Squamous Cell CarcinomaPhase 2NCT03714828
Study of TVEC in Patients With Cutaneous Squamous Cell Cancer
A Phase 2 study testing Injection of TVEC into target lesions - week 1-2, Injection of TVEC into target lesions 3wks after 1st injection and Injection of TVEC into target lesions 2wks after 2nd injection in people with Squamous Cell Carcinoma and Skin Cancer, run by University of Arizona at 2 sites in United States.
Trial summary
This is single arm Phase 2, single center study of talimogene laherparepvec (TVEC) to treat low risk cutaneous squamous cell carcinomas (cSCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma, Skin Cancer, Keratoacanthoma
- What is being tested?
- Injection of TVEC into target lesions - week 1-2, Injection of TVEC into target lesions 3wks after 1st injection and Injection of TVEC into target lesions 2wks after 2nd injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Dec 2018to 19 Jul 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Able to give informed consent in English or Spanish
- Age > 18
- Have at least one >0.5 cm to <5.0 cm, histologically confirmed low risk cutaneous SCC (including kerathoacanthomas)
- Size >0.5 cm on trunk or extremities (excluding face, neck feet, nail units, and ankles)
- Clinically consistent with primary tumors.
- Lesion considered unresectable (as defined in Section 1.2)
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- Recurrent lesions will be considered eligible if additional inclusion criteria are met.
- No immunosuppression
- Not a site of previous radiation therapy or chronic significant inflammation
- Fast growing lesions (doubling in size over a 4 week period of time) will be included if they are clinically suggestive of cSCC of the keratoacanthoma type.
- Well or moderately differentiated tumor as confirmed by skin biopsy
- Depth less than 2 mm (for non KA type cSCC )
- No perineural or vascular involvement in preliminary biopsy.
- Partial biopsy of squamous cell skin cancer identified as a target lesion(s) to determine the histological differentiation of the tumor or other adverse histological features
- In patients with multiple lesions, up to 3 lesions in a similar anatomical site, (trunk, limbs etc) that is at least 10 cm apart can be selected.
- Maximum of 5 lesions per patient can be selected for treatment
- Adequate organ function determined within 28 days prior to enrollment, defined as follows:
- Hematology:
- Absolute neutrophil count ≥ 1500/mm3 (1.5x109/L)
- Platelet count ≥ 75,000/mm3 (7.5x109/L)
- Hemoglobin ≥ 8 g/dL (without need for hematopoietic growth factor or transfusion support)
- Renal
- Serum creatinine ≤ 1.5 x upper limit of normal (ULN), OR 24-hour creatinine clearance ≥ 60 mL/min for subject with creatinine levels > 1.5 x ULN. (Note: Creatinine clearance need not be determined if the baseline serum creatinine is within normal limits. Creatinine clearance should be determined per institutional standard)
- Hepatic
- Serum bilirubin ≤ 1.5 x ULN
- Aspartate aminotransferase (AST) ≤ 2.5 x ULN 23 | Page Version 6-26-2018
- Alanine aminotransferase (ALT) ≤ 2.5 x ULN
- Coagulation
- International normalization ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN, unless the subject is receiving anticoagulant therapy, in which case PT and partial thromboplastin time (PTT)/ activated PTT (aPTT) must be within therapeutic range of intended use of anticoagulants.
- PTT or aPTT ≤ 1.5 x ULN unless the subject is receiving anticoagulant therapy as long as PT and PTT/aPTT is within therapeutic range of intended use of anticoagulants.
- Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to enrollment. If urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Who cannot join
- Any patient with diagnosis of invasive cancer in the last 3 years with the exception of stage I and II melanoma, cutaneous BCC and SCCs will be excluded.
- Subjects on acitretin, capecitabine, topical chemotherapies or treatments.
- History or evidence of symptomatic autoimmune disease (eg, pneumonitis, glomerulonephritis, vasculitis, or other), or history of active autoimmune disease that has required systemic treatment (ie, use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) in past 2 months prior to enrollment. Replacement therapy (eg, thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment for autoimmune disease.
- Evidence of clinically significant immunosuppression such as the following:
- Primary immunodeficiency state such as Severe Combined Immuno deficiency Disease
- Acquired immunodeficiency syndrome
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- Concurrent opportunistic infection
- Receiving systemic immunosuppressive therapy (> 2 weeks) including oral steroid doses > 10 mg/day of prednisone or equivalent within 2 months prior to enrollment.
- Active herpetic skin lesions or prior complications of herpetic infection (e.g., herpetic keratitis or encephalitis).
- Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (e.g., acyclovir), other than intermittent topical use.
- Previous treatment with talimogene laherparepvec or any other oncolytic virus
- Prior therapy with tumor vaccine
- Received live vaccine within 28 days prior to enrollment. 24 | Page Version 6-26-2018
- Currently receiving treatment with another investigational device or drug study, or < 28 days since ending treatment with another investigational device or drug study(s)
- Other investigational procedures while participating in this study are excluded.
- Known to have acute or chronic active hepatitis B infection
- Known to have acute or chronic active hepatitis C infection
- History of other malignancy within the past 3 years with the following exceptions:
- adequately treated mucosa associated lymphoid tissue (MALT) tumor
- malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment and felt to be at low risk for recurrence by the treating physician
- adequately treated non-melanoma skin cancer, lentigo maligna, stage I or II cutaneous melanoma, without evidence of disease.
- adequately treated cervical carcinoma in situ without evidence of disease
- adequately treated breast ductal carcinoma in situ without evidence of disease
- prostatic intraepithelial neoplasia without evidence of prostate cancer
- adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ
- Subject has known sensitivity to talimogene laherparepvec or any of its components to be administered during dosing.
- Female subject is pregnant or breast-feeding, or planning to become pregnant during study treatment and through 3 months after the last dose of talimogene laherparepvec
- Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 3 months after the last dose of talimogene laherparepvec. (Note: Women not of childbearing potential are defined as: Any female who is post-menopausal [age > 55 years with cessation of menses for 12 or more months or less than 55 years but not spontaneous menses for at least 2 years or less than 55 years and spontaneous menses within the past 1 year, but currently amenorrheic (eg, spontaneous or secondary to hysterectomy), and with postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating hormone levels > 40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved] or who have had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy). 25 | Page Version 6-26-2018
- Sexually active subjects and their partners unwilling to use male latex condom to avoid potential viral transmission during sexual contact while on treatment and within 30 days after treatment with talimogene laherparepvec.
- Subject who is unwilling to minimize exposure with his/her blood or other body fluids to individuals who are at higher risks for HSV-1 induced complications such as immunosuppressed individuals, individuals known to have HIV infection, pregnant women, or children under the age of 1 year, during talimogene laherparepvec treatment and through 30 days after the last dose of talimogene laherparepvec.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Honor Health Research Institute
Scottsdale, Arizona, 85258
University of Arizona Cancer Center
Tucson, Arizona, 85724
About this study
Official title: A Single Arm Phase 2 Study of Talimogene Laherparepvec in Patients With Cutaneous Squamous Cell Cancer
This is single arm Phase 2, single center study of talimogene laherparepvec (TVEC) to treat low risk cutaneous squamous cell carcinomas (cSCC).
Read the detailed description
The purpose of this study is to assess the effect of Talimogene laherparepvec (TVEC) in patients diagnosed with lower risk cSCC in need of alternative therapeutic approaches.
Immune recognition and cytotoxic responses play an important role in the pathogenesis and progression of cutaneous squamous cell carcinoma (cSCC). TVEC is an HSV-1 oncolytic immunological agent FDA approved for the local treatment of unresectable recurrent melanoma. It is proposed that T-VEC directly destroys cancer cells and induces production of GM-CSF to enhance systemic antitumor immune priming. This proposed mechanism of action supports the novel approach to implement TVEC in the management of cSCC. Particularly, in patients with increased burden of primary tumors.
The study subjects enrolled in the study were Immunocompetent, > 18 years of age, and diagnosed with at least one histologically confirmed primary low-risk cSCC according to the Brigham and Women staging system. Unresectable lesions or patients unable/unwilling to undergo standard of care treatment were eligible to participate. Study lesions included target lesions injected (TLIs) and target non-injected lesions (TNILs). TNILs were selected to evaluate for abscopal effect when feasible. The TLIs were treated according to TVEC FDA approved protocol and followed for 1yr after the 1st injection. The primary endpoint of the study was to evaluate the overall response rate, defined as the proportion of subjects who achieved complete response and partial response in the TLIs. Safety and adverse effect profile (AEs), duration of response, time to response, durable response rate, and time to progression, were the some of the secondary endpoints included.
- Conditions
- Squamous Cell Carcinoma, Skin Cancer, Keratoacanthoma, Cutaneous Tumor, Skin Cancer, Squamous Cell, Lesion Skin
- Being tested
- Injection of TVEC into target lesions - week 1-2, Injection of TVEC into target lesions 3wks after 1st injection, Injection of TVEC into target lesions 2wks after 2nd injection, Injection of TVEC into target lesions 2wks after 3rd injection
- Keywords
- Skin cancer, Squamous cell, Squamous Cell Carcinoma, Skin lesion, Keratoacanthoma, talimogene laherparepvec
- Medical subject headings
- Carcinoma, Squamous Cell, Skin Neoplasms, Keratoacanthoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of TVEC into target lesions - week 1-2Drug
Target lesions are identified and documented with measurements and photographs. Photographs will be taken with regional and close up view of the anatomical area and lesion.
Inject 0.5ml - 4ml (based on lesion size - section 7.1, Table 5) Talimogene laherparepvec at nominal concentration of 106 plaque forming units (PFU)/mL with approximately 1.15 mL in a 2 mL vial for the initial dose. This will be administered intralesionally to 1-3 cSCC lesions per anatomical site with a maximum of 5 injectable lesions per patient.
Injection of TVEC into target lesions 3wks after 1st injectionDrug
Target lesions are identified and documented with measurements and photographs. Photographs will be taken with global and close up view of the anatomical area and lesion.
Inject 0.5ml - 4ml (based on lesion size) and number of lesions selected. Talimogene laherparepvec at nominal concentration of 108 PFU/mL with approximately 1.15 mL in a 2 mL vial for the second and subsequent doses.
Injection of TVEC into target lesions 2wks after 2nd injectionDrug
Target lesions are identified and documented with measurements and photographs. Photographs will be taken with global and close up view of the anatomical area and lesion.
Inject 0.5ml - 4ml (based on lesion size) and number of lesions selected.Talimogene laherparepvec at nominal concentration of 108 PFU/mL with approximately 1.15 mL in a 2 mL vial for the subsequent doses.
Injection of TVEC into target lesions 2wks after 3rd injectionDrug
Target lesions are identified and documented with measurements and photographs. Photographs will be taken with global and close up view of the anatomical area and lesion.
Inject 0.5ml - 4ml (based on lesion size) and number of lesions selected. Talimogene laherparepvec at nominal concentration of 108 PFU/mL with approximately 1.15 mL in a 2 mL vial for the subsequent doses.
| Study group | Role | What they receive |
|---|---|---|
| Treatment (talimogene laherparepvec) | Experimental | The subject participation period will be approximately 48 weeks. This will include a screening visit, 4 injection visits and 5 follow up visits. Total length of study/patient is 8.5 to 10.5 months. TVEC will be administered by injection with a needle directly into one or more tumors. Receives: Drug: Injection of TVEC into target lesions - week 1-2; Drug: Injection of TVEC into target lesions 3wks after 1st injection; Drug: Injection of TVEC into target lesions 2wks after 2nd injection; Drug: Injection of TVEC into target lesions 2wks after 3rd injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
The primary end point is to evaluate the overall response rate (ORR) defined as proportion of subjects who achieved complete response (CR) and partial response (PR) in the cSCC Target injected lesions (TILs).
Measured: 8.5-10.5 months
Secondary outcomes (9)
Number of Participants With Events Requiring the Discontinuation of Study Drug
- Number of participants with events requiring the discontinuation of study drug
- 75% or greater number of Target injection lesions (TILs) meeting criteria for withdrawal.
- Identification of high-risk features in one or more TILs during study participation.
- Persistent discomfort (consecutive weeks of lesion pain, burning, or itching of Grade 2 or more).
Measured: 8.5-10.5 months
Time of Response.
To measure time of response in cSCC individual TILs.
Measured: 8.5-10.5 months
Duration of Overall Response.
To measure the duration of overall response (DOR) of individual TILs.
Measured: 8.5-10.5 months
Assess Durable Response.
Assess durable response rate (DRR) of TILs. DRR was assessed when the time of CR or PR with response lasting continuously for at least 6 months.
Measured: 8.5-10.5 months
Time to Progression.
To measure the time to progression (TTP) of individual TILs.
Measured: 8.5-10.5 months
Overall Response Rate by Ultrasound.
Overall response rate (ORR) (CR+PR) assessed by imaging technique (high frequency ultrasound). The subjects received ultrasound assessments of their TILs at baseline/screening visit (0), and at visit 6 (first follow up visit, approximately 4-5 months from baseline).The tumor volume change was assessed between the 2 visits, and percent of subjects with tumor volume reduction was reported.
Measured: Baseline and 4-5 months
Overall Clinical Response Rate - Targeted Lesions.
Overall clinical response rate (CR+PR) of individual TILs with talimogene laherparepvec (not as overall subject response).
Measured: 8.5-10.5 months
Percentage of Participants With Overall Clinical Response Rate - Non-injected Lesion(s).
Percentage of Participants with overall clinical response rate (CR+PR) in cSCC Target non-injected lesion(s) (TNILs).
Measured: 8.5-10.5 months
Number of Safety Adverse Events (SAE) as Assessed According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) 4.0
- Number of safety adverse events (SAE) as assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) 4.0
- Clinically significant laboratory values i. Clinically significant laboratory values are based on participant condition and side effect. These will vary and will be determined by the clinical judgement of the research healthcare provider. Note: laboratory values will be collected for initial participant screening and side effects only, no other clinical laboratory values are scheduled in this protocol.
Measured: 8.5-10.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start20 Dec 2018
- Primary completion19 Jul 2023
- Study completion19 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor
- Investigators
- Clara Curiel, MD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714828
- Sponsor's protocol ID
- 1807738975
- Other IDs
- 29088
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2018
- Last updated
- 9 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Phase 2 Study of Talimogene Laherparepvec in Patients With Cutaneous Squamous Cell Cancer
- ClinicalTrials.gov ID
- NCT03714828
- Acronym / sponsor ID
- 1807738975
- Conditions
- Squamous Cell Carcinoma, Skin Cancer, Keratoacanthoma, Cutaneous Tumor, Skin Cancer, Squamous Cell, Lesion Skin
- Keywords
- Skin cancer, Squamous cell, Squamous Cell Carcinoma, Skin lesion, Keratoacanthoma, talimogene laherparepvec
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 19 Jul 2023 (actual)
- First posted
- 22 Oct 2018 (actual)
- Results
- Posted 9 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is single arm Phase 2, single center study of talimogene laherparepvec (TVEC) to treat low risk cutaneous squamous cell carcinomas (cSCC).
Detailed description
The purpose of this study is to assess the effect of Talimogene laherparepvec (TVEC) in patients diagnosed with lower risk cSCC in need of alternative therapeutic approaches.
Immune recognition and cytotoxic responses play an important role in the pathogenesis and progression of cutaneous squamous cell carcinoma (cSCC). TVEC is an HSV-1 oncolytic immunological agent FDA approved for the local treatment of unresectable recurrent melanoma. It is proposed that T-VEC directly destroys cancer cells and induces production of GM-CSF to enhance systemic antitumor immune priming. This proposed mechanism of action supports the novel approach to implement TVEC in the management of cSCC. Particularly, in patients with increased burden of primary tumors.
The study subjects enrolled in the study were Immunocompetent, > 18 years of age, and diagnosed with at least one histologically confirmed primary low-risk cSCC according to the Brigham and Women staging system. Unresectable lesions or patients unable/unwilling to undergo standard of care treatment were eligible to participate. Study lesions included target lesions injected (TLIs) and target non-injected lesions (TNILs). TNILs were selected to evaluate for abscopal effect when feasible. The TLIs were treated according to TVEC FDA approved protocol and followed for 1yr after the 1st injection. The primary endpoint of the study was to evaluate the overall response rate, defined as the proportion of subjects who achieved complete response and partial response in the TLIs. Safety and adverse effect profile (AEs), duration of response, time to response, durable response rate, and time to progression, were the some of the secondary endpoints included.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (talimogene laherparepvec) | Experimental | Drug: Injection of TVEC into target lesions - week 1-2, Drug: Injection of TVEC into target lesions 3wks after 1st injection, Drug: Injection of TVEC into target lesions 2wks after 2nd injection, Drug: Injection of TVEC into target lesions 2wks after 3rd injectionThe subject participation period will be approximately 48 weeks. This will include a screening visit, 4 injection visits and 5 follow up visits. Total length of study/patient is 8.5 to 10.5 months. TVEC will be administered by injection with a needle directly into one or more tumors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Able to give informed consent in English or Spanish
- Age > 18
- Have at least one >0.5 cm to <5.0 cm, histologically confirmed low risk cutaneous SCC (including kerathoacanthomas)
- Partial biopsy of squamous cell skin cancer identified as a target lesion(s) to determine the histological differentiation of the tumor or other adverse histological features
- In patients with multiple lesions, up to 3 lesions in a similar anatomical site, (trunk, limbs etc) that is at least 10 cm apart can be selected.
Key exclusion criteria (30 listed)
- Any patient with diagnosis of invasive cancer in the last 3 years with the exception of stage I and II melanoma, cutaneous BCC and SCCs will be excluded.
- Subjects on acitretin, capecitabine, topical chemotherapies or treatments.
- History or evidence of symptomatic autoimmune disease (eg, pneumonitis, glomerulonephritis, vasculitis, or other), or history of active autoimmune disease that has required systemic treatment (ie, use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) in past 2 months prior to enrollment. Replacement therapy (eg, thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment for autoimmune disease.
- Evidence of clinically significant immunosuppression such as the following:
- Active herpetic skin lesions or prior complications of herpetic infection (e.g., herpetic keratitis or encephalitis).
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 |
|---|---|---|
| Injection of TVEC into target lesions - week 1-2Target lesions are identified and documented with measurements and photographs. Photographs will be taken with regional and close up view of the anatomical area and lesion. Inject 0.5ml - 4ml (based on lesion size - section 7.1, Table 5) Talimogene laherparepvec at nominal concentration of 106 plaque forming units (PFU)/mL with approximately 1.15 mL in a 2 mL vial for the initial dose. This will be administered intralesionally to 1-3 cSCC lesions per anatomical site with a maximum of 5 injectable lesions per patient. | Drug | Treatment (talimogene laherparepvec) |
| Injection of TVEC into target lesions 3wks after 1st injectionTarget lesions are identified and documented with measurements and photographs. Photographs will be taken with global and close up view of the anatomical area and lesion. Inject 0.5ml - 4ml (based on lesion size) and number of lesions selected. Talimogene laherparepvec at nominal concentration of 108 PFU/mL with approximately 1.15 mL in a 2 mL vial for the second and subsequent doses. | Drug | Treatment (talimogene laherparepvec) |
| Injection of TVEC into target lesions 2wks after 2nd injectionTarget lesions are identified and documented with measurements and photographs. Photographs will be taken with global and close up view of the anatomical area and lesion. Inject 0.5ml - 4ml (based on lesion size) and number of lesions selected.Talimogene laherparepvec at nominal concentration of 108 PFU/mL with approximately 1.15 mL in a 2 mL vial for the subsequent doses. | Drug | Treatment (talimogene laherparepvec) |
| Injection of TVEC into target lesions 2wks after 3rd injectionTarget lesions are identified and documented with measurements and photographs. Photographs will be taken with global and close up view of the anatomical area and lesion. Inject 0.5ml - 4ml (based on lesion size) and number of lesions selected. Talimogene laherparepvec at nominal concentration of 108 PFU/mL with approximately 1.15 mL in a 2 mL vial for the subsequent doses. | Drug | Treatment (talimogene laherparepvec) |
Primary outcome
Overall Response Rate
Time frame: 8.5-10.5 months
The primary end point is to evaluate the overall response rate (ORR) defined as proportion of subjects who achieved complete response (CR) and partial response (PR) in the cSCC Target injected lesions (TILs).
9 secondary outcomes
Number of Participants With Events Requiring the Discontinuation of Study Drug
Time frame: 8.5-10.5 months
Time of Response.
Time frame: 8.5-10.5 months
Duration of Overall Response.
Time frame: 8.5-10.5 months
Assess Durable Response.
Time frame: 8.5-10.5 months
Time to Progression.
Time frame: 8.5-10.5 months
Overall Response Rate by Ultrasound.
Time frame: Baseline and 4-5 months
Overall Clinical Response Rate - Targeted Lesions.
Time frame: 8.5-10.5 months
Percentage of Participants With Overall Clinical Response Rate - Non-injected Lesion(s).
Time frame: 8.5-10.5 months
Number of Safety Adverse Events (SAE) as Assessed According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) 4.0
Time frame: 8.5-10.5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clara Curiel, MD principal investigator
University of Arizona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Injection of TVEC into target lesions - week 1-2, Injection of TVEC into target lesions 3wks after 1st injection and Injection of TVEC into target lesions 2wks after 2nd injection in people with Squamous Cell Carcinoma and Skin Cancer, run by University of Arizona at 2 sites in United States.
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 31 inclusion and 30 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: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 9 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Response Rate (time frame: 8.5-10.5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2024.