Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07).

December 12, 2024 updated by: Amgen

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

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-programmed cell death protein (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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • North Sydney, New South Wales, Australia, 2060
        • Melanoma Institute Australia
    • Queensland
      • Southport, Queensland, Australia, 4215
        • Tasman Oncology Research
    • South Australia
      • Woodville South, South Australia, Australia, 5011
        • The Queen Elizabeth Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Centre
  • Canada
      • Quebec, Canada, G1R 2J6
        • CHU de Québec-Université Laval
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
  • France
      • Bordeaux, France, 33075
        • Centre Hospitalier Universitaire de Bordeaux - Hôpital Saint André
      • Grenoble Cedex 9, France, 38043
        • Centre Hospitalier Universitaire de Grenoble - Hopital Nord Michallon
      • Nantes Cedex 1, France, 44093
        • Centre Hospitalier Universitaire de Nantes, Hôpital Hôtel Dieu
      • Paris, France, 75010
        • Hopital Saint Louis
      • Pierre Benite Cedex, France, 69495
        • Centre Hospitalier Lyon Sud
      • Villejuif, France, 94805
        • Gustave Roussy
  • Germany
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus der Technischen Universität Dresden
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Regensburg, Germany, 93053
        • Universitätsklinikum Regensburg
      • Tübingen, Germany, 72076
        • Universitätsklinikum Tübingen
  • Greece
      • Athens, Greece, 11527
        • General Hospital of Athens Laiko
      • Ioannina, Greece, 45500
        • University Hospital of Ioannina
      • Thessaloniki, Greece, 546 22
        • Bioclinic of Thessaloniki
  • Italy
      • Bergamo, Italy, 24127
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
      • Meldola FC, Italy, 47014
        • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
      • Milano, Italy, 20141
        • IRCCS Istituto Europeo di Oncologia
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Nederlands Kanker Instituut, Antoni van Leeuwenhoekziekenhuis
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus Medisch Centrum
  • Poland
      • Gdansk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne Centrum Medycyny Nieinwazyjnej
      • Poznan, Poland, 60-780
        • Szpital Kliniczny im Heliodora Swiecickiego Uniwersytetu Medycznego im Karola Marcinkowskiego w Pozn
      • Warszawa, Poland, 02-781
        • Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie â€" Panstwowy Instytut Badawczy
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d Hebron
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28050
        • Hospital Universitario Madrid Sanchinarro
    • AndalucÃ-a
      • Malaga, AndalucÃ-a, Spain, 29010
        • Hospital Clinico Universitario Virgen de la Victoria
    • PaÃ-s Vasco
      • San Sebastian, PaÃ-s Vasco, Spain, 20014
        • Onkologikoa
  • United Kingdom
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden Hospital
      • London, United Kingdom, SE1 9RT
        • Guys Hospital
  • United States
    • California
      • Santa Barbara, California, United States, 93105
        • Sansum Clinic
    • Delaware
      • Newark, Delaware, United States, 19713
        • Medical Oncology Hematology Consultants Helen F Graham Cancer Center
    • Florida
      • Orlando, Florida, United States, 32806
        • University of Florida Health Cancer Center at Orlando Health
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville James Graham Brown Cancer Center
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Allina Health Systems dba Virginia Piper Cancer Institute
    • New York
      • Albany, New York, United States, 12208
        • New York Oncology Hematology, PC
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Texas
      • Austin, Texas, United States, 78731
        • Texas Oncology Austin Central
      • Dallas, Texas, United States, 75246
        • Baylor Scott and White Research Institute
      • The Woodlands, Texas, United States, 77380
        • United States Oncology Regulatory Affairs Corporate Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1 - Locally Recurrent/Metastatic - Primary Resistance

Includes participants who received anti-PD1 therapy in the locally recurrent/metastatic setting and experienced a best overall response of disease progression or stable disease prior to confirmed disease progression.

Participants will receive talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 plaque-forming units (PFU)/mL on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL will be administered every 3 weeks for up to 35 cycles in total. Participants will also receive pembrolizumab at a dose of 200 mg every 3 weeks for up to 35 cycles.
Drug: Pembrolizumab
Intravenous (IV) infusion.
Drug: Talimogene laherparepvec
Intralesional injection into injectable cutaneous, subcutaneous and nodal legions.
Experimental: Cohort 2 - Locally Recurrent/Metastatic - Acquired Resistance

Includes participants who received anti-PD-1 therapy in the locally recurrent/metastatic setting and experienced confirmed disease progression following a complete or partial response on anti-PD-1 therapy.

Participants will receive talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 plaque-forming units (PFU)/mL on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL will be administered every 3 weeks for up to 35 cycles in total. Participants will also receive pembrolizumab at a dose of 200 mg every 3 weeks for up to 35 cycles.
Drug: Pembrolizumab
Intravenous (IV) infusion.
Drug: Talimogene laherparepvec
Intralesional injection into injectable cutaneous, subcutaneous and nodal legions.
Experimental: Cohort 3 - Adjuvant Setting -Disease Free Interval < 6 months

Includes participants who received anti-PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of < 6 months after starting the adjuvant anti-PD-1 therapy.

Participants will receive talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 plaque-forming units (PFU)/mL on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL will be administered every 3 weeks for up to 35 cycles in total. Participants will also receive pembrolizumab at a dose of 200 mg every 3 weeks for up to 35 cycles.
Drug: Pembrolizumab
Intravenous (IV) infusion.
Drug: Talimogene laherparepvec
Intralesional injection into injectable cutaneous, subcutaneous and nodal legions.
Experimental: Cohort 4 - Adjuvant Setting -Disease Free Interval ≥ 6 months

Includes participants who received anti PD-1 therapy in the adjuvant setting and experienced confirmed disease progression following a disease-free interval of ≥ 6 months after starting the adjuvant PD-1 inhibitor.

Participants will receive talimogene laherparepvec at an initial dose of up to 4.0 mL of 10^6 plaque-forming units (PFU)/mL on Day 1. Subsequent doses of up to 4.0 mL of 10^8 PFU/mL will be administered every 3 weeks for up to 35 cycles in total. Participants will also receive pembrolizumab at a dose of 200 mg every 3 weeks for up to 35 cycles.
Drug: Pembrolizumab
Intravenous (IV) infusion.
Drug: Talimogene laherparepvec
Intralesional injection into injectable cutaneous, subcutaneous and nodal legions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) Per Modified RECIST v1.1
Time Frame: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

ORR was defined as the incidence of a best overall response (BOR) of complete response (CR) or partial response (PR) per modified RECIST v1.1:

  • CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to < 10 mm. All lymph nodes must have been non-pathological in size (< 10mm short axis).
  • PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
  • Non-CR/Non-progressive disease (PD): Persistence of 1 or more non-target lesion(s).
Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete Response Rate (CRR) Per Modified RECIST v1.1
Time Frame: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

CRR was defined as the incidence of a BOR of CR per modified RECIST v1.1:

  • CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to < 10 mm. All lymph nodes must have been non-pathological in size (< 10mm short axis).

Confirmation of CR was not required per modified RECIST v1.1.
Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months
Complete Response Rate (iCRR) Per Modified Immune-related Response Criteria (irRC) RECIST v1.1
Time Frame: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

iCRR was defined as the incidence of a best overall response (iBOR) of a complete response (iCR) per modified irRC-RECIST:

  • iCR: Disappearance of all lesions (whether measurable or not and whether baseline or new). Any pathological lymph nodes (whether target or nontarget) must have had a reduction in short axis to < 10 mm.

Confirmation of iCR was required per modified irRC-RECIST.
Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months
BOR Per Modified RECIST v1.1
Time Frame: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

BOR was the best overall visit response up to & including the first overall visit response of PD:

  • CR: Disappearance of all target & non-target lesions. Any pathological lymph nodes must have had a reduction in short axis to <10 mm. All lymph nodes must have been non-pathological in size.
  • PR: ≥30% decrease in the sum of diameters of target lesions.
  • Stable disease (SD): Neither sufficient shrinkage to qualify for PR/CR nor sufficient increase to qualify for PD.
  • PD: ≥20% increase in the sum of diameters of target lesions and an increase of ≥5mm. Progression of existing non-target lesions.
  • Unable to evaluate (UE): Any lesion present at baseline which was not assessed or unable to be evaluated leading to an inability to determine the status of that particular tumor.
  • Non-CR/Non-PD: Persistence of 1+ non-target lesion(s). Non-CR/non-PD was relevant to participants who did not have measurable disease at baseline.

Confirmation of CR, PR & PD were not required per modified RECIST 1.1.
Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months
Best Overall Response (iBOR) Per Modified irRC-RECIST
Time Frame: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

iBOR was defined as the best overall visit response up to and including the first overall visit response of progressive disease (iPD) per modified irRC-RECIST:

  • iCR: Disappearance of all lesions (whether measurable or not and whether baseline or new). Any pathological lymph nodes (whether target or nontarget) must have a reduction in short axis to < 10 mm.
  • Partial response (iPR): Decrease in tumor burden ≥ 30% relative to baseline.
  • Stable disease (iSD): Neither sufficient shrinkage to qualify for iPR or iCR nor sufficient increase to qualify for iPD.
  • iPD: Increase in tumor burden ≥ 20% and at least 5 mm absolute increase.
  • Unable to evaluate (iUE): Any lesion present at baseline or a new measurable lesion which was not assessed or was unable to be evaluated leading to an inability to determine the status of that particular tumor for that time point.

Confirmation of iCR, iPR and iPD was required per modified irRC-RECIST.
Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months
Durable Response Rate (DRR) Per Modified RECIST v1.1
Time Frame: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

DRR was defined as the percentage of participants with a CR or PR per modified RECIST v1.1 with a duration of response (DOR) ≥ 6 months. One month was calculated based on 365.25 days per year.

  • CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to < 10 mm. All lymph nodes must have been non-pathological in size (< 10mm short axis).
  • PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

Confirmation of CR and PR were not required per modified RECIST v1.1.
Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months
Durable Response Rate (iDRR) Per Modified irRC-RECIST
Time Frame: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

iDRR was defined as the percentage of participants with an iCR or iPR per modified irRC-RECIST with a duration of response (iDOR) ≥ 6 months. One month was calculated based on 365.25 days per year.

  • iCR: Disappearance of all lesions (whether measurable or not and whether baseline or new). Any pathological lymph nodes (whether target or nontarget) must have a reduction in short axis to < 10 mm.
  • iPR: Decrease in tumor burden ≥ 30% relative to baseline.

Confirmation of iCR and iPR were required per modified irRC-RECIST.
Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months
DOR Per Modified RECIST v1.1
Time Frame: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

DOR was defined as the time from the date of an initial response of CR or PR to the earlier of PD/death. Participants who had not ended their response at the time of analysis were censored at their last evaluable tumor assessment date before start of first subsequent anticancer therapy. One month was calculated based on 365.25 days per year.

  • CR:Disappearance of all target & non-target lesions. All lymph nodes must have a reduction in short axis to <10 mm. Any pathological lymph nodes must have had a reduction in short axis to <10 mm. All lymph nodes must have been non-pathological in size (<10mm short axis).
  • PR:At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
  • PD:At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an increase of at least 5mm. Unequivocal progression of existing non-target lesions.

Confirmation of CR, PR and PD were not required per modified RECIST v1.1.
Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months
iDOR Per Modified irRC-RECIST
Time Frame: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

iDOR was defined as the time from the date of an initial response that is subsequently confirmed to the earlier of iPD per modified irRC-RECIST.

Participants who had not ended their response at the time of analysis were censored at their last evaluable tumor assessment date before start of first subsequent anticancer therapy. One month was calculated based on 365.25 days per year.

  • iCR: Disappearance of all target and non-target lesions. All lymph nodes must have a reduction in short axis to < 10 mm.
  • iPR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
  • iPD: At least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. Unequivocal progression of existing non-target lesions.
Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months
Disease Control Rate (DCR) Per Modified RECIST v1.1
Time Frame: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

DCR per modified RECIST v1.1 was defined as the incidence of a BOR of CR, PR or SD.

  • CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have had a reduction in short axis to < 10 mm. All lymph nodes must have been non-pathological in size (< 10mm short axis
  • PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
  • SD: Neither sufficient shrinkage to qualify for PR or CR nor sufficient increase to qualify for PD.

Confirmation of CR and PR were not required per modified RECIST v1.1.
Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months
Disease Control Rate (iDCR) Per Modified irRC-RECIST
Time Frame: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

iDCR per modified irRC-RECIST was defined as the incidence of an iBOR of iCR, iPR or iSD.

  • iCR: Disappearance of all target and non-target lesions. All lymph nodes must have a reduction in short axis to < 10 mm.
  • iPR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
  • iSD: Neither sufficient shrinkage to qualify for iPR or iCR nor sufficient increase to qualify for iPD.

Confirmation of iCR and iPR were required per modified irRC-RECIST.
Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months
Objective Response Rate (iORR) Per Modified irRC-RECIST
Time Frame: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

iORR was defined as the incidence of an iBOR of iCR or iPR per modified irRC-RECIST

  • iCR: Disappearance of all lesions (whether measurable or not and whether baseline or new). Any pathological lymph nodes (whether target or nontarget) must have a reduction in short axis to < 10 mm.
  • iPR: Decrease in tumor burden ≥ 30% relative to baseline.

Confirmation of iCR and iPR were required per modified irRC-RECIST.
Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months
Progression Free Survival (PFS) Per Modified RECIST v1.1
Time Frame: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

PFS per modified RECIST 1.1 was defined as the interval from first dose to the earlier event of PD or death from any cause. Participants without an event were censored at their last evaluable post-baseline tumor assessment if available, otherwise were censored on study Day 1. One month was calculated based on 365.25 days per year.

- PD: At least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. Unequivocal progression of existing non-target lesions.
Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months
Progression Free Survival (iPFS) Per Modified irRC-RECIST
Time Frame: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

iPFS per modified irRC-RECIST was defined as the interval from first dose to the earlier event of iPD or death from any cause. Participants without an event were censored at their last evaluable post-baseline tumor assessment if available, otherwise were censored on study Day 1. One month was calculated based on 365.25 days per year.

- iPD: Increase in tumor burden ≥ 20% and at least 5 mm absolute increase.
Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months
Overall Survival (OS)
Time Frame: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months
OS was defined as the interval from first dose to death from any cause. Participants without an event were censored at the last date known to be alive. One month was calculated based on 365.25 days per year.
Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Time Frame: Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.

Evaluation of TEAEs included the number of participants with at least 1:

  • TEAE
  • Treatment-related TEAE
  • Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 TEAE
  • Treatment-related CTCAE grade ≥ 3 TEAE
  • Serious TEAE
  • Serious treatment-related TEAE
  • Fatal TEAE
  • Fatal treatment-related TEAE
  • TEAE of interest

Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment.

A CTCAE grade ≥ 3 was determined using the CTCAE grading systems based on CTCAE version 5.0 per the below definitions:

  • Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.
  • Grade 4: Life-threatening consequences; urgent intervention indicated.
  • Grade 5: Death related to TEAE.

Abnormal laboratory tests were also recorded as TEAEs.
Serious TEAEs were collected up to 90 days post-last dose of treatment. Non-serious TEAEs were collected up to 30 days post-last dose of treatment. The maximum duration of treatment exposure was 105.9 weeks.
Time to First Subsequent Anti-cancer Therapy
Time Frame: Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months
Time to first subsequent anti-cancer therapy was defined as the time from enrollment to the start of subsequent anticancer therapy. Participants who did not start subsequent anticancer therapy were censored as the last known to be alive date. One month was calculated based on 365.25 days per year.
Every 12 weeks. Maximum overall time on-study (treatment + follow up) was 46.23 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 19, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20180115
  • 2019-001906-61 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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