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Nivolumab in Patients With Advanced Cutaneous Squamous Cell Carcinoma (CA209-9JC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03834233
Recruitment Status : Active, not recruiting
First Posted : February 7, 2019
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Rodrigo R Munhoz, Instituto do Cancer do Estado de São Paulo

Brief Summary:

Cutaneous squamous cell carcinoma (cSCC) is one of the most frequent malignancies worldwide, and an increasing incidence has been documented over the past decades. Despite optimal initial approach, which can be curative in the majority of cases, a proportion of patients present with locally advanced or unresectable disease, leading to significant morbidity. In addition, metastases of cSCC may affect 2 to 5% of individuals diagnosed with this disease. In the setting of advanced cSCC, no standard systemic treatment has been established, and treatment options are frequently adapted from those applied to squamous cell carcinoma arising from other sites, based on a low level of evidence and often with short-lived benefits.

cSCC are potentially immunogenic neoplasms with an unmet need for therapeutic options, having sun exposure and chronic inflammation as the most significant risk factors. Using the anti-PD1 monoclonal antibody nivolumab to treat patients with cSCC and planned scientific correlates, investigators believe that the safety and efficacy of immune activating therapy for this disease can be assessed.

This is a multi-center, Simon two-stage, phase II study to evaluate the safety and efficacy of the anti-PD1 monoclonal antibody nivolumab for systemic-treatment-naïve patients with metastatic and/or locally advanced cSCC.

The primary objective of the study is to evaluate the efficacy, as assessed by the best objective response rate (complete response + partial response) at 24 weeks according to RECIST criteria, of nivolumab in patients with advanced cSCC. Secondary objectives are to assess the safety/tolerability of the treatment, to determine the progression-free survival (PFS) and overall survival (OS) rates at 24 weeks, and to evaluate the objective response rate as assessed by immune-related response criteria (irRC). Treatment will be given every 14 days until disease progression, unacceptable toxicity or withdrawal of consent/patient decision. If the patient continues to benefit from treatment with nivolumab, treatment will be continued for up to 12 months. Patients will be reassessed at week 12 and every 12 weeks thereafter until week 52, and then as per discretion of the treating investigator. A tumor biopsy will be performed before treatment initiation, unless contraindicated and optional biopsies will be performed at week 13 and following disease progression. Serial blood samples will be obtained at baseline, during, and after treatment.


Condition or disease Intervention/treatment Phase
Advanced Cutaneous Squamous Cell Carcinoma Drug: Nivolumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II of Study of Nivolumab in Patients With Advanced Cutaneous Squamous Cell Carcinoma
Actual Study Start Date : September 5, 2019
Actual Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Nivolumab
Nivolumab 3mg/kg IV every 14 days until disease progression, unacceptable toxicity or up to 12 months.
Drug: Nivolumab
Nivolumab 3mg/kg IV every 14 days until disease progression, unacceptable toxicity or up to 12 months.




Primary Outcome Measures :
  1. Best objective response rate (complete response + partial response) using RECIST criteria at 24 weeks [ Time Frame: From date of treatment initiation until week 24 ]
    To evaluate the efficacy, as assessed by the best objective response rate (complete response + partial response) at 24 weeks by RECIST 1.1, of nivolumab in patients with advanced cSCC.


Secondary Outcome Measures :
  1. Incidence of treatment related adverse events [ Time Frame: From date of treatment initiation until week 24 ]
    To assess the safety and tolerability of nivolumab in patients with advanced cSCC.

  2. Progression free survival (PFS) rate [ Time Frame: From date of treatment initiation until week 24 ]
    To determine the progression free survival (PFS) rate at 24 weeks

  3. Best objective response rate (complete response + partial response) using immune-related response criteria [ Time Frame: From date of treatment initiation until week 24 ]
    To evaluate the efficacy, as assessed by the best objective response rate (complete response + partial response) at 24 weeks by immune-related response criteria (irRC), of nivolumab in patients with advanced cSCC.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Males or females at least 18 years of age.
  • Subjects must have a histologically confirmed metastatic/locally advanced cutaneous squamous cell carcinoma
  • No prior systemic treatments for advanced (metastatic or locally advanced) cSCC
  • Measurable disease as defined by RECIST 1.1
  • Performance status: ECOG 0 to 1
  • Patients must be recovered from surgery or toxic effects of prior radiation therapy. Study treatment may not start until at least two weeks from completion of radiation therapy or surgery.
  • Adequate hematologic, hepatic and renal function as defined below i. Hemoglobin > 8.5 g/dl (can be post transfusion) ii. Absolute neutrophil count > 1,000/mm3 iii. Platelet count > 75,000/mm3 iv. Total Bilirubin <2.0 x upper limit of normal (ULN) in absence of Gilbert disease (Total Bilirubin ≤ 3 x ULN with Gilbert).

    v. ALT (SGOT) or AST (SGPT) <2.0 x ULN (or < 3 times the upper limit of normal are permitted if clearly attributed to liver metastasis) vi. Calculated creatinine clearance (CrCI) ≥ 30 mL/min using the lean body mass formula only (Modified Cockroft and Gault; Shargel and Yu 1985)

  • Ability to understand informed consent and comply with treatment protocol
  • Male and female patients with reproductive potential must use an approved contraceptive method if appropriate (eg, intrauterine device [IUD], birth control pills, or barrier device) during and for 5 months (females) or 7 months (males) after the study. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 30 days prior to study enrollment. Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study and for 7 months following the last dose of study drug

Exclusion Criteria:

  • Prior use of anti-PD-1 or anti-PD-L1 monoclonal antibody.
  • Uncontrolled intercurrent illness including active infection or symptomatic congestive heart failure within 6 months
  • Patients requiring systemic treatment with corticosteroids (>10mg daily of prednisone or equivalent) or using immunosuppressive medications within 10 days of study drug administration.
  • Patients with untreated or symptomatic brain metastases.
  • Known history of immunodeficiency virus disease with detectable viral load and CD4+ lymphocyte count <350 mm3. Patients with undetectable vital load and CD4+ lymphocyte count >350 mm3 are eligible
  • History or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease, or documented history of autoimmune disease or syndrome requiring systemic steroids or immunosuppressive agents except vitiligo or resolved childhood asthma/atopy.
  • Evidence of clinically significant immunosuppression, including primary immunodeficiency state such as Severe Combined Immunodeficiency Disease or concurrent opportunistic infection
  • Known active hepatitis B or hepatitis C infection. Patients with undetectable viral load for hepatitis B or C as determined by PCR are eligible.
  • History of stem-cell or solid organ transplant.
  • Received live vaccine within 28 days prior to enrollment
  • Female subject is pregnant or breast-feeding, or planning to become pregnant during study treatment and through 5 months after the last dose of nivolumab.

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): NCT03834233


Locations
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Brazil
Rodrigo Ramella Munhoz
São Paulo, Brazil, 01346000
Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo
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Responsible Party: Rodrigo R Munhoz, Principal Investigator, Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT03834233    
Other Study ID Numbers: 1258/18
First Posted: February 7, 2019    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action