Health TrialsbyHealthPanel

Response-Adaptive Treatment in Untreated Locoregional HPV-Negative Head and Neck Cancer

ConditionsHead and Neck CancerHPV
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago

About this trial

The purpose of this study is to assess the objective response rate following neoadjuvant therapy with volrustomig, paclitaxel, and carboplatin in previously untreated human papillomavirus (HPV)-negative locally advanced head and neck squamous cell carcinoma

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Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must have pathologically confirmed locally advanced, non-metastatic, head and neck squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, nasopharynx, larynx, or sinuses.

If a primary oropharyngeal squamous cell carcinoma is diagnosed, HPV must be ruled out by immunohistochemistry (defined as negative immunohistochemical staining of p16)

Non-oropharyngeal primary sites do not require immunohistochemical or other means of testing for HPV status, however if they are performed, must be negative for HPV.

Nasopharyngeal primary must have both EBV and HPV ruled out by immunohistochemistry to be eligible.

Disqualifiers

Unequivocal demonstration of distant metastatic disease (M1 disease).

Unidentifiable primary site.

Prior surgical therapy other than incisional/excisional biopsy or organ-sparing procedures such as debulking of airway-compromising tumors. Residual measurable tumor is required for enrollment as discussed above.

Patients who are receiving any other investigational agents.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Volrustomig

    Drug

    500mg or 750mg (cycles 1-2) and 250mg thereafter IV day 1.

  • Carboplatin

    Drug

    100mg/m2 IV day 1 and day 8.

  • Paclitaxel

    Drug

    AUC 5 IV day 1

Treatment groups

38 Participants
are divided into 3 treatment groups
Group A: VolrustomigExperimental treatment 1 intervention
Group B: Carboplatin (AUC)Experimental treatment 1 intervention
Group C: Paclitaxel (mg/m2)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Response rate

Assess the objective response rate following neoadjuvant therapy with volrustomig, paclitaxel, and carboplatin in previously untreated human papillomavirus (HPV)-negative locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The proportion of patients who achieve an objective response (30% or greater tumor shrinkage per RECIST v1.1 criteria) after chemoimmunotherapy.

Time frame
24 months

Secondary outcomes

1

Survival outcomes

Assess in patients receiving neoadjuvant therapy with volrustomig, paclitaxel, and carboplatin followed by response-adaptive treatment in previously untreated HPV(-) LA-HNSCC. * Progression-free survival at 24 months. * Overall survival at 24 months.

Time frame
24 months
2

Control of treatment failure

Assess disease control of treatment failure in patients receiving neoadjuvant volrustomig, paclitaxel, and carboplatin followed by response-adaptive treatment in previously untreated HPV(-) LA-HNSCC, and compare disease control and patterns of treatment failure between treatment arms.

Time frame
24 months
3

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Assess optimal dose and safety and tolerability of neoadjuvant volrustomig, paclitaxel, and carboplatin followed by response-adaptive treatment in previously untreated HPV(-) LA-HNSCC. Acute toxicity as assessed by CTCAE v5.0 measuring during treatment

Time frame
24 months
4

Patterns of treatment failure

Assess disease patterns of treatment failure in patients receiving neoadjuvant volrustomig, paclitaxel, and carboplatin followed by response-adaptive treatment in previously untreated HPV(-) LA-HNSCC, and compare disease control and patterns of treatment failure between treatment arms.

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Chicago

Lead sponsor

Source ClinicalTrials.gov
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