Trial Outcomes & Findings for Study of TVEC in Patients With Cutaneous Squamous Cell Cancer (NCT NCT03714828)

Last Updated: 2024-10-09

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

8.5-10.5 months

Results posted on

2024-10-09

Participant Flow

Unit of analysis: Target Injected Lesions

Participant milestones

Participant milestones
Measure	Treatment (Talimogene Laherparepvec) The subject participation period was approximately 48 weeks. This included a screening visit, 4 injection visits and 5 follow up visits. Total length of study/patient was 8.5 to 10.5 months. TVEC was administered by injection with a needle directly into one or more tumors.
Overall Study STARTED	11 24
Overall Study COMPLETED	11 24
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of TVEC in Patients With Cutaneous Squamous Cell Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Talimogene Laherparepvec) n=24 Target Injected Lesions The subject participation period was approximately 48 weeks. This included a screening visit, 4 injection visits and 5 follow up visits. Total length of study/patient was 8.5 to 10.5 months. TVEC was administered by injection with a needle directly into one or more tumors.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Age, Continuous	75.7 Years STANDARD_DEVIATION 6.4 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants
Number of TILs per participant 1 TIL	4 Participants n=5 Participants
Number of TILs per participant 2 TILs	4 Participants n=5 Participants
Number of TILs per participant 4 TILs	3 Participants n=5 Participants
Tumor subtype of TILs Keratoacanthoma	3 Target Injected Lesions n=24 Target Injected Lesions
Tumor subtype of TILs Non-keratoacanthoma	21 Target Injected Lesions n=24 Target Injected Lesions

PRIMARY outcome

Timeframe: 8.5-10.5 months

Population: All participants who received at least one dose of treatment.

Outcome measures

Outcome measures
Measure	Treatment (Talimogene Laherparepvec) n=11 Participants The subject participation period was approximately 48 weeks. This included a screening visit, 4 injection visits and 5 follow up visits. Total length of study/patient was 8.5 to 10.5 months. TVEC was administered by injection with a needle directly into one or more tumors.
Overall Response Rate Partial Response (PR)	1 Participants
Overall Response Rate Overall Response Rate (ORR)	11 Participants
Overall Response Rate Complete Response (CR)	10 Participants

SECONDARY outcome

Timeframe: 8.5-10.5 months

1\. Number of participants with events requiring the discontinuation of study drug 1. 75% or greater number of Target injection lesions (TILs) meeting criteria for withdrawal. 2. Identification of high-risk features in one or more TILs during study participation. 3. Persistent discomfort (consecutive weeks of lesion pain, burning, or itching of Grade 2 or more).

Outcome measures

Outcome measures
Measure	Treatment (Talimogene Laherparepvec) n=11 Participants The subject participation period was approximately 48 weeks. This included a screening visit, 4 injection visits and 5 follow up visits. Total length of study/patient was 8.5 to 10.5 months. TVEC was administered by injection with a needle directly into one or more tumors.
Number of Participants With Events Requiring the Discontinuation of Study Drug TILs meeting criteria for withdrawal	0 Participants
Number of Participants With Events Requiring the Discontinuation of Study Drug Identification of high-risk features	0 Participants
Number of Participants With Events Requiring the Discontinuation of Study Drug Persistent discomfort	0 Participants

SECONDARY outcome

Timeframe: 8.5-10.5 months

Population: All TILs across 11 patients enrolled on the trial that received at least one dose of treatment (24 TILs total).

To measure time of response in cSCC individual TILs.

Outcome measures

Outcome measures
Measure	Treatment (Talimogene Laherparepvec) n=24 Target Injected Lesions The subject participation period was approximately 48 weeks. This included a screening visit, 4 injection visits and 5 follow up visits. Total length of study/patient was 8.5 to 10.5 months. TVEC was administered by injection with a needle directly into one or more tumors.
Time of Response.	48.7 Days Standard Deviation 29.2

SECONDARY outcome

Timeframe: 8.5-10.5 months

Population: All TILs across 11 patients enrolled on the trial that received at least one dose of treatment (24 TILs total).

To measure the duration of overall response (DOR) of individual TILs.

Outcome measures

Outcome measures
Measure	Treatment (Talimogene Laherparepvec) n=24 Target Injected Lesions The subject participation period was approximately 48 weeks. This included a screening visit, 4 injection visits and 5 follow up visits. Total length of study/patient was 8.5 to 10.5 months. TVEC was administered by injection with a needle directly into one or more tumors.
Duration of Overall Response.	201.4 Days Standard Deviation 29.6

SECONDARY outcome

Timeframe: 8.5-10.5 months

Population: All TILs across 11 patients enrolled on the trial that received at least one dose of treatment (24 TILs total).

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.

Outcome measures

Outcome measures
Measure	Treatment (Talimogene Laherparepvec) n=24 Target Injected Lesions The subject participation period was approximately 48 weeks. This included a screening visit, 4 injection visits and 5 follow up visits. Total length of study/patient was 8.5 to 10.5 months. TVEC was administered by injection with a needle directly into one or more tumors.
Assess Durable Response.	83.3 Percentage of individual TILs with DRR

SECONDARY outcome

Timeframe: 8.5-10.5 months

Population: All TILs across 11 patients enrolled on the trial that received at least one dose of treatment (24 TILs total).

To measure the time to progression (TTP) of individual TILs.

Outcome measures

Outcome measures
Measure	Treatment (Talimogene Laherparepvec) n=24 Target Injected Lesions The subject participation period was approximately 48 weeks. This included a screening visit, 4 injection visits and 5 follow up visits. Total length of study/patient was 8.5 to 10.5 months. TVEC was administered by injection with a needle directly into one or more tumors.
Time to Progression.	NA Days No TILs progressed.

SECONDARY outcome

Timeframe: Baseline and 4-5 months

Population: The barriers for collecting this data in clinic was both due to the COVID-19 pandemic and limited staffing at the lead institution's imaging department.

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.

Outcome measures

Outcome measures
Measure	Treatment (Talimogene Laherparepvec) n=5 Participants The subject participation period was approximately 48 weeks. This included a screening visit, 4 injection visits and 5 follow up visits. Total length of study/patient was 8.5 to 10.5 months. TVEC was administered by injection with a needle directly into one or more tumors.
Overall Response Rate by Ultrasound.	60 Percentage of participants

SECONDARY outcome

Timeframe: 8.5-10.5 months

Population: All TILs across 11 patients enrolled on the trial that received at least one dose of treatment (24 TILs total).

Overall clinical response rate (CR+PR) of individual TILs with talimogene laherparepvec (not as overall subject response).

Outcome measures

Outcome measures
Measure	Treatment (Talimogene Laherparepvec) n=24 Target Injected Lesions The subject participation period was approximately 48 weeks. This included a screening visit, 4 injection visits and 5 follow up visits. Total length of study/patient was 8.5 to 10.5 months. TVEC was administered by injection with a needle directly into one or more tumors.
Overall Clinical Response Rate - Targeted Lesions. ORR of individual TILs	24 Count of TILs
Overall Clinical Response Rate - Targeted Lesions. PR of individual TILs	1 Count of TILs
Overall Clinical Response Rate - Targeted Lesions. CR of individual TILs	23 Count of TILs

SECONDARY outcome

Timeframe: 8.5-10.5 months

Population: Target, non-injected lesions of participants who received at least one dose of treatment in a TIL. Only 2 participants had non-injected lesions and received at least one dose of treatment in a TIL.

Percentage of Participants with overall clinical response rate (CR+PR) in cSCC Target non-injected lesion(s) (TNILs).

Outcome measures

Outcome measures
Measure	Treatment (Talimogene Laherparepvec) n=2 Participants The subject participation period was approximately 48 weeks. This included a screening visit, 4 injection visits and 5 follow up visits. Total length of study/patient was 8.5 to 10.5 months. TVEC was administered by injection with a needle directly into one or more tumors.
Percentage of Participants With Overall Clinical Response Rate - Non-injected Lesion(s).	100 Percentage of participants

SECONDARY outcome

Timeframe: 8.5-10.5 months

1\. Number of safety adverse events (SAE) as assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) 4.0 a. 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.

Outcome measures

Outcome measures
Measure	Treatment (Talimogene Laherparepvec) n=11 Participants The subject participation period was approximately 48 weeks. This included a screening visit, 4 injection visits and 5 follow up visits. Total length of study/patient was 8.5 to 10.5 months. TVEC was administered by injection with a needle directly into one or more tumors.
Number of Safety Adverse Events (SAE) as Assessed According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) 4.0	21 Number of safety adverse events assessed

Adverse Events

Treatment (Talimogene Laherparepvec)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Talimogene Laherparepvec) n=11 participants at risk The subject participation period was approximately 48 weeks. This included a screening visit, 4 injection visits and 5 follow up visits. Total length of study/patient was 8.5 to 10.5 months. TVEC was administered by injection with a needle directly into one or more tumors.
General disorders Fatigue	45.5% 5/11 • Number of events 11 • Adverse events (AEs) were assessed and collected starting from the first study treatment visit and continued through the last study follow-up visit, up to 10.5 months
General disorders Flu-like symptoms	36.4% 4/11 • Number of events 10 • Adverse events (AEs) were assessed and collected starting from the first study treatment visit and continued through the last study follow-up visit, up to 10.5 months
Nervous system disorders Headache	18.2% 2/11 • Number of events 5 • Adverse events (AEs) were assessed and collected starting from the first study treatment visit and continued through the last study follow-up visit, up to 10.5 months
Musculoskeletal and connective tissue disorders Bone pain	9.1% 1/11 • Number of events 1 • Adverse events (AEs) were assessed and collected starting from the first study treatment visit and continued through the last study follow-up visit, up to 10.5 months
General disorders Chills	9.1% 1/11 • Number of events 2 • Adverse events (AEs) were assessed and collected starting from the first study treatment visit and continued through the last study follow-up visit, up to 10.5 months
General disorders Fever	9.1% 1/11 • Number of events 1 • Adverse events (AEs) were assessed and collected starting from the first study treatment visit and continued through the last study follow-up visit, up to 10.5 months
General disorders Injection site pain	9.1% 1/11 • Number of events 1 • Adverse events (AEs) were assessed and collected starting from the first study treatment visit and continued through the last study follow-up visit, up to 10.5 months
Musculoskeletal and connective tissue disorders Leg pain	9.1% 1/11 • Number of events 1 • Adverse events (AEs) were assessed and collected starting from the first study treatment visit and continued through the last study follow-up visit, up to 10.5 months
General disorders Malaise	9.1% 1/11 • Number of events 4 • Adverse events (AEs) were assessed and collected starting from the first study treatment visit and continued through the last study follow-up visit, up to 10.5 months
Musculoskeletal and connective tissue disorders Muscle weakness	9.1% 1/11 • Number of events 1 • Adverse events (AEs) were assessed and collected starting from the first study treatment visit and continued through the last study follow-up visit, up to 10.5 months
Gastrointestinal disorders Nausea	9.1% 1/11 • Number of events 4 • Adverse events (AEs) were assessed and collected starting from the first study treatment visit and continued through the last study follow-up visit, up to 10.5 months
Nervous system disorders Paresthesia	9.1% 1/11 • Number of events 1 • Adverse events (AEs) were assessed and collected starting from the first study treatment visit and continued through the last study follow-up visit, up to 10.5 months
Gastrointestinal disorders Vomiting	9.1% 1/11 • Number of events 1 • Adverse events (AEs) were assessed and collected starting from the first study treatment visit and continued through the last study follow-up visit, up to 10.5 months

Additional Information

Clara Curiel-Lewandrowski, MD

University of Arizona Cancer Center

Phone: (520) 626-5351

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place