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

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Brief Title

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

Official Title

Multimodality Therapy With Induction Carboplatin/Nab-Paclitaxel/Durvalumab Followed by Surgical Resection and Risk-adapted Adjuvant Therapy for the Treatment of Locally-Advanced and Surgically Resectable Squamous Cell Carcinoma of the Head and Neck

Brief Summary

      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.
    

Detailed Description

      STUDY OBJECTIVES

      Primary Objective:

      Estimate the pathologic complete response rate (pCRR) after induction chemotherapy with
      carboplatin, nab-paclitaxel, and durvalumab in previously untreated stage III and IV SCCHN
      amenable to surgical resection

      Secondary Objectives:

        -  Report the clinical complete response rate (cCRR) and clinical response rate (cRR)
           following induction chemotherapy

        -  Estimate the percent of patients who have a change in estimated risk level. Prior to
           induction, this will be assessed clinically (by imagining and physical exam). Post
           induction, this will be assessed by surgical pathology report

        -  Estimate the overall survival (OS) and progression free survival (PFS) associated with 3
           part therapy consisting of induction chemotherapy, surgery and risk-adapted use of
           chemoradiation

        -  Characterize the toxicity profile associated with both induction therapy and total 3
           part therapy consisting of induction chemotherapy, surgery and risk-adapted use of
           chemoradiation

      Translational/Exploratory Objectives:

        -  Correlative studies will evaluate cellular correlates of response and changes in the
           tumor microenvironment across therapy

        -  Explore correlation between measures of clinical response to induction chemotherapy and
           long term outcomes (PFS and OS) and compare them to pathologic measures of response
           (pCRR)

      PROCEDURES This is a single-arm, nonrandomized phase II trial consisting of 3 parts. After
      informed consent and screening, pre-induction, risk levels will be assessed clinically, by a
      combination of physical exam and imaging.

      Part 1: All patients will then receive 6 weeks of induction chemotherapy in Part 1 comprised
      of weekly cycles of carboplatin and nab-paclitaxel for 6 cycles in combination with
      durvalumab administered once every two weeks for 5 cycles (Day 1 of the weeks 1, 3, 5, 7, and
      9).

      Part 2: Within a 1-4 the week window post induction, tumor imaging will be followed by
      surgical resection.

      Part 3: After surgery, patients will be stratified into one of 3 risk categories based on
      their disease pathology, assigned a treatment group based on their risk. Low risk patients
      with receive durvalumab once every two weeks for 3 cycles, while medium risk or high risks
      groups will receive concurrent chemoradiation therapy followed by durvalumab once every two
      weeks for 3 cycles.

      Follow up After completion of study therapy (which will vary by study arm) patients will be
      evaluated every three months during follow up for progression over a period of 18 months.
      Each follow up visit will include physical examination, CT or MRI imaging of the neck. Chest
      imaging will be obtained (or not) as indicated by standard of care. After the first 18
      months, patients will be followed-up per standard of care, with documentation in the case
      report form (CRF) limited to progression and survival noted at their standard of care visits.
      If a patient should move away or otherwise be lost to in-person follow up but is amenable to
      telephone follow up, this will be permitted during the standard of care follow up period.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Pathologic complete response rate (pCRR) after induction chemotherapy with carboplatin, nab-paclitaxel, and durvalumab in previously untreated stage III and IV SCCHN amenable to surgical resection

Secondary Outcome

 Clinical complete response rate and (cCRR) and clinical response rate (cRR) following induction chemotherapy

Condition

Carcinoma, Squamous Cell

Intervention

Durvalumab

Study Arms / Comparison Groups

 Low Risk
Description:  Part 1- Patients receive 6 weeks of induction chemotherapy comprised of weekly cycles of carboplatin dosed to an Area Under the Curve (AUC2) and nab-paclitaxel 100 mg/m2 X 6 cycles in combination with durvalumab 750 mg administered once every two weeks for 5 cycles (D1 of weeks 1, 3, 5, 7, and 9).
Part 2- Within a 2-6 week window post induction, tumor imaging will be followed by surgical resection.
Part 3- patients receive adjuvant durvalumab (750 mg) once every two weeks x 3 cycles

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

39

Start Date

December 19, 2017

Completion Date

September 1, 2026

Primary Completion Date

September 1, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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].

          -  Female subjects who are pregnant, breast-feeding or female patients of reproductive
             potential who are not employing an effective method of birth control from starting
             dose of study medications (Cycle 1 Day 1), including dosing interruptions through 90
             days after receipt of the last dose of durvalumab. Refrain from egg cell donation
             while taking durvalumab and for at least 90 days after the last dose of durvalumab.

          -  Male subjects who are not employing an effective method of birth control from starting
             dose of study medications (Cycle 1 Day 1), including dosing interruptions through 6
             months after receipt of study treatment. Male subjects should agree to refrain from
             sperm donation while taking study treatment and for at least 6 months after the last
             dose of nab-paclitaxel and at least 90 days after the last dose of durvalumab. Should
             a female partner of a male patient become pregnant or suspect she is pregnant while
             participating in the study, he should inform his treating physician and the female
             partner should call her physician immediately.

          -  Any previous treatment with a programmed cell death protein 1 (PD-1) or programmed
             death-ligand 1 (PD-L1) inhibitor, including durvalumab.

          -  History of primary immunodeficiency.

          -  History of organ transplant.

          -  Any condition that, in the opinion of the investigator, would interfere with
             evaluation of study treatment or interpretation of patient safety or study results
             (eg, uncontrolled intercurrent illness including, but not limited to, ongoing or
             active infection, symptomatic congestive heart failure, uncontrolled hypertension,
             unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or
             gastritis, active bleeding diatheses or psychiatric illness/social situations that
             would limit compliance with study requirements or compromise the ability of the
             subject to give written informed consent).

          -  Patients with known contraindications to radiotherapy including inherited syndromes
             associated with hypersensitivity to ionizing radiation (e.g., Ataxia Telangiectasia,
             Nijmegen Breakage Syndrome).
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jared Weiss, MD, 919-966-4432, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03174275

Organization ID

LCCC 1621


Responsible Party

Sponsor

Study Sponsor

UNC Lineberger Comprehensive Cancer Center

Collaborators

 AstraZeneca

Study Sponsor

Jared Weiss, MD, Principal Investigator, University of North Carolina, Chapel Hill


Verification Date

June 2020