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Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Participants With Advanced Melanoma (MK-3475-002/P08719/KEYNOTE-002)

Primary Purpose

Malignant Melanoma

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Pembrolizumab

Carboplatin

Paclitaxel

Dacarbazine

Temozolomide

About this trial

This is an interventional treatment trial for Malignant Melanoma focused on measuring Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic MEL not amenable to local therapy
Participants must be refractory to ipilimumab
Participants with BRAF gene mutant melanoma must have had a prior treatment regimen that included vemurafenib, dabrafenib, or an approved BRAF gene and/or mitogen-activated protein kinase (MEK) protein inhibitor
Must consent to allow correlative studies; must provide a newly obtained tissue/biopsy specimen (or specimen obtained within 60 days of consenting)
Radiographically measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

Chemotherapy, radiation therapy, or biological cancer therapy within 4 weeks prior to the first dose of study drug, or not recovered from the AEs due to cancer therapies administered more than 4 weeks earlier
Disease progression within 24 weeks of last dose of ipilimumab
Participating or has participated in a study of an investigational agent or using an investigational device within 30 days of the first dose of study drug
Expected to require any other form of systemic or localized antineoplastic therapy while on study
Chronic systemic steroid therapy within 2 weeks before the planned date for first dose randomized treatment or on any other form of immunosuppressive medication
Known history of any other than the current malignancy excepting adequately treated basal or squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, breast cancer, or other in situ cancers
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Active autoimmune disease or a history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
Prior treatment with any other anti-programmed cell death (PD) agent
Active infection requiring systemic therapy
Known history of Human Immunodeficiency Virus (HIV)
Active Hepatitis B or Hepatitis C
Regular user (including recreational use of) illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol)
Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study through 120 days after last dose of study drug

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Pembrolizumab 2 mg/kg

Pembrolizumab 10 mg/kg

Investigator-Choice Chemotherapy (ICC)

ICC→Pembrolizumab 2 mg/kg

ICC→Pembrolizumab 10 mg/kg

Arm Description

Participants were initially randomized to receive pembrolizumab 2 mg/kg intravenously (IV) once every 3 weeks (Q3W). With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)

Participants were initially randomized to receive pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)

Participants were initially randomized to receive 1 of 4 possible chemotherapy regimens decided at the treating institution (carboplatin+paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants were to receive study drug until discontinuation due to progression of disease, toxicity, or choice. (Up to ~66 months)

Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 2 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)

Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS) - Initial Treatment Period

PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1), PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered PD. Analysis of PFS was based on an integrated radiology and oncology (IRO) assessment and was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median PFS based on the product limit (Kaplan-Meier) method for censored data is presented. This was the final analysis for PFS.

Interim Overall Survival (OS) - Initial Treatment Period

OS was defined as the time from randomization to death due to any cause. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS based on the product-limit (Kaplan-Meier) method for censored data is presented. This was the interim analysis for OS.

Final Overall Survival (OS) - Initial Treatment Period

OS was defined as the time from randomization to death due to any cause. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS duration based on the product-limit (Kaplan-Meier) method for censored data is presented. This was the final analysis for OS.

Secondary Outcome Measures

Final Overall Survival (OS) By Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Status - Initial Treatment Period

OS was defined as the time from randomization to death due to any cause. Participants with an Allred Proportion Score (APS) ≥2 (membranous staining in ≥1% of cells for PD-L1) were considered to be PD-L1 Positive and participants with an APS of 0 or 1 were considered to be PD-L1 Negative. Analysis of OS was not planned or conducted for the switch-to-pembrolizumab treatment groups. Median OS duration based on the product-limit (Kaplan-Meier) method for censored data by PD-L1 tumor expression status is presented.

Overall Response Rate (ORR) - Initial Treatment Period

ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed using RECIST 1.1. Analysis of ORR was not planned or conducted for the switch-to-pembrolizumab treatment groups. The percentage of participants who experienced a CR or PR is presented. This was the final analysis for ORR.

Best Overall Response (BOR) - Initial Treatment Period

BOR was assessed by independent radiology review using RECIST 1.1 and was recorded from randomization until the last imaging assessment in this period. Response categories included: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. BOR for the Initial Treatment Period was based on IRO. BOR for participants during the Initial Treatment Period is presented.

Best Overall Response (BOR) - Switch-to-Pembrolizumab Treatment Period

The BOR was assessed using RECIST 1.1 and was recorded from the start of the second line of study drug (pembrolizumab) until the last imaging assessment in this period. Response categories included: Complete Response (CR): disappearance of all target lesions; Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): at least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. For the switch-to-pembrolizumab treatment groups, BOR was based on independent review committee (IRC) assessment. The BOR for switched-to pembrolizumab treatment groups is presented.

Duration of Response (DOR) - Initial Treatment Period

For participants who demonstrated a confirmed response (Complete Response [CR]: disappearance of all target lesions or Partial Response [PR]: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. DOR analysis was based on IRO assessment. Analysis of DOR was not planned or analyzed for the switch-to-pembrolizumab treatment groups. Median DOR for participants who demonstrated a confirmed response is presented.

Number of Participants Who Experienced an Adverse Event (AE) - Overall Study

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which was temporally associated with the use of study drug, was also an AE. Participants were included in the treatment group in which an AE was experienced. The number of participants who experienced at least one AE is presented.

Number of Participants Who Discontinued Study Drug Due to an Adverse Event (AE) - Overall Study

An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition which is temporally associated with the use of study drug, was also an AE. The number of participants who discontinued study drug due to an AE is presented.

Full Information

NCT ID

NCT01704287

First Posted

October 8, 2012

Last Updated

April 29, 2020

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT01704287

Brief Title

Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Participants With Advanced Melanoma (MK-3475-002/P08719/KEYNOTE-002)

Official Title

Randomized, Phase II Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Patients With Advanced Melanoma (KEYNOTE 002)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

November 20, 2012 (Actual)

Primary Completion Date

November 16, 2015 (Actual)

Study Completion Date

January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study was conducted to compare survival using pembrolizumab (SCH 900475, MK-3475) or standard chemotherapy in participants with advanced melanoma (MEL) who had progressed after prior therapy. Initial Treatment Period: Participants were initially randomized to receive either low-dose (2 mg/kg) pembrolizumab, higher dose (10 mg/kg) pembrolizumab or Investigator-choice chemotherapy (ICC). The four standard chemotherapy choices were: carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide. The randomization to either pembrolizumab or ICC was conducted in an open-label fashion. The starting pembrolizumab dose was initially blinded to Investigators and participants until Amendment 03. With Amendment 03, all ongoing pembrolizumab participants were to be treated with open label, fixed dose pembrolizumab 200 mg, instead of a weight-based dosing of pembrolizumab. Switch-to-Pembrolizumab Treatment Period: Participants who were initially randomized to receive ICC and experienced progressive disease (PD) may have been eligible to switch to receiving pembrolizumab provided they met protocol-specified requirements for switching. Qualified participants were re-randomized to receive either pembrolizumab 2 mg/kg or pembrolizumab 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. With Amendment 03, all switched-to-pembrolizumab participants were to be treated with open-label, fixed dose pembrolizumab 200 mg instead of a weight-based dosing of pembrolizumab.

Detailed Description

Two interim and one final statistical analyses were planned for and conducted during this study: Interim Analysis 1 (futility analysis), Interim Analysis 2 (~18 months into study): database cutoff date 12-May-2014, and Final Analysis (~36 months into study): database cutoff date 16-Nov-2015. The End of Trial Analysis for the study was conducted at ~75 months into the study: database cutoff date 31-Jan-2019.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Melanoma

Keywords

Programmed Cell Death-1 (PD1, PD-1), Programmed Death-Ligand 1 (PDL1, PD-L1)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

540 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pembrolizumab 2 mg/kg

Arm Type

Experimental

Arm Description

Arm Title

Pembrolizumab 10 mg/kg

Arm Type

Experimental

Arm Description

Arm Title

Investigator-Choice Chemotherapy (ICC)

Arm Type

Active Comparator

Arm Description

Arm Title

ICC→Pembrolizumab 2 mg/kg

Arm Type

Experimental

Arm Description

Arm Title

ICC→Pembrolizumab 10 mg/kg

Arm Type

Experimental

Arm Description

Participants who were initially randomized to ICC, subsequently experienced confirmed progressive disease (PD) and met all switching criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg. Participants received pembrolizumab 10 mg/kg IV Q3W. With Amendment 03, this dosing was discontinued and all study participants were to be treated with fixed-dose open label pembrolizumab 200 mg IV Q3W. Participants were to receive study drug until discontinuation due to PD, toxicity, or choice. (Up to ~66 months)

Intervention Type

Biological

Intervention Name(s)

Pembrolizumab

Other Intervention Name(s)

SCH 900475, MK-3475, KEYTRUDA®

Intervention Description

IV infusion

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Other Intervention Name(s)

PARAPLATIN®

Intervention Description

Carboplatin per institutional standard

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Other Intervention Name(s)

TAXOL®

Intervention Description

Paclitaxel per institutional standard

Intervention Type

Drug

Intervention Name(s)

Dacarbazine

Other Intervention Name(s)

DTIC

Intervention Description

Dacarbazine per institutional standard

Intervention Type

Drug

Intervention Name(s)

Temozolomide

Other Intervention Name(s)

TEMODAR®

Intervention Description

Temozolomide per institutional standard

Primary Outcome Measure Information:

Title

Progression-free Survival (PFS) - Initial Treatment Period

Description

Time Frame

Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)

Title

Interim Overall Survival (OS) - Initial Treatment Period

Description

Time Frame

Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)

Title

Final Overall Survival (OS) - Initial Treatment Period

Description

Time Frame

Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)

Secondary Outcome Measure Information:

Title

Final Overall Survival (OS) By Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Status - Initial Treatment Period

Description

Time Frame

Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)

Title

Overall Response Rate (ORR) - Initial Treatment Period

Description

Time Frame

Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)

Title

Best Overall Response (BOR) - Initial Treatment Period

Description

Time Frame

Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)

Title

Best Overall Response (BOR) - Switch-to-Pembrolizumab Treatment Period

Description

Time Frame

Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)

Title

Duration of Response (DOR) - Initial Treatment Period

Description

Time Frame

Up to approximately 36 months (Through Final Analysis database cutoff date of 16-Nov-2015)

Title

Number of Participants Who Experienced an Adverse Event (AE) - Overall Study

Description

Time Frame

Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)

Title

Number of Participants Who Discontinued Study Drug Due to an Adverse Event (AE) - Overall Study

Description

Time Frame

Up to approximately 75 months (Through End of Trial Analysis database cutoff date of 31-Jan-2019)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic MEL not amenable to local therapy Participants must be refractory to ipilimumab Participants with BRAF gene mutant melanoma must have had a prior treatment regimen that included vemurafenib, dabrafenib, or an approved BRAF gene and/or mitogen-activated protein kinase (MEK) protein inhibitor Must consent to allow correlative studies; must provide a newly obtained tissue/biopsy specimen (or specimen obtained within 60 days of consenting) Radiographically measurable disease Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: Chemotherapy, radiation therapy, or biological cancer therapy within 4 weeks prior to the first dose of study drug, or not recovered from the AEs due to cancer therapies administered more than 4 weeks earlier Disease progression within 24 weeks of last dose of ipilimumab Participating or has participated in a study of an investigational agent or using an investigational device within 30 days of the first dose of study drug Expected to require any other form of systemic or localized antineoplastic therapy while on study Chronic systemic steroid therapy within 2 weeks before the planned date for first dose randomized treatment or on any other form of immunosuppressive medication Known history of any other than the current malignancy excepting adequately treated basal or squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, breast cancer, or other in situ cancers Known active central nervous system (CNS) metastases and/or carcinomatous meningitis Active autoimmune disease or a history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents Prior treatment with any other anti-programmed cell death (PD) agent Active infection requiring systemic therapy Known history of Human Immunodeficiency Virus (HIV) Active Hepatitis B or Hepatitis C Regular user (including recreational use of) illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol) Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study through 120 days after last dose of study drug

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

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Links:

URL

http://merckoncologyclinicaltrials.com

Description

Merck Oncology Clinical Trials Information

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Study of Pembrolizumab (MK-3475) Versus Chemotherapy in Participants With Advanced Melanoma (MK-3475-002/P08719/KEYNOTE-002)

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