Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)

Conditions

• Hematologic Malignancies
• Solid Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pembrolizumab — DRUG
  200 or 400 mg IV infusion
• Standard of Care (SOC) — DRUG
  IV infusion or oral tablets
• Lenvatinib — DRUG
  Oral capsules
• Olaparib — DRUG
  300mg or 250mg or 100mg oral tablers
• MK-4280 — DRUG
  IV Infusion
• MK-4280A — BIOLOGICAL
  800mg favezelimab + 200mg pembrolizumab IV Infusion
• Pembrolizumab (+) Berahyaluronidase alfa — BIOLOGICAL
  395 mg or 790 mg SC administration

Study Details

The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment. Any participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.

Key Dates

Start date

Aug 21, 2018

Status verified

Jun 2026

Primary completion

Aug 4, 2043

Completion

Aug 4, 2043

Study Design

Enrollment

3,500 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Pembrolizumab 200 mg
  Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations or more for First Course participants and up to 17 administrations for Second Course participants.
• Experimental: Pembrolizumab 400 mg
  Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 17 administrations or more for First Course participants and up to 8 administrations for Second Course participants.
• Experimental: Pembrolizumab 200 mg + SOC: Per Parent Study)
  Participants receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle PLUS standard of care (SOC) treatment (or per parent study if there is no SOC) for up to 35 administrations or more for First Course participants and up to 17 administrations for Second Course participants. Participants receiving a pembrolizumab-based combination treatment will receive the dose regimen of the combination drug(s) which is recommended per SOC or was used in the parent study protocol if there is no SOC recommendation.
• Experimental: Pembrolizumab 400 mg + SOC (Per Parent Study)
  Participants receive pembrolizumab 400 mg via IV infusion on Day 1 of each 6-week cycle PLUS SOC treatment (or per parent study if there is no SOC) for up to 17 administrations or more for First Course participants and up to 8 administrations for Second Course participants. Participants receiving a pembrolizumab-based combination treatment will receive the dose regimen of the combination drug(s) which is recommended per SOC or was used in the parent study protocol if there is no SOC recommendation.
• Active Comparator: SOC (Per Parent Study)
  Participants receive the dose matched non-pembrolizumab SOC treatment (e.g. chemotherapy) they were receiving as per parent study protocol.
• Experimental: Lenvatinib 20 mg
  Participants with body weight (BW)\>60kg receive Lenvatinib 20mg orally once daily on a 21 or 42 day cycle. It is taken 0-4 hours after completion of pembrolizumabd administration in the clinic on cycle 1 day 1(C1D1), C2D1, C3D1, etc. Taken at home on all other days.
• Experimental: Lenvatinib 24 mg
  Participants with body weight (BW)\>60 kg receive Lenvatinib 24 mg orally once daily on a 21 or 42 day cycle. It is taken 0-4 hours after completion of pembrolizumabd administration in the clinic on cycle 1 day 1(C1D1), C2D1, C3D1, etc. Taken at home on all other days.
• Experimental: Lenvatinib 12 mg
  Participants with body weight (BW)\>60 kg receive Lenvatinib 12 mg orally once daily on a 21 or 42 day cycle. It is taken 0-4 hours after completion of pembrolizumabd administration in the clinic on cycle 1 day 1(C1D1), C2D1, C3D1, etc. Taken at home on all other days.
• Experimental: Lenvatinib 8 mg
  Participants with body weight (BW)\<60 kg receive Lenvatinib 8 mg orally once daily on a 21 or 42 day cycle. It is taken 0-4 hours after completion of pembrolizumabd administration in the clinic on cycle 1 day 1(C1D1), C2D1, C3D1, etc. Taken at home on all other days.
• Experimental: Lenvatinib 2mg
  Participants with body weight (BW)\<60 kg receive Lenvatinib 2 mg orally once daily on a 21 or 42 day cycle. It is taken 0-4 hours after completion of pembrolizumab administration in the clinic on cycle 1 day 1(C1D1), C2D1, C3D1, etc. Taken at home on all other days.
• Experimental: Olaparib 300mg
  Participants receive Olaparib 300 mg orally twice daily (BID) until disease progression or toxicity prohibits its administration.
• Experimental: Olaparib 250mg
  Participants receive Olaparib 250 mg orally twice daily (BID) until disease progression or toxicity prohibits its administration.
• Experimental: Olaparib 100mg
  Participants receive Olaparib 100 mg orally twice daily (BID) until disease progression or toxicity prohibits its administration.
• Experimental: MK-4280 800mg
  Participants receive MK-4280 800mg as IV infusion every 3 weeks (Q3W) and may continue study therapy until study treatment completion or may transition to pembrolizumab to complete their treatment.
• Experimental: MK-4280A
  Participants receive MK-4280A (800mg favezelimab + 200mg pembrolizumab) as IV infusion every 3 weeks (Q3W) and may continue study therapy until study treatment completion or may transition to pembrolizumab to complete their treatment.
• Experimental: Pembrolizumab (+) Berahyaluronidase alfa 395 mg
  Participants receive 395 mg of a fixed-dose formulation of pembrolizumab and berahyaluronidase alfa via subcutaneous (SC) administration on Day 1 of each 3-week cycle for up to 35 administrations.
• Experimental: Pembrolizumab (+) Berahyaluronidase alfa 790 mg
  Participants receive 790 mg of a fixed-dose formulation of pembrolizumab and berahyaluronidase alfa via SC administration on Day 1 of each 6-week cycle for up to 35 administrations.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to approximately 10 years ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (65)

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