Study of Proton SBRT and Immunotherapy for Recurrent/Progressive Locoregional or Metastatic Head and Neck Cancer

NCT ID: NCT03539198

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 19 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-03
• Study Completion Date: 2020-01-06

Brief Summary

This study observes the clinical efficacy of combining proton SBRT with PD-1 blockade immunotherapy in both the locoregionally recurrent and metastatic settings.

Conditions

Head and Neck Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Locoregional

Patients with recurrent locoregional head and neck cancer

Proton Stereotactic Body Radiation Therapy (SBRT) (5 fractions; 3500-4500 cGy)

Intervention Type: RADIATION

Patients will be receiving proton SBRT

Nivolumab 3 mg/kg IV q2 weeks

Intervention Type: DRUG

Patients will receive Nivolumab x2 cycles before SBRT q2 weeks, and continued q2 weeks after SBRT until progression or at the discretion of the treating physician.

Proton or Photon SBRT (3-5 fractions; various dose and fractionation regimens depending on treatment site).

Intervention Type: RADIATION

Patients with further oligoprogression (5 or fewer sites) will be eligible to receive additional SBRT to all sites of oligoprogression.

Metastatic

Patients with recurrent metastatic head and neck cancer

Proton Stereotactic Body Radiation Therapy (SBRT) (3-5 fractions; various dose and fractionation regimens depending on treatment site).

Intervention Type: RADIATION

Patients will receive proton SBRT.

Nivolumab 3 mg/kg IV q2 weeks

Intervention Type: DRUG

Patients will receive Nivolumab x2 cycles before SBRT q2 weeks, and continued q2 weeks after SBRT until progression or at the discretion of the treating physician.

Proton or Photon SBRT (3-5 fractions; various dose and fractionation regimens depending on treatment site).

Intervention Type: RADIATION

Patients with further oligoprogression (5 or fewer sites) will be eligible to receive additional SBRT to all sites of oligoprogression.

Interventions

Proton Stereotactic Body Radiation Therapy (SBRT) (5 fractions; 3500-4500 cGy)

Patients will be receiving proton SBRT

Intervention Type: RADIATION

Proton Stereotactic Body Radiation Therapy (SBRT) (3-5 fractions; various dose and fractionation regimens depending on treatment site).

Patients will receive proton SBRT.

Intervention Type: RADIATION

Nivolumab 3 mg/kg IV q2 weeks

Patients will receive Nivolumab x2 cycles before SBRT q2 weeks, and continued q2 weeks after SBRT until progression or at the discretion of the treating physician.

Intervention Type: DRUG

Proton or Photon SBRT (3-5 fractions; various dose and fractionation regimens depending on treatment site).

Patients with further oligoprogression (5 or fewer sites) will be eligible to receive additional SBRT to all sites of oligoprogression.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years old whose multidisciplinary care team has determined that the treatments outlined in the protocol are the treating physicians' equipoised clinical recommendation, the multidisciplinary head & neck tumor board's recommendation, and that any reasonable alternative treatments have been reviewed with the subject.
• Signed written informed consent in accordance with regulatory and institutional guidelines.
• Must be willing to comply with scheduled visits, treatment schedule, laboratory testing and other study obligations. Patients must be receiving SOC treatment for recurrent or progressive Head and Neck cancer. Please refer to UCM procedural manual.
• Histologically confirmed head and neck squamous cell carcinoma from any of the primary sites: oral cavity, pharynx, larynx, nasopharynx, sinonasal, cutaneous, or unknown head and neck primary.
• Subjects with head and neck squamous cell carcinoma that has progressed during chemotherapy with a platinum-based drug or that has recurred or metastasized after platinum-based chemotherapy or in patients with an intolerance to or contraindication for platinum-based chemotherapy will be eligible.
• ECOG performance status 0-2
• Subjects enrolled on the METASTATIC ARM must have at least two (≥) lesions:

One lesion must be safely amenable to irradiation with stereotactic body radiation therapy per the treating radiation oncologist. Prior radiation to this lesion is allowed if given ≥ 6 months prior. One lesion must be measurable by CT or MRI per iRECIST 1.1 criteria and should be separate from the lesion to be irradiated. If this target lesion has been previously irradiated, there must be documented disease progression after radiation per RECIST 1.1.

• Any prior radiotherapy must have been completed at least 3 weeks prior to enrollment.
• Adequate bone marrow, hepatic, and renal function based on screening lab values within 35 days prior to beginning immunotherapy:

• WBC ≥ 2 K/microliter
• Neutrophils ≥ 1.5 K/microliter
• Platelets ≥ 100 K/microliter
• Hemoglobin ≥ 9.0 g/deciliter
• Serum Creatinine ≤ 1.5 x ULN or creatinine clearance > 40ml/min using the Cockcroft-Gault formula.
• Female CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg/dL
• Male CrCl = (140 - age in years) x weight in kg x 1.00 72 x serum creatinine in mg/dL
• AST/ALT ≤ 3 x ULN
• Total bilirubin <1.5 x ULN (except subjects with Gilbert Syndrome who can have total bilirubin <3.0 mg/deciliter).
• Women of childbearing potential must have a negative serum or urine pregnancy test within 10 days prior to beginning immunotherapy.
• Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception from time of enrollment for the duration of treatment with nivolumab and for 6 months after discontinuation of nivolumab. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 6 months after the last dose of nivolumab.
• Ability to complete questionnaire(s) by themselves or with assistance.
• Insurance approval or personal pay for SBRT.
• Patient may undergo palliative surgery prior to postoperative proton SBRT and remain in the metastatic arm of the study, as long as the patient meets the other aforementioned criteria relating to the metastatic arm. Surgery is allowable for the locoregionally recurrent arm as per the study schema.

Exclusion Criteria

• Active brain metastases or leptomeningeal disease. Note: Treated brain metastases (e.g. GammaKnife or surgical resection) are eligible if these have been treated and are without MRI evidence of progression for at least 8 weeks after treatment. MRI must be performed within 35 days prior tobeginning immunotherapy.
• Histologically confirmed non-squamous histologies including salivary gland or other non-squamous histologies (e.g. mucosal melanoma) are not allowed; exception WHO Type I-III nasopharynx, which are allowed.
• Subjects with active autoimmune disease or on steroid therapy of >10 mg/day prednisone or equivalent.
• Subjects who have undergone bone marrow or solid organ transplantation.
• Known HIV, hepatitis B or C infection.
• Treatment with chemotherapy, radiation therapy or immunotherapy including investigational agents within 25 days of beginning immunotherapy.
• Women that are breastfeeding or pregnant.
• Any concurrent chemotherapy, hormonal therapy, immunotherapy, or investigational therapy apart from the prescribed treatment per protocol.
• Other active non-head and neck malignancy <1 year prior to registration. If there is a history of prior distinct malignancy, they must not be receiving chemotherapy, radiotherapy, or immunotherapy for their other disease at the time of protocol enrollment. Exceptions include: Non-melanotic skin cancer and carcinoma in situ of the cervix.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel J. Ma, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

ROR1771

Identifier Type: OTHER

Identifier Source: secondary_id

17-010910

Identifier Type: -

Identifier Source: org_study_id