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Head and Neck Squamous Cell Carcinoma (HNSCC)Phase 2NCT02684253

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)

A Phase 2 study testing Nivolumab and Stereotactic Body Radiation Therapy (SBRT) in people with Head and Neck Squamous Cell Carcinoma (HNSCC), run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nivolumab and Stereotactic Body Radiation Therapy (SBRT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
6 sitesUnited States
Study dates
11 Feb 2016to 22 Jan 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Subjects must have a resting baseline O2 saturation by pulse oximetry of >=92% at rest.
  • Reproductive Status
  • Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 28 days prior to randomization.
  • Women must not be breastfeeding
  • Women of childbearing potential must agree to follow instructions for method(s) of contraception from time of enrollment for the duration of treatment with Nivolumab plus 5 half- lives plus 30 days for a total of 23 weeks post treatment completion.
  • 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 31 weeks after the last dose of investigational product.
  • Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception.
  • Azoospermic males and women of childbearing potential who are continuously not heterosexually active are exempt from contraceptive requirements. However, they still must have a pregnancy test.
  • Insurance Approval
  • Insurance approval for SBRT should be obtained prior to randomization

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Memoral Sloan Kettering Cancer Center

    Basking Ridge, New Jersey

  • Memorial Sloan Kettering Cancer Center @ Suffolk

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering at Mercy Medical Center

    Rockville Centre, New York

Other trials in United States

About this study

Official title: A Phase II Randomized Controlled 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)

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.

Being tested
Nivolumab, Stereotactic Body Radiation Therapy (SBRT)
Keywords
Nivolumab, Stereotactic Body Radiotherapy (SBRT), 15-253
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabDrug

  • Stereotactic Body Radiation Therapy (SBRT)Radiation

Study groups in NCT02684253
Study groupRoleWhat they receive
Nivolumab 3mg/kg IV every 2 weeksExperimentalNivolumab 3mg/kg IV every 2 weeks
Receives: Drug: Nivolumab
Stereotactic Body Radiotherapy & NivolumabExperimentalImage Guided, Stereotactic Body Radiotherapy (27 Gy over 3 fractions given every other day) to a single lesion to start by study day 14 (study day 1 is day of first dose of Nivolumab). Nivolumab 3mg/kg IV starting day 1 and then every 2 weeks thereafter. Treatment with Nivolumab will continue until progression or unacceptable toxicity.
Receives: Drug: Nivolumab; Radiation: Stereotactic Body Radiation Therapy (SBRT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Overall Response Rate

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: 96 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2016 (estimated)
  2. Study start11 Feb 2016
  3. Primary completion22 Jan 2021
  4. Study completion22 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02684253
Sponsor's protocol ID
15-253
Status last verified
Jan 2021
First submitted
12 Feb 2016
Last updated
10 Mar 2022

Publications

  • McBride S, Sherman E, Tsai CJ, Baxi S, Aghalar J, Eng J, Zhi WI, McFarland D, Michel LS, Young R, Lefkowitz R, Spielsinger D, Zhang Z, Flynn J, Dunn L, Ho A, Riaz N, Pfister D, Lee N. Randomized Phase II Trial of Nivolumab With Stereotactic Body Radiotherapy Versus Nivolumab Alone in Metastatic Head and Neck Squamous Cell Carcinoma. J Clin Oncol. 2021 Jan 1;39(1):30-37. doi: 10.1200/JCO.20.00290. Epub 2020 Aug 21.

    PubMed 32822275

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab and Stereotactic Body Radiation Therapy (SBRT) in people with Head and Neck Squamous Cell Carcinoma (HNSCC), run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 35 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Overall Response Rate (time frame: 96 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02684253, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.

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