with adjuvant CRT for high-risk cases. Maintenance therapy is considered for patients with high-risk features after MDT discussion, and outcomes are evaluated three months after CRT. Primary outcomes include objective response rate, safety, and the rate of organ preservation.

Who should consider this trial

Good fit: Adults 18–70 years with previously untreated, resectable stage III or IVA head and neck squamous cell carcinoma, measurable disease per RECIST 1.1, ECOG 0–1, and adequate blood, liver, kidney, and cardiac function are ideal candidates.

Not a fit: Patients with distant metastases, poor performance status (ECOG >1), prior head and neck cancer treatment, or significant organ dysfunction are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could increase tumor shrinkage before local therapy and allow more patients to preserve organs or avoid more extensive surgery.

How similar studies have performed: Combinations of pembrolizumab with chemotherapy have shown benefit in recurrent or metastatic head and neck cancer, but using pembrolizumab as part of induction therapy before surgery or CRT is less established and remains under study.

Eligibility criteria

Inclusion Criteria:

1. Histologically or cytologically confirmed Head and Neck Squamous Cell Carcinoma (oral cavity, oropharynx, laryngeal and hypopharynx) with locoregionally-advanced disease stage III or IVA without metastasis , previously untreated (AJCC 8th) and had at least one tumour lesion measurable per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
2. Measurable disease based on RECIST 1.1
3. ECOG performance status 0-1
4. Men and women, Age ≥18 and ≤ 70 years at the time of signing informed consent,
5. Adequate hepatic, cardiac and renal function as demonstrated by 1) Hematology: ANC≥1.5×10\^9 /L, HGB≥9 g/dL, PLT≥80×10\^9 /L; 2) Renal: Serum creatinine \< 1.5x ULN or CrCl \> 60mL/min; 3) Hepatic: Total Bilirubin ≤ 1.5 x ULN, AST/ALT ≤ 2.5 x ULN and ALP≤5 x ULN.
6. Female subjects of childbearing potential should have a negative pregnancy test result within 28 days prior to enrollment. If the result is more than 7 days before receiving the first dose of study medication, a urine pregnancy test is required for verification.
7. Voluntary informed consent, joining the study with good compliance

Exclusion Criteria:

1. Active, known, or suspected autoimmune disease or Type I diabetes or hypothyroidism requiring hormone replacement therapy and skin diseases requiring systemic treatment.
2. currently received systemic steroid therapy with dose superior to 10 mg/day of prednisone or equivalent or any other form of immunosuppressive therapy within 14 days prior to the enrollment
3. Has known active Hepatitis B (e.g., HBsAg reactive and HBV DNA≥1×10\^4 copies /mL) or Hepatitis C or HIV
4. Active pulmonary tuberculosis (TB) infection was judged according to chest X-ray examination/CT, sputum examination and clinical physical examination.
5. Patients with severe heart disease include congestive heart failure, uncontrollable high-risk arrhythmias, unstable angina pectoris, myocardial infarction, and intractable hypertension.
6. Pregnant or breastfeeding women.
7. The patient (male or female) has the possibility of fertility, but is unwilling or does not take effective contraceptive measures.
8. Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device
9. Has had another known invasive malignancy or unresectable cancer.
10. Received a live vaccine within 30 days of planned start of study therapy.
11. History or current evidence of any condition, therapy, or laboratory abnormality that might influence the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

Where this trial is running

Guangzhou, Guangdong

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Haiqing Ma

Conditions Head and Neck Squamous Cell Carcinoma