Source: https://www.mycancergenome.org/content/clinical_trials/NCT02509507/
Timestamp: 2020-02-18 16:26:38
Document Index: 74891294

Matched Legal Cases: ['art 2', 'art 1', 'art 2', 'art 1', 'art 1', 'art 2', 'art 1']

Clinical Trial: NCT02509507 - My Cancer Genome
This is a phase 1b/2, multicenter, open-label trial to evaluate the safety of talimogene laherparepvec injected intrahepatically into liver tumors with known progression alone and in combination with systemic IV administration of pembrolizumab, in subjects with non-HCC liver metastases from BC, CRC, GEC, melanoma, NSCLC, RCC, and subjects with HCC. The study consists of 2 parts and 2 groups, and Part 2 includes 2 stages. The objective of Part 1 is to evaluate the safety of intrahepatic injection of talimogene laherparepvec into liver tumors alone and in combination with systemically administered pembrolizumab for the non-HCC (Group A) and HCC (Group B) cohorts separately. Part 2 consists of 2-stage design to evaluate the efficacy and safety of talimogene laherparepvec in combination with systemic pembrolizumab. Efficacy and safety will be evaluated in each of the six non-HCC tumor types from Group A separately. Similarly, the efficacy and safety of the combination treatment will be determined for Group B HCC subjects.
Brief Title: Safety Study of Talimogene Laheraprepvec Injected Into Hepatocellular Carcinoma and Metastatic Liver Tumors
Official Title: A Phase 1, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Liver Tumors
ORG STUDY ID: 20140318
SECONDARY ID: 2014-005386-67
NCT ID: NCT02509507
Talimogene Laherparepvec Phase 1 Talimogene Laherparepvec
This is a phase 1, multicenter, open-label trial to evaluate the safety of talimogene laherparepvec, injected intrahepatically, into liver tumors with known progression in subjects with Hepatocellular carcinoma and subjects with liver metastases from breast adenocarcinoma, colorectal adenocarcinoma, gastroesophageal cancer (adenocarcinoma or squamous cell carcinoma), melanoma, non-small cell lung cancer, or clear cell renal cell carcinoma. The study consists of 2 parts and 2 groups. Part 1 is a 3+3 dose escalation consisting of 3 sequential dose cohorts each administering talimogene laherparepvec in increasing dose concentrations and dose volumes. In Part 1, the Maximum Tolerated Dose determination of non-hepatocellular carcinoma liver metastases (Group A) will be evaluated separately from hepatocellular carcinoma (Group B), and each dose cohort will need to be deemed safe for non-hepatocellular carcinoma subjects before it will be administered in hepatocellular carcinoma subjects. Part 2 consists of expansion cohorts administering the Maximum Tolerated Dose of talimogene laherparepvec determined from Part 1 for Groups A (non-hepatocellular carcinoma) and B (hepatocellular carcinoma) to approximately 10 subjects for each tumor type.
Phase 1 Talimogene Laherparepvec Experimental Talimogene Laherparepvec
-  Subjects must have histologically confirmed breast adenocarcinoma, colorectal
adenocarcinoma, gastroesophageal cancer (adenocarcinoma or squamous cell carcinoma),
melanoma, non-small cell lung cancer, or clear cell renal cell carcinoma with liver
metastases or hepatocellular carcinoma with known disease progression.
-  Non-hepatocellular carcinoma subjects must have received at least 1 prior standard of
care systemic anti-cancer therapy for their metastatic disease.
-  Subjects must have measurable liver tumors that are suitable for injection.
-  Eastern Cooperative Oncology Group performance status must be 0 or 1, and life
expectancy should be approximately 5 months or more.
-  Adequate hematological, renal, hepatic and coagulation function is required.
-  Child-Pugh score must be A to B7.
-  Subjects must not be candidates for hepatic surgery or locoregional therapy of liver
tumors with curative intent or planned systemic anti-cancer therapy.
-  Liver tumors must not be estimated to invade approximately more than one-third of the
-  Liver tumor-directed therapy, hepatic surgery, antibody-based therapy, or
immunotherapy must not have been performed < 28 days, chemotherapy < 21 days, and
targeted small molecule therapy or hormonal therapy < 14 days prior to enrollment.
-  Subjects must have either no central nervous system metastasis or irradiated, stable
cerebral metastases from breast adenocarcinoma, non-small cell lung cancer, clear cell
renal cell carcinoma, or melanoma.
-  Subjects must not have history or evidence of symptomatic autoimmune pneumonitis,
glomerulonephritis, vasculitis, or other symptomatic autoimmune disease.
-  Subjects must not have symptomatic auto-immune disease or be immunosuppressed.
-  Subjects must not have a history of solid organ transplantation.
-  For non-hepatocellular carcinoma, there must not be acute or chronic hepatitis B virus
or hepatitis C virus infection.
-  For hepatocellular carcinoma,hepatitis B virus and hepatitis C virus viral load must
be undetectable, and they must not have had recent treatment with certain antiviral
-  There should be no macroscopic intravascular invasion of tumors into the main portal
vein, hepatic vein, or vena cava.
-  Subjects must not have active herpetic skin lesions or prior complications of herpetic
infection (eg, herpetic keratitis or encephalitis) and must not require treatment with
an antiherpetic drug.
-  Subjects must not require concomitant treatment with warfarin.
-  Female subjects of childbearing potential who is unwilling to use acceptable method(s)
of effective contraception during protocol treatment and through 3 months after the
last dose of talimogene laherparepvec.
Measure: Subject incidence of Dose-Limiting Toxicities in dose-escalation cohorts to determine the Maximum Tolerated Dose.
Measure: Safety: To evaluate the safety of intrahepatic injection of talimogene laherparepvec into liver tumors as assessed by subject incidence of treatment-emergent and treatment-related adverse events
Measure: Safety: To estimate the incidence of detectable talimogene laherparepvec DNA in blood and urine
Measure: Safety: To estimate the incidence of clearance of talimogene laherparepvec DNA from blood and urine
Measure: Safety: To estimate the rate of detection and incidence of talimogene laherparepvec DNA and virus at the surface of talimogene laherparepvec injection site, the exterior of the occlusive dressing, and the oral mucosa
Measure: Safety: To estimate the incidence of talimogene laherparepvec DNA detection in lesions suspected to be herpetic in origin