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

Summary

Participation Requirements

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 res...

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.

Tracking Information