Carcinoma, Squamous Cell Clinical Trial
Official title:
A Phase 2/3, Adaptive, Randomized, Open-label, Clinical Study to Evaluate Neoadjuvant and Adjuvant V940 (mRNA-4157) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care, and Pembrolizumab Monotherapy in Participants With Resectable Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (INTerpath-007)
This is a two-part (Phase 2/Phase 3) study of V940, an individualized neoantigen therapy (INT), plus pembrolizumab in participants with locally resectable advanced cutaneous squamous cell carcinoma (LA cSCC). Phase 2 has three arms V940 plus pembrolizumab given as neoadjuvant and adjuvant treatment with standard of care (SOC), standard of care (surgical resection with/without adjuvant radiation therapy (RT) only at investigator's discretion) and pembrolizumab monotherapy given as neoadjuvant and adjuvant treatment with SOC. This phase will assess the safety and efficacy of V940 in combination with pembrolizumab as neoadjuvant and adjuvant therapy in participants with resectable LA cSCC as compared to standard of care SOC only. The primary hypothesis is that V940 plus pembrolizumab with SOC is superior to SOC only with respect to event free survival (EFS) as assessed by the investigator. Phase 3 expansion will be determined by prespecified Go-No-Go decision in which 412 additional participants will be randomized to V940 plus pembrolizumab with SOC and SOC only, without changing the inclusion/exclusion criteria for the additional enrollment or study endpoints.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02743832 -
A Study on Tumor Budding Guiding Individualized Surgical Planning of Early-stage Oral Squamous Cell Carcinoma.
|
N/A | |
| Active, not recruiting |
NCT02229656 -
Olaparib and Radiotherapy in Head and Neck Cancer
|
Phase 1 | |
| Completed |
NCT00389727 -
Simultaneous Integrated Boost (SIB)- IMRT
|
Phase 2 | |
| Recruiting |
NCT02328391 -
STUDY OBSERVATIONAL OF ERLOTINIB AS SECOND LINE TREATMENT IN PATIENTS WITH SQUAMOUS NSCLC AND EGFR NATIVE
|
N/A | |
| Completed |
NCT00875381 -
Analysis of Melanocytes (Pigment Cells) in Sun-Exposed Skin
|
N/A | |
| Completed |
NCT00534950 -
Randomized Multicenter Study of 5 vs 6 Weekly Fraction of RT in the Treatment of SCC of the Head and Neck
|
N/A | |
| Terminated |
NCT00073450 -
Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530)
|
Phase 2 | |
| Terminated |
NCT01441128 -
-02341066 and PF-00299804 for Advanced Non-Small Cell Lung Cancer
|
Phase 1 | |
| Recruiting |
NCT05970497 -
A Study Assessing KB707 for the Treatment of Locally Advanced or Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT01362127 -
Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia
|
Phase 2 | |
| Completed |
NCT00240682 -
Study of Cetuximab in Squamous Cell Carcinoma of the Skin Expressing EGFR
|
Phase 2 | |
| Terminated |
NCT02254044 -
Dose Escalation of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck or Esophagus
|
Phase 1 | |
| Active, not recruiting |
NCT00829192 -
Phase II AK Study in Organ Transplant Patients
|
Phase 2 | |
| Completed |
NCT00539630 -
TAX + Cisplatin + 5 F/U vs Cisplatin + 5 F/U in SCCHN
|
Phase 3 | |
| Completed |
NCT00313027 -
Cervical Nodal Mets in Squamous Cell Carcinoma of H&N - MRI, FDG-PET, & Histopathologic Correlation
|
N/A | |
| Recruiting |
NCT04564989 -
Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
|
||
| Not yet recruiting |
NCT06094829 -
Tobacco and Alcohol Influence on Oncogenic Drivers and Somatic Evolution in the Oral Mucosa
|
||
| Recruiting |
NCT04481256 -
TGF-β And PDL-1 Inhibition in Esophageal Squamous Cell Carcinoma Combined With Chemoradiation TheRapY
|
N/A | |
| Active, not recruiting |
NCT02664935 -
National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer
|
Phase 2 | |
| Terminated |
NCT02438995 -
Super-Selective Intraarterial Infusion of Cetuximab (Erbitux) With or Without Radiation Therapy for the Treatment of Unresectable Recurrent Squamous Cell Carcinoma of the Head and Neck
|
Phase 1 |