Clinical trials: Recurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and Neck
Advanced Head and Neck Squamous Cell Carcinoma, Lung Non-Small Cell Carcinoma
CIMAvax Vaccine, Nivolumab, and Pembrolizumab in Treating Patients With Advanced Non-small Cell Lung Cancer or Squamous Head and Neck Cancer
This phase I/II trial studies the best dose and side effects of recombinant human EGF-rP64K/montanide ISA 51 vaccine (CIMAvax) and nivolumab and to see how well they work in treating patients with non-small cell lung cancer or…
- Conditions
- Advanced Head and Neck Squamous Cell Carcinoma, Lung Non-Small Cell Carcinoma, Metastatic Lung Non-Small Cell Carcinoma, PD-L1 Positive
- Trial name
- NCT02955290
- Testing
- Laboratory Biomarker Analysis, Nivolumab, Pembrolizumab
- Where
- 5 sites in United States
- Volunteers
- 51 people
- Sponsor
- Roswell Park Cancer Institute
Squamous Cell Carcinoma of Head and Neck
Reduction in the Number of Chemotherapy Cycles in Combination With Pembrolizumab in First-line Treatment of PD-L1-positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinomas
This is a phase II, prospective, non-randomized, single-arm, multicentric study to evaluate the activity and safety of treatment with 4 cycles (instead of 6) of chemotherapy (platinum (cisplatin or carboplatin) and…
- Trial name
- REDUCE (NCT06557889)
- Testing
- Pembrolizumab + Cisplatin/Carboplatin + 5-FU
- Where
- 13 sites in France
- Volunteers
- 86 people
- Sponsor
- Institut Claudius Regaud
Head and Neck Squamous Cell Carcinoma
Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
This is a multicenter, randomized, double-blind, controlled Phase 2/3 trial of zanzalintinib in combination with pembrolizumab versus zanzalintinib-matched placebo in combination with pembrolizumab in subjects with programmed…
- Trial name
- STELLAR-305 (NCT06082167)
- Testing
- Zanzalintinib, Pembrolizumab
- Where
- 168 sites in United States, Argentina and 24 more
- Volunteers
- 600 people
- Sponsor
- Exelixis
Recurrent or Metastatic PD-L1-positive or -Negative Squamous Cell Carcinoma of the Head and Neck SCCHN
Study of MEDI4736 Monotherapy and in Combination With Tremelimumab Versus Standard of Care Therapy in Patients With Head and Neck Cancer
This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus SoC therapy in the target patient…
- Trial name
- EAGLE (NCT02369874)
- Testing
- MEDI4736, MEDI4736 + Tremelimumab, Standard of Care
- Where
- 168 sites in United States, Argentina and 22 more
- Volunteers
- 736 people
- Sponsor
- AstraZeneca
Head and Neck Squamous Cell Carcinoma
A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)
This is a phase 3 study. All subjects arerecurrent or metastatic head and neck squamous Cell Carcinoma (R/M HNSCC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Trial name
- NCT06601335
- Testing
- AK117 in combination with AK112
- Where
- 2 sites in China
- Volunteers
- 510 people
- Sponsor
- Akeso
Recurrent Head and Neck Cancer, Metastatic Head and Neck Cancer
Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
This is a global, multi-center, Phase 3 study that is randomized 1:1, controlled, and open label to evaluate PDS0101 (Versamune + HPVMix) in combination with pembrolizumab vs.
- Conditions
- Recurrent Head and Neck Cancer, Metastatic Head and Neck Cancer, HPV Positive Oropharyngeal Squamous Cell Carcinoma, Neoplasms, Head and Neck
- Trial name
- VERSATILE-003 (NCT06790966)
- Testing
- Combination Treatment of PDS0101 and Pembrolizumab, Pembrolizumab Monotherapy
- Where
- 28 sites in United States
- Volunteers
- 12 people
- Sponsor
- PDS Biotechnology Corp.
HPV Positive Oropharyngeal Squamous Cell Carcinoma, HNSCC
Safety and Efficacy of VB10.16 and Pembrolizumab in Patients With Head-Neck Squamous Cell Carcinoma
This is a multi-center study in patients with un-resectable Recurrent or Metastatic HPV16-positive oropharyngeal Head and Neck Squamous Cell Carcinoma (HNSCC).
- Trial name
- NCT06016920
- Testing
- VB10.16, Pembrolizumab
- Where
- 12 sites in France, Germany and 5 more
- Volunteers
- 110 people
- Sponsor
- Nykode Therapeutics ASA
Head and Neck Squamous Cell Carcinoma (HNSCC)
A Study to See if Giving Fianlimab and Cemiplimab Together is Better Than Cemiplimab Alone at Treating Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
This study is researching an experimental drug called fianlimab (also called REGN3767), combined with a medication called cemiplimab compared against cemiplimab combined with placebo (a placebo looks like a treatment but does not…
- Trial name
- NCT06769698
- Testing
- FDC fianlimab+cemiplimab, Cemiplimab
- Where
- 38 sites in United States, Australia and 4 more
- Volunteers
- 120 people
- Sponsor
- Regeneron Pharmaceuticals
Head and Neck Squamous Cell Carcinoma
Tolerability and Efficacy of UV1 Vaccine in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Planned for First-line Treatment With Pembrolizumab
The primary objective of this study is to determine the clinical performance of UV1 vaccination as add on to standard pembrolizumab treatment in patients with recurrent or metastatic PD-L1 positive (CPS >=1) head and neck…
- Trial name
- FOCUS (NCT05075122)
- Testing
- UV1, Sargramostim for Injection, Pembrolizumab injection
- Where
- 10 sites in Germany
- Volunteers
- 75 people
- Sponsor
- Martin-Luther-Universität Halle-Wittenberg
Recurrent or Metastatic PD-L1-positive Squamous Cell Carcinoma of the Head and Neck
Phase II Study of MEDI4736 Monotherapy in Treatment of Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Primary Objective: To assess the efficacy of MEDI4736 monotherapy in terms of ORR
- Trial name
- NCT02207530
- Testing
- MEDI4736
- Where
- 108 sites in United States, Belgium and 12 more
- Volunteers
- 112 people
- Sponsor
- AstraZeneca
Unresectable Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Cancer
A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1
An open-label, controlled, multi-site, interventional, 2-arm, Phase II/III trial of BNT113 in combination with pembrolizumab vs pembrolizumab monotherapy as first line treatment in patients with unresectable recurrent or…
- Conditions
- Unresectable Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Cancer, Recurrent Head and Neck Cancer
- Trial name
- AHEAD-MERIT (NCT04534205)
- Testing
- BNT113, Pembrolizumab
- Where
- 138 sites in United States, Argentina and 19 more
- Volunteers
- 358 people
- Sponsor
- BioNTech SE
Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma
FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC
Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β).
- Trial name
- FORTIFI-HN01 (NCT06788990)
- Testing
- Ficerafusp alfa, Pembrolizumab (KEYTRUDA®)
- Where
- 231 sites in United States, Argentina and 26 more
- Volunteers
- 650 people
- Sponsor
- Bicara Therapeutics
Head and Neck Squamous Cell Carcinoma (HNSCC), HPV Oropharyngeal Squamous Cell Carcinoma (HPV+ OPSCC)
Ordastobart (INBRX-106) Add-on to Pembrolizumab in 1L HPV+ PD-L1+ R/M OPSCC (HexAgon-HN)
This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent OX40 agonist antibody ordastobart (INBRX-106) combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+…
- Trial name
- HexAgon-HN (NCT06295731)
- Testing
- INBRX-106, Pembrolizumab
- Where
- 89 sites in United States, Australia and 11 more
- Volunteers
- 450 people
- Sponsor
- Inhibrx Biosciences, Inc
Recurrent Head and Neck Cancer, Recurrent Head and Neck Squamous Cell Carcinoma
Ramucirumab and Pembrolizumab vs Pembrolizumab Monotherapy in PD-L1 Positive Head and Neck Squamous-Cell Carcinoma
This is a phase 2 study investigating the efficacy of ramucirumab in combination with pembrolizumab compared to pembrolizumab monotherapy.
- Conditions
- Recurrent Head and Neck Cancer, Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Carcinoma, Metastatic Head-and-neck Squamous-cell Carcinoma
- Trial name
- Rambro2 (NCT05980000)
- Testing
- Ramucirumab, Pembrolizumab
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Washington University School of Medicine
Oropharyngeal Squamous Cell Carcinoma
Real-world Study of First Line Pembrolizumab- or Nivolumab-treated HPV-positive Recurrent/Metastatic Oropharyngeal Squamous Cell Carcinoma
Pembrolizumab and nivolumab (with or without chemotherapy) are used to treat head and neck cancer. The middle part of the throat (oropharynx) is a common location for head and neck cancer.
- Trial name
- NCT06771674
- Testing
- Pembrolizumab, Nivolumab
- Where
- United States
- Volunteers
- 662 people
- Sponsor
- Hookipa Biotech GmbH