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Program for Pembrolizumab (MK-3475) in Participants With Metastatic Melanoma Who Have Failed Standard of Care Therapy Including Ipilimumab (MK-3475-030)

Primary Purpose

Melanoma

Status

No longer available

Phase

Locations

Study Type

Expanded Access

Intervention

Pembrolizumab

About this trial

This is an expanded access trial for Melanoma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All Sexes

Inclusion criteria:

Unresectable (Stage III) or metastatic melanoma
Failed or progressed on standard of care systemic therapy including ipilimumab (with the exception of a participant with progressive disease while on the ipilimumab arm of MK-3475-006, regardless of prior treatment with a BRAF/MEK inhibitor, as long as all other eligibility criteria for this study are met)
Willing to sign Informed Consent
Eastern Cooperative Oncology Group Performance status of 0 or 1
Female participants of childbearing potential must be willing to use adequate contraception or be surgically sterile, or abstain from heterosexual activity starting with the first dose of treatment through at least 120 days after the last dose of pembrolizumab
Male participants must agree to use an adequate method of contraception starting with the first dose of treatment through 120 days after the last dose of pembrolizumab
Adequate organ function

Exclusion criteria:

Eligible for an accessible pembrolizumab clinical study or previously participated in a pembrolizumab clinical study (with the exception of a participant with progressive disease while on the ipilimumab arm of MK-3475-006)
Eligible for treatment with a marketed BRAF inhibitor or MEK inhibitor (with the exception of a participant with progressive disease while on the ipilimumab arm of MK-3475-006, regardless of prior treatment with a BRAF/MEK inhibitor, as long as all other eligibility criteria for this study are met)
Not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better due to prior chemotherapy, radioactive, or biological cancer therapy (including monoclonal antibodies)
Not recovered from minor or major surgery and less than 4 weeks from major surgery
History of life-threatening or severe immune-related adverse events on treatment with another immunotherapy
Expected to require any other form of systemic antineoplastic therapy while receiving pembrolizumab
History of clinically severe autoimmune disease (e.g., requires chronic immunosuppressive therapy)
History of pneumonitis, organ transplant, human immunodeficiency virus (HIV), active hepatitis B or hepatitis C
Active central nervous system metastases, carcinomatous meningitis, untreated brain metastases
Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of treatment with pembrolizumab
Active infection requiring systemic therapy

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT02083484

First Posted

March 7, 2014

Last Updated

January 25, 2018

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT02083484

Brief Title

Program for Pembrolizumab (MK-3475) in Participants With Metastatic Melanoma Who Have Failed Standard of Care Therapy Including Ipilimumab (MK-3475-030)

Official Title

Expanded Access of MK-3475 in Metastatic Melanoma Patients With Limited to No Treatment Options

Study Type

Expanded Access

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

No longer available

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

Brief Summary

This is an expanded access program (EAP) for participants who have progressed after prior systemic therapy including ipilimumab, and V-raf murine sarcoma viral oncogene homolog B1 (BRAF) inhibitor or mitogen-activated protein kinase (MEK) enzyme inhibitor when indicated. Participants cannot be eligible for or have participated in any pembrolizumab (MK-3475) clinical trial with the exception of a participant enrolled in the pembrolizumab protocol MK-3475-006 who received treatment on the ipilimumab treatment arm and progressed; such participants will be eligible to participate in the EAP, regardless of prior treatment with a BRAF/MEK inhibitor, as long as all other eligibility criteria for MK-3475-030 are met.

Detailed Description

Pembrolizumab has been approved by the U.S. Food and Drug Administration for the treatment of patients with unresectable metastatic melanoma and disease progression following ipilimumab and if BRAF V600 mutation positive, a BRAF inhibitor. The Expanded Access Program (EAP) for this medicine in the U.S. is closed. The EAP will continue outside the U.S.

6. Conditions and Keywords

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

Melanoma

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

Pembrolizumab

Intervention Description

Each participant will receive pembrolizumab every 3 weeks for up to 2 years or until confirmed radiographic disease progression, unacceptable toxicity, confirmed positive pregnancy test, withdrawal of consent, or pembrolizumab approval in the participant's country.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Eligibility Criteria

Inclusion criteria: Unresectable (Stage III) or metastatic melanoma Failed or progressed on standard of care systemic therapy including ipilimumab (with the exception of a participant with progressive disease while on the ipilimumab arm of MK-3475-006, regardless of prior treatment with a BRAF/MEK inhibitor, as long as all other eligibility criteria for this study are met) Willing to sign Informed Consent Eastern Cooperative Oncology Group Performance status of 0 or 1 Female participants of childbearing potential must be willing to use adequate contraception or be surgically sterile, or abstain from heterosexual activity starting with the first dose of treatment through at least 120 days after the last dose of pembrolizumab Male participants must agree to use an adequate method of contraception starting with the first dose of treatment through 120 days after the last dose of pembrolizumab Adequate organ function Exclusion criteria: Eligible for an accessible pembrolizumab clinical study or previously participated in a pembrolizumab clinical study (with the exception of a participant with progressive disease while on the ipilimumab arm of MK-3475-006) Eligible for treatment with a marketed BRAF inhibitor or MEK inhibitor (with the exception of a participant with progressive disease while on the ipilimumab arm of MK-3475-006, regardless of prior treatment with a BRAF/MEK inhibitor, as long as all other eligibility criteria for this study are met) Not recovered to Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or better due to prior chemotherapy, radioactive, or biological cancer therapy (including monoclonal antibodies) Not recovered from minor or major surgery and less than 4 weeks from major surgery History of life-threatening or severe immune-related adverse events on treatment with another immunotherapy Expected to require any other form of systemic antineoplastic therapy while receiving pembrolizumab History of clinically severe autoimmune disease (e.g., requires chronic immunosuppressive therapy) History of pneumonitis, organ transplant, human immunodeficiency virus (HIV), active hepatitis B or hepatitis C Active central nervous system metastases, carcinomatous meningitis, untreated brain metastases Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of treatment with pembrolizumab Active infection requiring systemic therapy

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

Citations:

PubMed Identifier

26848796

Citation

Kottschade LA, McWilliams RR, Markovic SN, Block MS, Villasboas Bisneto J, Pham AQ, Esplin BL, Dronca RS. The use of pembrolizumab for the treatment of metastatic uveal melanoma. Melanoma Res. 2016 Jun;26(3):300-3. doi: 10.1097/CMR.0000000000000242.

Results Reference

result

PubMed Identifier

26951629

Citation

Bender C, Dimitrakopoulou-Strauss A, Enk A, Hassel JC. Safety of the PD-1 antibody pembrolizumab in patients with high-grade adverse events under ipilimumab treatment. Ann Oncol. 2016 Jul;27(7):1353-4. doi: 10.1093/annonc/mdw128. Epub 2016 Mar 6. No abstract available.

Results Reference

result

PubMed Identifier

29028788

Citation

Gangadhar TC, Hwu WJ, Postow MA, Hamid O, Daud A, Dronca R, Joseph R, O'Day SJ, Hodi FS, Pavlick AC, Kluger H, Oxborough RP, Yang A, Gazdoiu M, Kush DA, Ebbinghaus S, Salama AKS. Efficacy and Safety of Pembrolizumab in Patients Enrolled in KEYNOTE-030 in the United States: An Expanded Access Program. J Immunother. 2017 Nov/Dec;40(9):334-340. doi: 10.1097/CJI.0000000000000186.

Results Reference

result

Learn more about this trial

Program for Pembrolizumab (MK-3475) in Participants With Metastatic Melanoma Who Have Failed Standard of Care Therapy Including Ipilimumab (MK-3475-030)

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