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New treatment option for Squamous Cell Carcinoma of the Anal Canal
Official title Tiraglolumab Atezolizumab and Chemoradiotherapy in Localized Anal Carcinoma (TIRANUS)
ClinicalTrials.gov ID: NCT05661188
What this study is testing
What is Atezolizumab plus Tiraglolumab?
Atezolizumab plus Tiraglolumab is an investigational medicine, being studied as a potential treatment for squamous cell carcinoma of the anal canal.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The peculiarity of anal cancers, with well-established radical chemoradiotherapy that allows tumor-neoantigen formation with platinum-based chemotherapy and radiotherapy with radio-sensitizing chemotherapy could create the perfect environment for immunotherapy in this setting, not only to increase the probability of pathological complete response (CCR) but also creating neoantigen exposure and immune-prevention to reduce the relapse after surgery. TIRANUS trial is a Phase II, single-arm, open-label, non randomized, non controlled recruiting treatment-naive localized squamous cell carcinoma of the anal canal and are candidates for radical chemoradiotherapy.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Male or female people ≥ 18 years old.
- Written informed consent approved by the Independent Ethics Committee (IEC), prior to the performance of any trial activities.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Histologically confirmed squamous cell carcinoma of the anal canal. This may include non-keratinizing histological subtypes (i.e. basaloid...
- Locoregional squamous cell carcinoma of the anal canal with no distant metastasis: stages I, II, IIIA, and IIIB according to the American Joint...
You likely can't join if
- Previous or pre-planned potentially curative surgery for the anal carcinoma for the duration of the study. Major surgery (i.e. cystectomy) less than...
- Prior treatment for the control of the squamous cell carcinoma of the anal canal. Prior radiotherapy, chemotherapy or treatment with CD137 agonists...
- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins. Known hypersensitivity to Chinese hamster...
- History of allogeneic stem cell or solid organ transplant.
- Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis...
- Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
See the full eligibility criteria
Who can join
- Male or female people ≥ 18 years old.
- Written informed consent approved by the Independent Ethics Committee (IEC), prior to the performance of any trial activities.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Histologically confirmed squamous cell carcinoma of the anal canal. This may include non-keratinizing histological subtypes (i.e. basaloid, transitional, spheroidal and cloacogenic).
- Locoregional squamous cell carcinoma of the anal canal with no distant metastasis: stages I, II, IIIA, and IIIB according to the American Joint Cancer Committee (AJCC) Cancer Staging Handbook Seventh Edition (T1-4...
- Mandatory archival or recent paraffin-fixed (FFPE) tumor biopsy available at baseline for translational purposes. Fine-needle biopsy is acceptable. Note: If there is no archival tumor tissue or not enough tissue...
- At least one evaluable lesion.
- Patients should meet the criteria for radical chemoradiotherapy for squamous cell carcinoma of the anal canal following international guidelines.
- Normal life expectancy, excluding cancer mortality risk
- Patients with adequate normal organ and marrow function assessed within 14 days prior to start of the study treatment as defined below:
- Hemoglobin ≥ 9.0 g/dL (Patients may be transfused to meet this criterion).
- Absolute neutrophil count (ANC) \> 1500 per mm3.
- Platelet count ≥ 100,000 per mm3.
- Serum total bilirubin ≤ 1.5 X institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated...
- Serum transaminases: alanina aminotransferase (ALT), aspartato aminotransferase (AST) and fosfatase alcalina (ALP) ≤ 2.5X ULN.
- Serum albumin ≥ 25 g/L (2.5 g/dL).
- Creatinine ≤ 1.5 mg/dL or measured creatinine clearance (CL) \> 60 mL/min or Calculated creatinine CL \> 60 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for the...
- Absence of active infection that requires systemic antibiotics.
- Female people of childbearing potential (WOCBP) must provide a negative urine pregnancy test at screening, and must agree to use a medically accepted and highly effective birth control method (i.e. those with a failure...
- Amenorrheic for ≥1 year in the absence of chemotherapy and/or hormonal treatments
- Luteinizing hormone (LH) and/or follicle stimulating hormone and/or estradiol levels in the post-menopausal range
- Radiation induced oophorectomy with last menses \>1 year ago
- Chemotherapy induced menopause with \>1 year interval since last menses
- Surgical sterilization (bilateral oophorectomy or hysterectomy)
- Women \<50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and...
- Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, or underwent surgical sterilization (bilateral...
- For both male and female patients/partners: Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Non-sterile males must be...
- One for whom azoospermia has been previously demonstrated in a semen sample examination as definitive evidence of infertility.
- Males with known "low sperm counts" (consistent with "sub-fertility") are not to be considered sterile for purposes of this study.
- Willingness and ability of patients to comply with the protocol for the duration of the study including undergoing treatment as well as availability for scheduled visits and examinations including follow up.
What rules you out
- Previous or pre-planned potentially curative surgery for the anal carcinoma for the duration of the study. Major surgery (i.e. cystectomy) less than 28 days prior to the first dose of study treatment.
- Prior treatment for the control of the squamous cell carcinoma of the anal canal. Prior radiotherapy, chemotherapy or treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT...
- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins. Known hypersensitivity to Chinese hamster ovary cell products or to any component of the tiragolumab or...
- History of allogeneic stem cell or solid organ transplant.
- Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel...
- Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
- Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
- Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of the...
- people that have a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of study treatment, with the exceptions:
- Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for...
- Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal...
- Treatment with investigational therapy within 42 days prior to initiation of study treatment. Observational studies are permitted.
- Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2) within 28 days or 5 drug-elimination half-lives (whichever is longer) prior to first study treatment...
- Not stable treatment with anticoagulant therapies.
- Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that could...
- Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Note: Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic...
- Vaccination within 4 weeks of the first dose of study treatment, or anticipation of need for such a vaccine while on trial, and 5 months after last dose of atezolizumab and/or 90 days after last dose of tiragolumab is...
- Subject has a history of another uncontrolled malignancy before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy..
- Presence of the following conditions within the past 6 months:
- Uncontrolled diabetes
- Uncontrolled or symptomatic hypercalcemia (ionized calcium \> 1.5 mmol/L, calcium \> 12 mg/dL or corrected serum calcium \> ULN)
- New York Heart Association class II-IV congestive heart failure
- Cerebrovascular accident
- Transient ischemic attack
- Uncontrolled hypertension
- Unstable angina
- Myocardial infarction
- Grade ≥ 2 peripheral neuropathy as defined by NCI CTCAE v5.0 criteria
- Uncontrolled tumor-related pain. Patients requiring pain medication must be on a stable regimen at study entry
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage procedures
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis.
- Women pregnant or breastfeeding. Fertile and sexually active patients who are not willing to use the appropriate highly effective contraceptive methods.
- Any underlying medical or psychiatric disorder, which, in the opinion of the investigator, makes the administration of atezolizumab or tiragolumab unsafe or interferes with the informed consent process or trial...
The study team makes the final eligibility decision.
Where it's taking place
- Palma de Mallorca, Balearic Islands, Spain
- L'Hospitalet de Llobregat, Barcelona, Spain
- Lleida, Barcelona, Spain
- Martorell, Barcelona, Spain
- Sabadell, Barcelona, Spain
- Toledo, Castille-La Mancha, Spain
- Majadahonda, Madrid, Spain
- Barcelona, Spain
- Ciudad Real, Spain
- León, Spain
- Madrid, Spain
- Valencia, Spain
- Zaragoza, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palma de Mallorca, Balearic Islands, Spain; L'Hospitalet de Llobregat, Barcelona, Spain; Lleida, Barcelona, Spain; Martorell, Barcelona, Spain; Sabadell, Barcelona, Spain; Toledo, Castille-La Mancha, Spain and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.