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Study of REGN2810 Prior to Surgery in Patients With Advanced-Stage, Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck

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ClinicalTrials.gov Identifier: NCT03565783
Recruitment Status : Recruiting
First Posted : June 21, 2018
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of this clinical research study is to learn if giving REGN2810 before standard of care surgery and radiation can help to control advanced cutaneous squamous cell carcinoma (cSCC). The safety of this drug will also be studied.

Receiving REGN2810 in this study will not change your standard of care treatment (radiation and surgery). Researchers think that REGN2810 may help to control (or shrink) the cancer before receiving surgery/radiation, but it is not likely to help control the disease after surgery/radiation.

This is an investigational study. REGN2810 is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work.

Up to 22 participants will take part in this study. All will be enrolled at MD Anderson.


Condition or disease Intervention/treatment Phase
Melanoma and Other Malignant Neoplasms of Skin Drug: REGN2810 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of REGN2810 Prior to Surgery in Patients With Advanced-Stage, Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck
Actual Study Start Date : July 3, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: REGN2810 Drug: REGN2810
Open-label REGN2810 will be administered in an outpatient setting as a 30-minute by vein infusion. Each patient's dose will be administered as a flat dose of 350 mg every 3 weeks.




Primary Outcome Measures :
  1. Overall Response Rate to Neoadjuvant REGN2810 [ Time Frame: Baseline up to 5 years ]
    ORR (Overall Response Rate) to neoadjuvant REGN2810 determined by the RECIST v1.1 criteria.


Secondary Outcome Measures :
  1. Secondary outcome measures will include pathological response rate [ Time Frame: Baseline up to 5 years ]
    Survival outcomes will be compared to historical controls.

  2. Secondary outcome measures will include the time to recurrence [ Time Frame: Baseline up to 5 years ]
    Survival outcomes will be compared to historical controls.

  3. Secondary outcome measures will include patterns of failure [ Time Frame: Baseline up to 5 years ]
    Survival outcomes will be compared to historical controls.

  4. Secondary outcome measures will include 2-year disease-specific (DSS) [ Time Frame: Baseline up to 5 years ]
    Survival outcomes will be compared to historical controls.

  5. Secondary outcome measures will include disease-free (DFS) [ Time Frame: Baseline up to 5 years ]
    Survival outcomes will be compared to historical controls.

  6. Secondary outcome measures will include overall survival (OS) [ Time Frame: Baseline up to 5 years ]
    Survival outcomes will be compared to historical controls.

  7. Secondary outcome measures will include PD-1 expression [ Time Frame: Baseline up to 5 years ]
    Survival outcomes will be compared to historical controls.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Biopsy-proven, primary or recurrent advanced-stage (III/IV) cutaneous squamous cell carcinoma of the head and neck.
  2. Surgical resection must be planned as primary therapy with expected adjuvant radiation therapy. Patients are eligible with previous surgical intervention if they have residual or recurrent disease, and it is greater than 4 weeks since surgery and they have fully recovered from surgery.
  3. Signed Informed Consent Form (ICF).
  4. Ability and willingness to comply with the requirements of the study protocol.
  5. Age >/= 18 years.
  6. Adequate hematologic and end organ function, defined by the following laboratory results obtained within 4 weeks (+/-3 days ) prior to study entry: ANC >/= 1500 cells/uL; WBC counts >/= 2500/uL; Lymphocyte count >/= 300/uL; Platelet count >/= 100,000uL for patients with hematologic malignancies, platelet count >/= 75,000/uL; Hemoglobin >/= 9.0 g/dL; Total bilirubin </= 1.5 x upper limit of normal (ULN) with the following exception: Patients with known Gilbert disease who have serum bilirubin level </= 3 x ULN may be enrolled.; AST and ALT </= 3.0 x ULN; Alkaline phosphatase </= 2.5 x ULN with the following exception: Patients with documented bone metastases: alkaline phosphatase </= 5 x ULN; Serum creatinine </= 1.5 x ULN or creatinine clearance >/= 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation.
  7. Measurable disease per RECIST v1.1 (see Appendix 4) for patients with solid malignancies
  8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (see Appendix 6)
  9. INR and aPTT </= 1.5 x ULN [This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation (such as low-molecular-weight heparin or warfarin) should be on a stable dose.]
  10. No evidence of distant metastases and measurable disease (>1.5cm).

Exclusion Criteria:

  1. Any approved anticancer therapy, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment; however, the following are allowed: Hormone-replacement therapy; Palliative radiotherapy for bone metastases > 2 weeks prior to Cycle 1, Day 1
  2. AEs from prior anticancer therapy that have not resolved to Grade </= 1 except for alopecia
  3. Bisphosphonate therapy for symptomatic hypercalcemia [Use of bisphosphonate therapy for other reasons (e.g., osteoporosis) is allowed.]
  4. Patients with acute leukemias, accelerated/blast phase chronic myelogenous leukemia, chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory myeloma
  5. Pregnancy, lactation, or breastfeeding
  6. Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  7. Inability to comply with study and follow-up procedures
  8. History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis. (Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.; Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible.;
  9. History or risk of autoimmune disease (continued). (Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions: Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations; Rash must cover less than 10% of body surface area (BSA); Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%,fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%); No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
  10. History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. (History of radiation pneumonitis in the radiation field (fibrosis) is permitted.)
  11. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
  12. History of HIV infection or active hepatitis B (chronic or acute) or hepatitis C infection. (Patients with past or resolved hepatitis B infection; defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test, are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.)
  13. Active tuberculosis
  14. Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
  15. Signs or symptoms of infection as determined by the treating team within 2 weeks prior to Cycle 1, Day 1
  16. Received oral or IV antibiotics within 2 weeks prior to Cycle 1, Day 1 [Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible.]
  17. Major surgical procedure within 28 days prior to Cycle 1, Day 1.
  18. Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1 or anticipation that such a live, attenuated vaccine will be required during the study. [Influenza vaccination should be given during influenza season only (approximately October to March). Patients must not receive live, attenuated influenza vaccine (e.g., FluMist) within 4 weeks prior to Cycle 1, Day 1 or at any time during the study.]
  19. Malignancies other than the disease under study within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, or ductal carcinoma in situ treated surgically with curative intent) or undergoing active surveillance per standard-of-care management (e.g., chronic lymphocytic leukemia Rai Stage 0, prostate cancer with Gleason score </= 6, and prostate-specific antigen [PSA] </= 10 mg/mL, etc.)
  20. Continued sexual activity in men** or women of childbearing potential*** who are unwilling to practice highly effective contraception during the study and until 6 months after the last dose of study drug (highly effective contraceptive measures include stable use of oral contraceptives such as combined estrogen and progestogen and progestogen only hormonal contraception or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; intrauterine hormone-releasing system [IUS]; bilateral tubal ligation; vasectomy, and sexual abstinence). (**Contraception is not required for men with documented vasectomy ***Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of childbearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.)
  21. Prior treatment with anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway targeting agents. (Patients who have received prior treatment with anti-CTLA-4 may be enrolled, provided the following requirements are met: Minimum of 12 weeks from the first dose of anti-CTLA-4 and > 6 weeks from the last dose. No history of severe immune-related adverse effects from anti-CTLA 4 (NCI CTCAE Grade 3 and 4)
  22. Treatment with systemic immunostimulatory agents (including but not limited to interferon [IFN] or interleukin [IL]-2) within 6 weeks or five half-lives of the drug (whichever is shorter) prior to Cycle 1, Day 1
  23. Treatment with investigational agent within 4 weeks prior to Cycle 1, Day 1 (or within five half lives of the investigational product, whichever is longer)
  24. Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 2 weeks prior to Cycle 1, Day 1. [Patients who have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled. The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.]
  25. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  26. Patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation
  27. Patients with prior treatment with idelalisib

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565783


Contacts
Contact: Neil Gross, MD 713-792-6920 ngross@mdanderson.org

Locations
United States, Texas
Md Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: , MD       ngross@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
Regeneron Pharmaceuticals
Investigators
Principal Investigator: Neil Gross, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03565783     History of Changes
Other Study ID Numbers: 2017-0332
NCI-2018-01313 ( Registry Identifier: NCI CTRP )
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Neoplasms
Head and Neck Neoplasms
Skin Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Skin Diseases