Carcinoma, Basal CellPhase 2virgilioNCT02956889
To Assess The Efficacy And Safety Of Vismodegib And Radiotherapy In Advanced Basal Cell Carcinoma
A Phase 2 study testing Vismodegib and Radiotherapy in people with Carcinoma, Basal Cell, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
This is a Fleming-A' Hern, single arm, multicenter, no-profit, phase II study of radiotherapy and Vismodegib in adult patients with high risk or locally advanced basal cell carcinoma not amenable to radical surgery cell carcinoma (BCC) (comparator: not applicable). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Basal Cell
- What is being tested?
- Vismodegib and Radiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2016to Jan 2020
- 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
- Written, signed informed consent
- Age ≥ 18 years
- Histopathologic confirmation that the lesion is BCC before enrollment
- Patients with high risk of relapse BCC not undergone radical surgery, for which treating physician must consider the disease to be no more operable.
- Clinical features defining high risk of relapse include infiltrative growth margins, size, tumor location, histological subtype (the morpheaform, the sclerosing, the infiltrating, the micronodular and the metatypical subtypes are associated with higher risk of relapse as compared to the risk associated with the superficial and the nodular types), recurrent-refractory tumors (see Table 1), basal cell carcinoma size (largest tumor diameter) ≤ 5 cm for head and neck tumors
- Clinical features for definition of "BCC not amenable for radical surgery" include:
Show all 24Show fewer
- BCC that has recurred in the same location after minimum 2 surgical procedures (excluding biopsies) and/or curative resection is deemed unlikely
- multifocal BCC or extensive tumors (see table 1) with bleeding or infected areas
- anticipated substantial morbidity and/or deformity from surgery (e.g., removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation)
- Patients with BCCs localized where surgery is technically difficult, or would result in unacceptable tissue destruction
- Patients with a clinical contraindication to surgery
- Previous radiotherapy on other BCC
- Patients with measurable and/or non-measurable disease (as defined by RECIST, v1.1) are allowed
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Adequate hematopoietic capacity, defined as the following:
- Hemoglobin : 8.5 g/dl
- Absolute neutrophil count (ANC) ≥ 1500/mL
- Platelet count ≥ 75,000/mL
- Adequate hepatic function, defined as the following:
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN)Total bilirubin ≤ 1.5 × ULN or within 3 × ULN for patients with documented Gilbert syndrome. Adequate renal function, defined by calculated serum creatinine clearance (CrCl) ≥ 30 mL/min
- For women of childbearing potential, a negative serum pregnancy test within 7days prior to commencement of dosing is required.
- Women of child-bearing potential must use two methods of acceptable contraception including one highly effective method and a barrier method, as directed by their physician, during treatment and for at least 24 months after completion of study treatment. Highly effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (e.g., implants, injectables, combined oral contraception, or intra-uterine devices). At the discretion of the Investigator, acceptable methods of contraception may include total abstinence. Periodic abstinence (e.g., calendar, ovulation, symptothermal, and post ovulation methods) and withdrawal are not acceptable methods of contraception (See Appendix B).
- For male patients with female partners of childbearing potential, agreement to use a condom, even after a vasectomy, during sexual intercourse with female partners while being treated with Vismodegib, and for 2 months after completion of study treatment
- Agreement not to donate blood or blood products during the study and for at least 24 months after completion of study treatment (Vismodegib).
Who cannot join
- Inability or unwillingness to swallow capsules
- Inability or unwillingness to comply with study procedures
- Pregnancy or lactation (lactation not allowed for at least 24 months after completion of study treatment)
- Concurrent non-protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy, photodynamic therapy, including participation in an experimental drug study)
- Metastatic BCC
- Gorlin Syndrome or any other contraindication to radiotherapy
Show all 9Show fewer
- Recent (i.e., within the past 28 days prior to enrollment in this study) or current participation in another experimental drug study
- Uncontrolled medical illness, including advanced malignancies, at the discretion of the Investigator
- History of other disease, 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 might affect interpretation of the results of the study or renders the patient at high risk for treatment complications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Arm, Phase II, Multicenter Study To Assess The Efficacy And Safety Of Vismodegib And Radiotherapy In Patients With High Risk Or Locally Advanced Basal Cell Carcinoma Not Amenable To Radical Surgery
This is a Fleming-A' Hern, single arm, multicenter, no-profit, phase II study of radiotherapy and Vismodegib in adult patients with high risk or locally advanced basal cell carcinoma not amenable to radical surgery cell carcinoma (BCC) (comparator: not applicable).
The recruitment period is expected to be approximately 24 months. The trial will consist of a Screening/Baseline period (Day -28 to -1), a Treatment Period when patients will be treated with radiotherapy (4 weeks) followed by Vismodegib 150 mg/die continuously for six cycles (24 weeks).
The study will end 14 months after start of treatment of the last patient enrolled and evaluable according to primary end point.
Read the detailed description
This is a Fleming-A' Hern, single arm, multicenter, no-profit, phase II study of radiotherapy and Vismodegib in adult patients with high risk or locally advanced basal cell carcinoma not amenable to radical surgery cell carcinoma (BCC) (comparator: not applicable).
The recruitment period is expected to be approximately 24 months. The trial will consist of a Screening/Baseline period (Day -28 to -1), a Treatment Period when patients will be treated with radiotherapy (4 weeks) followed by Vismodegib 150 mg/die continuously for six cycles (24 weeks).
The study will end 14 months after start of treatment of the last patient enrolled and evaluable according to primary end point.
The primary objective is to evaluate the activity of the study therapy (radiotherapy followed by six cycles of Vismodegib 150 mg/d continuously) in terms of proportion of patients progression free at 12 months.
The secondary objectives are: to evaluate the efficacy of the study therapy in terms of progression free survival (PFS) and overall survival (OS); to assess the response in terms of overall response rate (ORR) (complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)); to assess duration of response (DoR); to assess the safety in terms of incidence, type, and severity of adverse events (AEs) and serious adverse events (SAEs) ;to measure the effects of skin disease on quality of life (QoL) of patients under therapy (Skindex-16)
- Conditions
- Carcinoma, Basal Cell
- Being tested
- Vismodegib, Radiotherapy
- Keywords
- Carcinoma, Basal Cell, Vismodegib, Radiotherapy
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VismodegibDrug
Also called Erivedge
Patients will receive a continuous once-daily oral dosing of Vismodegib at a dosage of 150 mg .
RadiotherapyRadiation
Radiotherapy (RT) will be administered with a total dose of 50 Gy/2.5 Gy per fraction over 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Vismodegib & Radiotherapy | Experimental | Radiotherapy (RT) will be administered with a total dose of 50 Gy/2.5 Gy per fraction over 4 weeks.
Treatment with Vismodegib will start within 4 weeks by the end of radiotherapy and will continue for 6 cycles Receives: Drug: Vismodegib; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the activity of the study therapy in terms of proportion of patients progression free
The primary objective is to evaluate the activity of the study therapy (radiotherapy followed by six cycles of Vismodegib 150 mg/d continuously) in terms of proportion of patients progression free at 12 months.
Measured: 1 years
Secondary outcomes (6)
evaluate the efficacy of the study therapy in terms of progression free survival
The secondary objectives are: to evaluate the efficacy of the study therapy in terms of progression free survival (PFS)
Measured: 2 years
evaluate the efficacy of the study therapy in terms overall survival
The secondary objectives are: to evaluate the efficacy of the study therapy in terms of overall survival (OS);
Measured: 2 years
response in terms of overall response rate (ORR)
to assess the response in terms of ORR (complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD))
Measured: 2 years
duration of response
to assess duration of response (DoR);
Measured: 2 years
assess the safety in terms of incidence, type, and severity of adverse events (AEs) and serious adverse events (SAEs)
to assess the safety in terms of incidence, type, and severity of AEs and SAEs
Measured: 2 years
measure the effects of skin disease on quality of life (QoL) of patients
to measure the effects of skin disease on quality of life (QoL) of patients under therapy (Skindex-16)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionFeb 2019
- Study completionJan 2020
Why it stopped: low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Basal CellStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Armando Santoro, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956889
- Sponsor's protocol ID
- ONC-2015-001
- Acronym
- virgilio
- Status last verified
- Jan 2020
- First submitted
- 20 Jul 2016
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: not planned
Publications
Diffey BL, Langtry JA. Skin cancer incidence and the ageing population. Br J Dermatol. 2005 Sep;153(3):679-80. doi: 10.1111/j.1365-2133.2005.06799.x. No abstract available.
PubMed 16120172Gailani MR, Stahle-Backdahl M, Leffell DJ, Glynn M, Zaphiropoulos PG, Pressman C, Unden AB, Dean M, Brash DE, Bale AE, Toftgard R. The role of the human homologue of Drosophila patched in sporadic basal cell carcinomas. Nat Genet. 1996 Sep;14(1):78-81. doi: 10.1038/ng0996-78.
PubMed 8782823Von Hoff DD, LoRusso PM, Rudin CM, Reddy JC, Yauch RL, Tibes R, Weiss GJ, Borad MJ, Hann CL, Brahmer JR, Mackey HM, Lum BL, Darbonne WC, Marsters JC Jr, de Sauvage FJ, Low JA. Inhibition of the hedgehog pathway in advanced basal-cell carcinoma. N Engl J Med. 2009 Sep 17;361(12):1164-72. doi: 10.1056/NEJMoa0905360. Epub 2009 Sep 2.
PubMed 19726763Telfer NR, Colver GB, Morton CA; British Association of Dermatologists. Guidelines for the management of basal cell carcinoma. Br J Dermatol. 2008 Jul;159(1):35-48. doi: 10.1111/j.1365-2133.2008.08666.x.
PubMed 18593385Sekulic A, Migden MR, Oro AE, Dirix L, Lewis KD, Hainsworth JD, Solomon JA, Yoo S, Arron ST, Friedlander PA, Marmur E, Rudin CM, Chang AL, Low JA, Mackey HM, Yauch RL, Graham RA, Reddy JC, Hauschild A. Efficacy and safety of vismodegib in advanced basal-cell carcinoma. N Engl J Med. 2012 Jun 7;366(23):2171-9. doi: 10.1056/NEJMoa1113713.
PubMed 22670903Chang AL, Solomon JA, Hainsworth JD, Goldberg L, McKenna E, Day BM, Chen DM, Weiss GJ. Expanded access study of patients with advanced basal cell carcinoma treated with the Hedgehog pathway inhibitor, vismodegib. J Am Acad Dermatol. 2014 Jan;70(1):60-9. doi: 10.1016/j.jaad.2013.09.012. Epub 2013 Nov 1.
PubMed 24189279Tang JY, Mackay-Wiggan JM, Aszterbaum M, Yauch RL, Lindgren J, Chang K, Coppola C, Chanana AM, Marji J, Bickers DR, Epstein EH Jr. Inhibiting the hedgehog pathway in patients with the basal-cell nevus syndrome. N Engl J Med. 2012 Jun 7;366(23):2180-8. doi: 10.1056/NEJMoa1113538.
PubMed 22670904Strasswimmer JM. Potential Synergy of Radiation Therapy With Vismodegib for Basal Cell Carcinoma. JAMA Dermatol. 2015 Sep;151(9):925-6. doi: 10.1001/jamadermatol.2015.0977. No abstract available.
PubMed 25874820Pollom EL, Bui TT, Chang AL, Colevas AD, Hara WY. Concurrent Vismodegib and Radiotherapy for Recurrent, Advanced Basal Cell Carcinoma. JAMA Dermatol. 2015 Sep;151(9):998-1001. doi: 10.1001/jamadermatol.2015.0326.
PubMed 25874733
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Phase II, Multicenter Study To Assess The Efficacy And Safety Of Vismodegib And Radiotherapy In Patients With High Risk Or Locally Advanced Basal Cell Carcinoma Not Amenable To Radical Surgery
- ClinicalTrials.gov ID
- NCT02956889
- Acronym / sponsor ID
- virgilio / ONC-2015-001
- Conditions
- Carcinoma, Basal Cell
- Keywords
- Carcinoma, Basal Cell, Vismodegib, Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment rate
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Fleming-A' Hern, single arm, multicenter, no-profit, phase II study of radiotherapy and Vismodegib in adult patients with high risk or locally advanced basal cell carcinoma not amenable to radical surgery cell carcinoma (BCC) (comparator: not applicable).
The recruitment period is expected to be approximately 24 months. The trial will consist of a Screening/Baseline period (Day -28 to -1), a Treatment Period when patients will be treated with radiotherapy (4 weeks) followed by Vismodegib 150 mg/die continuously for six cycles (24 weeks).
The study will end 14 months after start of treatment of the last patient enrolled and evaluable according to primary end point.
Detailed description
This is a Fleming-A' Hern, single arm, multicenter, no-profit, phase II study of radiotherapy and Vismodegib in adult patients with high risk or locally advanced basal cell carcinoma not amenable to radical surgery cell carcinoma (BCC) (comparator: not applicable).
The recruitment period is expected to be approximately 24 months. The trial will consist of a Screening/Baseline period (Day -28 to -1), a Treatment Period when patients will be treated with radiotherapy (4 weeks) followed by Vismodegib 150 mg/die continuously for six cycles (24 weeks).
The study will end 14 months after start of treatment of the last patient enrolled and evaluable according to primary end point.
The primary objective is to evaluate the activity of the study therapy (radiotherapy followed by six cycles of Vismodegib 150 mg/d continuously) in terms of proportion of patients progression free at 12 months.
The secondary objectives are: to evaluate the efficacy of the study therapy in terms of progression free survival (PFS) and overall survival (OS); to assess the response in terms of overall response rate (ORR) (complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)); to assess duration of response (DoR); to assess the safety in terms of incidence, type, and severity of adverse events (AEs) and serious adverse events (SAEs) ;to measure the effects of skin disease on quality of life (QoL) of patients under therapy (Skindex-16)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vismodegib & Radiotherapy | Experimental | Drug: Vismodegib, Radiation: RadiotherapyRadiotherapy (RT) will be administered with a total dose of 50 Gy/2.5 Gy per fraction over 4 weeks. Treatment with Vismodegib will start within 4 weeks by the end of radiotherapy and will continue for 6 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Written, signed informed consent
- Age ≥ 18 years
- Histopathologic confirmation that the lesion is BCC before enrollment
- Patients with high risk of relapse BCC not undergone radical surgery, for which treating physician must consider the disease to be no more operable.
- Clinical features defining high risk of relapse include infiltrative growth margins, size, tumor location, histological subtype (the morpheaform, the sclerosing, the infiltrating, the micronodular and the metatypical subtypes are associated with higher risk of relapse as compared to the risk associated with the superficial and the nodular types), recurrent-refractory tumors (see Table 1), basal cell carcinoma size (largest tumor diameter) ≤ 5 cm for head and neck tumors
Key exclusion criteria (9 listed)
- Inability or unwillingness to swallow capsules
- Inability or unwillingness to comply with study procedures
- Pregnancy or lactation (lactation not allowed for at least 24 months after completion of study treatment)
- Concurrent non-protocol-specified anti-tumor therapy (e.g., chemotherapy, other targeted therapy, photodynamic therapy, including participation in an experimental drug study)
- Metastatic BCC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VismodegibAlso: ErivedgePatients will receive a continuous once-daily oral dosing of Vismodegib at a dosage of 150 mg . | Drug | Vismodegib & Radiotherapy |
| RadiotherapyRadiotherapy (RT) will be administered with a total dose of 50 Gy/2.5 Gy per fraction over 4 weeks. | Radiation | Vismodegib & Radiotherapy |
Primary outcome
evaluate the activity of the study therapy in terms of proportion of patients progression free
Time frame: 1 years
The primary objective is to evaluate the activity of the study therapy (radiotherapy followed by six cycles of Vismodegib 150 mg/d continuously) in terms of proportion of patients progression free at 12 months.
6 secondary outcomes
evaluate the efficacy of the study therapy in terms of progression free survival
Time frame: 2 years
evaluate the efficacy of the study therapy in terms overall survival
Time frame: 2 years
response in terms of overall response rate (ORR)
Time frame: 2 years
duration of response
Time frame: 2 years
assess the safety in terms of incidence, type, and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 2 years
measure the effects of skin disease on quality of life (QoL) of patients
Time frame: 2 years
Results and safety
The study was stopped early (reason given: low recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Background: PubMed 16120172Diffey BL, Langtry JA. Skin cancer incidence and the ageing population. Br J Dermatol. 2005 Sep;153(3):679-80. doi: 10.1111/j.1365-2133.2005.06799.x. No abstract available.
- Background: PubMed 8782823Gailani MR, Stahle-Backdahl M, Leffell DJ, Glynn M, Zaphiropoulos PG, Pressman C, Unden AB, Dean M, Brash DE, Bale AE, Toftgard R. The role of the human homologue of Drosophila patched in sporadic basal cell carcinomas. Nat Genet. 1996 Sep;14(1):78-81. doi: 10.1038/ng0996-78.
- Background: PubMed 19726763Von Hoff DD, LoRusso PM, Rudin CM, Reddy JC, Yauch RL, Tibes R, Weiss GJ, Borad MJ, Hann CL, Brahmer JR, Mackey HM, Lum BL, Darbonne WC, Marsters JC Jr, de Sauvage FJ, Low JA. Inhibition of the hedgehog pathway in advanced basal-cell carcinoma. N Engl J Med. 2009 Sep 17;361(12):1164-72. doi: 10.1056/NEJMoa0905360. Epub 2009 Sep 2.
- Background: PubMed 18593385Telfer NR, Colver GB, Morton CA; British Association of Dermatologists. Guidelines for the management of basal cell carcinoma. Br J Dermatol. 2008 Jul;159(1):35-48. doi: 10.1111/j.1365-2133.2008.08666.x.
- Background: PubMed 22670903Sekulic A, Migden MR, Oro AE, Dirix L, Lewis KD, Hainsworth JD, Solomon JA, Yoo S, Arron ST, Friedlander PA, Marmur E, Rudin CM, Chang AL, Low JA, Mackey HM, Yauch RL, Graham RA, Reddy JC, Hauschild A. Efficacy and safety of vismodegib in advanced basal-cell carcinoma. N Engl J Med. 2012 Jun 7;366(23):2171-9. doi: 10.1056/NEJMoa1113713.
- Background: PubMed 24189279Chang AL, Solomon JA, Hainsworth JD, Goldberg L, McKenna E, Day BM, Chen DM, Weiss GJ. Expanded access study of patients with advanced basal cell carcinoma treated with the Hedgehog pathway inhibitor, vismodegib. J Am Acad Dermatol. 2014 Jan;70(1):60-9. doi: 10.1016/j.jaad.2013.09.012. Epub 2013 Nov 1.
- Background: PubMed 22670904Tang JY, Mackay-Wiggan JM, Aszterbaum M, Yauch RL, Lindgren J, Chang K, Coppola C, Chanana AM, Marji J, Bickers DR, Epstein EH Jr. Inhibiting the hedgehog pathway in patients with the basal-cell nevus syndrome. N Engl J Med. 2012 Jun 7;366(23):2180-8. doi: 10.1056/NEJMoa1113538.
- Background: PubMed 25874820Strasswimmer JM. Potential Synergy of Radiation Therapy With Vismodegib for Basal Cell Carcinoma. JAMA Dermatol. 2015 Sep;151(9):925-6. doi: 10.1001/jamadermatol.2015.0977. No abstract available.
- Background: PubMed 25874733Pollom EL, Bui TT, Chang AL, Colevas AD, Hara WY. Concurrent Vismodegib and Radiotherapy for Recurrent, Advanced Basal Cell Carcinoma. JAMA Dermatol. 2015 Sep;151(9):998-1001. doi: 10.1001/jamadermatol.2015.0326.
- Individual participant dataSharing planned: No. not planned
Related trials for Carcinoma, Basal Cell
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (BCC) Patients
Basal Cell Carcinoma (BCC), First Line Treatment
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
A Study Comparing Cemiplimab-based Treatments for Adult Participants With Locally Advanced Basal Cell Skin Cancer (laBCC)
Locally Advanced Basal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armando Santoro, MD principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vismodegib and Radiotherapy in people with Carcinoma, Basal Cell, run by Istituto Clinico Humanitas at 1 site in Italy.
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 24 inclusion and 9 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: stopped early, as of the sponsor's last update on 29 Jan 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 Italy. 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?
The study was stopped early (reason given: low recruitment rate). 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?
evaluate the activity of the study therapy in terms of proportion of patients progression free (time frame: 1 years). 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 NCT02956889, which also lists 9 linked publications.
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 29 Jan 2020.