Screening Trial of Nivolumab With Image Guided, Stereotactic Body Radiotherapy (SBRT) Versus Nivolumab Alone in Patients With Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Completed · Phase 2

Conditions studied: Head and Neck Squamous Cell Carcinoma (HNSCC)

In brief

Nivolumab is an antibody (a type of human protein) that is designed to boost your body's immune system. It does this by allowing immune cells to grow and fight the cancer. Nivolumab has been approved by the FDA for the treatment of melanoma (a form of skin cancer) and lung cancer. It is currently under study for the treatment of head and neck squamous cell cancer.

Key facts

Study ID: NCT02684253
Run by: Memorial Sloan Kettering Cancer Center
People needed: 65
Starts: 2016-02-11
Expected to finish: 2021-01-22
Last updated by the study team: 2022-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Signed Written Informed Consent
Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines.
Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other study obligations.
Target Population
Males and females ≥ 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Histologically confirmed metastatic HNSCC, including nasopharynx WHO Type I-III histologies; patients can have simultaneous loco-regional disease. Central biopsy review at MSKCC is not required.
Subjects must have at least two lesions:
At least one lesion must be safely amenable to irradiation and likely to meet criteria delineated in Section 9.2.1 in the judgment of the treating radiation oncologist. This can be a lesion that was previously irradiated as long as prior radiation was at least 6 months prior to projected first fraction of SBRT and as long as reirradiation dose constraints as outlined in appendix are being met.
A separate, not-to-be-irradiated lesion measurable by CT or MRI per RECIST 1.1 criteria.
A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or a minimum of 3 unstained slides of tumor sample obtained via excisional, incisional, or core needle biopsy from a metastatic or loco-regionally recurrent lesion. A new baseline biopsy does not need to be obtained for study purposes. If 3 unstained are unavailable from a metastatic or loco-regionally recurrent lesion, with permission of the PI, FFPE tumor tissue from the primary disease site at the time of original diagnosis is acceptable.
For oropharynx or nasopharynx primary lesions, documentation of viral status is required (e.g. high risk HPV sub-type PCR, p16 IHC, HPV ISH, EBER, etc). Tests done on primary tumor specimens from date of initial diagnosis at outside institutions are sufficient to meet this criterion
Prior palliative or curative radiotherapy must be completed at least 14 days prior to randomization.
Immunosuppressive doses of systemic medication, such as steroids or absorbed topical steroids (doses >10mg/day prednisone or equivalent) must be discontinued at least 14 days prior to Nivolumab administration.
Screening laboratory values must meet the following criteria (using CTCAE v4.0) and should be obtained within 28 days prior to randomization:
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) Calcium levels must be normalized and maintained within normal limits for study entry and while on treatment.
Subjects with an initial magnesium <0.5 mmol/liter (1.2 mg/deciliter) may receive corrective magnesium supplementation but should continue to receive either prophylactic weekly infusion of magnesium and/or oral magnesium supplementation.

You may not qualify if…

Target Disease Exceptions
Active brain metastases (untreated brain metastases or growth on imaging as defined below) or leptomeningeal disease are not allowed. Subjects with brain metastases are eligible if these have been treated and there is no MRI (or CT if MRI contraindicated) evidence of progression for at least 8 weeks after treatment for these metastases is complete and within 28 days prior to first study treatment.
Histologically confirmed non-squamous histologies are not allowed; an exception is made for WHO Type I-III nasopharynx histologies.
Medical History and Concurrent Diseases:
Any medical disorder that, in the opinion of the investigator, might increase the risk associated with study participation or interferes with the interpretation of study results.
Prior active malignancy within the previous 3 years except for locally curable cancers such as basal or squamous skin cancer, superficial bladder, low risk prostate cancer, breast, or cervix cancer. If other prior malignancy was active within prior 3 years, enrollment requires approval of a principal investigator.
Patients should be excluded if they have an active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration should be excluded. Inhaled or topical steroids and adrenal replacement doses >10mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
As there is potential for hepatic toxicity with Nivolumab, drugs with a predisposition to hepatoxicity should be used with caution in patients treated with Nivolumab-containing regimen.
Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 antibody.
NB-patients who have received prior anti-CTLA-4 antibody therapy are eligible assuming such therapy was discontinued within 28 days of enrollment.
Treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 14 days of randomization.
Physical and Laboratory Test Findings
Positive test for hepatitis B virus surface antigen or hepatitis C virus ribonucleic acid indicating acute or chronic infection.
Known history of testing positive for HIV or known AIDS.
Any grade 4 laboratory abnormalities.
Allergies and Adverse Drug Reaction
History of allergy to Nivolumab components
History of severe hypersensitivity reaction to any monoclonal antibody.
Prohibited or Restricted Treatments
The following medications are prohibited during the study:
Immunosuppressive agents (except to treat a drug-related adverse event).
Systemic corticosteroids > 10 mg daily prednisone equivalent save for exclusion outlined in the below paragraphs.
Any concurrent chemotherapy, hormonal therapy, immunotherapy, or investigational agents for treatment of cancer.

Where it is running

Memoral Sloan Kettering Cancer Center — Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk — Commack, New York, United States
Memorial Sloan Kettering Westchester — Harrison, New York, United States
Memorial Sloan Kettering Cancer Center — New York, New York, United States
Memorial Sloan Kettering at Mercy Medical Center — Rockville Centre, New York, United States

Full record on ClinicalTrials.gov

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