Cancer clinical trial database.
Every new trial and trial result from New in Oncology, our weekly research briefing, since the first issue on . Search by NCT number, drug, or cancer type.
All entries in head and neck cancer
- Trial result Spotlight
Head and neck cancer
Pembrolizumab (PD-1) + Definitive RT Improves 2-Year PFS vs Cisplatin CRT in Unfavorable-Risk p16+ HNSCC (KEYCHAIN)
KEYCHAIN was an open-label, randomized Phase II trial across 6 US academic centers testing definitive RT (70 Gy/35 fx) plus concurrent/adjuvant pembrolizumab (anti–PD-1; 200 mg starting 2 weeks pre-RT, then q3w up to…
- Trial result Spotlight
Head and neck cancer
Tosposertib (TGFβRI/VEGFR2 inhibitor) + pembrolizumab drives 75% ORR in 1L R/M HNSCC
Tosposertib (TU2218) is an oral dual TGFβRI/ALK5 and VEGFR2 inhibitor designed to counter TGF-β–mediated immune exclusion and angiogenesis, here combined with pembrolizumab (anti–PD-1) in an open-label, multicenter,…
NCT05784688 - Trial result Spotlight
Head and neck cancer
Ficerafusp alfa (EGFR×TGF-β trap) + pembrolizumab drives deeper shrinkage and ~10-mo mPFS in 1L HPV− R/M HNSCC
Ficerafusp alfa (BCA101) is a bifunctional EGFR-directed antibody engineered to trap TGF-β, combined here with pembrolizumab (anti–PD-1) in two Phase 1/1b first-line dose-expansion cohorts for PD-L1 CPS≥1,…
NCT04429542 - Trial result
Head and neck cancer
Pembrolizumab (PD-1) + definitive CRT improves 5-year EFS in PD-L1 CPS≥10 unresected LA HNSCC
Pembrolizumab is a PD-1 checkpoint inhibitor added concurrently to definitive cisplatin-based chemoradiotherapy (CRT) and continued as maintenance (17 total q3w cycles) in the randomized, double-blind Phase 3…
NCT03040999 - Trial result
Head and neck cancer
ASP-1929 (EGFR–IR700 photoimmunotherapy) lifts OS to 15.7mo vs 9.6mo in heavily pretreated recurrent HNSCC, but underpowered
ASP-1929 photoimmunotherapy (PIT) is an anti‑EGFR monoclonal antibody–IR700 dye conjugate activated by 690nm light to cause localized tumor cell kill (and potentially immune priming); it was tested in a global Phase…
NCT03769506 - Trial result
Head and neck cancer
VV1 (VSV‑IFNβ‑NIS) intratumoral oncolytic virus + PD‑1 blockade (cemiplimab) hits 30% ORR in 1L R/M HNSCC (Simon’s stage 1)
VV1 is an intratumoral oncolytic vesicular stomatitis virus engineered to express IFNβ and NIS (VSV‑IFNβ‑NIS), combined here with the anti–PD‑1 antibody cemiplimab in a Phase 2, Simon two-stage, first-line…
NCT04291105 - Trial result
Head and neck cancer
Metronomic carboplatin/paclitaxel + PD-1 blocker cemiplimab delivers 42.5% ORR (15% CR) in 1L R/M HNSCC, with cytokine shifts tied to outcome
Cemiplimab is an anti–PD-1 monoclonal antibody combined here with metronomic weekly carboplatin (AUC1) and paclitaxel (25 mg/m²) to potentially retain chemo–immune priming with less toxicity than standard-dose…
NCT04862650 - Trial result
Head and neck cancer
Cemiplimab (PD-1) + cisplatin/docetaxel induction delivers 83% ORR in stage IV LA SCCHN (Phase 1)
Cemiplimab is an anti–PD-1 checkpoint inhibitor combined here with induction cisplatin + docetaxel (TP) ahead of definitive standard-of-care surgery and/or concurrent chemoradiation, followed by adjuvant cemiplimab,…
NCT05376553 - Trial result
Head and neck cancer
Cetuximab (EGFR IgG1) After PD-1 Failure Delivers 33% PR Rate in R/M HNSCC
Cetuximab is an EGFR-targeting IgG1 monoclonal antibody with potential immune-effector activity, evaluated as monotherapy in a non-randomized, single-institution cohort of recurrent/metastatic HNSCC progressing on or…
NCT04375384 - New trial
Head and neck cancer
Pilot (early feasibility) ConformalFLASH ultra-high–dose-rate proton therapy (FLASH radiotherapy) for HNSCC reirradiation
This pilot interventional study (C-FLASH-01) evaluates whether ultra-high dose-rate conformal proton therapy (ConformalFLASH®) can be planned and delivered safely and reproducibly for patients who need head and neck…
NCT07644585 Exploratory - New trial
Head and neck cancer
Phase 1 camonsertib (ATR kinase inhibitor) plus SBRT re-irradiation in recurrent HNSCC
This Phase 1 NCI-sponsored study tests safety, tolerability, and the recommended Phase 2 dose of camonsertib—Repare Therapeutics’ oral ATR (ataxia telangiectasia and Rad3-related) kinase inhibitor—given concurrently…
NCT07156227 Exploratory - Trial result
Head and neck cancer
Pembrolizumab (PD-1) + nab-paclitaxel (albumin-bound taxane) + platinum hits 64% ORR and 12.7-mo PFS in 1L R/M HNSCC
Pembrolizumab is an anti–PD-1 antibody combined here with nab-paclitaxel (a solvent-free, albumin-bound paclitaxel) plus cisplatin or carboplatin as first-line therapy in a single-arm Phase 2 trial in treatment-naïve…
NCT04857164 - Trial result Spotlight
Head and neck cancer
BCA101 (EGFR/TGF‑β bifunctional antibody) + pembrolizumab drives 54% ORR in 1L HPV− R/M HNSCC
Ficerafusp alfa (BCA101) is a bifunctional EGFR-targeting antibody fused to a TGF‑β “trap,” designed to counter EGFR-driven signaling and TGF‑β–mediated immune exclusion; it was combined with pembrolizumab…
NCT04429542 - Trial result Spotlight
Head and neck cancer
Trastuzumab deruxtecan (HER2 ADC) drives 67% RECIST responses in HER2-low/HER2-mutant salivary/lacrimal cancers
Trastuzumab deruxtecan (T-DXd; DS-8201), a HER2-directed antibody–drug conjugate delivering a topoisomerase I inhibitor payload, was given to patients with recurrent/metastatic secretory gland cancers of the head and…
- Trial result
Head and neck cancer
ReACT 1.0 HPV ctDNA (TTMV-HPV DNA) response-adaptive de-escalation delivers 93% 2-year PFS in HPV+ OPC
LBx-guided risk-adapted therapy: ReACT 1.0 (exploratory Phase II; NCT04900623) enrolled 102 patients with HPV-positive oropharyngeal carcinoma and used on-treatment HPV circulating tumor DNA (ctDNA) kinetics to…
NCT04900623 - New trial Spotlight
Head and neck cancer
Phase 1/2 ficerafusp alfa EGFR×TGF-β bifunctional antibody with pembrolizumab + neoadjuvant SBRT
Washington University School of Medicine is running this open-label, sequential-assignment Phase 1/2 trial testing whether short-course neoadjuvant SBRT plus pembrolizumab (Merck’s anti–PD-1 antibody) can be safely…
NCT07552558 Exploratory - New trial
Head and neck cancer
Phase 2 CADI-05 poly‑TLR agonist (heat‑killed Mycobacterium indicus pranii immunotherapy) + pembrolizumab PD‑1 inhibitor in resectable LA‑HNSCC.
This single-site, open-label neoadjuvant study at Fox Chase Cancer Center tests whether adding CADI-05—an intradermal innate-immune activator described by NCI as a poly‑TLR agonist, polyantigenic vaccine made from…
NCT07455032 Exploratory - New trial
Head and neck cancer
Pilot randomized trial of Avive+ amnion soft‑tissue barrier to reduce radial nerve morbidity
This University of Alabama at Birmingham (UAB) single-blind, randomized, parallel-group pilot study tests whether adding Avive+ Soft Tissue Matrix to the radial forearm free flap (RFFF) donor site can reduce…
NCT07558096 Exploratory - New trial
Head and neck cancer
Phase 2 zanzalintinib (c-MET/VEGFR tyrosine kinase inhibitor) in recurrent/metastatic olfactory neuroblastoma.
This single-arm Phase 2 study at MD Anderson Cancer Center evaluates whether zanzalintinib can control recurrent or metastatic olfactory neuroblastoma (ONB) that is unresectable and not amenable to curative-intent…
NCT07527169 Exploratory - Trial result
Head and neck cancer
Lifileucel/LN-145 (autologous TIL) posts 11% ORR and 76% DCR in R/M HNSCC
One-time autologous tumor-infiltrating lymphocyte (TIL) therapy—cryopreserved lifileucel (22- vs 16-day manufacturing) and a PD-1–selected TIL product (LN-145-S1)—was given after non-myeloablative lymphodepletion…
NCT03083873 - New trial
Head and neck cancer
Phase II trial of Carboplatin, a platinum-based DNA synthesis inhibitor, in oral cancer.
This study evaluates personalized treatment for resectable oral squamous cell carcinoma using sentinel lymph node mapping combined with targeted radiation and chemotherapy. Interventions include carboplatin…
NCT07121595 Exploratory - Trial result Spotlight
Head and neck cancer
Sequential Pembrolizumab (PD-1) Tops Concurrent for 4-yr Control in LA-HNSCC
Pembrolizumab—an anti-PD-1 antibody—was tested with definitive chemoradiation (CRT: weekly cisplatin 40 mg/m² + 70 Gy RT) either concurrently (start 1 wk pre-CRT) or sequentially (start 2 wks post-CRT) in a…
NCT02777385 - Trial result
Head and neck cancer
ECOG-ACRIN E3311: TOS + Reduced-Dose RT Yields 54-mo PFS 90.6% in HPV+ Oropharyngeal Cancer
ECOG-ACRIN E3311 (phase II; NCT01898494) tested transoral surgery (TOS) with risk-based adjuvant management—observation for low-risk (arm A), IMRT 50 (arm B) vs 60 Gy (arm C) for intermediate-risk, or weekly…
NCT01898494 - New trial Spotlight
Head and neck cancer
Phase II Trial of Ivonescimab, a PD-1/VEGF bispecific antibody in resectable head and neck cancer
This phase II study by the University of Michigan Rogel Cancer Center evaluates neoadjuvant ivonescimab in patients with stage II-IV resectable head and neck cancer. Ivonescimab, a bispecific antibody targeting PD-1…
NCT07094685 Exploratory - New trial
Head and neck cancer
Phase 2 Brachytherapy Radiation Device delivering targeted radiation-induced DNA damage
This Phase 2 study by the University of Utah evaluates a reduced radiation course, using 10 fractions delivered via a brachytherapy radiation device, compared to standard radiation therapy (with chemotherapy if…
NCT07044635 Exploratory - New trial
Head and neck cancer
Phase II Sacituzumab Govitecan (TROP2-directed ADC) and Cetuximab (EGFR mAb) in Recurrent HNSCC
This Phase II trial evaluates the safety and efficacy of combining sacituzumab govitecan, a TROP2-directed antibody-drug conjugate delivering SN38, with cetuximab, an EGFR monoclonal antibody. It enrolls patients…
NCT07063212 Exploratory - New trial
Head and neck cancer
Phase II MEDI5752 CTLA-4/PD-1 bispecific mAb trial in locoregional head and neck cancer
This study, sponsored by University of Chicago, aims to assess response rate in untreated, HPV‐negative, locoregional head and neck squamous cell carcinoma using neoadjuvant therapy with volrustomig (investigational…
NCT07065630 Exploratory - New trial
Head and neck cancer
Phase II trial of BMX-001, a manganese superoxide dismutase mimetic, in head and neck cancer
This Phase II trial by NRG Oncology evaluates adding BMX-001 to standard symptom management for patients with head and neck squamous cell carcinoma undergoing chemoradiation. BMX-001 is administered subcutaneously…
NCT06532279 Exploratory - New trial
Head and neck cancer
Phase 2 GdContrast: Gadolinium agent enhances T1 relaxation for improved margin visualization
This prospective study sponsored by Case Comprehensive Cancer Center evaluates whether enhanced pre-operative MRI protocols—including noncontrast, contrast-enhanced, T2 weighted, and T2 SPACE sequences—can predict…
NCT07060261 Exploratory - New trial
Head and neck cancer
Phase II Pilot: SCRT – hypofractionated radiation for high-risk cSCC local control
This Phase II trial evaluates whether five-fraction SCRT offers effective local control for adults with head and neck cutaneous squamous cell carcinoma and if active surveillance is a safe alternative in…
NCT06998342 Exploratory
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