Trial Outcomes & Findings for A Study of T-VEC (Talimogene Laherparepvec) With or Without Radiotherapy for Melanoma, Merkel Cell Carcinoma, or Other Solid Tumors (NCT NCT02819843)
NCT ID: NCT02819843
Last Updated: 2025-01-29
Results Overview
Overall subject level response is defined as partial or complete (\>50% or greater decrease in largest lesion) by the modified World Health Organization (mWHO) criteria, and will include measurements of tumor size by CT component of PET/CT, and clinically by digital photography.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
16 weeks
Results posted on
2025-01-29
Participant Flow
Participant milestones
| Measure |
Intralesional TALIMOGENE LAHERPAREPVEC Without Radiotherapy
Patients will receive Talimogene Laherparepvec alone, as described above, without radiotherapy.
TALIMOGENE LAHERPAREPVEC (TVEC)
|
Intralesional TALIMOGENE LAHERPAREPVEC With Radiotherapy
Patients will receive 3 radiotherapy treatments (one treatment every 3-5 days) during weeks 3 and 4. The first treatment will occur 6 (+/- 2) hours after the Talimogene Laherparepvec administration at week 3.Talimogene Laherparepvec will be administered at weeks 0, 3, 5, 7, 9, 11, 13 and 15. The first dose of Talimogene Laherparepvec will be 10\^6 plaque forming units (PFU)/mL, followed three weeks later by a dose of 10\^8 pfu/mL.
TALIMOGENE LAHERPAREPVEC (TVEC)
Hypofractionated Radiotherapy
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Intralesional TALIMOGENE LAHERPAREPVEC Without Radiotherapy
Patients will receive Talimogene Laherparepvec alone, as described above, without radiotherapy.
TALIMOGENE LAHERPAREPVEC (TVEC)
|
Intralesional TALIMOGENE LAHERPAREPVEC With Radiotherapy
Patients will receive 3 radiotherapy treatments (one treatment every 3-5 days) during weeks 3 and 4. The first treatment will occur 6 (+/- 2) hours after the Talimogene Laherparepvec administration at week 3.Talimogene Laherparepvec will be administered at weeks 0, 3, 5, 7, 9, 11, 13 and 15. The first dose of Talimogene Laherparepvec will be 10\^6 plaque forming units (PFU)/mL, followed three weeks later by a dose of 10\^8 pfu/mL.
TALIMOGENE LAHERPAREPVEC (TVEC)
Hypofractionated Radiotherapy
|
|---|---|---|
|
Overall Study
Disease progression before RT
|
0
|
1
|
Baseline Characteristics
A Study of T-VEC (Talimogene Laherparepvec) With or Without Radiotherapy for Melanoma, Merkel Cell Carcinoma, or Other Solid Tumors
Baseline characteristics by cohort
| Measure |
Intralesional TALIMOGENE LAHERPAREPVEC Without Radiotherapy
n=9 Participants
Patients will receive Talimogene Laherparepvec alone, as described above, without radiotherapy.
TALIMOGENE LAHERPAREPVEC (TVEC)
|
Intralesional TALIMOGENE LAHERPAREPVEC With Radiotherapy
n=10 Participants
Patients will receive 3 radiotherapy treatments (one treatment every 3-5 days) during weeks 3 and 4. The first treatment will occur 6 (+/- 2) hours after the Talimogene Laherparepvec administration at week 3.Talimogene Laherparepvec will be administered at weeks 0, 3, 5, 7, 9, 11, 13 and 15. The first dose of Talimogene Laherparepvec will be 10\^6 plaque forming units (PFU)/mL, followed three weeks later by a dose of 10\^8 pfu/mL.
TALIMOGENE LAHERPAREPVEC (TVEC)
Hypofractionated Radiotherapy
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
n=5 Participants
|
62 years
n=7 Participants
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksOverall subject level response is defined as partial or complete (\>50% or greater decrease in largest lesion) by the modified World Health Organization (mWHO) criteria, and will include measurements of tumor size by CT component of PET/CT, and clinically by digital photography.
Outcome measures
| Measure |
Intralesional TALIMOGENE LAHERPAREPVEC Without Radiotherapy
n=9 Participants
Patients will receive Talimogene Laherparepvec alone, as described above, without radiotherapy.
TALIMOGENE LAHERPAREPVEC (TVEC)
|
Intralesional TALIMOGENE LAHERPAREPVEC With Radiotherapy
n=10 Participants
Patients will receive 3 radiotherapy treatments (one treatment every 3-5 days) during weeks 3 and 4. The first treatment will occur 6 (+/- 2) hours after the Talimogene Laherparepvec administration at week 3.Talimogene Laherparepvec will be administered at weeks 0, 3, 5, 7, 9, 11, 13 and 15. The first dose of Talimogene Laherparepvec will be 10\^6 plaque forming units (PFU)/mL, followed three weeks later by a dose of 10\^8 pfu/mL.
TALIMOGENE LAHERPAREPVEC (TVEC)
Hypofractionated Radiotherapy
|
|---|---|---|
|
Best Response
Progressive Disease
|
6 Participants
|
4 Participants
|
|
Best Response
Complete Response
|
1 Participants
|
1 Participants
|
|
Best Response
Partial Response
|
0 Participants
|
0 Participants
|
|
Best Response
Stable Disease
|
2 Participants
|
5 Participants
|
Adverse Events
Intralesional TALIMOGENE LAHERPAREPVEC Without Radiotherapy
Serious events: 0 serious events
Other events: 9 other events
Deaths: 8 deaths
Intralesional TALIMOGENE LAHERPAREPVEC With Radiotherapy
Serious events: 0 serious events
Other events: 10 other events
Deaths: 9 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intralesional TALIMOGENE LAHERPAREPVEC Without Radiotherapy
n=9 participants at risk
Patients will receive Talimogene Laherparepvec alone, as described above, without radiotherapy.
TALIMOGENE LAHERPAREPVEC (TVEC)
|
Intralesional TALIMOGENE LAHERPAREPVEC With Radiotherapy
n=10 participants at risk
Patients will receive 3 radiotherapy treatments (one treatment every 3-5 days) during weeks 3 and 4. The first treatment will occur 6 (+/- 2) hours after the Talimogene Laherparepvec administration at week 3.Talimogene Laherparepvec will be administered at weeks 0, 3, 5, 7, 9, 11, 13 and 15. The first dose of Talimogene Laherparepvec will be 10\^6 plaque forming units (PFU)/mL, followed three weeks later by a dose of 10\^8 pfu/mL.
TALIMOGENE LAHERPAREPVEC (TVEC)
Hypofractionated Radiotherapy
|
|---|---|---|
|
General disorders
Fever
|
55.6%
5/9 • Up to 30 months
|
30.0%
3/10 • Up to 30 months
|
|
General disorders
Fatigue
|
22.2%
2/9 • Up to 30 months
|
30.0%
3/10 • Up to 30 months
|
|
General disorders
Chills
|
22.2%
2/9 • Up to 30 months
|
50.0%
5/10 • Up to 30 months
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Up to 30 months
|
10.0%
1/10 • Up to 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/9 • Up to 30 months
|
10.0%
1/10 • Up to 30 months
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Up to 30 months
|
0.00%
0/10 • Up to 30 months
|
|
Vascular disorders
Hypotension
|
11.1%
1/9 • Up to 30 months
|
0.00%
0/10 • Up to 30 months
|
|
Injury, poisoning and procedural complications
Radiation dermatitis
|
0.00%
0/9 • Up to 30 months
|
30.0%
3/10 • Up to 30 months
|
|
General disorders
Pain
|
11.1%
1/9 • Up to 30 months
|
0.00%
0/10 • Up to 30 months
|
|
Psychiatric disorders
Confusion
|
11.1%
1/9 • Up to 30 months
|
0.00%
0/10 • Up to 30 months
|
Additional Information
Dr. Christopher Barker, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-8168
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place