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Platinum-based Chemotherapy

Chemotherapy + Immunotherapy Before Surgery for Head and Neck Cancer

Phase 2

Waitlist Available

Led By Jared Weiss, MD

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

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

Must not have

Any metastatic disease

Known history of previous clinical diagnosis of tuberculosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a chemotherapy regimen to see if it can effectively treat squamous cell carcinoma of the head and neck while also reducing side effects.

Who is the study for?

This trial is for adults with a type of cancer called squamous cell carcinoma of the head and neck, which hasn't spread beyond its original location and can be surgically removed. Participants must have good performance status, measurable disease, proper bone marrow function, and adequate liver and kidney function. They should not have had major surgery recently or suffer from active serious infections or certain autoimmune diseases.

What is being tested?

The study tests a combination of chemotherapy drugs (carboplatin and nab-paclitaxel) with an immunotherapy drug (durvalumab), before surgical removal of the tumor. The goal is to shrink tumors without radiation therapy's side effects, hoping to improve cure rates and long-term quality of life related to speech and swallowing.

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking normal organs (autoimmune reactions), infusion-related reactions from the drugs being administered into the bloodstream, fatigue, blood disorders like low counts that increase infection risk, as well as potential liver or kidney issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My liver and kidney functions are within normal ranges.

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I have a type of throat cancer that has not spread and can be removed by surgery.

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I am 18 years old or older.

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My blood tests show normal white blood cells, hemoglobin, and platelets.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to other parts of my body.

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I have been diagnosed with tuberculosis in the past.

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I had major surgery less than 28 days ago and haven't fully recovered.

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I have HIV, HCV, or active HBV.

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I am not currently on any cancer treatments like chemotherapy or hormone therapy.

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I have been treated with a PD-1 or PD-L1 inhibitor before.

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I cannot have radiotherapy due to a genetic condition.

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I have had an organ transplant.

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I have had or currently have pneumonitis.

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My throat cancer is caused by a low-risk HPV infection.

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I do not have any serious infections or health conditions that could risk my safety in the study.

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I have had an autoimmune or inflammatory disorder in the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Clinical Complete Response Rate and (cCRR) and Clinical Response Rate (cRR) Following Induction Chemotherapy

Overall Survival (OS) Associated With 3 Part Therapy Consisting of Induction Chemotherapy, Surgery and Risk-adapted Use of Chemoradiation

Percent of Patients Who Have a Change in Estimated Risk Level

+2 more

Other study objectives

Cellular Correlates of Response and Changes in the Tumor Microenvironment Across Therapy

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).

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Medium RiskExperimental Treatment6 Interventions

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 ipsilateral involved field radiation concurrent with weekly cisplatin 30mg/m2. Once chemoradiotherapy is complete these patients will receive durvalumab 750 mg every two weeks for 3 cycles.

Group II: Low RiskExperimental Treatment4 Interventions

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

Group III: High RiskExperimental Treatment6 Interventions

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- All patients will be treated with intensity modulation radiation therapy (IMRT) concurrent with weekly cisplatin 30mg/m2 or other standard of care chemoradiotherapy regimen.Once chemoradiotherapy is complete these patients will receive durvalumab 750 mg every two weeks for 3 cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~3120

Durvalumab

2017

Completed Phase 2

~3750