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. 2021 Sep 2;147(10):1–8. doi: 10.1001/jamaoto.2021.2191

Table. Characteristics of Studies of Neoadjuvant Immunotherapy in Head and Neck Cancer.

Source ClinicalTrials.gov identifier Study phase Intervention model Masking Study type Randomization method Main inclusion criteria Article type Outcome reported
Wise-Draper et al,11 2021 NCT02641093 Phase 2 Single arm Open label Cohort study NA Clinically high risk (T3 or T4 and/or ≥2 LNs) in resectable HNSCC Conference abstract

  • MPR

  • Postoperative TRAEs (grade 3-4)
Uppaluri et al,12 2020 NCT02296684 Phase 2 Sequential assignment, dual arm Open label Cohort study Nonrandomized Surgically resectable stage III and IV head and neck cancer Full text

  • pCR

  • MPR

  • Preoperative TRAEs (grade 3-4)

  • Surgical delay

  • Downstaging
IMCISION trial,13 2020 NCT03003637 Phase 1B/2 Single arm Open label Cohort study NA Advanced (T3-4, N0-3, M0) HNSCC eligible for curative-intent surgical resection Conference abstract

  • MPR

  • Preoperative TRAEs (grade 3-4)

  • Surgical delay
Horton et al,14 2019 NCT03021993 Phase 2 Single arm Open label Cohort study NA Stage II-IVA OCSSC Conference abstract

  • pCR

  • Preoperative TRAEs (grade 3-4)

  • Surgical delay
CIAO study,15 2019 NCT03144778 Phase 1 Parallel assignment, dual arm Open label RCT Randomized Stage II-IVA oropharyngeal SCC Full text

  • pCR

  • MPR

  • Adverse events (grade 3-4)

  • Downstaging
CheckMate 358 study,16 2021 NCT02488759 Phase 1/2 Single arm Open label Cohort study Randomized Resectable SCC of the oral cavity, pharynx, or larynx with ≥T1 primary lesions and ≥N1 nodal disease Full text

  • MPR

  • pCR

  • Preoperative TRAEs (grade 3-4)

  • Surgical delay
Schoenfeld et al,17 2020 NCT02919683 Phase 2 Parallel assignment, dual arm Open label RCT Randomized ≥T2 and/or evidence of regional nodal involvement OCSCC Full text

  • MPR

  • pCR

  • Preoperative TRAEs (grade 3-4)

  • Surgical delay

  • Downstaging
Kim et al,18 2021 NCT03737968 Phase 2 Single arm Open label Cohort study Randomized Surgically resectable head and neck cancer Conference abstract

  • pCR

  • Preoperative TRAEs (grade 3-4)

  • Surgical delay
Neoadjuvant immunotherapy in combination with chemotherapy or radiation therapy
Leidner et al,19 2021 NCT03247712 Phase 1/2 Single arm Open label Cohort study Nonrandomized Locally advanced HPV-associated oropharyngeal HNSCC Full text

  • MPR

  • pCR
Zinner et al,20 2020 NCT03342911 Phase 2 Single arm Open label Cohort study NA Stage II-III HPV + SCCHN without distant metastasis and candidates for surgery Conference abstract

  • MPR

  • pCR

Abbreviations: HNSCC, head and neck squamous cell carcinoma; HPV, human papillomavirus; LN, lymph node; MPR, major pathological response; NA, not applicable; OCSSC, oral cavity squamous cell carcinoma, pCR, pathological complete response; RCT, randomized clinical trial; SCC, squamous cell carcinoma; SCCHN, squamous cell carcinoma of the head and neck; TRAEs, treatment-related adverse event.