Pancreatic CancerPhase 1NCT03086642
Study of Talimogene Laherparepvec (T-VEC) in Pancreatic Cancer
A Phase 1 study testing Talimogene laherparepvec in people with Pancreatic Cancer, run by Karie D. Runcie, MD at 1 site in United States.
Trial summary
The purpose of this study is to find out which doses of talimogene laherparepvec (T-Vec) can be given safely to participants with pancreatic cancer that is either too big to be taken out by surgery or has spread to other parts of the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Talimogene laherparepvec
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2017to 31 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Patient must have pathologically confirmed, locally advanced or metastatic pancreatic adenocarcinoma deemed surgically unresectable by a surgeon with expertise in pancreatic cancer
- Disease must be refractory to or intolerant of at least first-line chemotherapy which contains 5-fluorouracil or gemcitabine
- The primary lesion must be accessible for endoscopic biopsy and injection as evaluated by a gastroenterologist at NewYork Presbyterian -Columbia. Further, the patient must be deemed able to tolerate repeated endoscopy procedures by an anesthesiologist and/or gastroenterologist at NewYork Presbyterian-Columbia
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Radiologically measurable injectable disease in the pancreas or surgical bed from prior ≥1cm, as defined by RECIST v1.1
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- Ability to understand and the willingness to sign a written informed consent document
- Females of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must:
- Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis), or agree to use, and be able to comply with, effective contraception (</=1% failure rate annually) without interruption, 28 days prior to starting therapy (including dose interruptions), and while on study medication or for a period of 30 days following treatment completion. [Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception].
- 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.This applies even if the subject practices true abstinence from heterosexual contact.
- Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 30 days following treatment discontinuation, even if he has undergone a successful vasectomy.
- Adequate organ and marrow function as defined below without need for hematopoietic growth factor or transfusion support:
- Hemoglobin ≥8.0g/dl
- Platelets ≥75,000/microliter (mcL)
- Absolute neutrophil count (ANC) ≥1500/mm3 (1.5x109/L)
- Total bilirubin ≤1.5 x institutional upper limit of normal (ULN) or Direct bilirubin ≤ ULN with total bilirubin >1.5 x ULN
- Aspartate aminotransferase (AST) (SGOT)/alanine transaminase (ALT) (SGPT) ≤1.5 x ULN
- INR and aPTT ≤ 1.5 x ULN Unless the patient is on therapeutic anticoagulation in which case the international normalized ratio (INR) and activated partial thromboplastin time (aPTT) must be within the therapeutic range of intended use of anti-coagulants
- Serum creatinine ≤1.5 x ULN or 24 hour creatinine clearance ≥60 mL/min/1.73 m2 by Cockcroft-Gault
- Lipase ≤3 x ULN
Who cannot join
- Cystic pancreatic cancer. Microcystic disease may be eligible
- Patients with pancreatic metastases deemed likely to limit the patient's ability to participate in the study for the complete duration (ie. >3 months), including but not limited to:
- Presence of central nervous system (CNS) metastasis including brain metastasis or compromise resulting from extrinsic disease in the bone or dura b. Presence of more than 5 liver metastases or one liver metastasis measuring more than 3cm c. Oxygen requirement attributable to pleural effusion or other malignant process d. Symptomatic ascites or radiographic evidence of more than trace ascites
- History of other malignancy within the past 3 years with the following exceptions:
- malignancy treated with curative intent and with no known active disease present and has not received chemotherapy for >3 years before randomization and felt to be at low risk for recurrence by the treating physician
- adequately treated non-melanoma skin cancer without evidence of disease at the time of randomization • adequately treated cervical carcinoma in situ without evidence of disease at the time of randomization
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- adequately treated breast ductal carcinoma in situ without evidence of disease at the time of randomization • prostatic intraepithelial neoplasia without evidence of prostate cancer at the time of randomization
- adequately treated superficial or in situ carcinoma of the bladder without evidence of disease at the time of randomization
- Pancreatitis that is active or within the preceding 3 months which in the judgment of the endoscopist would make tumor injection likely to trigger severe recurrent pancreatitis.
- Prior chemotherapy or radiotherapy within 14 days prior to first dose of therapy or has not recovered to CTCAE grade 1 or better from adverse event at time of enrollment due to cancer therapy administered more than 28 days prior to enrollment. or prior biological cancer therapy, targeted therapy, or major surgery within 28 days prior to first dose of therapy or unresolved grade 2 or greater toxicity from prior treatment, including chemotherapy, hormonal therapy, or radiotherapy, at the time of study enrollment. The following ongoing treatments are permitted:
- Hormone-replacement therapy or oral contraceptives
- Hormone therapy for primary prevention of breast cancer
- 5. Patients may not receive Coumadin while on study. Patients may receive low molecular weight heparin or novel oral anticoagulants (eg. dabigatran, apixaban, rivaroxaban) provided that the dose is held 1-2 days before injections are given and biopsies are performed per the protocol. Anti-platelet agents and herbal substances are allowed at the discretion of the treating endoscopist.
- 6. Radiation to the abdominal area within 28 days of first dose of therapy or prior radiotherapy in which the field does not overlap the injection sites or non-immunosuppressive targeted therapy within 14 days prior to enrollment or has not recovered to CTCAE grade 1 or better from adverse event due to cancer therapy administered more than 14 days prior to enrollment. .
- 7. The patient has not recovered to CTCAE grade 1 or better from adverse event at time of enrollment due to cancer therapy administered more than 28 days prior to enrollment
- 8. Prior biological cancer therapy, targeted therapy, or major surgery within 28 days prior to first dose of therapy or major surgery within 28 days prior to enrollment or has not recovered to CTCAE grade 1 or better from adverse event due to cancer therapy administered more than 28 days prior to enrollment. Adjuvant hormonal therapy is allowed..
- 9. Unresolved grade 2 or greater toxicity from most recent treatment, including chemotherapy, hormonal therapy, or radiotherapy, at the time of study enrollment.
- 10. The following ongoing treatments are permitted:
- Hormone-replacement therapy or oral contraceptives
- Hormone therapy for primary prevention of breast cancer
- 11. Patients may not receive Coumadin while on study. Patients may receive low molecular weight heparin or novel oral anticoagulants (eg. dabigatran, apixiban, rivaroxaban) provided that the dose is held 1-2 days before injections are given and biopsies are performed per the protocol. Anti-platelet agents and herbal substances are allowed at the discretion of the treating endoscopist.
- 12. Active herpetic skin lesions or prior complications of herpetic infection (e.g., herpetic keratitis or encephalitis) or requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (e.g., acyclovir), other than intermittent topical use.
- 13. Previous treatment with talimogene laherparepvec or any other oncolytic virus
- 14. Prior therapy with tumor vaccine
- 15. Received live vaccine within 28 days of tumor enrollment
- 16. 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
- 17. Known to have acute or chronic active hepatitis B infection, hepatitis C infection, or known to have human immunodeficiency virus (HIV) infection.
- 18. Subject has known sensitivity to talimogene laherparepvec or any of its components to be administered during dosing.
- 19. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection including Tuberculosis (TB) and C. difficile, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. This includes known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease
- 20. Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
- 21. Major surgical procedure within 28 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study
- 22. 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).
- 23. Sexually active subjects and their partners unwilling to use male or female latex condom to avoid potential viral transmission during sexual contact while on treatment and within 30 days after treatment with talimogene laherparepvec.
- 24. Nursing patients are not allowed on the study and women must commit to no lactation during the course of the study.
- 25. 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.
- Immunotherapy-Related Exclusion Criteria:
- 26. History or evidence of active autoimmune disease that requires systemic treatment (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment for patients with prior allogeneic bone marrow transplantation or prior solid organ transplantation.
- The use of inhaled or oral corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed.
- 27. Received live vaccine within 28 days prior to enrollment.
- 28. Evidence of clinically significant immunosuppression such as the following:
- Primary immunodeficiency state such as Severe Combined Immunodeficiency Disease
- HIV positive
- Receiving systemic immunosuppressive therapy (> 2 weeks) including oral steroid doses > 10 mg/day of prednisone or equivalent within 2 months prior to enrollment
- Concurrent opportunistic infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Study of Talimogene Laherparepvec Administered Endoscopically for the Treatment of Locally Advanced or Metastatic Pancreas Cancer Refractory to at Least One Chemotherapy Regimen
The purpose of this study is to find out which doses of talimogene laherparepvec (T-Vec) can be given safely to participants with pancreatic cancer that is either too big to be taken out by surgery or has spread to other parts of the body. The study will also see if T-Vec can cause tumor shrinkage or prevent its growth.
The primary objective is to determine the rate of dose limiting toxicity at tested doses of talimogene laherparepvec administered endoscopically to pancreatic tumors, and to identify a maximum tolerated dose (MTD).
Read more
Secondary exploratory efficacy endpoints include change in longest diameter in the injected lesion(s), overall response rate (ORR) per RECIST v1.1 and modified immune-related response criteria (mirRC as defined in section 11), progression free survival (PFS) and overall survival (OS) at 6, 12, and 24 months.
Funding Source - FDA OOPD
Read the detailed description
Pancreatic ductal adenocarcinoma (PDA) is an area of great unmet need. PDA accounts for 90% of pancreatic tumors in 2016. The standard of care for pancreas cancer is cytotoxic chemotherapy, but this is not particularly effective with best response rates reported of 20-30% and no significant long-term 5-year survival for patients who are not surgical candidates. Talimogene laherparepvec (previously known as OncoVEXGM-CSF) is an intratumorally delivered oncolytic immunotherapy comprised of an immune-enhanced herpes simplex virus type-1 (HSV-1) that selectively replicates in solid tumors. Talimogene laherparepvec was the first oncolytic viral therapy to be approved by the Federal Drug Administration (FDA) for the treatment of cancer, specifically melanoma. There is the potential that talimogene laherparepvec could exert a systemic effect mitigating the potential of PDA to metastasize.
This is a phase 1 dose escalation study to evaluate the safety of talimogene laherparepvec in PDA. To find out which doses are safe, all participants enrolled in this study will receive up to 4 injections of T-Vec. At least two doses will be evaluated in this study, depending on how many side effects are seen at each dose. Participants will not be able to pick the dose, as this will be determined based on the study experience with participants enrolled previously.
- Conditions
- Pancreatic Cancer
- Being tested
- Talimogene laherparepvec
- Keywords
- locally advanced pancreatic cancer, locally advanced pancreas cancer, metastatic pancreatic cancer, metastatic pancreas cancer, refractory, refractory pancreatic cancer, refractory pancreas cancer, T-Vec, T Vec
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talimogene laherparepvecDrug
Also called T-Vec, T Vec
T-Vec will be administered by intratumoral injection into pancreatic tumors accessible endoscopically with ultrasound guidance (at least one pancreatic lesion must be injected during each treatment).
On day 1 of week 1 the first dose of talimogene laherparepvec will be up to 4.0 mL of 10^6 PFU/mL. The second injection up to 4.0 mL of 10^6, 10^7, or 10^8 PFU/mL should be administered no sooner than day 1 of week 4 but should not be delayed more than 7 days after the scheduled time point. The maximum volume of T-Vec administered at any one time is 4.0 mL for any individual lesion.
| Study group | Role | What they receive |
|---|---|---|
| T-Vec | Experimental | All enrolled patients will receive a test dose of talimogene laherparepvec (10^6 plaque forming units (PFU)/ml) on day 1, followed by treatment doses at escalating concentrations weeks 4, 7, and 10. A biopsy will be obtained during each scheduled endoscopy prior to talimogene laherparepvec injection. Receives: Drug: Talimogene laherparepvec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
To determine the highest dose of study treatment that does not cause unacceptable side effects.
Measured: 36-48 months
Secondary outcomes (4)
Change in size of injected lesion(s)
To make an exploratory assessment of activity of talimogene laherparepvec in pancreatic cancer, as measured by change in size of the injected lesion(s)
Measured: baseline, 11 weeks
Overall response rate (ORR)
The percentage of patients whose cancer shrinks or disappears after treatment.
Measured: Up to 24 months
Progression-free survival (PFS)
The length of time during and after the study treatment of cancer, that a patient lives with the disease but it does not get worse.
Measured: Up to 24 months
Overall survival (OS)
The length of time from either the date of diagnosis or the start of study treatment for cancer, that patients diagnosed with the disease are still alive.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start16 Nov 2017
- Primary completion13 May 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karie D. Runcie, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Sponsor-investigator, Karie D. Runcie, MD, Columbia University
- Investigators
- Karie Runcie, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086642
- Sponsor's protocol ID
- AAAQ9966
- Other IDs
- 1R01FD006108-01
- Status last verified
- Nov 2024
- First submitted
- 16 Mar 2017
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Runcie K, Bracero Y, Samouha A, Manji G, Remotti HE, Gonda TA, Saenger Y. Phase I study of intratumoral injection of talimogene laherparepvec for the treatment of advanced pancreatic cancer. Oncologist. 2025 Jan 17;30(1):oyae200. doi: 10.1093/oncolo/oyae200.
PubMed 39673447
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Talimogene Laherparepvec Administered Endoscopically for the Treatment of Locally Advanced or Metastatic Pancreas Cancer Refractory to at Least One Chemotherapy Regimen
- ClinicalTrials.gov ID
- NCT03086642
- Acronym / sponsor ID
- AAAQ9966
- Conditions
- Pancreatic Cancer
- Keywords
- locally advanced pancreatic cancer, locally advanced pancreas cancer, metastatic pancreatic cancer, metastatic pancreas cancer, refractory, refractory pancreatic cancer, refractory pancreas cancer, T-Vec
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Karie D. Runcie, MDUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 13 May 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out which doses of talimogene laherparepvec (T-Vec) can be given safely to participants with pancreatic cancer that is either too big to be taken out by surgery or has spread to other parts of the body. The study will also see if T-Vec can cause tumor shrinkage or prevent its growth.
The primary objective is to determine the rate of dose limiting toxicity at tested doses of talimogene laherparepvec administered endoscopically to pancreatic tumors, and to identify a maximum tolerated dose (MTD).
Secondary exploratory efficacy endpoints include change in longest diameter in the injected lesion(s), overall response rate (ORR) per RECIST v1.1 and modified immune-related response criteria (mirRC as defined in section 11), progression free survival (PFS) and overall survival (OS) at 6, 12, and 24 months.
Funding Source - FDA OOPD
Detailed description
Pancreatic ductal adenocarcinoma (PDA) is an area of great unmet need. PDA accounts for 90% of pancreatic tumors in 2016. The standard of care for pancreas cancer is cytotoxic chemotherapy, but this is not particularly effective with best response rates reported of 20-30% and no significant long-term 5-year survival for patients who are not surgical candidates. Talimogene laherparepvec (previously known as OncoVEXGM-CSF) is an intratumorally delivered oncolytic immunotherapy comprised of an immune-enhanced herpes simplex virus type-1 (HSV-1) that selectively replicates in solid tumors. Talimogene laherparepvec was the first oncolytic viral therapy to be approved by the Federal Drug Administration (FDA) for the treatment of cancer, specifically melanoma. There is the potential that talimogene laherparepvec could exert a systemic effect mitigating the potential of PDA to metastasize.
This is a phase 1 dose escalation study to evaluate the safety of talimogene laherparepvec in PDA. To find out which doses are safe, all participants enrolled in this study will receive up to 4 injections of T-Vec. At least two doses will be evaluated in this study, depending on how many side effects are seen at each dose. Participants will not be able to pick the dose, as this will be determined based on the study experience with participants enrolled previously.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T-Vec | Experimental | Drug: Talimogene laherparepvecAll enrolled patients will receive a test dose of talimogene laherparepvec (10^6 plaque forming units (PFU)/ml) on day 1, followed by treatment doses at escalating concentrations weeks 4, 7, and 10. A biopsy will be obtained during each scheduled endoscopy prior to talimogene laherparepvec injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patient must have pathologically confirmed, locally advanced or metastatic pancreatic adenocarcinoma deemed surgically unresectable by a surgeon with expertise in pancreatic cancer
- Disease must be refractory to or intolerant of at least first-line chemotherapy which contains 5-fluorouracil or gemcitabine
- The primary lesion must be accessible for endoscopic biopsy and injection as evaluated by a gastroenterologist at NewYork Presbyterian -Columbia. Further, the patient must be deemed able to tolerate repeated endoscopy procedures by an anesthesiologist and/or gastroenterologist at NewYork Presbyterian-Columbia
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Key exclusion criteria (44 listed)
- Cystic pancreatic cancer. Microcystic disease may be eligible
- Patients with pancreatic metastases deemed likely to limit the patient's ability to participate in the study for the complete duration (ie. >3 months), including but not limited to:
- History of other malignancy within the past 3 years with the following exceptions:
- Pancreatitis that is active or within the preceding 3 months which in the judgment of the endoscopist would make tumor injection likely to trigger severe recurrent pancreatitis.
- Prior chemotherapy or radiotherapy within 14 days prior to first dose of therapy or has not recovered to CTCAE grade 1 or better from adverse event at time of enrollment due to cancer therapy administered more than 28 days prior to enrollment. or prior biological cancer therapy, targeted therapy, or major surgery within 28 days prior to first dose of therapy or unresolved grade 2 or greater toxicity from prior treatment, including chemotherapy, hormonal therapy, or radiotherapy, at the time of study enrollment. The following ongoing treatments are permitted:
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 |
|---|---|---|
| Talimogene laherparepvecAlso: T-Vec, T VecT-Vec will be administered by intratumoral injection into pancreatic tumors accessible endoscopically with ultrasound guidance (at least one pancreatic lesion must be injected during each treatment). On day 1 of week 1 the first dose of talimogene laherparepvec will be up to 4.0 mL of 10^6 PFU/mL. The second injection up to 4.0 mL of 10^6, 10^7, or 10^8 PFU/mL should be administered no sooner than day 1 of week 4 but should not be delayed more than 7 days after the scheduled time point. The maximum volume of T-Vec administered at any one time is 4.0 mL for any individual lesion. | Drug | T-Vec |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 36-48 months
To determine the highest dose of study treatment that does not cause unacceptable side effects.
4 secondary outcomes
Change in size of injected lesion(s)
Time frame: baseline, 11 weeks
Overall response rate (ORR)
Time frame: Up to 24 months
Progression-free survival (PFS)
Time frame: Up to 24 months
Overall survival (OS)
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Derived from this study: PubMed 39673447Runcie K, Bracero Y, Samouha A, Manji G, Remotti HE, Gonda TA, Saenger Y. Phase I study of intratumoral injection of talimogene laherparepvec for the treatment of advanced pancreatic cancer. Oncologist. 2025 Jan 17;30(1):oyae200. doi: 10.1093/oncolo/oyae200.
- Cancer Center's clinical trials online search toolLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Karie Runcie, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Talimogene laherparepvec in people with Pancreatic Cancer, run by Karie D. Runcie, MD at 1 site 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 44 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 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum Tolerated Dose (MTD) (time frame: 36-48 months). 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 NCT03086642, which also lists 1 linked publication.
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 22 Nov 2024.