Carboplatin, Nab-Paclitaxel, Durvalumab Before Surgery and Adjuvant Therapy in Head and Neck Squamous Cell Carcinoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

December 19, 2017

Primary Completion Date

February 2, 2022

Study Completion Date

February 2, 2027

Conditions
Carcinoma, Squamous CellOral CancerOropharynx CancerLarynx CancerLip CancerEsophageal Cancer
Interventions
DRUG

Durvalumab

Subjects will receive durvalumab, 750 mg every 2 weeks by IV infusion over approximately 1 hour (± 5 minutes).

DRUG

Carboplatin

Carboplatin is commercially available and approved by the US FDA for use in patients with ovarian cancer.

DRUG

Nab-paclitaxel

Nab-paclitaxel is commercially available and approved by the US Food and Drug Administration (FDA) for use in patients with metastatic breast cancer, metastatic pancreatic cancer, and for the treatment of locally advanced or metastatic NSCLC.

DRUG

Cisplatin

Cisplatin is commercially available and approved by the US Food and Drug Administration (FDA) for the treatment of advanced bladder, ovarian and testicular cancer. It has been widely studied in a variety of solid tumor types.

PROCEDURE

Surgical resection

Surgical therapy will be at the discretion of the treating surgeon per standard of care.

RADIATION

IMRT

"involved field radiation will refer to areas demonstrated to harbor disease on pathology, and not elective areas"

Trial Locations (2)

27599

Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill, Chapel Hill

37232

Vanderbilt University Medical Center, Nashville

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

AstraZeneca

INDUSTRY

collaborator

Celgene

INDUSTRY

lead

UNC Lineberger Comprehensive Cancer Center

OTHER