Other Clinical Trial - Expanded Access Protocol of Talimogene

Clinical Trial Description

Expanded access of Talimogene Laherparepvec for subjects with unresected, stage IIIb to IVM1c Melanoma that may not meet the eligibility criteria to enroll in another ongoing Talimogene Laherparepvec study or do not have access to enroll in an ongoing Talimogene Laherparepvec study. ;

Study Design

N/A

Related Conditions & MeSH terms

Melanoma
Unresected Stage IIIb to IVM1c Melanoma

See also
	Status	Clinical Trial	Phase
	Completed	`NCT02366195` - Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma	Phase 2
	No longer available	`NCT02297529` - Expanded Access Study of Talimogene Laherparepvec for Treatment of Subjects With Unresected Stage IIIB-IVM1c Melanoma

See also

Status

Clinical Trial

Phase

Completed

NCT02366195 - Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma

Phase 2

No longer available

NCT02297529 - Expanded Access Study of Talimogene Laherparepvec for Treatment of Subjects With Unresected Stage IIIB-IVM1c Melanoma

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT02147951
Study type	Expanded Access
Source	Amgen
Contact
Status	No longer available
Phase	Phase 3

Expanded Access Protocol of Talimogene Laherparepvec for Subjects With Unresected, Stage lllB to IVM1c Melanoma

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms