Re-irradiation With NBTXR3 in Combination With Pembrolizumab for the Treatment of Inoperable Locoregional Recurrent Head and Neck Squamous Cell Cancer

Overseen by Jack Phan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies the effect of re-irradiation with NBTXR3 in combination with pembrolizumab in treating patients with head and neck squamous cell cancer that cannot be removed by surgery (inoperable) and has come back (recurrent). NBTXR3 is a drug that is designed to improve the effectiveness (how well something works) of radiation therapy. The drug is injected into a tumor and activated (turned on) by radiation. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Radiation therapy, such as intensity modulated radiation therapy or intensity modulated proton therapy, uses high energy to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving NBTXR3 activated by radiation together with pembrolizumab may help to control head and neck squamous cell cancer.

Research Team

Jack Phan, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Inclusion Criteria

Patients with biopsy proven locoregional recurrent squamous cell carcinoma of the head and neck, or second primary HNSCC

Not eligible (unresectable) or poor candidate or patient refusal of surgery for HNSCC recurrence

Previous documented receipt of at least 30 Gy and up to 70 Gy of radiation for HNSCC with overlapping fields based on actual dose, prescription percentage

Treatment Details

Interventions

• Intensity-Modulated Proton Therapy (Radiation)
• Intensity-Modulated Radiation Therapy (Radiation)
• NBTXR3 (Radiosensitizer)
• Pembrolizumab (Checkpoint Inhibitor)
• Stereotactic Body Radiation Therapy (Radiation)

Participant Groups

Group I: Cohort II (NBTXR3, IMRT/IMPT, pembrolizumab) Experimental Treatment 6 Interventions

Patients receive NBTXR3 IT on day 1. Patients then undergo IMRT/IMPT QD on days 15-50. Beginning the first day of radiation therapy, patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Group II: Cohort I (NBTXR3, SBRT, pembrolizumab) Experimental Treatment 5 Interventions

Patients receive NBTXR3 IT on day 1. Patients then undergo SBRT QOD on days 15-29. Beginning the first day of radiation therapy, patients also receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

Intensity-Modulated Proton Therapy is already approved in Canada, Japan for the following indications:

Approved in Canada as IMPT for:

• Head and neck cancers
• Squamous cell carcinoma
• Nasopharyngeal cancer
• Oropharyngeal cancer
• Thyroid cancer
• Salivary gland cancer

Approved in Japan as IMPT for:

• Head and neck cancers
• Squamous cell carcinoma
• Nasopharyngeal cancer
• Oropharyngeal cancer
• Thyroid cancer
• Salivary gland cancer

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine