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NCT02509507

Trial to Evaluate the Safety ofTalimogene Laherparepvec Injected Into Liver Tumors Alone and in Combination With Systemic Pembrolizumab

Datenbasis: WHO (Import vom 26.01.2020)
Geändert: 12.01.2020
Krankheitskategorie:

Health conditions (Datenquelle: WHO)

Hepatocellular Carcinoma;Liver Metastases

Interventions (Datenquelle: WHO)

Drug: Talimogene Laherparepvec;Drug: Pembrolizumab

Inclusion/Exclusion Criteria (Datenquelle: WHO)


Summary of Subject Eligibility Criteria:

Key Inclusion Criteria:

Subjects must be age = 18 years at the time of informed consent. They must have
histologically or cytologically confirmed BC, CRC, GEC, melanoma, NSCLC, or RCC with liver
metastases or HCC.

Part 2 Group B is restricted to HCC (fibrolamellar and mixed
hepatocellular/cholangiocarcinoma subtypes are not eligible). Non-HCC subjects must have
received at least 1 prior standard of care systemic anti-cancer therapy for their locally
advanced or metastatic disease.

For the combination cohorts (Cohorts 5 and 6 in Part 1) and Part 2, subjects with
metastatic melanoma or NSCLC do not need to have received prior therapy.

Subjects must have measurable liver tumors and lesions that are suitable for injection.

Eastern Cooperative Oncology Group (ECOG) 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.

Liver function tests may be mildly abnormal but within the parameters. Child Pugh score
must be A to B7.

Key Exclusion Criteria:

Subjects must not be candidates for hepatic surgery or locoregional therapy of liver tumors
with curative intent or planned immediate systemic anti-cancer therapy, with the exception
of immunotherapy in the combination cohorts (Cohorts 5 and 6 in Part 1 and all subjects in
Part 2).

Liver tumors must not be estimated to invade approximately more than one-third of the
liver.

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 either have no central nervous system (CNS) metastasis, or carcinomatous
meningitis, or if CNS metastasis is present, must have stable treated cerebral metastases
from BC, NSCLC, RCC, CRC, GEC, or melanoma.

Subjects must not have symptomatic auto-immune disease or be immunosuppressed. They must
not have a history of solid organ transplantation.

For non-HCC, there must not be acute or chronic active hepatitis B virus (HBV) or hepatitis
C virus (HCV) infection. For HCC with prior hepatitis B and/or C infection, HBV and/or HCV
viral load by real time polymerase chain reaction (qPCR) must be undetectable, and they
must not have had recent treatment within 12 weeks for HBV or HCV with certain antiviral
medications.

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); require treatment with an oral or
intravenous systemic antiherpetic drug; have received live-virus vaccination within 30 days
of planned treatment start; have previous therapy with talimogene laherparepvec, oncolyic
viruses, or tumor vaccine.

They must not require concomitant treatment with warfarin. Subjects in the combination
treatment cohort must not have: a history or evidence of psychiatric, substance abuse, or
any other clinically significant disorder; toxic effects of the most recent prior
chemotherapy not resolved to grade 1 or less (except alopecia); or expected other cancer
therapy while on study with the exception of local radiation to the site of bone or other
metastasis for palliative treatment.

Male subjects of reproductive potential in the combination treatment must be willing to use
acceptable methods of effective contraception during treatment and through 4 months after
the last dose of pembrolizumab.

Weitere Angaben zur Studie im WHO-Primärregister

https://clinicaltrials.gov/show/NCT02509507

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT02509507

Weitere Informationen zur Studie

Registrationsdatum der Studie

10.07.2015

Einschluss der ersten teilnehmenden Person

05.02.2016

Rekrutierungsstatus

Recruiting

Wissenschaftlicher Titel (Datenquelle: WHO)

A Phase 1b/2, Multicenter, Open-label Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Liver Tumors Alone and in Combination With Systemic Pembrolizumab (MASTERKEY-318)

Studientyp (Datenquelle: WHO)

Interventional

Design der Studie (Datenquelle: WHO)

Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Datenquelle: WHO)

Phase 1

Primäre Endpunkte (Datenquelle: WHO)

Subject incidence DLTs separately in Group A and B observed in monotherapy and combination cohorts and in each tumor type seperately in Part 2;To evaluate in Part 2 ORR per modified irRC-RECIST separately by tumor type (BC, CRC, GEC, melanoma, NSCLC, RCC, and HCC)

Sekundäre Endpunkte (Datenquelle: WHO)

Safety: Subject incidence of treatment-related and treatment-emergent adverse events in monotherapy and combination of Part 1 and each separate tumour type in Part 2;Safety: To estimate the incidence of detectable talimogene laherparepvec DNA in blood and urine;Safety: To estimate the incidence of clearance of talimogene laherparepvec DNA from blood and urine;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;Safety: To estimate the incidence of talimogene laherparepvec DNA detection in lesions suspected to be herpetic in origin;Efficacy: Objective response rate (ORR);Efficacy: Best overall response (BOR);Efficacy: Durable response rate (DRR);Efficacy: Duration of response (DOR);Efficacy: Response in injected and uninjected lesions;Efficacy: Disease control rate (DCR);Efficacy Progression-free survival (PFS);Efficacy: Overall survival (OS)

Kontakt für Auskünfte (Datenquelle: WHO)

Please refer to primary and secondary sponsors

Studiendurchführungsorte

Durchführungsländer (Datenquelle: WHO)

Austria, Belgium, Germany, Korea, Republic of, Spain, Switzerland, United States

Kontakt für weitere Auskünfte zur Studie

Kontakt für allgemeine Auskünfte (Datenquelle: WHO)

MD;Amgen Call Center
Amgen
866-572-6436
medinfo@amgen.com

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

MD;Amgen Call Center
Amgen
866-572-6436
medinfo@amgen.com

Studienverantwortliche

Hauptsponsor (Datenquelle: WHO)

Amgen

Weitere Sponsoren (Datenquelle : WHO)

Merck Sharp & Dohme Corp.

Weitere Studienidentifikationsnummern

Secondary ID (Datenquelle: WHO)

2014-005386-67;20140318