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Closed (no longer recruiting)Last updated: 7 February 2024

MASTERKEY-115: This phase 2 trial is evaluating the effectiveness of using an immunotherapy (talimogene laherparepvec) in combination with a targeted therapy (pembrolizumab) to treat patients with melanoma, who have had disease progression while on immune checkpoint inhibitors (anti-PD-1 therapy)Phase 2 Study of Talimogene Laherparepvec in Combination With Pembrolizumab in Subjects With Unresectable/Metastatic Stage IIIB-IVM1d Melanoma Who Have Progressed on Prior Anti PD-1 Based Therapy

Clinical summary

Summary

Patients eligible to participate in this trial will receive injections of talimogene laherparepvec directly into the lesions on Day 1 of the trial and every 3 weeks after the first injection. Pembrolizumab will be administered intravenously every 3 weeks.

Conditions

This trial is treating patients with Melanoma.

Cancer

Skin Cancers Skin

Age

People18+

Phase

II

Trial Acronym

MASTERKEY-115

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

AMGEN

Scientific Title

Phase 2 Study of Talimogene Laherparepvec in Combination With Pembrolizumab in Subjects With Unresectable/Metastatic Stage IIIB-IVM1d Melanoma Who Have Progressed on Prior Anti PD-1 Based Therapy

Eligibility

Inclusion

  • Age ≥ 18 years with histologically confirmed diagnosis of stage IIIB to IVM1d melanoma and for whom surgery is not recommended. Subjects with stage IVM1d disease may be enrolled with up to 3 cerebral metastases, provided that all lesions have been adequately treated with stereotactic radiation therapy, craniotomy, or gamma knife therapy, with no evidence of progression and not requiring steroids for at least 2 months prior to enrollment.
  • Subjects must have measurable disease and be a candidate for intralesional therapy administration into cutaneous, subcutaneous, or nodal lesions.
  • Subjects must have had prior treatment (for at least 2 to 3 consecutive cycles within an 8 week period) with a PD-1 inhibitor and have confirmed disease progression (as defined by RECIST v1.1 criteria). The anti-PD-1 therapy must be the immediate prior line of therapy before enrollment and subjects with disease progression on more than 1 line of anti-PD-1 therapy are not eligible.
  • ECOG performance status of 0 or 1.
  • Adequate hematologic, renal, hepatic, and coagulation function.

Exclusion

  • Subjects considered by the investigator to have rapid clinical progression due to melanoma
  • Subjects with prior treatment and disease progression on more than 1 line of anti-PD-1 therapy
  • Stage IVM1d subjects must not have greater than 3 cerebral melanoma metastases, or clinically active cerebral melanoma metastases requiring therapy, and/or carcinomatous meningitis regardless of clinical stability.
  • Primary uveal or mucosal melanoma, history or evidence of melanoma associated with immunodeficiency states or history of other malignancy within the past 3 years.
  • Subjects must not have history or evidence of symptomatic autoimmune glomerulonephritis, vasculitis, or other symptomatic autoimmune disease, or active autoimmune disease or syndrome requiring systemic treatment in the past 2 years (ie, with use of disease modifying agents, steroids or immunosuppressive agents) except vitiligo or resolved childhood asthma/atopy, or evidence of clinically significant immunosuppression.
  • Subjects may not have been previously treated with talimogene laherparepvec or any other oncolytic virus.
  • Subjects must not have active herpetic skin lesions or prior complications of herpetic infection and must not require intermittent or chronic treatment with an antiherpetic drug (eg, acyclovir), other than intermittent topical use.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

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