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SarcomaPhase 2NCT03069378

A Study of Talimogene Laherparepvec (T-VEC) in Combination With Pembrolizumab in Patients With Metastatic and/or Locally Advanced Sarcoma

A Phase 2 study testing Talimogene Laherparepvec (T-VEC) and Pembrolizumab in people with Sarcoma and Epithelioid Sarcoma, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to determine how well the combination of therapy of talimogene laherparepvec (T-VEC) and pembrolizumab works in the treatment of patients with sarcoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Talimogene Laherparepvec (T-VEC) and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
5 sitesUnited States
Study dates
3 Mar 2017to Mar 2027
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

  • Male or female age ≥ 18 years at the time of informed consent
  • Be willing and able to provide written informed consent/assent for the trial
  • Be willing to comply with treatment protocol
  • Subjects must have a histologically confirmed metastatic and/or locally advanced inoperable sarcoma (metastatic/locally advanced cohort)
  • For histology specific additional metastatic cohorts, patients must have undifferentiated pleomorphic sarcoma/myxofibrosarcoma, epithelioid sarcoma or cutaneous angiosarcoma.
  • Subjects must have at least 1 injectable cutaneous, subcutaneous (superficial or deep) soft tissue or nodal lesion ≥ 10 mm in longest diameter. Of note, bone lesions are not eligible for injection unless there is a soft tissue component that is amenable to injection. Injectable lesions must not be chosen from a previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression in that lesion prior to enrollment
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  • Subjects with locally advanced/metastatic sarcoma must have at least one prior line of systemic therapy (e.g. chemotherapy, immunotherapy, targeted or biological therapy). An exception to this criterion will be made for patients with sarcoma histological subtypes for which there is no known standard systemic therapy (e.g., epithelioid sarcoma). Treatment naive patients may be enrolled if they have refused standard systemic treatment. Prior adjuvant therapy will not count provided it was completed more than 6 months previously
  • Adequate performance status: ECOG 0 or 1/KPS 100-70%
  • Adequate organ function determined within 3 weeks of treatment initiation, defined as follows:
  • I. Hemoglobin ≥ 8.0 g/dl
  • II. Absolute neutrophil count ≥ 1,000/mm^3 (1.0 x 10^9/L)
  • III. Platelet count ≥ 75,000/mm3 (75 x 109/L)
  • IV. Serum bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for a subject with total bilirubin level > 1.5 x ULN
  • V. Aspartate aminotransferase (AST) ≤ 2.5 x ULN OR ≤ 5 x ULN for subjects with liver metastases
  • VI. Alanine aminotransferase (ALT) ≤ 2.5 x ULN OR ≤ 5 x ULN for subjects with liver metastases
  • VII. Alkaline Phosphatase < 5 x ULN
  • VIII. Albumin ≥2.5mg/dL
  • IX. Serum creatinine ≤ 1.5 x ULN or a measured or calculateda* creatinine clearance ≥ 60mL/min for subject with creatinine levels > 1.5 x institutional ULN (Note: Creatinine clearance need not be determined if the baseline serum creatinine is within normal limits. GFR can also be used in place of creatinine or CrCl) X. International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants XI. Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT and PTT is within therapeutic range of intended use of anticoagulants
  • aCreatinine clearance should be calculated per institutional standard
  • Female subject of childbearing potential should have a negative serum pregnancy testing at screening visit and within 72 hours prior to the first dose of study medication

Who cannot join

  • Uncontrolled intercurrent illness including active infection requiring systemic therapy or symptomatic congestive heart failure within 6 months
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability
  • Evidence of clinically significant immunosuppression such as the following:
  • Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease
  • Concurrent opportunistic infection
  • Receiving systemic immunosuppressive therapy (> 2 weeks) including oral steroid doses > 10 mg/day of prednisone or equivalent within 7 days prior to enrollment. However, in the setting of non-immune mediated indications for use, chronic/active low dose steroid use may be permitted at the discretion of the principal investigator
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  • Known history of human immunodeficiency virus (HIV) disease
  • History or evidence of symptomatic autoimmune disease (e.g., pneumonitis, glomerulonephritis, vasculitis, or other), or history of active autoimmune disease that has required systemic treatment (i.e., use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) in past 2 years prior to enrollment. Replacement therapy (e.g., 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
  • Active herpetic skin lesions or prior complications of herpetic infection
  • Require intermittent or chronic treatment with an intravenous or oral antiherpetic drug (e.g., acyclovir), other than intermittent topical use
  • Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected)
  • Received live vaccine or live-attenuated vaccine within 30 days prior to enrollment. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed
  • Has a known history of active TB (Bacillus Tuberculosis)
  • Female subject is pregnant or breast-feeding, or planning to become pregnant or male subject is planning to father a child within the projected duration of the trial, starting with the pre-screening or screening visit, during study treatment and through 3 months after the last dose of talimogene laherparepvec or 4 months after the last dose of pembrolizumab, whichever is later
  • Male and female subjects of childbearing potential who are unwilling to use acceptable method(s) of effective contraception during study treatment and through 3 months after the last dose of talimogene laherparepvec and 4 months after the last dose of pembrolizumab. (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 amenorrhoeic(e.g., 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)
  • Sexually active subjects and their partners unwilling to use male or female latex condom or polyurethane condoms for patients with latex allergies to avoid potential viral transmission during sexual contact while on treatment and within 30days 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
  • Known previous history of sensitivity to talimogene laherparepvec or any of its components to be administered during dosing (e.g. sorbitol, myo-inositol)
  • Hypersensitivity to pembrolizumab or any of its excipients
  • Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Prior therapy with talimogene laherparepvec, tumor vaccine
  • Prior chemotherapy, radiotherapy, biological cancer therapy, targeted small molecule therapy or major surgery within 21 days prior to study Day 1 or who has not recovered (i.e., to CTCAE ≤ grade 1 or at baseline) from adverse events due to previously administered therapy. Note: Subjects with ≤ grade 2 neuropathy and alopecia are an exception to this criterion and may qualify for the study. Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy
  • Is currently participating and receiving study therapy with another investigational device or study drug or has participated in a study of an investigational agent and received study therapy or used an investigational device within 3 weeks of the first dose of treatment
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • The presence of any other concurrent active malignancy

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604

  • MD Anderson Cancer Center (Data Analysis Only)

    Houston, Texas, 77030

  • Enable Medicine (Specimen Analysis Only)

    Menlo Park, California, 94025

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Stanford University Medical Center

    Stanford, California, 94305-5408

Other trials in United States

About this study

Official title: A Phase II Study of Talimogene Laherparepvec (T-VEC) Administered Concurrently With the Anti-PD1 Monoclonal Antibody Pembrolizumab in Patients With Metastatic and/or Locally Advanced Sarcoma

The purpose of this study is to determine how well the combination of therapy of talimogene laherparepvec (T-VEC) and pembrolizumab works in the treatment of patients with sarcoma.

Being tested
Talimogene Laherparepvec (T-VEC), Pembrolizumab
Keywords
Metastatic, Locally Advanced, Talimogene Laherparepvec (T-VEC), Pembrolizumab, 16-1534
Medical subject headings
Sarcoma, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Talimogene Laherparepvec (T-VEC)Drug

    Talimogene laherparepvec treatment will be given at Day 1 Week 1, and every 3 weeks thereafter .

  • PembrolizumabDrug

    Pembrolizumab will be given at Day 1 week 1 and every 3 weeks thereafter.

Study groups in NCT03069378
Study groupRoleWhat they receive
Talimogene Laherparepvec (T-VEC) Administered with PembrolizuExperimentalPatients will initiate treatment with talimogene laherparepvec given intralesionally and pembrolizumab.
Receives: Drug: Talimogene Laherparepvec (T-VEC); Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best Objective Response Rate

    (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.

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2017
  2. Study start3 Mar 2017
  3. Primary completion22 Jul 2025
  4. Study completionMar 2027 (estimated)

Resources

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
Model description
This is a single-center, phase II study to evaluate the efficacy of the oncolytic herpes virus talimogene laherparepvec, given in combination with pembrolizumab for patients with metastatic and/or locally advanced sarcomas.
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03069378
Sponsor's protocol ID
16-1534
Status last verified
Jun 2026
First submitted
27 Feb 2017
Last updated
17 Jul 2026
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Goff PH, Riolobos L, LaFleur BJ, Spraker MB, Seo YD, Smythe KS, Campbell JS, Pierce RH, Zhang Y, He Q, Kim EY, Schaub SK, Kane GM, Mantilla JG, Chen EY, Ricciotti R, Thompson MJ, Cranmer LD, Wagner MJ, Loggers ET, Jones RL, Murphy E, Blumenschein WM, McClanahan TK, Earls J, Flanagan KC, LaFranzo NA, Kim TS, Pollack SM. Neoadjuvant Therapy Induces a Potent Immune Response to Sarcoma, Dominated by Myeloid and B Cells. Clin Cancer Res. 2022 Apr 14;28(8):1701-1711. doi: 10.1158/1078-0432.CCR-21-4239.

    PubMed 35115306

  • Kelly CM, Antonescu CR, Bowler T, Munhoz R, Chi P, Dickson MA, Gounder MM, Keohan ML, Movva S, Dholakia R, Ahmad H, Biniakewitz M, Condy M, Phelan H, Callahan M, Wong P, Singer S, Ariyan C, Bartlett EK, Crago A, Yoon S, Hwang S, Erinjeri JP, Qin LX, Tap WD, D'Angelo SP. Objective Response Rate Among Patients With Locally Advanced or Metastatic Sarcoma Treated With Talimogene Laherparepvec in Combination With Pembrolizumab: A Phase 2 Clinical Trial. JAMA Oncol. 2020 Mar 1;6(3):402-408. doi: 10.1001/jamaoncol.2019.6152.

    PubMed 31971541

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Talimogene Laherparepvec (T-VEC) and Pembrolizumab in people with Sarcoma and Epithelioid Sarcoma, run by Memorial Sloan Kettering Cancer Center at 5 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 20 inclusion and 25 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: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 29 Oct 2025). 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?

Best Objective Response Rate (time frame: 24 weeks). 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 NCT03069378, which also lists 2 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 17 Jul 2026.

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