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Select Ongoing Trials Currently Enrolling Patients with Head and Neck Cancer

August 2022, Vol 12, No 8

The following clinical trials represent a selection of key studies currently recruiting patients with head and neck cancer for inclusion in investigations of new therapies and new regimens of existing treatments for the disease. Each clinical trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. This information can help oncology practice managers and providers direct eligible patients to one of these clinical trials.


1. Monalizumab plus Cetuximab Combination versus Cetuximab Monotherapy in Recurrent or Metastatic HNSCC

The purpose of this randomized, double-blind, multicenter, global, phase 3 study is to assess the efficacy and safety of monalizumab, an anti-NKG2A monoclonal antibody, plus cetuximab (Erbitux) versus placebo plus cetuximab in patients with recurrent or metastatic head and neck squamous-cell carcinoma (HNSCC). Patients aged ≥18 years with recurrent or metastatic HNSCC that has progressed on or after previous systemic cancer therapy and is not amenable to curative therapy, who have received previous treatment with a PD-L1 inhibitor and 1 or 2 previous systemic regimens for recurrent or metastatic disease, who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and who have measurable disease per RECIST version 1.1 may be eligible if other criteria are met. Eligible patients will be randomized to receive monalizumab in combination with cetuximab or placebo in combination with cetuximab.

The primary outcome measure is overall survival (OS), defined as the time from date of randomization until date of death due to any cause up to approximately 3 years. Secondary outcome measures include OS; progression-free survival (PFS); disease-related symptoms, functioning, and quality of life measured by European Organisation for Research and Treatment of Cancer (EORTC) quality of life (QLQ)-C30 questionnaire; the immunogenicity of monalizumab; association of natural killer cell–related protein markers; assessment of adverse events (AEs); objective response rate (ORR); and duration of response. The study plans to enroll 624 participants throughout the United States and worldwide. For more information, contact the AstraZeneca Clinical Study Information Center at 1-877-240-9479 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT04590963.


2. Pembrolizumab Given Before Surgery and in Combination with Standard-of-Care Radiotherapy as Postsurgical Therapy in Advanced HNSCC

The purpose of this randomized, active-controlled, open-label, phase 3 study is to evaluate the efficacy of pembrolizumab (Keytruda) given before surgery and in combination with standard-of-care radiotherapy (with or without cisplatin) as postsurgical therapy in treatment-naïve patients with newly diagnosed stage III/IVA, resectable, locoregionally advanced HNSCC. Patients aged ≥18 years with a histologically confirmed new diagnosis of resectable, nonmetastatic squamous-cell carcinoma; who are eligible for primary surgery; who have evaluable tumor burden based on RECIST version 1.1; and who have an ECOG performance status of 0 or 1 within 10 days of randomization may be eligible if other criteria are met. Eligible patients will be randomized to receive pembrolizumab 200 mg intravenously (IV) on day 1 of a 21-day cycle for 2 cycles as neoadjuvant therapy before surgery, followed by either pembrolizumab 200 mg IV on day 1 every 3 weeks for fifteen 21-day cycles plus standard-of-care radiotherapy plus cisplatin 100 mg/m2 IV on day 1 every 3 weeks for three 21-day cycles as adjuvant therapy, or pembrolizumab 200 mg IV on day 1 every 3 weeks for fifteen 21-day cycles plus standard-of-care radiotherapy as adjuvant therapy; or no neoadjuvant therapy before surgery followed by standard-of-care radiotherapy plus cisplatin 100 mg/m2 by intravenous infusion on day 1 every 3 weeks for three 21-day cycles as adjuvant therapy after surgical resection.

The primary outcome measures include major pathologic response and event-free survival. Secondary outcome measures include OS, pathologic complete response, change from baseline in EORTC QLQ-C30 and EORTC QLQ-Head and Neck Questionnaire, and the percentage of patients experiencing an AE or discontinuing the study drug due to AEs. The study plans to enroll 704 participants throughout the United States and worldwide. For more information, contact Merck Sharp & Dohme Corp at 1-888-577-8839 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT03765918.


3. Bempegaldesleukin plus Pembrolizumab versus Pembrolizumab Alone in Metastatic or Recurrent HNSCC

The purpose of this multicenter, randomized, open-label, phase 2/3 study is to evaluate the efficacy and safety of bempegaldesleukin (BEMPEG), a CD122-preferential interleukin-2 pathway agonist, plus pembrolizumab (Keytruda) versus pembrolizumab monotherapy in patients with recurrent or metastatic HNSCC with positive PD-L1 expression (combined positive score ≥1). Patients aged ≥18 years with histologically or cytologically confirmed recurrent or metastatic HNSCC that is considered incurable by local therapies, whose disease has a positive PD-L1 expression, who have measurable disease based on RECIST version 1.1, and who have an ECOG performance status of 0 or 1 may be eligible if other criteria are met. Eligible patients will be randomized to receive bempegaldesleukin plus pembrolizumab every 3 weeks for up to 35 cycles (approximately 2 years) or pembrolizumab monotherapy every 3 weeks for up to 35 cycles.

The primary outcome measures are OS and ORR. Secondary outcome measures include PFS, time to deterioration, change from baseline of EORTC QLQ-C30, and the percentage of patients with treatment-emergent AEs and serious AEs. The study plans to enroll 500 participants throughout the United States and worldwide. For more information, contact Nektar Medical Affairs at 1-855-482-8676 or This email address is being protected from spambots. You need JavaScript enabled to view it.. The NLM identifier is NCT04969861.


4. Intensity-Modulated Proton Beam Therapy versus Intensity-Modulated Photon Therapy in Stage III-IVB Oropharyngeal Cancer

The purpose of this randomized, parallel-assignment, phase 2/3 study is to evaluate the toxicity and efficacy of intensity-modulated proton beam therapy compared with intensity-modulated photon therapy in patients with stage III-IVB oropharyngeal cancer. Patients aged ≥18 years with histologically documented squamous-cell carcinoma of the oropharynx, who are receiving concurrent chemotherapy and bilateral neck radiation, and who have an ECOG performance status of 0, 1, or 2 may be eligible if other criteria are met. Eligible patients will be randomized to receive intensity-modulated proton beam therapy daily 5 days a week for approximately 6.5 weeks or intensity-modulated photon therapy daily 5 days a week for approximately 6.5 weeks.

The primary outcome measures include the cumulative incidence of late-onset grade ≥3 toxicity anytime and acute grade ≥3 toxicity and OS in phase 2; and OS and PFS in phase 3. Secondary outcome measures include quality of life in phases 2 and 3 of the study up to 5 years. The study plans to enroll 442 participants throughout the United States and worldwide. For more information, contact the recruiting sites directly. The NLM identifier is NCT01893307.


5. Adding Docetaxel-Cetuximab or Atezolizumab to Standard-of-Care Chemotherapy and Radiation Therapy in High-Risk, Stage III-IV HNSCC

The purpose of this randomized, open-label, phase 2/3 study is to evaluate the efficacy of adding cisplatin, docetaxel (Taxotere), cetuximab (Erbitux), and/or atezolizumab (Tecentriq) to radiation therapy after surgery in patients with high-risk, stage III-IV HNSCC. Patients aged ≥18 years with pathologically proven HNSCC involving the oral cavity, oropharynx, larynx, or hypopharynx; who have had gross total surgical resection of high-risk oral cavity, oropharynx, larynx, or hypopharynx within 63 days before registration; who have either extracapsular nodal extension or invasive cancer at primary tumor resection margin; and who have a Zubrod performance status of 0 or 1 may be eligible if other criteria are met. Eligible patients will be randomized to receive intensity-modulated radiation therapy (IMRT) daily 5 days a week for 6 weeks with concurrent cisplatin IV once weekly for 6 weeks; IMRT daily 5 days a week for 6 weeks with concurrent docetaxel IV once weekly for 6 weeks; IMRT daily 5 days a week for 6 weeks with concurrent docetaxel IV once weekly for 6 weeks plus cetuximab IV over 120 minutes on week 1 and over 60 minutes once weekly on weeks 2 to 7; or atezolizumab IV 1 week before IMRT and every 3 weeks for up to 8 doses and IMRT daily 5 days a week for 6 weeks with concurrent cisplatin IV once weekly for 6 weeks.

The primary outcome measures are disease-free survival from date of randomization until date of local-regional recurrence, distant metastasis, or death due to any cause, and OS from date of randomization to death due to any cause. Secondary outcome measures include local-regional failure, distant metastasis, toxicity, patient-reported outcomes for symptom burden, and change from baseline in patient quality of life. The study plans to enroll 613 participants throughout the United States and worldwide. For more information, contact the recruitment sites directly. The NLM identifier is NCT01810913.

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