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Advanced Cutaneous Squamous Cell CarcinomaPhase 2CA209-9JCNCT03834233

Nivolumab in Patients With Advanced Cutaneous Squamous Cell Carcinoma

A Phase 2 study testing Nivolumab in people with Advanced Cutaneous Squamous Cell Carcinoma, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nivolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteBrazil
Study dates
5 Sep 2019to 1 Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

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

  • 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.
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  • 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).
  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Rodrigo Ramella Munhoz

    São Paulo, 01346000

Other trials in Brazil

About this study

Official title: A Phase II of Study of Nivolumab in Patients With Advanced Cutaneous Squamous Cell Carcinoma

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.

Read more

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.

Being tested
Nivolumab

What participants receive

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

  • NivolumabDrug

    Nivolumab 3mg/kg IV every 14 days until disease progression, unacceptable toxicity or up to 12 months.

Study groups in NCT03834233
Study groupRoleWhat they receive
NivolumabExperimentalNivolumab 3mg/kg IV every 14 days until disease progression, unacceptable toxicity or up to 12 months.
Receives: Drug: Nivolumab

What is being measured

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

  1. Best objective response rate (complete response + partial response) using RECIST criteria at 24 weeks

    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.

    Measured: From date of treatment initiation until week 24

Secondary outcomes (3)

  1. Incidence of treatment related adverse events

    To assess the safety and tolerability of nivolumab in patients with advanced cSCC.

    Measured: From date of treatment initiation until week 24

  2. Progression free survival (PFS) rate

    To determine the progression free survival (PFS) rate at 24 weeks

    Measured: From date of treatment initiation until week 24

  3. Best objective response rate (complete response + partial response) using immune-related response criteria

    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.

    Measured: From date of treatment initiation until week 24

Timeline

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

  1. First posted7 Feb 2019
  2. Study start5 Sep 2019
  3. Primary completion1 Dec 2019
  4. Study completion1 Dec 2022 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03834233
Sponsor's protocol ID
1258/18
Acronym
CA209-9JC
Status last verified
Feb 2020
First submitted
3 Feb 2019
Last updated
12 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Munhoz RR, Nader-Marta G, de Camargo VP, Queiroz MM, Cury-Martins J, Ricci H, de Mattos MR, de Menezes TAF, Machado GUC, Bertolli E, Barros M, de Souza CE, Franke F, Ferreira FO, Feher O, de Castro G Jr. A phase 2 study of first-line nivolumab in patients with locally advanced or metastatic cutaneous squamous-cell carcinoma. Cancer. 2022 Dec 15;128(24):4223-4231. doi: 10.1002/cncr.34463. Epub 2022 Oct 24.

    PubMed 36274573

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab in people with Advanced Cutaneous Squamous Cell Carcinoma, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.

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 10 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. 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?

Results are not available in the source record.

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?

Best objective response rate (complete response + partial response) using RECIST criteria at 24 weeks (time frame: From date of treatment initiation until week 24). 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 NCT03834233, 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 12 Feb 2020.

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