Trial Outcomes & Findings for A Study of Talimogene Laherparepvec (T-VEC) in Combination With Pembrolizumab in Patients With Metastatic and/or Locally Advanced Sarcoma (NCT NCT03069378)
NCT ID: NCT03069378
Last Updated: 2025-10-29
Results Overview
(complete response + partial response) RECIST 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
24 weeks
Results posted on
2025-10-29
Participant Flow
Participant milestones
| Measure |
Talimogene Laherparepvec (T-VEC) Administered With Pembrolizu
Patients will initiate treatment with talimogene laherparepvec given intralesionally and pembrolizumab.
Talimogene Laherparepvec (T-VEC): Talimogene laherparepvec treatment will be given at Day 1 Week 1, and every 3 weeks thereafter .
Pembrolizumab: Pembrolizumab will be given at Day 1 week 1 and every 3 weeks thereafter.
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Talimogene Laherparepvec (T-VEC) Administered With Pembrolizu
Patients will initiate treatment with talimogene laherparepvec given intralesionally and pembrolizumab.
Talimogene Laherparepvec (T-VEC): Talimogene laherparepvec treatment will be given at Day 1 Week 1, and every 3 weeks thereafter .
Pembrolizumab: Pembrolizumab will be given at Day 1 week 1 and every 3 weeks thereafter.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Study of Talimogene Laherparepvec (T-VEC) in Combination With Pembrolizumab in Patients With Metastatic and/or Locally Advanced Sarcoma
Baseline characteristics by cohort
| Measure |
Talimogene Laherparepvec (T-VEC) Administered With Pembrolizu
n=41 Participants
Patients will initiate treatment with talimogene laherparepvec given intralesionally and pembrolizumab.
Talimogene Laherparepvec (T-VEC): Talimogene laherparepvec treatment will be given at Day 1 Week 1, and every 3 weeks thereafter .
Pembrolizumab: Pembrolizumab will be given at Day 1 week 1 and every 3 weeks thereafter.
|
|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 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
|
6 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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 weeks(complete response + partial response) RECIST 1.1. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Talimogene Laherparepvec (T-VEC) Administered With Pembrolizu
n=41 Participants
Patients will initiate treatment with talimogene laherparepvec given intralesionally and pembrolizumab.
Talimogene Laherparepvec (T-VEC): Talimogene laherparepvec treatment will be given at Day 1 Week 1, and every 3 weeks thereafter .
Pembrolizumab: Pembrolizumab will be given at Day 1 week 1 and every 3 weeks thereafter.
|
|---|---|
|
Best Objective Response Rate
Complete Response + Partial Response
|
13 Participants
|
|
Best Objective Response Rate
Stable Disease
|
13 Participants
|
|
Best Objective Response Rate
Progressive Disease
|
14 Participants
|
|
Best Objective Response Rate
Not Evaluable
|
1 Participants
|
Adverse Events
Talimogene Laherparepvec (T-VEC) Administered With Pembrolizu
Serious events: 8 serious events
Other events: 41 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Talimogene Laherparepvec (T-VEC) Administered With Pembrolizu
n=41 participants at risk
Patients will initiate treatment with talimogene laherparepvec given intralesionally and pembrolizumab.
Talimogene Laherparepvec (T-VEC): Talimogene laherparepvec treatment will be given at Day 1 Week 1, and every 3 weeks thereafter .
Pembrolizumab: Pembrolizumab will be given at Day 1 week 1 and every 3 weeks thereafter.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/41 • 24 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
2.4%
1/41 • 24 weeks
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, spec
|
2.4%
1/41 • 24 weeks
|
|
General disorders
Chills
|
4.9%
2/41 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
1/41 • 24 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
2.4%
1/41 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.3%
3/41 • 24 weeks
|
|
General disorders
Fatigue
|
4.9%
2/41 • 24 weeks
|
|
General disorders
Fever
|
14.6%
6/41 • 24 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.4%
1/41 • 24 weeks
|
|
Vascular disorders
Hypotension
|
4.9%
2/41 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.4%
1/41 • 24 weeks
|
|
Infections and infestations
Lung infection
|
2.4%
1/41 • 24 weeks
|
|
General disorders
Malaise
|
2.4%
1/41 • 24 weeks
|
|
Gastrointestinal disorders
Nausea
|
4.9%
2/41 • 24 weeks
|
|
Investigations
Neutrophil count decreased
|
2.4%
1/41 • 24 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.4%
1/41 • 24 weeks
|
|
Eye disorders
Papilledema
|
2.4%
1/41 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.9%
2/41 • 24 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.4%
1/41 • 24 weeks
|
|
Eye disorders
Uveitis
|
2.4%
1/41 • 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/41 • 24 weeks
|
Other adverse events
| Measure |
Talimogene Laherparepvec (T-VEC) Administered With Pembrolizu
n=41 participants at risk
Patients will initiate treatment with talimogene laherparepvec given intralesionally and pembrolizumab.
Talimogene Laherparepvec (T-VEC): Talimogene laherparepvec treatment will be given at Day 1 Week 1, and every 3 weeks thereafter .
Pembrolizumab: Pembrolizumab will be given at Day 1 week 1 and every 3 weeks thereafter.
|
|---|---|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
80.5%
33/41 • 24 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
75.6%
31/41 • 24 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
68.3%
28/41 • 24 weeks
|
|
Investigations
Lymphocyte count decreased
|
53.7%
22/41 • 24 weeks
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
41.5%
17/41 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
39.0%
16/41 • 24 weeks
|
|
Investigations
Alkaline phosphatase increased
|
34.1%
14/41 • 24 weeks
|
|
Investigations
Activated partial thromboplastin time prolonged
|
31.7%
13/41 • 24 weeks
|
|
Investigations
INR increased
|
31.7%
13/41 • 24 weeks
|
|
Investigations
Serum amylase increased
|
31.7%
13/41 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
29.3%
12/41 • 24 weeks
|
|
Investigations
White blood cell decreased
|
29.3%
12/41 • 24 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
26.8%
11/41 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
26.8%
11/41 • 24 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
26.8%
11/41 • 24 weeks
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
24.4%
10/41 • 24 weeks
|
|
Investigations
Lipase increased
|
24.4%
10/41 • 24 weeks
|
|
Investigations
Creatinine increased
|
22.0%
9/41 • 24 weeks
|
|
Investigations
Alanine aminotransferase increased
|
17.1%
7/41 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
17.1%
7/41 • 24 weeks
|
|
Investigations
Blood bilirubin increased
|
12.2%
5/41 • 24 weeks
|
|
Investigations
Neutrophil count decreased
|
12.2%
5/41 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.3%
3/41 • 24 weeks
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
7.3%
3/41 • 24 weeks
|
Additional Information
Dr. Ciara Kelly, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4312
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place