Clinical Trials /

Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115)

NCT04068181

Description:

This is a phase 2, open-label, single-arm, multicenter clinical trial designed to evaluate the efficacy and safety of talimogene laherparepvec in combination with pembrolizumab following disease progression on prior anti-PD-1 therapy in unresectable/metastatic melanoma (stage IIIB-IVM1d) or prior anti-PD-1 therapy in the adjuvant setting. Subjects will be treated with talimogene laherparepvec and pembrolizumab until confirmed complete response, disappearance of all injectable lesions, documented confirmed disease progression per modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST), intolerance of study treatment, or 102 weeks from the first dose of talimogene laherparepvec and/or pembrolizumab, whichever occurs first.

Related Conditions:
  • Melanoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115)
  • Official 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

Clinical Trial IDs

  • ORG STUDY ID: 20180115
  • SECONDARY ID: 2019-001906-61
  • NCT ID: NCT04068181

Conditions

  • Melanoma

Interventions

DrugSynonymsArms
Talimogene laherparepvecTalimogene Laherparepvec and Pembrolizumab
PembrolizumabTalimogene Laherparepvec and Pembrolizumab

Purpose

This is a phase 2, open-label, single-arm, multicenter clinical trial designed to evaluate the efficacy and safety of talimogene laherparepvec in combination with pembrolizumab following disease progression on prior anti-PD-1 therapy in unresectable/metastatic melanoma (stage IIIB-IVM1d) or prior anti-PD-1 therapy in the adjuvant setting. Subjects will be treated with talimogene laherparepvec and pembrolizumab until confirmed complete response, disappearance of all injectable lesions, documented confirmed disease progression per modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST), intolerance of study treatment, or 102 weeks from the first dose of talimogene laherparepvec and/or pembrolizumab, whichever occurs first.

Trial Arms

NameTypeDescriptionInterventions
Talimogene Laherparepvec and PembrolizumabExperimentalTo evaluate the efficacy and safety of talimogene laherparepvec in combination with pembrolizumab following disease progression on prior anti-PD-1 therapy in unresectable/metastatic melanoma (stage IIIB-IVM1d) or prior anti-PD-1 therapy in the adjuvant setting.
  • Talimogene laherparepvec
  • Pembrolizumab

Eligibility Criteria

        Key Inclusion Criteria:

          -  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.

        Key Exclusion Criteria:

          -  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.
      
Maximum Eligible Age:99 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response (Complete Response [CR] plus partial response [PR] by investigator assessment using modified Response Evaluation Criteria in Solid Tumor [RECIST v1.1])
Time Frame:Up to 4 years
Safety Issue:
Description:To evaluate the efficacy of talimogene laherparepvec in combination with pembrolizumab as assessed by Objective Response Rate (ORR) in subjects with unresectable/metastatic stage IIIB-IVM1d melanoma who have progressed on prior anti-PD-1 therapy.

Secondary Outcome Measures

Measure:Complete Response by investigator assessment using modified Response Evaluation Criteria in Solid Tumor (RECIST v1.1) and modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST).
Time Frame:Up to 4 years
Safety Issue:
Description:To evaluate the efficacy of talimogene laherparepvec in combination with pembrolizumab, as assessed by Complete Response Rate.
Measure:Best Overall Response (BOR) by investigator assessment using modified Response Evaluation Criteria in Solid Tumor (RECIST v1.1) and modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST).
Time Frame:Up to 4 years
Safety Issue:
Description:To evaluate the efficacy of talimogene laherparepvec in combination with pembrolizumab, as assessed by Best Overall Response.
Measure:Durable Response by investigator assessment using modified Response Evaluation Criteria in Solid Tumor (RECIST v1.1) and modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST).
Time Frame:Up to 4 years
Safety Issue:
Description:To evaluate the efficacy of talimogene laherparepvec in combination with pembrolizumab, as assessed by Durable Response Rate.
Measure:Duration Of Response (DOR) by investigator assessment using modified Response Evaluation Criteria in Solid Tumor (RECIST v1.1) and modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST).
Time Frame:Up to 4 years
Safety Issue:
Description:To evaluate the efficacy of talimogene laherparepvec in combination with pembrolizumab, as assessed by Duration Of Response.
Measure:Disease Control by investigator assessment using modified Response Evaluation Criteria in Solid Tumor (RECIST v1.1) and modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST).
Time Frame:Up to 4 years
Safety Issue:
Description:To evaluate the efficacy of talimogene laherparepvec in combination with pembrolizumab, as assessed by Disease Control Rate.
Measure:Overall Response by investigator assessment using modified immune-related Response Criteria simulating Response Evaluation Criteria in Solid Tumors (irRC-RECIST).
Time Frame:Up to 4 years
Safety Issue:
Description:To evaluate the efficacy of talimogene laherparepvec in combination with pembrolizumab, as assessed by Objective Response Rate using modified irRC-RECIST.
Measure:Progression Free Survival (PFS) by investigator assessment using modified Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 and modified immune-related Response Criteria simulating Response evaluation criteria in Solid Tumors (irRC-RECIST).
Time Frame:Up to 4 years
Safety Issue:
Description:To evaluate the efficacy of talimogene laherparepvec in combination with pembrolizumab, as assessed by Progression Free Survival.
Measure:Overall Survival (OS)
Time Frame:Up to 4 years
Safety Issue:
Description:To evaluate the efficacy of talimogene laherparepvec in combination with pembrolizumab, as assessed by Overall Survival.
Measure:Incidence of treatment-emergent adverse events.
Time Frame:Up to 4 years
Safety Issue:
Description:To evaluate the safety of talimogene laherparepvec in combination with pembrolizumab as assessed by incidence of treatment emergent adverse events in patients who have progressed on prior anti-PD-1 therapy.
Measure:Incidence of treatment related adverse events.
Time Frame:Up to 4 years
Safety Issue:
Description:To evaluate the safety of talimogene laherparepvec in combination with pembrolizumab as assessed by incidence of treatment-related adverse events in patients who have progressed on prior anti-PD-1 therapy.
Measure:Incidence of abnormal laboratory tests.
Time Frame:Up to 4 years
Safety Issue:
Description:To evaluate the safety of talimogene laherparepvec in combination with pembrolizumab as assessed by abnormal laboratory tests in patients who have progressed on prior anti-PD-1 therapy.
Measure:Time to subsequent anti-cancer therapy.
Time Frame:Up to 4 years
Safety Issue:
Description:To evaluate time to subsequent anti-cancer therapy.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Amgen

Trial Keywords

  • Melanoma
  • Talimogene Laherparepvec
  • Pembrolizumab
  • Oncolytic immunotherapy
  • Anti-PD-1
  • Checkpoint inhibitor
  • MASTERKEY-115

Last Updated

May 11, 2020