QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Subjects With SCC Who Have Progressed

Squamous Cell Carcinoma Clinical Trial

Official title:
QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Molecularly Informed Integrated Immunotherapy Combining (haNK) Cell Therapy With Adenoviral and Yeast-based Vaccines to Induce T-cell Responses in Subjects With SCC Who Have Progressed on or After Platinum-based Chemotherapy and Anti-programmed Cell Death Protein 1 (PD-1)/Programmed Death-ligand 1 (PD-L1) Therapy

Status Active, not recruiting

Clinical Trial Summary

This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with SCC who have progressed on or after previous platinum-based chemotherapy and anti-PD-1/PD-L1 therapy. Phase 2 will be based on Simon's two-stage optimal design.

Clinical Trial Description

Treatment will be administered in 2 phases, an induction and a maintenance phase, as described below. Subjects will continue induction treatment for up to 1 year. Treatment in the study will be discontinued if the subject experiences progressive disease (PD) or unacceptable toxicity (not corrected with dose reduction), withdraws consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment. Those who have a complete response (CR) in the induction phase will enter the maintenance phase of the study. Subjects who experience ongoing stable disease (SD) or an ongoing partial response (PR) at 1 year may enter the maintenance phase at the Investigator's and Sponsor's discretion. Subjects may remain in the maintenance phase of the study for up to 1 year. The duration of the maintenance phase can exceed 1 year if the subject continues to benefit, per the Investigator's and Sponsor's discretion. Treatment will continue in the maintenance phase until the subject experiences PD or unacceptable toxicity (not corrected with dose reduction), withdraws consent, or if the Investigator feels it is no longer in the subject's best interest to continue treatment. The time on study treatment, including both the induction and maintenance phases, is up to 2 years. The duration of the study may exceed 2 years if the subject remains in the maintenance phase for more than 1 year, as described above. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03387111
Study type	Interventional
Source	NantKwest, Inc.
Contact
Status	Active, not recruiting
Phase	Phase 1/Phase 2
Start date	January 13, 2018
Completion date	April 2021

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT02213133` - Selinexor Treatment of Advanced Relapsed/Refractory Squamous Cell Carcinomas	Phase 2
Not yet recruiting	`NCT04533321` - A Biomarker-implemented Clinical Study Evaluating Mutations in MET and TP53 in a Population of Treatment-refractory Squamous Cell Carcinoma	Phase 2
Terminated	`NCT02890368` - Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides	Phase 1
Active, not recruiting	`NCT01232374` - Nimotuzumab in Combination With Chemoradiation for Local Advanced Esophageal Squamous Cell Carcinoma	Phase 2
Withdrawn	`NCT01148082` - School Response to Families Who Have Children With Cancer	N/A
Completed	`NCT01208883` - A Feasibility Study On Continuous Adaptive [18f]Fdg-Pet-Guided Radiotherapy For Head and Neck Cancer	Phase 1
Completed	`NCT01089803` - Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer	N/A
Terminated	`NCT00707655` - Zalutumumab in Combination With Radiotherapy in Head and Neck Cancer Patients Ineligible for Platinum Based Chemotherapy	Phase 1/Phase 2
Completed	`NCT00793169` - Serum Concentration of Lidocaine After Local Injection During Mohs Micrographic Surgery
Completed	`NCT01127737` - Warning Signs of Squamous Cell Carcinoma and Prevention of SCC by at Risk Organ Transplant Recipients	N/A
Completed	`NCT00586040` - Photochemical Tissue Bonding	Phase 2
Completed	`NCT00409565` - A Phase II Trial of Cetuximab and Bevacizumab in Patients With Recurrent or Metastatic Head and Neck Cancer	Phase 2
Completed	`NCT00176267` - Paclitaxel, Carboplatin And Low Dose Radiation As Induction Therapy In Locally Advanced Head And Neck Cancer	Phase 2
Terminated	`NCT04685798` - Optimized Diffusion-Weighted Imaging for the Evaluation of Post-Treatment Squamous Cell Carcinoma in the Neck: Comparative Study With FDG PET/CT	N/A
Recruiting	`NCT04370587` - A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT04475952` - Early Diagnosis of Upper Digestive Tract Disease
Recruiting	`NCT04435938` - A Study of SBRT for Squamous Cell Carcinoma of the Head and Neck	Phase 2
Not yet recruiting	`NCT05852665` - Buccal Cancer Resection Ultrasound Guided	N/A
Recruiting	`NCT05048459` - Comparing Two Surveillance Approaches for People Who Have Received Treatment for HPV-associated Head and Neck Cancer and Show No Signs of Disease	N/A
Suspended	`NCT03952585` - De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer	Phase 2/Phase 3