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
Head and neck cancer
Setanaxib + pembrolizumab misses its tumor-shrinkage endpoint but shows exploratory survival signals in CAF-rich head and neck cancer
Setanaxib (GKT137831) is an oral dual NADPH oxidase (NOX)1/NOX4 inhibitor intended to reduce reactive oxygen species (ROS)–driven, fibroblast-associated immune suppression, and it was combined with pembrolizumab…
NCT05323656 - Trial result Spotlight
Head and neck cancer
PDS0101 (HPV16-targeted immunotherapy) + pembrolizumab drives 34% ORR and 39.3-mo mOS in 1L HPV16+ R/M HNSCC
PDS0101 is a therapeutic HPV16-targeted immunotherapy designed to generate HPV16-specific T-cell responses, here combined with the PD-1 inhibitor pembrolizumab in VERSATILE-002, a Phase 2 open-label, multicenter,…
NCT04260126 - New trial
Head and neck cancer
Phase 2 pembrolizumab PD-1 inhibitor plus hypofractionated RT tests ENI nodal-sparing strategy
Medical College of Wisconsin is running this non-comparative randomized Phase 2 “INITIUM” platform in resectable, locally advanced head and neck squamous cell carcinoma (HPV-negative oropharynx and resectable oral…
NCT07773987 Exploratory - New trial
Head and neck cancer
Phase 2 ficerafusp alfa (BCA101) EGFR×TGF-β bifunctional antibody + pembrolizumab
Bicara Therapeutics is running a multicenter, open-label Phase 2 study in first-line PD-L1–positive recurrent or metastatic head and neck squamous cell carcinoma testing maintenance dosing strategies for ficerafusp…
NCT07807163 Exploratory - New trial
Head and neck cancer
Phase 2 toripalimab PD-1 (CD279) antibody “priming” before paclitaxel microtubule inhibitor in HNSCC
This Phase 2 pilot, single-arm, sequential regimen study at Barbara Ann Karmanos Cancer Institute tests whether upfront toripalimab (a PD-1 immune checkpoint–blocking monoclonal antibody; Coherus BioSciences/Junshi…
NCT07796126 Exploratory - Trial result Spotlight
Head and neck cancer
Pemetrexed (antifolate chemo) + pembrolizumab (PD-1) delivers 37.5% ORR—and 63.6% in salivary duct carcinoma—in R/M salivary gland cancer
MC200708 (NCT04895735) is a single-arm Phase II (Simon two-stage) testing pemetrexed 500mg/m² IV q3w + pembrolizumab 200mg IV q3w in recurrent/metastatic non-adenoid cystic salivary gland cancers; any number of prior…
NCT04895735 - New trial
Head and neck cancer
Phase 2 OSPRI tests pembrolizumab (PD‑1 inhibitor) with proton SFRT vs photon SBRT
Mayo Clinic is running this randomized Phase 2 neoadjuvant study in oral cavity squamous cell carcinoma to compare two “immune‑priming” radiation approaches added to pembrolizumab (Keytruda; an anti‑PD‑1 monoclonal…
NCT07783581 Exploratory - Trial result
Head and neck cancer
Imaging-detected extranodal extension (iENE) upstages HPV+ OPC but only modestly improves TNM9 risk separation
In this secondary analysis of the Phase III NRG/RTOG 1016 HPV-mediated (p16+) oropharyngeal cancer trial (NCT01302834), pretreatment CT simulation scans were reread by 2 expert head-and-neck radiologists to…
NCT01302834 - New trial Spotlight
Head and neck cancer
Phase 3 CRB-701 nectin-4–targeted ADC (MMAE tubulin inhibitor) vs chemo/EGFR options in R/M OPSCC
Corbus Pharmaceuticals’ TEMPO-1 is a randomized, open-label, 2-arm Phase 3 trial testing CRB-701 (also referenced as SYS6002), a nectin-4–directed monoclonal antibody–drug conjugate that delivers the microtubule…
NCT07768189 Registrational - Trial result Spotlight
Head and neck cancer
TG4050 (individualized MVA neoantigen vaccine) shows 0/16 per-protocol relapses at 30 months in resected HPV-negative HNSCC
TG4050 is a personalized therapeutic cancer vaccine delivered through a Modified Vaccinia Ankara (MVA) vector encoding up to 30 patient-specific predicted neoantigens to generate tumor-directed T-cell immunity. In…
NCT04183166 - Trial result
Head and neck cancer
TPF induction (docetaxel/cisplatin/5-FU) fails to beat PF adjuvant after CCRT in LA-NPC, with more myelosuppression
TPF is a taxane–platinum–fluoropyrimidine triplet induction chemotherapy regimen given pre-radiation, while PF (cisplatin/5-fluorouracil) is a platinum–fluoropyrimidine doublet commonly used in older…
NCT03574324 - New trial
Head and neck cancer
Phase 2 RiMO-301 hafnium-based MOF radiosensitizer + pembrolizumab (PD-1) with neoadjuvant RT in HNC.
This Phase 2 neoadjuvant study at the University of Illinois Chicago tests whether adding intratumoral RiMO-301—a hafnium-based nanoscale metal–organic framework (MOF) radio-enhancer that increases local radiation…
NCT07732634 Exploratory - Trial result
Head and neck cancer
Multikine (Leukocyte Interleukin Injection) + CIZ neoadjuvant immune conditioning cuts death risk in PD-L1–low, node-negative LA OSCC
Leukocyte Interleukin Injection (LI; “Multikine”) is a locally delivered cytokine-based immunotherapy given pre-operatively and paired with CIZ (low-dose IV cyclophosphamide + indomethacin + zinc/multivitamins) to…
NCT01265849 - New trial
Head and neck cancer
Phase 2 64Cu-DOTA-ECL1i CCR2-targeted PET radiotracer imaging in HNSCC.
This prospective, two-cohort precision-imaging study at Washington University School of Medicine evaluates whether 64Cu-DOTA-ECL1i PET/CT—a copper-64–labeled peptide radiotracer that binds CCR2 (C-C chemokine…
NCT07659678 Exploratory - New trial
Head and neck cancer
Phase 1/2 SX-682 CXCR1/2 inhibitor plus docetaxel microtubule inhibitor in R/M HNSCC
This National Cancer Institute (NCI) Phase 1/2 study tests SX-682, an oral small-molecule CXCR1/CXCR2 inhibitor designed to block IL-8–axis chemokine signaling that recruits pro-tumor myeloid cells, in combination…
NCT07667400 Exploratory - Trial result
Head and neck cancer
Pembrolizumab (PD-1) + Quad‑Shot RT (14.8Gy/4fx) Delivers 47% ORR in Recurrent/Metastatic HNSCC
Pembrolizumab is an anti–PD‑1 immune checkpoint inhibitor; quad‑shot radiotherapy (QSRT) is a low-dose hypofractionated regimen (14.8Gy in four 3.7Gy fractions BID over 2 days) intended to improve local control and…
NCT04454489 - Trial result
Head and neck cancer
Metformin (AMPK modulation) + pembrolizumab (PD-1) posts 50% ORR in metastatic HNSCC feasibility Phase 2
Metformin ER (up-titrated to 2000mg daily) was combined with pembrolizumab 200mg q3w in a randomized Phase 2 feasibility study in recurrent/metastatic HNSCC (NCT04414540), with sequencing (metformin lead-in vs…
NCT04414540 - Trial result
Head and neck cancer
TPF induction (docetaxel/cisplatin/5-FU) fails to beat PF adjuvant after CCRT in LA-NPC
TPF is a 3-drug cytotoxic induction regimen (taxane + platinum + fluoropyrimidine) given pre-radiation to debulk disease and reduce distant relapse risk; here it was tested as 3 cycles of TPF induction → IMRT +…
NCT03574324 - Trial result Spotlight
Head and neck cancer
Emiltatug Ledadotin B7-H4 ADC Reaches 40% ORR in Aggressive ACC
Emiltatug ledadotin (Emi-Le; XMT-1660) is a B7-H4–directed ADC with an auristatin F-HPA microtubule-inhibitor payload, evaluated in a Phase 1 dose-escalation/backfill cohort enriched for aggressive adenoid cystic…
NCT05377996 - Trial result
Head and neck cancer
Pembrolizumab (PD-1) + Docetaxel/Doxorubicin Delivers Modest Responses in Advanced Salivary/Thyroid Cancers
Pembrolizumab is an anti–PD-1 immune checkpoint inhibitor combined here with cytotoxic chemotherapy (docetaxel or doxorubicin) in the single-center, parallel-cohort iPRIME study (Phase 2–like design; NCT03360890) for…
NCT03360890 - Trial result
Head and neck cancer
AVA6000 FAP-Released Doxorubicin Posts 90% Disease Control in Salivary Gland Cancer
AVA6000 is a fibroblast activation protein-cleavable peptide-drug conjugate designed to release doxorubicin preferentially in the tumor microenvironment. In the first-in-human Phase Ia/Ib trial (NCT04969835), the…
NCT04969835 - Trial result
Head and neck cancer
Darolutamide + Leuprolide Yields 40% PR Rate in AR+ Salivary Gland Cancer
Darolutamide is a nonsteroidal androgen-receptor inhibitor, combined here with leuprolide acetate to deepen androgen-axis suppression in hormone-therapy-naïve recurrent/metastatic or unresectable AR+ salivary gland…
NCT05669664 - Trial result
Head and neck cancer
REM-422 MYB mRNA Degrader Hits 42% ORR at RP2D in MYB+ ACC
REM-422 is a first-in-class oral small-molecule MYB mRNA degrader tested in recurrent/metastatic adenoid cystic carcinoma in the Phase 1/2 ARIA trial (NCT06118086). Among efficacy-evaluable patients (n=59), activity…
NCT06118086 - Trial result
Head and neck cancer
Pemetrexed + pembrolizumab (antifolate chemo + PD-1) posts 75% clinical benefit but just 5% ORR in R/M adenoid cystic carcinoma
Pemetrexed (PTX; multitargeted antifolate chemotherapy) plus pembrolizumab (PMB; PD-1 inhibitor) was evaluated in the MC200708 single-arm Phase II trial (NCT04895735) in recurrent/metastatic adenoid cystic carcinoma…
NCT04895735 - Trial result
Head and neck cancer
FMISO PET hypoxia imaging guides 30Gy chemoradiation with 97% 5-year OS in HPV+ OPC
Integrated analysis of three consecutive Phase II trials tested ^18F-fluoromisonidazole PET (FMISO PET) to stratify definitive chemoradiotherapy intensity in T0–3/N1–2c HPV+ oropharyngeal cancer (n=430; enrollment…
NCT06563479 - Trial result
Head and neck cancer
ICT (carboplatin/paclitaxel/cetuximab) + FMISO-PET Hypoxia Clearance Enables 30Gy De-escalation in T3–T4 HPV+ OPC
In this pilot study (NCT05491512), weekly induction chemotherapy with carboplatin (AUC2) + paclitaxel (90 mg/m²) + cetuximab (after 400 mg/m² load, then 250 mg/m² weekly) for 6 weeks was used to downstage very…
NCT05491512 - Trial result
Head and neck cancer
HB200 (HPV16 E6/E7 viral immunotherapy) + carbo/pac drives 88% deep responses and enables de-escalation in HPV16+ OPSCC
HB200 is an HPV16-directed arenavirus-based therapeutic vaccine regimen (HB201 and HB202 vectors encoding a non-oncogenic HPV16 E6/E7 fusion) given neoadjuvantly with carboplatin/paclitaxel in an…
NCT05108870 - Trial result
Head and neck cancer
Adebrelimab (anti–PD-L1) + cisplatin/docetaxel delivers 64% path response rate in stage IVB OSCC
Adebrelimab is an anti–PD-L1 IgG4 checkpoint inhibitor combined here with platinum–taxane chemotherapy (cisplatin + docetaxel) as 2-cycle neoadjuvant immunochemotherapy in a prospective, single-arm Phase II…
NCT06277791 - New trial
Head and neck cancer
Phase 2 cemiplimab PD-1 inhibitor ± fianlimab LAG-3 antibody with induction chemo for NPC.
This Memorial Sloan Kettering–sponsored pilot randomized trial tests whether adding immune checkpoint blockade to induction therapy can maintain control while enabling de-escalated definitive chemoradiation in…
NCT07650266 Exploratory - Trial result Spotlight
Head and neck cancer
NBTXR3 (hafnium oxide radioenhancer) + SBRT reirradiation followed by anti–PD-1 drives 48% ORR in recurrent/metastatic HNSCC
NBTXR3 is an intratumoral hafnium oxide nanoparticle “radioenhancer” designed to locally amplify radiation effects and potentially augment immune priming; in Study 1100 (Phase I dose escalation/expansion;…
NCT03589339
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