Radiotherapy, Carboplatin/Paclitaxel and Nivolumab for High Risk HPV-related Head and Neck Cancer

Phase 2

Active, not recruiting

• Conditions: Oropharynx Squamous Cell Carcinoma
• Interventions: Drug: Nivolumab; Drug: Carboplatin; Drug: Paclitaxel; Radiation: Radiation Therapy

• Registration Number: NCT03829722
• Lead Sponsor: University of Michigan Rogel Cancer Center

Brief Summary

The purpose of this study is to find out if the addition of nivolumab can improve 2 year progression free survival (PFS) as compared to standard of care of fractionated radiation therapy (RT) and carboplatin/paclitaxel in subjects with high risk HPV-related squamous cell carcinoma of the oropharynx (tonsil, base of tongue, oropharyngeal wall, soft palate). Fractionated means the radiation will be administered in fragments or parts across multiple days.

Detailed Description

PCD details were updated as RECIST is not appropriate for tumor response assessment in this population. Tumor response will be assessed via clinical assessment and PET response (determining progression and location, if any evidence of disease).

Study Timeline

• Study First Submitted: 2019-02-01
• Study First Submitted QC: 2019-02-01
• Study First Posted: 2019-02-04
• Study Start: 2019-09-05
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nivolumab, Carboplatin/Paclitaxel, Radiotherapy	Carboplatin	Therapy will continue for 21 weeks total. This includes 4 doses of of nivolumab (240mg/m2) before and concurrent with RT/carboplatin/paclitaxel and 4 adjuvant nivolumab doses (480mg/m2) after the end of RT.
Nivolumab, Carboplatin/Paclitaxel, Radiotherapy	Radiation Therapy	Therapy will continue for 21 weeks total. This includes 4 doses of of nivolumab (240mg/m2) before and concurrent with RT/carboplatin/paclitaxel and 4 adjuvant nivolumab doses (480mg/m2) after the end of RT.
Nivolumab, Carboplatin/Paclitaxel, Radiotherapy	Paclitaxel	Therapy will continue for 21 weeks total. This includes 4 doses of of nivolumab (240mg/m2) before and concurrent with RT/carboplatin/paclitaxel and 4 adjuvant nivolumab doses (480mg/m2) after the end of RT.
Nivolumab, Carboplatin/Paclitaxel, Radiotherapy	Nivolumab	Therapy will continue for 21 weeks total. This includes 4 doses of of nivolumab (240mg/m2) before and concurrent with RT/carboplatin/paclitaxel and 4 adjuvant nivolumab doses (480mg/m2) after the end of RT.

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	Up to 2 years after completion of study treatment	Estimated using the Kaplan-Meier method. Evaluated using imaging and clinical exams

Secondary Outcome Measures

Name	Time	Method
Proportion of patients who progressed in any location	Up to 2 years after completion of study treatment	To characterize patterns of failure, investigators will summarize the proportion of patients who progressed in any location and whether the first progression was local, regional, distant or in multiple locations.
Overall survival (OS)	Up to 2 years after completion of study treatment	Estimated using the Kaplan-Meier method
Incidence of acute toxicity	Up to 6 months after completion of study treatment	Toxicity evaluation per CTCAE v 5.0
Incidence of late toxicity	Up to 2 years after completion of study treatment	Toxicity evaluation per CTCAE v 5.0
Correlation of mid-treatment FDG-PET scans with post-treatment PET-CT.	12 weeks after completion of study treatment	Correlation of metabolic image uptake data on mid-treatment FDG-PET scans performed between fractions 8-12 with standard 12 week post-treatment PET-CT.

Trial Locations

Locations (1)

University of Michigan Rogel Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States