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

Running, not enrolling · Phase 2

Conditions studied: Carcinoma, Squamous Cell, Oral Cancer, Oropharynx Cancer, Larynx Cancer, Lip Cancer, Esophageal Cancer

In brief

Participants in this study have a type of cancer called squamous cell carcinoma of the head and neck (SCCHN). Their SCCHN has spread around the area where the cancer first started. This is called locally-advanced SCCHN. These participants are eligible for surgery. Previous research with a similar therapy regimen resulted in high rates of cancer shrinkage, high rates of avoiding radiation and its side effects, high cure rate and good quality of life. Radiation can be very toxic. The purpose on this study is to try to avoid radiation. If the participants are not on this study they would be receiving radiation as it is standard treatment of their cancer. In the last study with a similar regimen, about a third of cancers had a pathologic complete response with the first part of the study. This means that the chemotherapy had killed the cancer. The investigators are trying to improve the regimen further with a goal of increasing this rate of complete response to the first part of therapy. The investigators also hope that by improving results in the first part, that more people will be cured and that long term quality of life (especially speech and swallowing) will be improved, both compared to standard therapies and to the last study. Doctors do not know how this therapy will effect the participants. There is no guarantee that this study will benefit the participants. The prior study used a combination of chemotherapy consisting of carboplatin, paclitaxel and a third targeted anti-cancer drug. In this study the investigators are testing the combination of carboplatin, nano-albumin bound paclitaxel and durvalumab. Nano-albumin bound paclitaxel has been shown to be more active against other types of squamous cancers than regular paclitaxel. It is FDA approved for squamous lung cancer, but experimental for head and neck cancer. Durvalumab is an experimental drug that uses the body's own immune system to fight the cancer. Doctors hope that combining Durvalumab with 2 chemotherapy drugs will be effective in treating SCCHN. Durvalumab on its own has been studied in patients with SCCHN and initial results have shown that some subjects' cancer has responded to it. The purpose of this study is to test a combination of chemotherapy to hopefully both increase the number of subjects that respond to therapy while also decreasing the number of side effects that subjects experience.

Key facts

Study ID: NCT03174275
Run by: UNC Lineberger Comprehensive Cancer Center
People needed: 39
Starts: 2017-12-19
Expected to finish: 2027-02-02
Last updated by the study team: 2026-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Previously untreated, histologically proven, surgically resectable primary squamous cell carinoma of the head and neck, stage III or IV (HPV positive or negative non-metastatic disease). SCCHN of unknown primary is excluded. SCCHN of the oral cavity is allowed*. Unambiguously squamous Epstein-Barr virus (EBV)-negative nasopharynx cancer will be excluded nor will unambiguously squamous cancers of the skull base that are clearly surgically resectable and clearly squamous. Squamous skin cancer occurring in the head/neck region will not be eligible nor will EBV+positive nasopharynx cancer. (*Note: Induction chemotherapy is not considered standard therapy for SCCHN of the oral cavity and participation on this trial will lead to a delay in time to definitive, potentially curative therapy i.e., surgery).
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Measurable disease as per RECIST 1.1
Age greater than or equal to 18 at time of study entry
Adequate bone marrow function as demonstrated by:
Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
Hgb > 10 g/dL (use of transfusion to reach this threshold prior to study initiation is acceptable)
Platelet count ≥ 100,000/mm3
Adequate hepatic and renal function as demonstrated by:
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN);
Total serum bilirubin ≤1.5 x ULN
Creatinine clearance (CrCL) > 40 mL/min as measured via Cockcroft-Gault
Males: Creatinine CL (mL/min) = (Weight (kg) x (140 - Age))/(72 x serum creatinine (mg/dL))
Females: Creatinine CL (mL/min) = (Weight (kg) x (140 - Age))/(72 x serum creatinine (mg/dL)) x 0.85
Negative serum β human chorionic gonadotropin (β-hCG) pregnancy test within 72 hours of day 1 of induction chemotherapy in women of child-bearing potential.
All males and females of childbearing potential must agree to use adequate contraception during the study. Adequate contraception is defined as any medically recommended method (or combination of methods) as per standard of care. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy or bilateral oophorectomy. See section 4.13 for list of acceptable methods of contraception.
Signed an institutional review board (IRB)-approved informed consent and HIPAA authorization.
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Subjects must agree to allow use of any pre-treatment tissue remaining after definitive diagnosis is made (ie, archival and or fresh tissue) for research purposes. In addition, subjects must consent to allow use of their residual post-operative tissue for research purposes.

You may not qualify if…

Involvement in the planning and/or conduct of the study (applies to staff at the study site) or previous enrollment in the present study.
Any metastatic disease.
Known history of previous clinical diagnosis of tuberculosis.
History and/or confirmed pneumonitis.
Low-risk HPV+ disease of the oropharynx, defined as meeting all of the following criteria:
Patients with known HPV+ by fluorescence in situ hybridization (FISH) and/or p16
Smoking history ≤ 10 pack years
Stage T1-2N0-2b, T3N0
Not considered eligible for any of the chemotherapy agents included in the induction regimen.
Current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment).
Major surgery within 28 days prior to day 1 of study treatment from which the patient has not completely recovered.
Receiving any investigational agent currently or within 28 days or 5 half-lives of Day 1 of treatment on this study, whichever is shorter.
Active, serious infection, medical, or psychiatric condition that would represent an inappropriate risk to the patient or would likely compromise achievement of the primary study objective, including unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction ≤ 6 months prior to study entry.
Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis, Crohn's disease], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener's syndrome [granulomatosis with polyangiitis]; myasthenia gravis;; rheumatoid arthritis; hypophysitis, uveitis; etc) within the past 2 years prior to the start of treatment. [Note: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded]
Known mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Frediricia's Correction. (Note that ECG is not required for study entry and is not part of study procedures).
Other prior or concomitant malignancies with the exception of:
Non-melanoma skin cancer
In-situ malignancy
Low-risk prostate cancer after curative therapy
Other cancer for which the patient has been disease free for ≥ 5 years before the first dose of study drug and of low potential risk for recurrence.
Any concurrent chemotherapy, investigational product, biologic or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g. hormone replacement therapy) is acceptable.
Current or prior use of immunosuppressive medication within 14 days prior to the first dose of durvalumab. The following are exceptions to this criterion: intranasal, inhaled, topical or local steroid injections (eg. intra-articular injection); steroids as premedication for hypersensitivity reactions; systemic corticosteroid at physiologic doses not to exceed 10mg/day of prednisone or equivalent.[Note: If systemic corticosteroids are part of the treatment regimen for the indication under study, the systemic corticosteroid is permitted].
Known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or evidence of active hepatitis B virus (HBV).
History of hypersensitivity to durvalumab or any excipient.
Receipt of live attenuated vaccination within 30 days prior the first dose of durvalumab [Note: If a vaccine is part of the treatment regimen for the indication under study, the vaccine is permitted].

Where it is running

Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States
Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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