Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)

About this trial

This phase II trial tests the addition of chemotherapy, with carboplatin and paclitaxel, or chemo-immunotherapy, with carboplatin, paclitaxel and cemiplimab to standard salvage surgery followed by post operative radiation therapy and cisplatin for high risk patients, for the treatment of patients with PD-L1 positive head and neck squamous cell carcinoma that has come back and spread to nearby tissue or lymph nodes after a period of improvement (locally recurrent) or is persistent. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Salvage surgery is surgery that takes place to remove tumor tissue after a failure of other treatment. High risk patients also receive radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Adding chemotherapy or chemo-immunotherapy to standard salvage surgery may kill more tumor cells than salvage surgery alone in patients with PD-L1 positive locally recurrent or persistent head and neck squamous cell carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologically (histologically or cytologically) proven diagnosis of locally recurrent or persistent squamous cell carcinoma of head and neck (SCCHN) arising within the oral cavity, oropharynx, larynx, or hypopharynx

PD-L1 combined positive score (CPS) ≥ 1 using a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory

Verify insurance (or other payment) coverage for neoadjuvant chemotherapy

Measurable disease as defined by RECIST 1.1

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Carboplatin

    Drug

    Given IV

  • Cemiplimab

    Biological/Vaccine

    Given IV

  • Cisplatin

    Drug

    Given IV

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan

  • Paclitaxel

    Drug

    Given IV

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET scan

  • Radiation Therapy

    Radiation

    Undergo radiation therapy

  • Salvage Surgery

    Procedure/Surgery

    Undergo standard of care salvage surgery

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Arm 1 (Salvage surgery)Active comparator 6 interventions
Group B: Arm 2 (Chemotherapy, salvage surgery)Experimental treatment 8 interventions
Group C: Arm 3 (Chemo-immunotherapy, salvage surgery)Experimental treatment 9 interventions

Trial outcomes

Primary outcomes

1

Event free survival (EFS)

Will be summarized by treatment arm using standard Kaplan-Meier methods, reporting the estimated 2-year EFS rate with corresponding 95% confidence intervals.

Time frame
From randomization to disease progression or treatment-related toxicities that precludes surgery, disease progression in the absence of surgery, disease recurrence after surgery, or death due to any cause, up to 7 years

Secondary outcomes

1

Disease free survival (DFS)

Will be summarized by treatment arm using standard Kaplan-Meier methods, where estimates of the 2-year DFS will be obtained with 95% confidence intervals. Comparisons between the experimental arms and the control arm will be made using the stratified log-rank test.

Time frame
From randomization until disease recurrence, death due to any cause, up to 7 years
2

Overall survival (OS)

Will be summarized by treatment arm using standard Kaplan-Meier methods, where estimates of the 2-year OS will be obtained with 95% confidence intervals. Comparisons between the experimental arms and the control arm will be made using the stratified log-rank test.

Time frame
From randomization until death due to any cause, up to 7 years
3

Time to distant metastasis

The cumulative incidence method will be used to estimate the incidence of distant metastases; where estimates of the 2-year distant metastasis rates will be obtained with 95% confidence intervals. Comparisons between the experimental arms and the control arm will be made using the stratified Gray's test.

Time frame
From randomization until detection of distant metastases or death, up to 7 years
4

Surgical complications

Will be assessed using the Comprehensive Complication Index. Surgical complications will be summarized by treatment arm using frequencies and relative frequencies; where the overall complication rate will be estimated by treatment arm using 95% confidence intervals obtained by the Clopper-Pearson method. Comparisons between the experimental arms and the control arm will be made using the Cochran-Mantel-Haenszel test.

Time frame
Up to 7 years

Other outcomes

Sponsors and contacts

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