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
Ulevostinag (STING agonist) + Pembrolizumab Scores 50% ORR in First-Line R/M HNSCC
Ulevostinag, a cyclic-dinucleotide STING agonist given intratumorally at its RP2D 540 µg, was tested with pembrolizumab 200 mg Q3W in a phase 1 dose-escalation (n = 156) and a small randomized phase 2 head-to-head in…
- Trial result Spotlight
Head and neck cancer
HPV16-Targeted Vaccine PDS0101 + Pembrolizumab Pushes 1L OS to 30–39 mo in Recurrent/Metastatic HNSCC
PDS0101 (Versamune® HPV16) is a synthetic lipid nanoparticle vaccine that primes HPV16-specific CD4 and CD8 T cells. In the single-arm Phase 2 VERSATILE-002 trial (NCT04260126), it was combined with pembrolizumab…
NCT04260126 - New trial
Head and neck cancer
Phase 2 Trial of Cisplatin, a DNA crosslinker, in dose-adjusted chemoradiation.
Investigating whether reduced-dose, smaller-field IMRT with weekly cisplatin maintains survival while lessening long-term toxicities compared to standard treatment, the trial enrolls elderly patients with p16+…
NCT06309225 - Trial result
Head and neck cancer
TORS-Based Risk-Adapted De-Escalation Sustains 97% 5-Year OS in Early HPV-Positive Oropharyngeal Cancer
Transoral robotic surgery (TORS) followed by pathologic risk–stratified adjuvant therapy (observation n = 31, 50 Gy RT n = 15, or 56 Gy cisplatin-CRT n = 17) was evaluated in the single-arm Phase II SIRS trial…
NCT02072148 - Trial result
Head and neck cancer
Cemiplimab + platinum-docetaxel/cetuximab delivers 31% pCR, 97% 1-yr OS in resectable HNSCC
Cemiplimab, an anti-PD-1 IgG4, was added to cisplatin / carboplatin-docetaxel and EGFR-blocker cetuximab in a single-arm pilot (NCT04722523) of 30 locally advanced head-and-neck SCC patients slated for surgery and…
NCT04722523 - New trial
Head and neck cancer
Phase Ib/II trial of NT219, an IRS1/2 and STAT3 inhibitor
This study evaluates fixed-dose NT219 combined with pembrolizumab or cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma. Conducted by University of Colorado, Denver, it enrolls…
NCT06919666 - New trial
Head and neck cancer
Phase I Decitabine DNA-methyltransferase inhibitor trial in surgically resectable HPV-negative head and neck cancer
This Phase I trial at Mayo Clinic evaluates the safety, dose tolerance, and potential efficacy of decitabine when given before standard-of-care surgery followed by radiation and chemotherapy. It enrolls patients with…
NCT06997094 - New trial
Head and neck cancer
Phase 1 Pilot: HB-200 HPV16 E6/E7 mRNA vaccine for HPV+ head and neck cancer.
This study evaluates alternate dosing of HB-201/HB-202 as a post-treatment intervention in HPV16+ head and neck squamous cell carcinoma patients with a positive NavDx test but no radiographic evidence of disease.…
NCT06373380 - New trial
Head and neck cancer
Phase II Trial of Reduced-Dose Radiotherapy in HPV+ Oropharyngeal Cancer
This trial led by Georgetown University evaluates if omitting chemotherapy from full-dose radiotherapy (66Gy) maintains cancer control while reducing long-term side effects in Stage I–II HPV/p16+ oropharyngeal…
NCT06902623 - New trial
Head and neck cancer
Phase 2 Cetuximab EGFR-directed mAb in de-escalated radiation therapy for HPV+ carcinoma
Researchers at Memorial Sloan Kettering Cancer Center are evaluating reduced radiation doses with standard chemotherapy post-induction in advanced HPV-positive oropharyngeal carcinoma. Eligible patients must…
NCT06984861 - New trial
Head and neck cancer
Phase II Trial: Erlotinib EGFR Inhibitor in Triple Oral Regimen
This Phase II study sponsored by Mayo Clinic evaluates the safety, feasibility, and potential efficacy of a triple oral chemotherapy regimen (methotrexate, erlotinib, celecoxib) in rural Midwest patients with…
NCT06997068 - Trial result
Head and neck cancer
SIRPα blocker BI 765063 + PD-1 (ezabenlimab) + cetuximab drives 47% ORR in 2L SIRPα-V1 HNSCC
In an open-label Phase Ib trial (NCT05249426), 17 eligible patients with recurrent/metastatic HNSCC after one prior systemic therapy—all homozygous for the SIRPα V1 allele—received BI 765063, a signal regulatory…
NCT05249426 - Trial result
Head and neck cancer
Pembrolizumab (PD-1) boosts peri-operative EFS in resectable head-and-neck SCC by ~21 mo
In the Phase 3 KEYNOTE-689 study (NCT03765918), 714 adults with stage III–IVA, resectable HNSCC were randomised to two neoadjuvant cycles, three concurrent cycles (during PORT), and 12 adjuvant cycles of…
NCT03765918 - Trial result
Head and neck cancer
T-DM1 Hits 88% Response in HER2-Amplified Salivary Gland Cancers in Basket Trial
Ado-trastuzumab emtansine (T-DM1), an HER2-targeted antibody–drug conjugate approved for breast cancer, was tested in a single-arm Phase 2 basket study (NCT02675829) enrolling 88 patients with HER2-amplified NSCLC,…
NCT02675829 - Trial result
Head and neck cancer
ROR2-ADC Ozuriftamab Vedotin Posts 36% ORR in PD-1-Refractory Head-and-Neck Cancer
Ozuriftamab vedotin is a conditionally binding antibody–drug conjugate that releases MMAE only in the low-pH tumor microenvironment to target ROR2. In this open-label Phase 2 trial (NCT03504488), 31 patients with…
NCT03504488 - Trial result
Head and neck cancer
PDL1V ADC Plus Pembrolizumab Achieves 50% ORR in PD-L1+ r/mHNSCC
In a phase 1 trial cohort of 14 PD-L1+ (CPS ≥1) patients with recurrent or metastatic HNSCC, the combination of PDL1V and pembrolizumab yielded a 50% ORR, including a 21.4% complete response rate. Common…
- Trial result
Head and neck cancer
Petosemtamab + Pembrolizumab: Dual EGFR & LGR5 Targeting Yields 60% ORR in PD-L1+ r/mHNSCC
In this Phase 2 trial, treatment of 43 evaluable r/m PD-L1+ HNSCC patients with petosemtamab 1500 mg Q2W plus pembrolizumab produced a 60% overall response rate (5 complete responses; 11%) and a median duration of…
NCT06525220 - Trial result
Head and neck cancer
Ficerafusp alfa (EGFR/TGF‑β) + Pembrolizumab Achieves 64% ORR in HPV‑Negative R/M HNSCC
In a Phase 1/1b expansion (N=42; 39 evaluable), the combination yielded a 54% ORR overall and 64% in HPV‑negative patients—with 21% achieving complete response—with durable responses (≥ 6 months in 72% overall and…
- Trial result
Head and neck cancer
Pembrolizumab (PD-1 inhibitor) in neoadjuvant/adjuvant setting extends event‐free survival in locally advanced HNSCC
In the Phase 3 KEYNOTE-689 study, pembrolizumab plus SOC increased median EFS from 26.9 to 59.7 months in the PD-L1 combined positive score (CPS) ≥ 10 group, and from 29.6 to 59.7 months in the CPS ≥ 1 group. The…
- New trial
Head and neck cancer
Phase II De-escalation Trial for HPV/p16+ Oropharyngeal Cancer
Georgetown is evaluating whether a lower-than-standard, neck-only radiation regimen (50Gy in 25 fractions via IMRT or proton beam therapy) leads to tumor control comparable to historical outcomes in favorable-risk,…
NCT06554158 - New trial
Head and neck cancer
Phase I Study: Zanzalintinib with Pembrolizumab and Cetuximab in Recurrent/Metastatic HNSCC
University of Chicago is evaluating the safety, tolerability, and optimal dosing of zanzalintinib—a dual cMet and VEGFR inhibitor—in combination with cetuximab and pembrolizumab in a Phase I dose-escalation/expansion…
NCT06912087 - New trial
Head and neck cancer
Window Trial of Fluorescently Labeled Panitumumab in Head and Neck Cancer
This trial at Vanderbilt is evaluating Panitumumab-IRDye800 in resectable HNSCC to optimize dosing and enhance tumor visualization during surgery. The study aims to refine the balance between effective cancer imaging…
NCT06819228 - New trial
Head and neck cancer
Pilot Evaluating 111In-Panitumumab for Nodal Staging in Head and Neck Cancer
Stanford University is conducting a pilot diagnostic study to assess the safety of 111In-panitumumab—an EGFR-directed SPECT imaging agent—for nodal staging in patients with head and neck squamous cell carcinoma. The…
NCT04840472 - New trial
Head and neck cancer
Circulating Tumor HPV DNA Driven Adjuvant Treatment Deintensification After Transoral Surgery for HPV+ OPSCC
Indiana University is conducting this Phase II trial to assess whether postoperative ctHPVDNA levels can guide adjuvant therapy deintensification after transoral surgery and neck dissection in HPV+ oropharyngeal…
NCT06915038 - New trial
Head and neck cancer
Pilot Window Study: Imatinib Combined with Cetuximab in Head and Neck Squamous Cell Carcinomas
University of Wisconsin – Madison is investigating whether tumor AXL levels correlate with treatment response to imatinib mesilate combined with cetuximab in patients with head and neck squamous cell carcinoma.…
NCT05816785 - Trial result
Head and neck cancer
KN-B10 Emerges as a Strong Contender in First-Line Treatment for R/M HNSCC
An indirect treatment comparison using matched patient-level data from KEYNOTE-B10 and six pivotal trials revealed that pembrolizumab plus carboplatin and paclitaxel (KN-B10) delivers comparable or superior objective…
- Trial result
Head and neck cancer
Tolinapant and Radiation Combine to Offer a Platinum-Free Option for Advanced HNSCC
In this early-phase, single-arm trial, cisplatin-ineligible patients with locally advanced head and neck squamous cell carcinoma received definitive radiation therapy alongside tolinapant, an IAP antagonist, with…
- Trial result
Head and neck cancer
Penpulimab Plus Chemotherapy Significantly Prolongs PFS in Global NPC Trial
In the AK105-304 Phase 3 trial, penpulimab combined with gemcitabine and cisplatin/carboplatin showed a statistically significant improvement in progression‑free survival (9.6 vs. 7.0 months; HR=0.45) versus placebo…
- New trial
Head and neck cancer
Phase II Chemoimmunotherapy Combining Nivolumab with Standard Chemo in Newly Diagnosed NPC
The National Cancer Institute is evaluating the addition of nivolumab to gemcitabine and cisplatin chemotherapy, followed by radiation, for patients with stage II–IV nasopharyngeal carcinoma. This innovative trial…
NCT06064097 - New trial
Head and neck cancer
Phase 2 Platform Study of Novel Combination Therapies in HNSCC
Gilead Sciences is leading a master protocol trial evaluating innovative regimens for metastatic or recurrent head and neck squamous cell carcinoma. The study tests two investigational arms—DOM plus ZIM with…
NCT06727565
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