OncoMatch/Clinical Trials/NCT04671667
Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell Carcinoma
Is NCT04671667 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Carboplatin for recurrent head and neck squamous cell carcinoma.
Treatment: Carboplatin · Cisplatin · Pembrolizumab — This phase II trial studies the effect of pembrolizumab alone compared to the usual approach (chemotherapy \[cisplatin and carboplatin\] plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head and neck cancer that is not from metastasis (primary). Radiation therapy uses high energy radiation or protons to kill tumor cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Carboplatin is also in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab alone after surgery may work better than the usual approach in shrinking recurrent or primary head and neck squamous cell carcinoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) cps >= 1 (cps >= 1)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: radiation therapy — to area of recurrent or second primary tumor
Patient must have had prior radiation to the area of recurrent or second primary tumor. This is defined as > 50% of the presurgical tumor volume having previously received a dose of > 45 Gy as determined by the treating radiation oncologist
Must have received: surgery — gross total resection
Patient must have undergone surgery with gross total resection and must be randomized within 8 weeks of surgery
Cannot have received: anti-PD-1 therapy
Exception: Allowed if received as part of initial upfront curative intent treatment and last dose >1 year prior to randomization
Patient must not have received anti-PD-1/PD-L1 therapy for recurrent disease. If the patient received anti-PD-1/PD-L1 therapy as part of initial upfront curative intent treatment (either as part of definitive non-surgical therapy or in the adjuvant setting) in the past, the last dosage of anti-PD-1/PD-L1 therapy must have been given greater than one year prior to randomization
Lab requirements
Blood counts
Absolute neutrophil count (ANC) >= 1,500/mcL; Platelets >= 100,000/mcL
Kidney function
Creatinine clearance > 30 ml/min using the Cockcroft-Gault formula
Liver function
Total bilirubin <= 1.5 x institutional upper limit of normal (ULN); AST/ALT <= 3.0 x institutional ULN
Cardiac function
Patients with New York Heart Association class III or IV heart failure are not eligible
ANC >= 1,500/mcL; Platelets >= 100,000/mcL; Total bilirubin <= 1.5 x institutional ULN; AST/ALT <= 3.0 x institutional ULN; Creatinine clearance > 30 ml/min; NYHA class III or IV heart failure not eligible
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Oklahoma Health Sciences Center · Oklahoma City, Oklahoma
- Clackamas Radiation Oncology Center · Clackamas, Oregon
- University of Alabama at Birmingham Cancer Center · Birmingham, Alabama
- University of Arkansas for Medical Sciences · Little Rock, Arkansas
- Kaiser Permanente-Anaheim · Anaheim, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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